Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

PubMed

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

Laser micromachining of biofactory-on-a-chip devices

NASA Astrophysics Data System (ADS)

Burt, Julian P.; Goater, Andrew D.; Hayden, Christopher J.; Tame, John A.

2002-06-01

Excimer laser micromachining provides a flexible means for the manufacture and rapid prototyping of miniaturized systems such as Biofactory-on-a-Chip devices. Biofactories are miniaturized diagnostic devices capable of characterizing, manipulating, separating and sorting suspension of particles such as biological cells. Such systems operate by exploiting the electrical properties of microparticles and controlling particle movement in AC non- uniform stationary and moving electric fields. Applications of Biofactory devices are diverse and include, among others, the healthcare, pharmaceutical, chemical processing, environmental monitoring and food diagnostic markets. To achieve such characterization and separation, Biofactory devices employ laboratory-on-a-chip type components such as complex multilayer microelectrode arrays, microfluidic channels, manifold systems and on-chip detection systems. Here we discuss the manufacturing requirements of Biofactory devices and describe the use of different excimer laser micromachined methods both in stand-alone processes and also in conjunction with conventional fabrication processes such as photolithography and thermal molding. Particular attention is given to the production of large area multilayer microelectrode arrays and the manufacture of complex cross-section microfluidic channel systems for use in simple distribution and device interfacing.

All-inkjet-printed thin-film transistors: manufacturing process reliability by root cause analysis

PubMed Central

Sowade, Enrico; Ramon, Eloi; Mitra, Kalyan Yoti; Martínez-Domingo, Carme; Pedró, Marta; Pallarès, Jofre; Loffredo, Fausta; Villani, Fulvia; Gomes, Henrique L.; Terés, Lluís; Baumann, Reinhard R.

2016-01-01

We report on the detailed electrical investigation of all-inkjet-printed thin-film transistor (TFT) arrays focusing on TFT failures and their origins. The TFT arrays were manufactured on flexible polymer substrates in ambient condition without the need for cleanroom environment or inert atmosphere and at a maximum temperature of 150 °C. Alternative manufacturing processes for electronic devices such as inkjet printing suffer from lower accuracy compared to traditional microelectronic manufacturing methods. Furthermore, usually printing methods do not allow the manufacturing of electronic devices with high yield (high number of functional devices). In general, the manufacturing yield is much lower compared to the established conventional manufacturing methods based on lithography. Thus, the focus of this contribution is set on a comprehensive analysis of defective TFTs printed by inkjet technology. Based on root cause analysis, we present the defects by developing failure categories and discuss the reasons for the defects. This procedure identifies failure origins and allows the optimization of the manufacturing resulting finally to a yield improvement. PMID:27649784

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

Manufacturing process and material selection in concurrent collaborative design of MEMS devices

NASA Astrophysics Data System (ADS)

Zha, Xuan F.; Du, H.

2003-09-01

In this paper we present knowledge of an intensive approach and system for selecting suitable manufacturing processes and materials for microelectromechanical systems (MEMS) devices in concurrent collaborative design environment. In the paper, fundamental issues on MEMS manufacturing process and material selection such as concurrent design framework, manufacturing process and material hierarchies, and selection strategy are first addressed. Then, a fuzzy decision support scheme for a multi-criteria decision-making problem is proposed for estimating, ranking and selecting possible manufacturing processes, materials and their combinations. A Web-based prototype advisory system for the MEMS manufacturing process and material selection, WebMEMS-MASS, is developed based on the client-knowledge server architecture and framework to help the designer find good processes and materials for MEMS devices. The system, as one of the important parts of an advanced simulation and modeling tool for MEMS design, is a concept level process and material selection tool, which can be used as a standalone application or a Java applet via the Web. The running sessions of the system are inter-linked with webpages of tutorials and reference pages to explain the facets, fabrication processes and material choices, and calculations and reasoning in selection are performed using process capability and material property data from a remote Web-based database and interactive knowledge base that can be maintained and updated via the Internet. The use of the developed system including operation scenario, use support, and integration with an MEMS collaborative design system is presented. Finally, an illustration example is provided.

Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials.

PubMed

Zadpoor, Amir A

2017-07-25

Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials

PubMed Central

Zadpoor, Amir A.

2017-01-01

Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes. PMID:28757572

High-Volume Production of Lightweight Multijunction Solar Cells

NASA Technical Reports Server (NTRS)

Youtsey, Christopher

2015-01-01

MicroLink Devices, Inc., has transitioned its 6-inch epitaxial lift-off (ELO) solar cell fabrication process into a manufacturing platform capable of sustaining large-volume production. This Phase II project improves the ELO process by reducing cycle time and increasing the yield of large-area devices. In addition, all critical device fabrication processes have transitioned to 6-inch production tool sets designed for volume production. An emphasis on automated cassette-to-cassette and batch processes minimizes operator dependence and cell performance variability. MicroLink Devices established a pilot production line capable of at least 1,500 6-inch wafers per month at greater than 80 percent yield. The company also increased the yield and manufacturability of the 6-inch reclaim process, which is crucial to reducing the cost of the cells.

78 FR 34156 - Hazardous Materials: Emergency Recall Order

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... unilateral changes to its manufacturing process, quality control oversight, and cylinder designs without... never functioned as designed, and indicated that the shutdown device had not stopped the manufacturing... 33-pound cylinders. Jurisdiction Lite Cylinder manufactures or has manufactured, marked, certified...

The 1995 Medical Device Technology raw materials survey.

PubMed

Pearson, L S

1995-09-01

Using information supplied by manufacturers, this article reports on the use of raw materials and compounding and conversion practices in the European medical device manufacturing industry. The findings of the survey provide an indication of which materials are being used and how frequently, and the process of selecting suppliers.

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY.

PubMed

Dutot, Camille; Mercier, Grégoire; Borget, Isabelle; de Sauvebeuf, Côme; Martelli, Nicolas

2017-01-01

Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers' insights into Hb-HTA processes. A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers' market access strategies was administered. Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity. Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

New orthopedic devices and the FDA.

PubMed

Sheth, Ujash; Nguyen, Nhu-An; Gaines, Sean; Bhandari, Mohit; Mehlman, Charles T; Klein, Guy

2009-01-01

Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U.S. Food and Drug Administration (FDA). Among the regulatory pathways available, the 510(k) premarket notification is by far the one most commonly used. The 510(k) premarket notification allows the manufacturer to receive prompt approval of their device by demonstrating that it is "substantially equivalent" to an existing legally marketed device. In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.

21 CFR 807.35 - Notification of registrant.

Code of Federal Regulations, 2014 CFR

2014-04-01

... manufacture or process biological products (including devices licensed under section 351 of the Public Health... device activities described in § 807.20, validation of registration and the assignment of a device...

21 CFR 807.35 - Notification of registrant.

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacture or process biological products (including devices licensed under section 351 of the Public Health... device activities described in § 807.20, validation of registration and the assignment of a device...

Method of forming crystalline silicon devices on glass

DOEpatents

McCarthy, Anthony M.

1995-01-01

A method for fabricating single-crystal silicon microelectronic components on a silicon substrate and transferring same to a glass substrate. This is achieved by utilizing conventional silicon processing techniques for fabricating components of electronic circuits and devices on bulk silicon, wherein a bulk silicon surface is prepared with epitaxial layers prior to the conventional processing. The silicon substrate is bonded to a glass substrate and the bulk silicon is removed leaving the components intact on the glass substrate surface. Subsequent standard processing completes the device and circuit manufacturing. This invention is useful in applications requiring a transparent or insulating substrate, particularly for display manufacturing. Other applications include sensors, actuators, optoelectronics, radiation hard electronics, and high temperature electronics.

Reticle variation influence on manufacturing line and wafer device performance

NASA Astrophysics Data System (ADS)

Nistler, John L.; Spurlock, Kyle

1994-01-01

Cost effective manufacturing of devices at 0.5, 0.35 and 0.25μm geometries will be highly dependent on a companys' ability to obtain an economic return on investment. The high capital investment in equipment and facilities, not to mention the related chemical and wafer costs, for producing 200mm silicon wafers requires aspects of wafer processing to be tightly controlled. Reduction in errors and enhanced yield management requires early correction or avoidance of reticle problems. It is becoming increasingly important to recognize and track all pertinent factors impacting both the technical and financial viability of a wafer manufacturing fabrication area. Reticle related effects on wafer manufacturing can be costly and affect the total quality perceived by the device customer.

21 CFR 807.35 - Notification of registrant.

Code of Federal Regulations, 2012 CFR

2012-04-01

... regulations. (b) Owners and operators of device establishments who also manufacture or process blood or drug... and device listing are required to engage in the device activities described in § 807.20, validation...

Problems caused by regulatory delays and lack of regulation

NASA Astrophysics Data System (ADS)

Reamer, Lynne A.

1994-12-01

An FDA perspective on some of the problems encountered during the device review process is described. Emphasis is placed on the need for communication and teamwork among all parties to make the system work. Manufacturers are encouraged to `Do it right the first time.' Pertinent questions are asked of the manufacturers and proposed solutions are presented. Day to day reality at FDA is described and document workload is revealed. Lack of regulation, or more appropriately, when less regulation is appropriate is discussed. FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device. This and other mechanisms are in place at the FDA to streamline the review process. Manufacturers are cautioned about their decisions and to seek advice from qualified persons. FDA emphasizes that help is available and that when in doubt, call.

Manufacturing of embedded multimode waveguides by reactive lamination of cyclic olefin polymer and polymethylmethacrylate

NASA Astrophysics Data System (ADS)

Kelb, Christian; Rother, Raimund; Schuler, Anne-Katrin; Hinkelmann, Moritz; Rahlves, Maik; Prucker, Oswald; Müller, Claas; Rühe, Jürgen; Reithmeier, Eduard; Roth, Bernhard

2016-03-01

We demonstrate the manufacturing of embedded multimode optical waveguides through linking of polymethylmethacrylate (PMMA) foils and cyclic olefin polymer (COP) filaments based on a lamination process. Since the two polymeric materials cannot be fused together through interdiffusion of polymer chains, we utilize a reactive lamination agent based on PMMA copolymers containing photoreactive 2-acryloyloxyanthraquinone units, which allows the creation of monolithic PMMA-COP substrates through C-H insertion reactions across the interface between the two materials. We elucidate the lamination process and evaluate the chemical link between filament and foils by carrying out extraction tests with a custom-built tensile testing machine. We also show attenuation measurements of the manufactured waveguides for different manufacturing parameters. The lamination process is in particular suited for large-scale and low-cost fabrication of board-level devices with optical waveguides or other micro-optical structures, e.g., optofluidic devices.

Manufacture of micro fluidic devices by laser welding using thermal transfer printing techniques

NASA Astrophysics Data System (ADS)

Klein, R.; Klein, K. F.; Tobisch, T.; Thoelken, D.; Belz, M.

2016-03-01

Micro-fluidic devices are widely used today in the areas of medical diagnostics and drug research, as well as for applications within the process, electronics and chemical industry. Microliters of fluids or single cell to cell interactions can be conveniently analyzed with such devices using fluorescence imaging, phase contrast microscopy or spectroscopic techniques. Typical micro-fluidic devices consist of a thermoplastic base component with chambers and channels covered by a hermetic fluid and gas tight sealed lid component. Both components are usually from the same or similar thermoplastic material. Different mechanical, adhesive or thermal joining processes can be used to assemble base component and lid. Today, laser beam welding shows the potential to become a novel manufacturing opportunity for midsize and large scale production of micro-fluidic devices resulting in excellent processing quality by localized heat input and low thermal stress to the device during processing. For laser welding, optical absorption of the resin and laser wavelength has to be matched for proper joining. This paper will focus on a new approach to prepare micro-fluidic channels in such devices using a thermal transfer printing process, where an optical absorbing layer absorbs the laser energy. Advantages of this process will be discussed in combination with laser welding of optical transparent micro-fluidic devices.

Materials, Processes, and Facile Manufacturing for Bioresorbable Electronics: A Review.

PubMed

Yu, Xiaowei; Shou, Wan; Mahajan, Bikram K; Huang, Xian; Pan, Heng

2018-05-07

Bioresorbable electronics refer to a new class of advanced electronics that can completely dissolve or disintegrate with environmentally and biologically benign byproducts in water and biofluids. They have provided a solution to the growing electronic waste problem with applications in temporary usage of electronics such as implantable devices and environmental sensors. Bioresorbable materials such as biodegradable polymers, dissolvable conductors, semiconductors, and dielectrics are extensively studied, enabling massive progress of bioresorbable electronic devices. Processing and patterning of these materials are predominantly relying on vacuum-based fabrication methods so far. However, for the purpose of commercialization, nonvacuum, low-cost, and facile manufacturing/printing approaches are the need of the hour. Bioresorbable electronic materials are generally more chemically reactive than conventional electronic materials, which require particular attention in developing the low-cost manufacturing processes in ambient environment. This review focuses on material reactivity, ink availability, printability, and process compatibility for facile manufacturing of bioresorbable electronics. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A hybrid life cycle inventory of nano-scale semiconductor manufacturing.

PubMed

Krishnan, Nikhil; Boyd, Sarah; Somani, Ajay; Raoux, Sebastien; Clark, Daniel; Dornfeld, David

2008-04-15

The manufacturing of modern semiconductor devices involves a complex set of nanoscale fabrication processes that are energy and resource intensive, and generate significant waste. It is important to understand and reduce the environmental impacts of semiconductor manufacturing because these devices are ubiquitous components in electronics. Furthermore, the fabrication processes used in the semiconductor industry are finding increasing application in other products, such as microelectromechanical systems (MEMS), flat panel displays, and photovoltaics. In this work we develop a library of typical gate-to-gate materials and energy requirements, as well as emissions associated with a complete set of fabrication process models used in manufacturing a modern microprocessor. In addition, we evaluate upstream energy requirements associated with chemicals and materials using both existing process life cycle assessment (LCA) databases and an economic input-output (EIO) model. The result is a comprehensive data set and methodology that may be used to estimate and improve the environmental performance of a broad range of electronics and other emerging applications that involve nano and micro fabrication.

Solid state laser applications in photovoltaics manufacturing

NASA Astrophysics Data System (ADS)

Dunsky, Corey; Colville, Finlay

2008-02-01

Photovoltaic energy conversion devices are on a rapidly accelerating growth path driven by increasing government and societal pressure to use renewable energy as part of an overall strategy to address global warming attributed to greenhouse gas emissions. Initially supported in several countries by generous tax subsidies, solar cell manufacturers are relentlessly pushing the performance/cost ratio of these devices in a quest to reach true cost parity with grid electricity. Clearly this eventual goal will result in further acceleration in the overall market growth. Silicon wafer based solar cells are currently the mainstay of solar end-user installations with a cost up to three times grid electricity. But next-generation technology in the form of thin-film devices promises streamlined, high-volume manufacturing and greatly reduced silicon consumption, resulting in dramatically lower per unit fabrication costs. Notwithstanding the modest conversion efficiency of thin-film devices compared to wafered silicon products (around 6-10% versus 15-20%), this cost reduction is driving existing and start-up solar manufacturers to switch to thin-film production. A key aspect of these devices is patterning large panels to create a monolithic array of series-interconnected cells to form a low current, high voltage module. This patterning is accomplished in three critical scribing processes called P1, P2, and P3. Lasers are the technology of choice for these processes, delivering the desired combination of high throughput and narrow, clean scribes. This paper examines these processes and discusses the optimization of industrial lasers to meet their specific needs.

Limiting factors in the production of deep microstructures

NASA Astrophysics Data System (ADS)

Tolfree, David W. L.; O'Neill, William; Tunna, Leslie; Sutcliffe, Christopher

1999-10-01

Microsystems increasingly require precision deep microstructures that can be cost-effectively designed and manufactured. New products must be able to meet the demands of the rapidly growing markets for microfluidic, micro- optical and micromechanical devices in industrial sectors which include chemicals, pharmaceuticals, biosciences, medicine and food. The realization of such products, first requires an effective process to design and manufacture prototypes. Two process methods used for the fabrication of high aspect-ratio microstructures are based on X-ray beam lithography with electroforming processes and direct micromachining with a frequency multiplied Nd:YAG laser using nanosecond pulse widths. Factors which limit the efficiency and precision obtainable using such processes are important parameters when deciding on the best fabrication method to use. A basic microstructure with narrow channels suitable for a microfluidic mixer have been fabricated using both these techniques and comparisons made of the limitations and suitability of the processes in respect of fast prototyping and manufacture or working devices.

Text analysis devices, articles of manufacture, and text analysis methods

DOEpatents

Turner, Alan E; Hetzler, Elizabeth G; Nakamura, Grant C

2013-05-28

Text analysis devices, articles of manufacture, and text analysis methods are described according to some aspects. In one aspect, a text analysis device includes processing circuitry configured to analyze initial text to generate a measurement basis usable in analysis of subsequent text, wherein the measurement basis comprises a plurality of measurement features from the initial text, a plurality of dimension anchors from the initial text and a plurality of associations of the measurement features with the dimension anchors, and wherein the processing circuitry is configured to access a viewpoint indicative of a perspective of interest of a user with respect to the analysis of the subsequent text, and wherein the processing circuitry is configured to use the viewpoint to generate the measurement basis.

Method of forming crystalline silicon devices on glass

DOEpatents

McCarthy, A.M.

1995-03-21

A method is disclosed for fabricating single-crystal silicon microelectronic components on a silicon substrate and transferring same to a glass substrate. This is achieved by utilizing conventional silicon processing techniques for fabricating components of electronic circuits and devices on bulk silicon, wherein a bulk silicon surface is prepared with epitaxial layers prior to the conventional processing. The silicon substrate is bonded to a glass substrate and the bulk silicon is removed leaving the components intact on the glass substrate surface. Subsequent standard processing completes the device and circuit manufacturing. This invention is useful in applications requiring a transparent or insulating substrate, particularly for display manufacturing. Other applications include sensors, actuators, optoelectronics, radiation hard electronics, and high temperature electronics. 7 figures.

MATERIALS DEGRADATION ANALYSIS AND DEVELOPMENT TO ENABLE ULTRA LOW COST, WEB-PROCESSED WHITE P-OLED FOR SSL

DOE Office of Scientific and Technical Information (OSTI.GOV)

DR. DEVIN MACKENZIE

2011-12-13

Progress over Phase II of DE-FG02-07ER86293 'Materials Degradation Analysis and Development to Enable Ultra Low Cost, Web-Processed White P-OLED for SSL' was initially rapid in terms of device performance improvements. We exceeded our device luminance lifetime goals for printed flexible white OLEDs as laid out in our project proposal. Our Phase II performance target was to demonstrate >1500 hours luminance lifetime at 100 Cd/m2 from a printed flexible device. We now have R&D devices well in excess of 8000 hrs lifetime at 100 Cd/m2, tested in air. We also were able to produce devices which met the voltage target ofmore » >1500 hours below 15V operation. After completing the initial performance milestones, we went on to focus on color-related degradation issues which were cited as important to commercialization of the technology by our manufacturing partners. We also put additional focus on cathode work as the active material development that occurred over the STTR time period required an adaptation of the cathode from the original cathode formulations which were developed based on previous generation active layer materials. We were able to improve compatibility of the cathode with some of the newer generation active layer materials and improve device yield and voltage behavior. An additional objective of the initial Phase II was to further develop the underlying manufacturing technology and real-life product specifications. This is a key requirement that must be met to ensure eventual commercialization of this DOE-funded technology. The link between commercial investment for full commercialization and R&D efforts in OLED solid State Lighting is often a large one. Add-Vision's lower cost, printed OLED manufacturing approach is an attraction, but close engagement with manufacturing partners and addressing customer specifications is a very important link. Manufacturing technology encompasses development of moisture reduction encapsulation technology, improved cost performance, and reductions in operating voltage through thinner and higher uniformity active device layers. We have now installed a pilot encapsulation system at AVI for controlled, high throughput lamination encapsulation of flexible OLEDs in a novel process. Along with this, we have developed, with our materials supply partners, adhesives, barrier films and other encapsulation materials and we are showing total air product lifetimes in the 2-4 years range from a process consistent with our throughput goals of {approx}1M device per month ({approx}30,000 sq. ft. of processed OLEDs). Within the last year of the project, we have been working to introduce the manufacturing improvements made in our LEP deposition and annealing process to our commercial partners. Based on the success of this, a pilot scale-up program was begun. During this process, Add-Vision was acquired by a strategic partner, in no small part, because of the promise of future success of the technology as evidenced by our commercial partners pilot scale-up plans. Overall, the performance, manufacturing and product work in this project has been successful. Additional analysis and device work at LBL has also shown a unique adhesion change with device bias stressing which may result from active layer polymer cross-linking during bias stressing of device. It was shown that even small bias stresses, as a fraction of a full device lifetime stress period, result in measurable chemical change in the device. Further work needs to be conducted to fully understand the chemical nature of this interaction. Elucidation of this effect would enable doped OLED formulation to be engineered to suppress this effect and further extend lifetimes and reduce voltage climb.« less

33 CFR 159.121 - Sewage processing test.

Code of Federal Regulations, 2010 CFR

2010-07-01

... crevices that could come in contact with a person using the device or servicing the device in accordance..., the device must be tilted to the maximum angles specified by the manufacturer under §§ 159.55 and 159...

78 FR 4418 - Electronic Submission Process for Requesting Export Certificates From the Center for Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... (CDRH). The electronic process will help fulfill both the legislative and application time processing... Devices and Radiological Health (CDRH), Division of Small Manufacturers, International and Consumer... regulated by CDRH as a voluntary alternative to paper submissions. With electronic submissions, CDRH can...

Improving the postmarket surveillance of total joint arthroplasty devices.

PubMed

Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H

2008-01-01

To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.

Design and high-volume manufacture of low-cost molded IR aspheres for personal thermal imaging devices

NASA Astrophysics Data System (ADS)

Zelazny, A. L.; Walsh, K. F.; Deegan, J. P.; Bundschuh, B.; Patton, E. K.

2015-05-01

The demand for infrared optical elements, particularly those made of chalcogenide materials, is rapidly increasing as thermal imaging becomes affordable to the consumer. The use of these materials in conjunction with established lens manufacturing techniques presents unique challenges relative to the cost sensitive nature of this new market. We explore the process from design to manufacture, and discuss the technical challenges involved. Additionally, facets of the development process including manufacturing logistics, packaging, supply chain management, and qualification are discussed.

Design and fabrication of conductive polyaniline transducers via computer controlled direct ink writing

NASA Astrophysics Data System (ADS)

Holness, F. Benjamin; Price, Aaron D.

2017-04-01

The intractable nature of the conjugated polymer (CP) polyaniline (PANI) has largely limited PANI-based transducers to monolithic geometries derived from thin-film deposition techniques. To address this limitation, we have previously reported additive manufacturing processes for the direct ink writing of three-dimensional electroactive PANI structures. This technology incorporates a modified delta robot having an integrated polymer paste extrusion system in conjunction with a counter-ion induced thermal doping process to achieve these 3D structures. In this study, we employ an improved embodiment of this methodology for the fabrication of functional PANI devices with increasingly complex geometries and enhanced electroactive functionality. Advances in manufacturing capabilities achieved through the integration of a precision pneumatic fluid dispenser and redesigned high-pressure end-effector enable extrusion of viscous polymer formulations, improving the realizable resolutions of features and deposition layers. The integration of a multi-material dual-extrusion end-effector has further aided the fabrication of these devices, enabling the concurrent assembly of passive and active structures, which reduces the limitations on device geometry. Subsequent characterization of these devices elucidates the relationships between polymer formulation, process parameters, and device design such that electromechanical properties can be tuned according to application requirements. This methodology ultimately leads to the improved manufacturing of electroactive polymer-enabled devices with high-resolution 3D features and enhanced electroactive performance.

Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

PubMed Central

Morrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.

2015-01-01

Abstract Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device. PMID:26243449

Surface modification of biomaterials and biomedical devices using additive manufacturing.

PubMed

Bose, Susmita; Robertson, Samuel Ford; Bandyopadhyay, Amit

2018-01-15

The demand for synthetic biomaterials in medical devices, pharmaceutical products and, tissue replacement applications are growing steadily due to aging population worldwide. The use for patient matched devices is also increasing due to availability and integration of new technologies. Applications of additive manufacturing (AM) or 3D printing (3DP) in biomaterials have also increased significantly over the past decade towards traditional as well as innovative next generation Class I, II and III devices. In this review, we have focused our attention towards the use of AM in surface modified biomaterials to enhance their in vitro and in vivo performances. Specifically, we have discussed the use of AM to deliberately modify the surfaces of different classes of biomaterials with spatial specificity in a single manufacturing process as well as commented on the future outlook towards surface modification using AM. It is widely understood that the success of implanted medical devices depends largely on favorable material-tissue interactions. Additive manufacturing has gained traction as a viable and unique approach to engineered biomaterials, for both bulk and surface properties that improve implant outcomes. This review explores how additive manufacturing techniques have been and can be used to augment the surfaces of biomedical devices for direct clinical applications. Copyright © 2017 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Contamination-Free Manufacturing: Tool Component Qualification, Verification and Correlation with Wafers

NASA Astrophysics Data System (ADS)

Tan, Samantha H.; Chen, Ning; Liu, Shi; Wang, Kefei

2003-09-01

As part of the semiconductor industry "contamination-free manufacturing" effort, significant emphasis has been placed on reducing potential sources of contamination from process equipment and process equipment components. Process tools contain process chambers and components that are exposed to the process environment or process chemistry and in some cases are in direct contact with production wafers. Any contamination from these sources must be controlled or eliminated in order to maintain high process yields, device performance, and device reliability. This paper discusses new nondestructive analytical methods for quantitative measurement of the cleanliness of metal, quartz, polysilicon and ceramic components that are used in process equipment tools. The goal of these new procedures is to measure the effectiveness of cleaning procedures and to verify whether a tool component part is sufficiently clean for installation and subsequent routine use in the manufacturing line. These procedures provide a reliable "qualification method" for tool component certification and also provide a routine quality control method for reliable operation of cleaning facilities. Cost advantages to wafer manufacturing include higher yields due to improved process cleanliness and elimination of yield loss and downtime resulting from the installation of "bad" components in process tools. We also discuss a representative example of wafer contamination having been linked to a specific process tool component.

Detecting Nano-Scale Vibrations in Rotating Devices by Using Advanced Computational Methods

PubMed Central

del Toro, Raúl M.; Haber, Rodolfo E.; Schmittdiel, Michael C.

2010-01-01

This paper presents a computational method for detecting vibrations related to eccentricity in ultra precision rotation devices used for nano-scale manufacturing. The vibration is indirectly measured via a frequency domain analysis of the signal from a piezoelectric sensor attached to the stationary component of the rotating device. The algorithm searches for particular harmonic sequences associated with the eccentricity of the device rotation axis. The detected sequence is quantified and serves as input to a regression model that estimates the eccentricity. A case study presents the application of the computational algorithm during precision manufacturing processes. PMID:22399918

Development of a Self Aligned CMOS Process for Flash Lamp Annealed Polycrystalline Silicon TFTs

NASA Astrophysics Data System (ADS)

Bischoff, Paul

The emerging active matrix liquid crystal (AMLCD) display market requires a high performing semiconductor material to meet rising standards of operation. Currently amorphous silicon (a-Si) dominates the market but it does not have the required mobility for it to be used in AMLCD manufacturing. Other materials have been developed including crystallizing a-Si into poly-silicon. A new approach to crystallization through the use of flash lamp annealing (FLA) decreases manufacturing time and greatly improves carrier mobility. Previous work on FLA silicon for the use in CMOS transistors revealed significant lateral dopant diffusion into the channel greatly increasing the minimum channel length required for a working device. This was further confounded by the gate overlap due to misalignment during lithography patterning steps. Through the use of furnace dopant activation instead of FLA dopant activation and a self aligned gate the minimum size transistor can be greatly reduced. A new lithography mask and process flow were developed for the furnace annealing and self aligned gate. Fabrication of the self aligned devices resulted in oxidation of the Molybdenum self aligned gate. Further development is needed to successfully manufacture these devices. Non-self aligned transistors were made simultaneously with self aligned devices and used the furnace activation. These devices showed an increase in sheet resistance from 250 O to 800 O and lower mobility from 380 to 40.2 V/cm2s. The lower mobility can be contributed to an increase in implanted trap density indicating furnace annealing is an inferior activation method over FLA. The minimum transistor size however was reduced from 20 to 5 mum. With improvements in the self aligned process high performing small devices can be manufactured.

Waveguide device and method for making same

DOEpatents

Forman, Michael A [San Francisco, CA

2007-08-14

A monolithic micromachined waveguide device or devices with low-loss, high-power handling, and near-optical frequency ranges is set forth. The waveguide and integrated devices are capable of transmitting near-optical frequencies due to optical-quality sidewall roughness. The device or devices are fabricated in parallel, may be mass produced using a LIGA manufacturing process, and may include a passive component such as a diplexer and/or an active capping layer capable of particularized signal processing of the waveforms propagated by the waveguide.

Additive manufacturing of three-dimensional (3D) microfluidic-based microelectromechanical systems (MEMS) for acoustofluidic applications.

PubMed

Cesewski, Ellen; Haring, Alexander P; Tong, Yuxin; Singh, Manjot; Thakur, Rajan; Laheri, Sahil; Read, Kaitlin A; Powell, Michael D; Oestreich, Kenneth J; Johnson, Blake N

2018-06-13

Three-dimensional (3D) printing now enables the fabrication of 3D structural electronics and microfluidics. Further, conventional subtractive manufacturing processes for microelectromechanical systems (MEMS) relatively limit device structure to two dimensions and require post-processing steps for interface with microfluidics. Thus, the objective of this work is to create an additive manufacturing approach for fabrication of 3D microfluidic-based MEMS devices that enables 3D configurations of electromechanical systems and simultaneous integration of microfluidics. Here, we demonstrate the ability to fabricate microfluidic-based acoustofluidic devices that contain orthogonal out-of-plane piezoelectric sensors and actuators using additive manufacturing. The devices were fabricated using a microextrusion 3D printing system that contained integrated pick-and-place functionality. Additively assembled materials and components included 3D printed epoxy, polydimethylsiloxane (PDMS), silver nanoparticles, and eutectic gallium-indium as well as robotically embedded piezoelectric chips (lead zirconate titanate (PZT)). Electrical impedance spectroscopy and finite element modeling studies showed the embedded PZT chips exhibited multiple resonant modes of varying mode shape over the 0-20 MHz frequency range. Flow visualization studies using neutrally buoyant particles (diameter = 0.8-70 μm) confirmed the 3D printed devices generated bulk acoustic waves (BAWs) capable of size-selective manipulation, trapping, and separation of suspended particles in droplets and microchannels. Flow visualization studies in a continuous flow format showed suspended particles could be moved toward or away from the walls of microfluidic channels based on selective actuation of in-plane or out-of-plane PZT chips. This work suggests additive manufacturing potentially provides new opportunities for the design and fabrication of acoustofluidic and microfluidic devices.

Large-area copper indium diselenide (CIS) process, control and manufacturing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gillespie, T.J.; Lanning, B.R.; Marshall, C.H.

1997-12-31

Lockheed Martin Astronautics (LMA) has developed a large-area (30x30cm) sequential CIS manufacturing approach amenable to low-cost photovoltaics (PV) production. A prototype CIS manufacturing system has been designed and built with compositional uniformity (Cu/In ratio) verified within {+-}4 atomic percent over the 30x30cm area. CIS device efficiencies have been measured by the National Renewable Energy Laboratory (NREL) at 7% on a flexible non-sodium-containing substrate and 10% on a soda-lime-silica (SLS) glass substrate. Critical elements of the manufacturing capability include the CIS sequential process selection, uniform large-area material deposition, and in-situ process control. Details of the process and large-area manufacturing approach aremore » discussed and results presented.« less

Construction of an automated fiber pigtailing machine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Strand, O.T.

1996-01-01

At present, the high cost of optoelectronic (OE) devices is caused in part by the labor-intensive processes involved with packaging. Automating the packaging processes should result in a significant cost reduction. One of the most labor-intensive steps is aligning and attaching the fiber to the OE device, the so-called pigtailing process. Therefore, the goal of this 2-year ARPA-funded project is to design and build 3 low-cost machines to perform sub-micron alignments and attachments of single-mode fibers to different OE devices. These Automated Fiber Pigtailing Machines (AFPMS) are intended to be compatible with a manufacturing environment and have a modular designmore » for standardization of parts and machine vision for maximum flexibility. This work is a collaboration among Uniphase Telecommunications Products (formerly United Technologies Photonics, UTP), Ortel, Newport/Klinger, the Massachusetts Institute of Technology Manufacturing Institute (MIT), and Lawrence Livermore National Laboratory (LLNL). UTP and Ortel are the industrial partners for whom two of the AFPMs are being built. MIT and LLNL make up the design and assembly team of the project, while Newport/Klinger is a potential manufacturer of the AFPM and provides guidance to ensure that the design of the AFPM is marketable and compatible with a manufacturing environment. The AFPM for UTP will pigtail LiNbO{sub 3} waveguide devices and the AFPM for Ortel will pigtail photodiodes. Both of these machines will contain proprietary information, so the third AFPM, to reside at LLNL, will pigtail a non-proprietary waveguide device for demonstrations to US industry.« less

Radiation analysis devices, radiation analysis methods, and articles of manufacture

DOEpatents

Roybal, Lyle Gene

2010-06-08

Radiation analysis devices include circuitry configured to determine respective radiation count data for a plurality of sections of an area of interest and combine the radiation count data of individual of sections to determine whether a selected radioactive material is present in the area of interest. An amount of the radiation count data for an individual section is insufficient to determine whether the selected radioactive material is present in the individual section. An article of manufacture includes media comprising programming configured to cause processing circuitry to perform processing comprising determining one or more correction factors based on a calibration of a radiation analysis device, measuring radiation received by the radiation analysis device using the one or more correction factors, and presenting information relating to an amount of radiation measured by the radiation analysis device having one of a plurality of specified radiation energy levels of a range of interest.

Silicon photonics and challenges for fabrication

NASA Astrophysics Data System (ADS)

Feilchenfeld, N. B.; Nummy, K.; Barwicz, T.; Gill, D.; Kiewra, E.; Leidy, R.; Orcutt, J. S.; Rosenberg, J.; Stricker, A. D.; Whiting, C.; Ayala, J.; Cucci, B.; Dang, D.; Doan, T.; Ghosal, M.; Khater, M.; McLean, K.; Porth, B.; Sowinski, Z.; Willets, C.; Xiong, C.; Yu, C.; Yum, S.; Giewont, K.; Green, W. M. J.

2017-03-01

Silicon photonics is rapidly becoming the key enabler for meeting the future data speed and volume required by the Internet of Things. A stable manufacturing process is needed to deliver cost and yield expectations to the technology marketplace. We present the key challenges and technical results from both 200mm and 300mm facilities for a silicon photonics fabrication process which includes monolithic integration with CMOS. This includes waveguide patterning, optical proximity correction for photonic devices, silicon thickness uniformity and thick material patterning for passive fiber to waveguide alignment. The device and process metrics show that the transfer of the silicon photonics process from 200mm to 300mm will provide a stable high volume manufacturing platform for silicon photonics designs.

Technology development of high-quality semiconductor devices using solution-processed crystallization of pentacene

NASA Astrophysics Data System (ADS)

Liu, Hung-Wei

Organic electronic materials and processing techniques have attracted considerable attention for developing organic thin-film transistors (OTFTs), since they may be patterned on flexible substrates which may be bent into a variety of shapes for applications such as displays, smart cards, solar devices and sensors Various fabrication methods for building pentacene-based OTFTs have been demonstrated. Traditional vacuum deposition and vapor deposition methods have been studied for deposition on plastic and paper, but these are unlikely to scale well to large area printing. Researchers have developed methods for processing OTFTs from solution because of the potential for low-cost and large area device manufacturing, such as through inkjet or offset printing. Most methods require the use of precursors which are used to make pentacene soluble, and these methods have typically produced much lower carrier mobility than the best vacuum deposited devices. We have investigated devices built from solution-processed pentacene that is locally crystallized at room temperature on the polymer substrates. Pentacene crystals grown in this manner are highly localized at pre-determined sites, have good crystallinity and show good carrier mobility, making this an attractive method for large area manufacturing of semiconductor devices.

Xurography as a Rapid Fabrication Alternative for Point-of-Care Devices: Assessment of Passive Micromixers

PubMed Central

Martínez-López, J. Israel; Mojica, Mauricio; Rodríguez, Ciro A.; Siller, Héctor R.

2016-01-01

Despite the copious amount of research on the design and operation of micromixers, there are few works regarding manufacture technology aimed at implementation beyond academic environments. This work evaluates the viability of xurography as a rapid fabrication tool for the development of ultra-low cost microfluidic technology for extreme Point-of-Care (POC) micromixing devices. By eschewing photolithographic processes and the bulkiness of pumping and enclosure systems for rapid fabrication and passively driven operation, xurography is introduced as a manufacturing alternative for asymmetric split and recombine (ASAR) micromixers. A T-micromixer design was used as a reference to assess the effects of different cutting conditions and materials on the geometric features of the resulting microdevices. Inspection by stereographic and confocal microscopy showed that it is possible to manufacture devices with less than 8% absolute dimensional error. Implementation of the manufacturing methodology in modified circular shape- based SAR microdevices (balanced and unbalanced configurations) showed that, despite the precision limitations of the xurographic process, it is possible to implement this methodology to produce functional micromixing devices. Mixing efficiency was evaluated numerically and experimentally at the outlet of the microdevices with performances up to 40%. Overall, the assessment encourages further research of xurography for the development of POC micromixers. PMID:27196904

Xurography as a Rapid Fabrication Alternative for Point-of-Care Devices: Assessment of Passive Micromixers.

PubMed

Martínez-López, J Israel; Mojica, Mauricio; Rodríguez, Ciro A; Siller, Héctor R

2016-05-16

Despite the copious amount of research on the design and operation of micromixers, there are few works regarding manufacture technology aimed at implementation beyond academic environments. This work evaluates the viability of xurography as a rapid fabrication tool for the development of ultra-low cost microfluidic technology for extreme Point-of-Care (POC) micromixing devices. By eschewing photolithographic processes and the bulkiness of pumping and enclosure systems for rapid fabrication and passively driven operation, xurography is introduced as a manufacturing alternative for asymmetric split and recombine (ASAR) micromixers. A T-micromixer design was used as a reference to assess the effects of different cutting conditions and materials on the geometric features of the resulting microdevices. Inspection by stereographic and confocal microscopy showed that it is possible to manufacture devices with less than 8% absolute dimensional error. Implementation of the manufacturing methodology in modified circular shape- based SAR microdevices (balanced and unbalanced configurations) showed that, despite the precision limitations of the xurographic process, it is possible to implement this methodology to produce functional micromixing devices. Mixing efficiency was evaluated numerically and experimentally at the outlet of the microdevices with performances up to 40%. Overall, the assessment encourages further research of xurography for the development of POC micromixers.

Biological implications of lab-on-a-chip devices fabricated using multi-jet modelling and stereolithography processes

NASA Astrophysics Data System (ADS)

Zhu, Feng; Macdonald, Niall; Skommer, Joanna; Wlodkowic, Donald

2015-06-01

Current microfabrication methods are often restricted to two-dimensional (2D) or two and a half dimensional (2.5D) structures. Those fabrication issues can be potentially addressed by emerging additive manufacturing technologies. Despite rapid growth of additive manufacturing technologies in tissue engineering, microfluidics has seen relatively little developments with regards to adopting 3D printing for rapid fabrication of complex chip-based devices. This has been due to two major factors: lack of sufficient resolution of current rapid-prototyping methods (usually >100 μm ) and optical transparency of polymers to allow in vitro imaging of specimens. We postulate that adopting innovative fabrication processes can provide effective solutions for prototyping and manufacturing of chip-based devices with high-aspect ratios (i.e. above ration of 20:1). This work provides a comprehensive investigation of commercially available additive manufacturing technologies as an alternative for rapid prototyping of complex monolithic Lab-on-a-Chip devices for biological applications. We explored both multi-jet modelling (MJM) and several stereolithography (SLA) processes with five different 3D printing resins. Compared with other rapid prototyping technologies such as PDMS soft lithography and infrared laser micromachining, we demonstrated that selected SLA technologies had superior resolution and feature quality. We also for the first time optimised the post-processing protocols and demonstrated polymer features under scanning electronic microscope (SEM). Finally we demonstrate that selected SLA polymers have optical properties enabling high-resolution biological imaging. A caution should be, however, exercised as more work is needed to develop fully bio-compatible and non-toxic polymer chemistries.

Wafer-shape metrics based foundry lithography

NASA Astrophysics Data System (ADS)

Kim, Sungtae; Liang, Frida; Mileham, Jeffrey; Tsai, Damon; Bouche, Eric; Lee, Sean; Huang, Albert; Hua, C. F.; Wei, Ming Sheng

2017-03-01

As device shrink, there are many difficulties with process integration and device yield. Lithography process control is expected to be a major challenge due to tighter overlay and focus control requirement. The understanding and control of stresses accumulated during device fabrication has becoming more critical at advanced technology nodes. Within-wafer stress variations cause local wafer distortions which in turn present challenges for managing overlay and depth of focus during lithography. A novel technique for measuring distortion is Coherent Gradient Sensing (CGS) interferometry, which is capable of generating a high-density distortion data set of the full wafer within a time frame suitable for a high volume manufacturing (HVM) environment. In this paper, we describe the adoption of CGS (Coherent Gradient Sensing) interferometry into high volume foundry manufacturing to overcome these challenges. Leveraging this high density 3D metrology, we characterized its In-plane distortion as well as its topography capabilities applied to the full flow of an advanced foundry manufacturing. Case studies are presented that summarize the use of CGS data to reveal correlations between in-plane distortion and overlay variation as well as between topography and device yield.

Simple and inexpensive microfluidic devices for the generation of monodisperse multiple emulsions

NASA Astrophysics Data System (ADS)

Li, Er Qiang; Zhang, Jia Ming; Thoroddsen, Sigurdur T.

2014-01-01

Droplet-based microfluidic devices have become a preferred versatile platform for various fields in physics, chemistry and biology. Polydimethylsiloxane soft lithography, the mainstay for fabricating microfluidic devices, usually requires the usage of expensive apparatus and a complex manufacturing procedure. Here, we report the design and fabrication of simple and inexpensive microfluidic devices based on microscope glass slides and pulled glass capillaries, for generating monodisperse multiple emulsions. The advantages of our method lie in a simple manufacturing procedure, inexpensive processing equipment and flexibility in the surface modification of the designed microfluidic devices. Different types of devices have been designed and tested and the experimental results demonstrated their robustness for preparing monodisperse single, double, triple and multi-component emulsions.

21 CFR 26.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... regulatory systems means that the systems are sufficiently comparable to assure that the process of... require that the respective regulatory systems have identical procedures. (c) Good Manufacturing Practices...

Innovation and the medical devices Farady partnership.

PubMed

Tavakoli, M; Dunkerton, S B

2005-06-01

Demand for development of new generation medical devices has led many governments to support medical-sector research. In the United Kingdom, the Medical Devices Faraday Partnership was created to establish a collaborative network that would enhance the transfer of good ideas into new products and processes. The services it offers medical device manufacturers are outlined here.

3D printing and milling a real-time PCR device for infectious disease diagnostics.

PubMed

Mulberry, Geoffrey; White, Kevin A; Vaidya, Manjusha; Sugaya, Kiminobu; Kim, Brian N

2017-01-01

Diagnosing infectious diseases using quantitative polymerase chain reaction (qPCR) offers a conclusive result in determining the infection, the strain or type of pathogen, and the level of infection. However, due to the high-cost instrumentation involved and the complexity in maintenance, it is rarely used in the field to make a quick turnaround diagnosis. In order to provide a higher level of accessibility than current qPCR devices, a set of 3D manufacturing methods is explored as a possible option to fabricate a low-cost and portable qPCR device. The key advantage of this approach is the ability to upload the digital format of the design files on the internet for wide distribution so that people at any location can simply download and feed into their 3D printers for quick manufacturing. The material and design are carefully selected to minimize the number of custom parts that depend on advanced manufacturing processes which lower accessibility. The presented 3D manufactured qPCR device is tested with 20-μL samples that contain various concentrations of lentivirus, the same type as HIV. A reverse-transcription step is a part of the device's operation, which takes place prior to the qPCR step to reverse transcribe the target RNA from the lentivirus into complementary DNA (cDNA). This is immediately followed by qPCR which quantifies the target sequence molecules in the sample during the PCR amplification process. The entire process of thermal control and time-coordinated fluorescence reading is automated by closed-loop feedback and a microcontroller. The resulting device is portable and battery-operated, with a size of 12 × 7 × 6 cm3 and mass of only 214 g. By uploading and sharing the design files online, the presented low-cost qPCR device may provide easier access to a robust diagnosis protocol for various infectious diseases, such as HIV and malaria.

40 CFR 63.11940 - What continuous monitoring requirements must I meet for control devices required to install CPMS...

Code of Federal Regulations, 2012 CFR

2012-07-01

... consistent with the manufacturer's recommendations within 15 days or by the next time any process vent stream... the manufacturer's recommendations within 15 days or by the next time any process vent stream is...) Determine gas stream flow using the design blower capacity, with appropriate adjustments for pressure drop...

Human-centered design (HCD) of a fault-finding application for mobile devices and its impact on the reduction of time in fault diagnosis in the manufacturing industry.

PubMed

Kluge, Annette; Termer, Anatoli

2017-03-01

The present article describes the design process of a fault-finding application for mobile devices, which was built to support workers' performance by guiding them through a systematic strategy to stay focused during a fault-finding process. In collaboration with a project partner in the manufacturing industry, a fault diagnosis application was conceptualized based on a human-centered design approach (ISO 9241-210:2010). A field study with 42 maintenance workers was conducted for the purpose of evaluating the performance enhancement of fault finding in three different scenarios as well as for assessing the workers' acceptance of the technology. Workers using the mobile device application were twice as fast at fault finding as the control group without the application and perceived the application as very useful. The results indicate a vast potential of the mobile application for fault diagnosis in contemporary manufacturing systems. Copyright © 2016 Elsevier Ltd. All rights reserved.

Additive manufacturing of hybrid circuits

DOE PAGES

Bell, Nelson S.; Sarobol, Pylin; Cook, Adam; ...

2016-03-26

There is a rising interest in developing functional electronics using additively manufactured components. Considerations in materials selection and pathways to forming hybrid circuits and devices must demonstrate useful electronic function; must enable integration; and must complement the complex shape, low cost, high volume, and high functionality of structural but generally electronically passive additively manufactured components. This article reviews several emerging technologies being used in industry and research/development to provide integration advantages of fabricating multilayer hybrid circuits or devices. First, we review a maskless, noncontact, direct write (DW) technology that excels in the deposition of metallic colloid inks for electrical interconnects.more » Second, we review a complementary technology, aerosol deposition (AD), which excels in the deposition of metallic and ceramic powder as consolidated, thick conformal coatings and is additionally patternable through masking. As a result, we show examples of hybrid circuits/devices integrated beyond 2-D planes, using combinations of DW or AD processes and conventional, established processes.« less

Fabrication of Three-dimensional Paper-based Microfluidic Devices for Immunoassays.

PubMed

Fernandes, Syrena C; Wilson, Daniel J; Mace, Charles R

2017-03-09

Paper wicks fluids autonomously due to capillary action. By patterning paper with hydrophobic barriers, the transport of fluids can be controlled and directed within a layer of paper. Moreover, stacking multiple layers of patterned paper creates sophisticated three-dimensional microfluidic networks that can support the development of analytical and bioanalytical assays. Paper-based microfluidic devices are inexpensive, portable, easy to use, and require no external equipment to operate. As a result, they hold great promise as a platform for point-of-care diagnostics. In order to properly evaluate the utility and analytical performance of paper-based devices, suitable methods must be developed to ensure their manufacture is reproducible and at a scale that is appropriate for laboratory settings. In this manuscript, a method to fabricate a general device architecture that can be used for paper-based immunoassays is described. We use a form of additive manufacturing (multi-layer lamination) to prepare devices that comprise multiple layers of patterned paper and patterned adhesive. In addition to demonstrating the proper use of these three-dimensional paper-based microfluidic devices with an immunoassay for human chorionic gonadotropin (hCG), errors in the manufacturing process that may result in device failures are discussed. We expect this approach to manufacturing paper-based devices will find broad utility in the development of analytical applications designed specifically for limited-resource settings.

Manufacturing of the ISO 25178-70 material measures with direct laser writing: a feasibility study

NASA Astrophysics Data System (ADS)

Eifler, M.; Hering, J.; von Freymann, G.; Seewig, J.

2018-06-01

The standard ISO 25178-70 defines material measures for the calibration of 2D- and 3D-topography measurement devices. Some of the suggested material measures are established within the industrial application for a long time while others have not yet been extensively researched regarding their practical abilities. This paper describes a holistic and systematic investigation of the ISO 25178-70 material measures. The manufacturing of the suggested geometries is executed with two-photon laser lithography, alias direct laser writing (DLW). Since this manufacturing process is not yet frequently used in a material measures context, it is examined regarding its suitability for the fabrication of the ISO 25178-70 material measures. With DLW, it is possible to manufacture multiple material measures on one sample in order to enable a comprehensive calibration of optical topography measurement devices. The manufactured ISO 25178-70 geometries are examined using different 3D-topography measuring devices. In doing so, their abilities regarding the calibration of the devices can be evaluated and the practical feasibility of their industrial application is assessed. For the review of this practical usefulness, varying calibration and evaluation strategies are taken into account.

Assembly processes comparison for a miniaturized laser used for the Exomars European Space Agency mission

NASA Astrophysics Data System (ADS)

Ribes-Pleguezuelo, Pol; Inza, Andoni Moral; Basset, Marta Gilaberte; Rodríguez, Pablo; Rodríguez, Gemma; Laudisio, Marco; Galan, Miguel; Hornaff, Marcel; Beckert, Erik; Eberhardt, Ramona; Tünnermann, Andreas

2016-11-01

A miniaturized diode-pumped solid-state laser (DPSSL) designed as part of the Raman laser spectrometer (RLS) instrument for the European Space Agency (ESA) Exomars mission 2020 is assembled and tested for the mission purpose and requirements. Two different processes were tried for the laser assembling: one based on adhesives, following traditional laser manufacturing processes; another based on a low-stress and organic-free soldering technique called solderjet bumping technology. The manufactured devices were tested for the processes validation by passing mechanical, thermal cycles, radiation, and optical functional tests. The comparison analysis showed a device improvement in terms of reliability of the optical performances from the soldered to the assembled by adhesive-based means.

Manufacturing Demonstration Facility: Roll-to-Roll Processing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Datskos, Panos G; Joshi, Pooran C; List III, Frederick Alyious

This Manufacturing Demonstration Facility (MDF)e roll-to-roll processing effort described in this report provided an excellent opportunity to investigate a number of advanced manufacturing approaches to achieve a path for low cost devices and sensors. Critical to this effort is the ability to deposit thin films at low temperatures using nanomaterials derived from nanofermentation. The overarching goal of this project was to develop roll-to-roll manufacturing processes of thin film deposition on low-cost flexible substrates for electronics and sensor applications. This project utilized ORNL s unique Pulse Thermal Processing (PTP) technologies coupled with non-vacuum low temperature deposition techniques, ORNL s clean roommore » facility, slot dye coating, drop casting, spin coating, screen printing and several other equipment including a Dimatix ink jet printer and a large-scale Kyocera ink jet printer. The roll-to-roll processing project had three main tasks: 1) develop and demonstrate zinc-Zn based opto-electronic sensors using low cost nanoparticulate structures manufactured in a related MDF Project using nanofermentation techniques, 2) evaluate the use of silver based conductive inks developed by project partner NovaCentrix for electronic device fabrication, and 3) demonstrate a suite of low cost printed sensors developed using non-vacuum deposition techniques which involved the integration of metal and semiconductor layers to establish a diverse sensor platform technology.« less

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

Optical surface analysis: a new technique for the inspection and metrology of optoelectronic films and wafers

NASA Astrophysics Data System (ADS)

Bechtler, Laurie; Velidandla, Vamsi

2003-04-01

In response to demand for higher volumes and greater product capability, integrated optoelectronic device processing is rapidly increasing in complexity, benefiting from techniques developed for conventional silicon integrated circuit processing. The needs for high product yield and low manufacturing cost are also similar to the silicon wafer processing industry. This paper discusses the design and use of an automated inspection instrument called the Optical Surface Analyzer (OSA) to evaluate two critical production issues in optoelectronic device manufacturing: (1) film thickness uniformity, and (2) defectivity at various process steps. The OSA measurement instrument is better suited to photonics process development than most equipment developed for conventional silicon wafer processing in two important ways: it can handle both transparent and opaque substrates (unlike most inspection and metrology tools), and it is a full-wafer inspection method that captures defects and film variations over the entire substrate surface (unlike most film thickness measurement tools). Measurement examples will be provided in the paper for a variety of films and substrates used for optoelectronics manufacturing.

Semiconductors: In Situ Processing of Photovoltaic Devices

NASA Technical Reports Server (NTRS)

Curreri, Peter A.

1998-01-01

The possible processing of semiconductor photovoltaic devices is discussed. The requirements for lunar PV cells is reviewed, and the key challenges involved in their manufacturing are investigated. A schematic diagram of a passivated emitter and rear cell (PERC) is presented. The possible fabrication of large photovoltaic arrays in space from lunar materials is also discussed.

40 CFR 60.562-1 - Standards: Process emissions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Compound (VOC) Emissions from the Polymer Manufacturing Industry § 60.562-1 Standards: Process emissions... vent stream from a control device shall have car-sealed opened all valves in the vent system from the emission source to the control device and car-sealed closed all valves in vent system that would lead the...

Environmental effects of information and communications technologies.

PubMed

Williams, Eric

2011-11-16

The digital revolution affects the environment on several levels. Most directly, information and communications technology (ICT) has environmental impacts through the manufacturing, operation and disposal of devices and network equipment, but it also provides ways to mitigate energy use, for example through smart buildings and teleworking. At a broader system level, ICTs influence economic growth and bring about technological and societal change. Managing the direct impacts of ICTs is more complex than just producing efficient devices, owing to the energetically expensive manufacturing process, and the increasing proliferation of devices needs to be taken into account. © 2011 Macmillan Publishers Limited. All rights reserved

Patient views on financial relationships between surgeons and surgical device manufacturers.

PubMed

Camp, Mark W; Gross, Allan E; McKneally, Martin F

2015-10-01

Over the past decade, revelations of inappropriate financial relationships between surgeons and surgical device manufacturers have challenged the presumption that surgeons can collaborate with surgical device manufacturers without damaging public trust in the surgical profession. We explored postoperative Canadian patients' knowledge and opinions about financial relationships between surgeons and surgical device manufacturers. This complex issue was explored using qualitative methods. We conducted semistructured face-to-face interviews with postoperative patients in follow-up arthroplasty clinics at an academic hospital in Toronto, Canada. Interviews were audiotaped, transcribed and analyzed. Patient-derived concepts and themes were uncovered. We interviewed 33 patients. Five major themes emerged: 1) many patients are unaware of the existence of financial relationships between surgeons and surgical device manufacturers; 2) patients approve of financial relationships that support innovation and research but are opposed to relationships that involve financial incentives that benefit only the surgeon and the manufacturer; 3) patients do not support disclosure of financial relationships during the consent process as it may shift focus away from the more important risks; 4) patients support oversight at the professional level but reject the idea of government involvement in oversight; and 5) patients entrust their surgeons to make appropriate patient-centred choices. This qualitative study deepens our understanding of financial relationships between surgeons and industry. Patients support relationships with industry that provide potential benefit to current or future patients. They trust our ability to self-regulate. Disclosure combined with appropriate oversight will strengthen public trust in professional collaboration with industry.

3D printing for health & wealth: Fabrication of custom-made medical devices through additive manufacturing

NASA Astrophysics Data System (ADS)

Colpani, Alessandro; Fiorentino, Antonio; Ceretti, Elisabetta

2018-05-01

Additive Manufacturing (AM) differs from traditional manufacturing technologies by its ability to handle complex shapes with great design flexibility. These features make the technique suitable to fabricate customized components, particularly answering specific custom needs. Although AM mainly referred to prototyping, nowadays the interest in direct manufacturing of actual parts is growing. This article shows the application of AM within the project 3DP-4H&W (3D Printing for Health & Wealth) which involves engineers and physicians for developing pediatric custom-made medical devices to enhance the fulfilling of the patients specific needs. In the project, two types of devices made of a two-component biocompatible silicone are considered. The first application (dental field) consists in a device for cleft lip and palate. The second one (audiological field) consists in an acoustic prosthesis. The geometries of the devices are based on the anatomy of the patient that is obtained through a 3D body scan process. For both devices, two different approaches were planned, namely direct AM and indirect Rapid Tooling (RT). In particular, direct AM consists in the FDM processing of silicone, while RT consists in molds FDM fabrication followed by silicone casting. This paper presents the results of the RT method that is articulated in different phases: the acquisition of the geometry to be realized, the design of the molds taking into account the casting feasibility (as casting channel, vents, part extraction), the realization of molds produced through AM, molds surface chemical finishing, pouring and curing of the silicone. The fabricated devices were evaluated by the physicians team that confirmed the effectiveness of the proposed procedure in fabricating the desired devices. Moreover, the procedure can be used as a general method to extend the range of applications to any custom-made device for anatomic districts, especially where complex shapes are present (as tracheal or maxillary prostheses).

New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues.

PubMed

Martelli, Nicolas; van den Brink, Hélène; Borget, Isabelle

2016-01-01

We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Rapid prototyping of multi-scale biomedical microdevices by combining additive manufacturing technologies.

PubMed

Hengsbach, Stefan; Lantada, Andrés Díaz

2014-08-01

The possibility of designing and manufacturing biomedical microdevices with multiple length-scale geometries can help to promote special interactions both with their environment and with surrounding biological systems. These interactions aim to enhance biocompatibility and overall performance by using biomimetic approaches. In this paper, we present a design and manufacturing procedure for obtaining multi-scale biomedical microsystems based on the combination of two additive manufacturing processes: a conventional laser writer to manufacture the overall device structure, and a direct-laser writer based on two-photon polymerization to yield finer details. The process excels for its versatility, accuracy and manufacturing speed and allows for the manufacture of microsystems and implants with overall sizes up to several millimeters and with details down to sub-micrometric structures. As an application example we have focused on manufacturing a biomedical microsystem to analyze the impact of microtextured surfaces on cell motility. This process yielded a relevant increase in precision and manufacturing speed when compared with more conventional rapid prototyping procedures.

Gastroresistant capsular device prepared by injection molding.

PubMed

Zema, Lucia; Loreti, Giulia; Melocchi, Alice; Maroni, Alessandra; Palugan, Luca; Gazzaniga, Andrea

2013-01-20

In the present work, the possibility of manufacturing by injection molding (IM) a gastro-resistant capsular device based on hydroxypropyl methyl cellulose acetate succinate (HPMCAS) was investigated. By performing as an enteric soluble container, such a device may provide a basis for the development of advantageous alternatives to coated dosage forms. Preliminarily, the processability of the selected thermoplastic polymer was evaluated, and the need for a plasticizer (polyethylene glycol 1500) in order to counterbalance the glassy nature of the molded items was assessed. However, some critical issues related to the physical/mechanical stability (shrinkage and warpage) and opening time of the device after the pH change were highlighted. Accordingly, an in-depth formulation study was carried out taking into account differing release modifiers potentially useful for enhancing the dissolution/disintegration rate of the capsular device at intestinal pH values. Capsule prototypes with thickness of 600 and 900 μm containing Kollicoat(®) IR and/or Explotab(®) CLV could be manufactured, and a promising performance was achieved with appropriate gastric resistance in pH 1.2 medium and break-up in pH 6.8 within 1h. These results would support the design of a dedicated mold for the development of a scalable manufacturing process. Copyright © 2012 Elsevier B.V. All rights reserved.

Space Manufacturing: The Next Great Challenge

NASA Technical Reports Server (NTRS)

Whitaker, Ann F.; Curreri, Peter; Sharpe, Jonathan B.; Colberg, Wendell R.; Vickers, John H.

1998-01-01

Space manufacturing encompasses the research, development and manufacture necessary for the production of any product to be used in near zero gravity, and the production of spacecraft required for transporting research or production devices to space. Manufacturing for space, and manufacturing in space will require significant breakthroughs in materials and manufacturing technology, as well as in equipment designs. This report reviews some of the current initiatives in achieving space manufacturing. The first initiative deals with materials processing in space, e.g., processing non-terrestrial and terrestrial materials, especially metals. Some of the ramifications of the United States Microgravity Payloads fourth (USMP-4) mission are discussed. Some problems in non-terrestrial materials processing are mentioned. The second initiative is structures processing in space. In order to accomplish this, the International Space Welding Experiment was designed to demonstrate welding technology in near-zero gravity. The third initiative is advancements in earth-based manufacturing technologies necessary to achieve low cost access to space. The advancements discussed include development of lightweight material having high specific strength, and automated fabrication and manufacturing methods for these materials.

All-inkjet-printed flexible ZnO micro photodetector for a wearable UV monitoring device.

PubMed

Tran, Van-Thai; Wei, Yuefan; Yang, Hongyi; Zhan, Zhaoyao; Du, Hejun

2017-03-03

Fabrication of small-sized patterns of inorganic semiconductor onto flexible substrates is a major concern when manufacturing wearable devices for measuring either biometric or environmental parameters. In this study, micro-sized flexible ZnO UV photodetectors have been thoroughly prepared by a facile inkjet printing technology and followed with heat treatments. A simple ink recipe of zinc acetate precursor solution was investigated. It is found that the substrate temperature during zinc precursor ink depositing has significant effects on ZnO pattern shape, film morphology, and crystallization. The device fabricated from the additive manufacturing approach has good bendability, Ohmic contact, short response time as low as 0.3 s, and high on/off ratio of 3525. We observed the sensor's dependence of response/decay time by the illuminating UV light intensity. The whole process is based on additive manufacturing which has many benefits such as rapid prototyping, saving material, being environmentally friendly, and being capable of creating high-resolution patterns. In addition, this method can be applied to flexible substrates, which makes the device more applicable for applications requiring flexibility such as wearable devices. The proposed all-inkjet-printing approach for a micro-sized ZnO UV photodetector would significantly simplify the fabrication process of micro-sized inorganic semiconductor-based devices. A potential application is real-time monitoring of UV light exposure to warn users about unsafe direct sunlight to implement suitable avoidance solutions.

Logistics for the implementation of lead-free solders on electronic assemblies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vianco, P.T.; Artaki, I.

1993-12-31

The prospects of legislative and regulatory action aimed at taxing, restricting or banning lead-bearing materials from manufactured products has prompted the electronics community to examine the implementation of lead-free solders to replace currently used lead-containing alloys in the manufacture of electronic devices and assemblies. The logistics for changing the well established ``tin-lead solder technology`` require not only the selection of new compositions but also the qualification of different surface finishes and manufacturing processes. The meniscometer/wetting balance technique was used to evaluate the wettability of several candidate lead-free solders as well as to establish windows on processing parameters so as tomore » facilitate prototype manufacturing. Electroplated and electroless 100Sn coatings, as well as organic preservatives, were also examined as potential alternative finishes for device leads and terminations as well as circuit board conductor surfaces to replace traditional tin-lead layers. Sandia National Laboratories and AT&T have implemented a program to qualify the manufacturing feasibility of surface mount prototype circuit boards using several commercial lead-free solders by infrared reflow technology.« less

Text analysis devices, articles of manufacture, and text analysis methods

DOEpatents

Turner, Alan E; Hetzler, Elizabeth G; Nakamura, Grant C

2015-03-31

Text analysis devices, articles of manufacture, and text analysis methods are described according to some aspects. In one aspect, a text analysis device includes a display configured to depict visible images, and processing circuitry coupled with the display and wherein the processing circuitry is configured to access a first vector of a text item and which comprises a plurality of components, to access a second vector of the text item and which comprises a plurality of components, to weight the components of the first vector providing a plurality of weighted values, to weight the components of the second vector providing a plurality of weighted values, and to combine the weighted values of the first vector with the weighted values of the second vector to provide a third vector.

Additive Manufacturing of a Microbial Fuel Cell—A detailed study

PubMed Central

Calignano, Flaviana; Tommasi, Tonia; Manfredi, Diego; Chiolerio, Alessandro

2015-01-01

In contemporary society we observe an everlasting permeation of electron devices, smartphones, portable computing tools. The tiniest living organisms on Earth could become the key to address this challenge: energy generation by bacterial processes from renewable stocks/waste through devices such as microbial fuel cells (MFCs). However, the application of this solution was limited by a moderately low efficiency. We explored the limits, if any, of additive manufacturing (AM) technology to fabricate a fully AM-based powering device, exploiting low density, open porosities able to host the microbes, systems easy to fuel continuously and to run safely. We obtained an optimal energy recovery close to 3 kWh m−3 per day that can power sensors and low-power appliances, allowing data processing and transmission from remote/harsh environments. PMID:26611142

Additive Manufacturing of a Microbial Fuel Cell—A detailed study

NASA Astrophysics Data System (ADS)

Calignano, Flaviana; Tommasi, Tonia; Manfredi, Diego; Chiolerio, Alessandro

2015-11-01

In contemporary society we observe an everlasting permeation of electron devices, smartphones, portable computing tools. The tiniest living organisms on Earth could become the key to address this challenge: energy generation by bacterial processes from renewable stocks/waste through devices such as microbial fuel cells (MFCs). However, the application of this solution was limited by a moderately low efficiency. We explored the limits, if any, of additive manufacturing (AM) technology to fabricate a fully AM-based powering device, exploiting low density, open porosities able to host the microbes, systems easy to fuel continuously and to run safely. We obtained an optimal energy recovery close to 3 kWh m-3 per day that can power sensors and low-power appliances, allowing data processing and transmission from remote/harsh environments.

3D printing and milling a real-time PCR device for infectious disease diagnostics

PubMed Central

Mulberry, Geoffrey; White, Kevin A.; Vaidya, Manjusha; Sugaya, Kiminobu

2017-01-01

Diagnosing infectious diseases using quantitative polymerase chain reaction (qPCR) offers a conclusive result in determining the infection, the strain or type of pathogen, and the level of infection. However, due to the high-cost instrumentation involved and the complexity in maintenance, it is rarely used in the field to make a quick turnaround diagnosis. In order to provide a higher level of accessibility than current qPCR devices, a set of 3D manufacturing methods is explored as a possible option to fabricate a low-cost and portable qPCR device. The key advantage of this approach is the ability to upload the digital format of the design files on the internet for wide distribution so that people at any location can simply download and feed into their 3D printers for quick manufacturing. The material and design are carefully selected to minimize the number of custom parts that depend on advanced manufacturing processes which lower accessibility. The presented 3D manufactured qPCR device is tested with 20-μL samples that contain various concentrations of lentivirus, the same type as HIV. A reverse-transcription step is a part of the device’s operation, which takes place prior to the qPCR step to reverse transcribe the target RNA from the lentivirus into complementary DNA (cDNA). This is immediately followed by qPCR which quantifies the target sequence molecules in the sample during the PCR amplification process. The entire process of thermal control and time-coordinated fluorescence reading is automated by closed-loop feedback and a microcontroller. The resulting device is portable and battery-operated, with a size of 12 × 7 × 6 cm3 and mass of only 214 g. By uploading and sharing the design files online, the presented low-cost qPCR device may provide easier access to a robust diagnosis protocol for various infectious diseases, such as HIV and malaria. PMID:28586401

Biocompatibility of Advanced Manufactured Titanium Implants-A Review.

PubMed

Sidambe, Alfred T

2014-12-19

Titanium (Ti) and its alloys may be processed via advanced powder manufacturing routes such as additive layer manufacturing (or 3D printing) or metal injection moulding. This field is receiving increased attention from various manufacturing sectors including the medical devices sector. It is possible that advanced manufacturing techniques could replace the machining or casting of metal alloys in the manufacture of devices because of associated advantages that include design flexibility, reduced processing costs, reduced waste, and the opportunity to more easily manufacture complex or custom-shaped implants. The emerging advanced manufacturing approaches of metal injection moulding and additive layer manufacturing are receiving particular attention from the implant fabrication industry because they could overcome some of the difficulties associated with traditional implant fabrication techniques such as titanium casting. Using advanced manufacturing, it is also possible to produce more complex porous structures with improved mechanical performance, potentially matching the modulus of elasticity of local bone. While the economic and engineering potential of advanced manufacturing for the manufacture of musculo-skeletal implants is therefore clear, the impact on the biocompatibility of the materials has been less investigated. In this review, the capabilities of advanced powder manufacturing routes in producing components that are suitable for biomedical implant applications are assessed with emphasis placed on surface finishes and porous structures. Given that biocompatibility and host bone response are critical determinants of clinical performance, published studies of in vitro and in vivo research have been considered carefully. The review concludes with a future outlook on advanced Ti production for biomedical implants using powder metallurgy.

Biocompatibility of Advanced Manufactured Titanium Implants—A Review

PubMed Central

Sidambe, Alfred T.

2014-01-01

Titanium (Ti) and its alloys may be processed via advanced powder manufacturing routes such as additive layer manufacturing (or 3D printing) or metal injection moulding. This field is receiving increased attention from various manufacturing sectors including the medical devices sector. It is possible that advanced manufacturing techniques could replace the machining or casting of metal alloys in the manufacture of devices because of associated advantages that include design flexibility, reduced processing costs, reduced waste, and the opportunity to more easily manufacture complex or custom-shaped implants. The emerging advanced manufacturing approaches of metal injection moulding and additive layer manufacturing are receiving particular attention from the implant fabrication industry because they could overcome some of the difficulties associated with traditional implant fabrication techniques such as titanium casting. Using advanced manufacturing, it is also possible to produce more complex porous structures with improved mechanical performance, potentially matching the modulus of elasticity of local bone. While the economic and engineering potential of advanced manufacturing for the manufacture of musculo-skeletal implants is therefore clear, the impact on the biocompatibility of the materials has been less investigated. In this review, the capabilities of advanced powder manufacturing routes in producing components that are suitable for biomedical implant applications are assessed with emphasis placed on surface finishes and porous structures. Given that biocompatibility and host bone response are critical determinants of clinical performance, published studies of in vitro and in vivo research have been considered carefully. The review concludes with a future outlook on advanced Ti production for biomedical implants using powder metallurgy. PMID:28788296

Printed polymer photonic devices for optical interconnect systems

NASA Astrophysics Data System (ADS)

Subbaraman, Harish; Pan, Zeyu; Zhang, Cheng; Li, Qiaochu; Guo, L. J.; Chen, Ray T.

2016-03-01

Polymer photonic device fabrication usually relies on the utilization of clean-room processes, including photolithography, e-beam lithography, reactive ion etching (RIE) and lift-off methods etc, which are expensive and are limited to areas as large as a wafer. Utilizing a novel and a scalable printing process involving ink-jet printing and imprinting, we have fabricated polymer based photonic interconnect components, such as electro-optic polymer based modulators and ring resonator switches, and thermo-optic polymer switch based delay networks and demonstrated their operation. Specifically, a modulator operating at 15MHz and a 2-bit delay network providing up to 35.4ps are presented. In this paper, we also discuss the manufacturing challenges that need to be overcome in order to make roll-to-roll manufacturing practically viable. We discuss a few manufacturing challenges, such as inspection and quality control, registration, and web control, that need to be overcome in order to realize true implementation of roll-to-roll manufacturing of flexible polymer photonic systems. We have overcome these challenges, and currently utilizing our inhouse developed hardware and software tools, <10μm alignment accuracy at a 5m/min is demonstrated. Such a scalable roll-to-roll manufacturing scheme will enable the development of unique optoelectronic devices which can be used in a myriad of different applications, including communication, sensing, medicine, security, imaging, energy, lighting etc.

High Power Laser Processing Of Materials

NASA Astrophysics Data System (ADS)

Martyr, D. R.; Holt, T.

1987-09-01

The first practical demonstration of a laser device was in 1960 and in the following years, the high power carbon dioxide laser has matured as an industrial machine tool. Modern carbon dioxide gas lasers can be used for cutting, welding, heat treatment, drilling, scribing and marking. Since their invention over 25 years ago they are now becoming recognised as highly reliable devices capable of achieving huge savings in production costs in many situations. This paper introduces the basic laser processing techniques of cutting, welding and heat treatment as they apply to the most common engineering materials. Typical processing speeds achieved with a wide range of laser powers are reported. Accuracies achievable and fit-up tolerances required are presented. Methods of integrating lasers with machine tools are described and their suitability in a wide range of manufacturing industries is described by reference to recent installations. Examples from small batch manufacturing, high volume production using dedicated laser welding equipment, and high volume manufacturing using 'flexible' automated laser welding equipment are described Future applications of laser processing are suggested by reference to current process developments.

Product-based Safety Certification for Medical Devices Embedded Software.

PubMed

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

Data visualization methods, data visualization devices, data visualization apparatuses, and articles of manufacture

DOE Office of Scientific and Technical Information (OSTI.GOV)

Turner, Alan E.; Crow, Vernon L.; Payne, Deborah A.

Data visualization methods, data visualization devices, data visualization apparatuses, and articles of manufacture are described according to some aspects. In one aspect, a data visualization method includes accessing a plurality of initial documents at a first moment in time, first processing the initial documents providing processed initial documents, first identifying a plurality of first associations of the initial documents using the processed initial documents, generating a first visualization depicting the first associations, accessing a plurality of additional documents at a second moment in time after the first moment in time, second processing the additional documents providing processed additional documents, secondmore » identifying a plurality of second associations of the additional documents and at least some of the initial documents, wherein the second identifying comprises identifying using the processed initial documents and the processed additional documents, and generating a second visualization depicting the second associations.« less

Considerations for an institution for evaluation of diabetes technology devices to improve their quality in the European Union.

PubMed

Heinemann, Lutz; Freckmann, Guido; Koschinsky, Theodor

2013-03-01

All medical devices used for self-monitoring of blood glucose (BG), insulin injection, continuous subcutaneous insulin infusion, and continuous glucose monitoring in the European Union (EU) must have a Communauté Européenne (CE) mark. However, the approval process for obtaining this mark is different from that used by the European Medicines Agency in the EU for drugs or by the Food and Drug Administration in the United States for such medical and in vitro diagnostic devices. The notified bodies involved in the CE mark process perform this evaluation in cooperation with the manufacturers. They have only limited diabetes know-how; they have to handle all kinds of medical devices. There are devices for therapy on the market in the EU (i.e., they have market approval) that do not fulfill quality requirements, as indicated, for example, in the international norm ISO 15197 for BG test systems. Evaluation of the performance of such systems is usually provided by the manufacturers. What is missing in the EU is an independent institution that performs regular and critical evaluation of the quality of devices used for diabetes therapy before and also after their market approval. The work of such an institution would focus on BG test systems (these represent two-thirds of the market of medical devices for diabetes treatment) but would also evaluate the performance of other devices. It has to be clarified what legal framework is required for such an institution and how it can be financed; probably this can be done in a shared manner by the manufacturers of such devices and the health insurance companies. Positive evaluation results should be a prerequisite prior to any reimbursement for such devices. © 2013 Diabetes Technology Society.

Consumable core for manufacture of composite articles and related method

DOEpatents

Taxacher, Glenn Curtis; de Diego, Peter; Gray, Paul Edward; Monaghan, Philip Harold

2017-09-05

Systems, methods and devices adapted to ease manufacture of composite articles (e.g., ceramic composite articles), particularly composite articles which include a hollow feature are disclosed. In one embodiment, a system includes: a consumable core formed to be disposed within an inner portion of a composite precursor, the consumable core adapted to convert into an infiltrant during a manufacturing process and infiltrate the composite precursor.

George E. Pake Prize: A Few Challenges in the Evolution of Semiconductor Device/Manufacturing Technology

NASA Astrophysics Data System (ADS)

Doering, Robert

In the early 1980s, the semiconductor industry faced the related challenges of ``scaling through the one-micron barrier'' and converting single-level-metal NMOS integrated circuits to multi-level-metal CMOS. Multiple advances in lithography technology and device materials/process integration led the way toward the deep-sub-micron transistors and interconnects that characterize today's electronic chips. In the 1990s, CMOS scaling advanced at an accelerated pace enabled by rapid advances in many aspects of optical lithography. However, the industry also needed to continue the progress in manufacturing on ever-larger silicon wafers to maintain economy-of-scale trends. Simultaneously, the increasing complexity and absolute-precision requirements of manufacturing compounded the necessity for new processes, tools, and control methodologies. This talk presents a personal perspective on some of the approaches that addressed the aforementioned challenges. In particular, early work on integrating silicides, lightly-doped-drain FETs, shallow recessed isolation, and double-level metal will be discussed. In addition, some pioneering efforts in deep-UV lithography and single-wafer processing will be covered. The latter will be mainly based on results from the MMST Program - a 100 M +, 5-year R&D effort, funded by DARPA, the U.S. Air Force, and Texas Instruments, that developed a wide range of new technologies for advanced semiconductor manufacturing. The major highlight of the program was the demonstration of sub-3-day cycle time for manufacturing 350-nm CMOS integrated circuits in 1993. This was principally enabled by the development of: (1) 100% single-wafer processing, including rapid-thermal processing (RTP), and (2) computer-integrated-manufacturing (CIM), including real-time, in-situ process control.

Effects of Processing and Medical Sterilization Techniques on 3D-Printed and Molded Polylactic Acid

NASA Astrophysics Data System (ADS)

Geritano, Mariah Nicole

Manufacturing industries have evolved tremendously in the past decade with the introduction of Additive Manufacturing (AM), also known as 3D Printing. The medical device industry has been a leader in adapting this new technology into research and development. 3D printing enables medical devices and implants to become more customizable, patient specific, and allows for low production numbers. This study compares the mechanical and thermal properties of traditionally manufactured parts versus parts manufactured through 3D printing before and after sterilization, and the ability of an FDM printer to produce reliable, identical samples. It was found that molded samples and 100% infill high-resolution samples have almost identical changes in properties when exposed to different sterilization methods, and similar cooling rates. The data shown throughout this investigation confirms that manipulation of printing parameters can result in an object with comparable material properties to that created through traditional manufacturing methods.

Patient views on financial relationships between surgeons and surgical device manufacturers

PubMed Central

Camp, Mark W.; Gross, Allan E.; McKneally, Martin F.

2015-01-01

Background Over the past decade, revelations of inappropriate financial relationships between surgeons and surgical device manufacturers have challenged the presumption that surgeons can collaborate with surgical device manufacturers without damaging public trust in the surgical profession. We explored postoperative Canadian patients’ knowledge and opinions about financial relationships between surgeons and surgical device manufacturers. Methods This complex issue was explored using qualitative methods. We conducted semistructured face-to-face interviews with postoperative patients in follow-up arthroplasty clinics at an academic hospital in Toronto, Canada. Interviews were audiotaped, transcribed and analyzed. Patient-derived concepts and themes were uncovered. Results We interviewed 33 patients. Five major themes emerged: 1) many patients are unaware of the existence of financial relationships between surgeons and surgical device manufacturers; 2) patients approve of financial relationships that support innovation and research but are opposed to relationships that involve financial incentives that benefit only the surgeon and the manufacturer; 3) patients do not support disclosure of financial relationships during the consent process as it may shift focus away from the more important risks; 4) patients support oversight at the professional level but reject the idea of government involvement in oversight; and 5) patients entrust their surgeons to make appropriate patient-centred choices. Conclusion This qualitative study deepens our understanding of financial relationships between surgeons and industry. Patients support relationships with industry that provide potential benefit to current or future patients. They trust our ability to self-regulate. Disclosure combined with appropriate oversight will strengthen public trust in professional collaboration with industry. PMID:26384147

Plasma-based EUV light source

DOEpatents

Shumlak, Uri; Golingo, Raymond; Nelson, Brian A.

2010-11-02

Various mechanisms are provided relating to plasma-based light source that may be used for lithography as well as other applications. For example, a device is disclosed for producing extreme ultraviolet (EUV) light based on a sheared plasma flow. The device can produce a plasma pinch that can last several orders of magnitude longer than what is typically sustained in a Z-pinch, thus enabling the device to provide more power output than what has been hitherto predicted in theory or attained in practice. Such power output may be used in a lithography system for manufacturing integrated circuits, enabling the use of EUV wavelengths on the order of about 13.5 nm. Lastly, the process of manufacturing such a plasma pinch is discussed, where the process includes providing a sheared flow of plasma in order to stabilize it for long periods of time.

78 FR 45194 - General Electric Company; Analysis of Proposed Agreement Containing Consent Order To Aid Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... industries throughout the globe. GE's aviation segment, among other things, designs and manufactures jet... anticompetitive effects of the proposed transaction. The design and production of an aircraft engine, along with... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes...

ANALYSIS AND EVALUATION OF MYCELIUM REINFORCED NATURAL FIBER BIO-COMPOSITES

USDA-ARS?s Scientific Manuscript database

There is a need for biodegradable alternatives to the inert plastics and expanded foams that are common in both the manufacturing process and device componentry. The material in this study is a bio-composite patented by Ecovative Design LLC. The manufacturer's bio-composite utilizes fungal mycelium ...

Utilising three-dimensional printing techniques when providing unique assistive devices: A case report.

PubMed

Day, Sarah Jane; Riley, Shaun Patrick

2018-02-01

The evolution of three-dimensional printing into prosthetics has opened conversations about the availability and cost of prostheses. This report will discuss how a prosthetic team incorporated additive manufacture techniques into the treatment of a patient with a partial hand amputation to create and test a unique assistive device which he could use to hold his French horn. Case description and methods: Using a process of shape capture, photogrammetry, computer-aided design and finite element analysis, a suitable assistive device was designed and tested. The design was fabricated using three-dimensional printing. Patient satisfaction was measured using a Pugh's Matrix™, and a cost comparison was made between the process used and traditional manufacturing. Findings and outcomes: Patient satisfaction was high. The three-dimensional printed devices were 56% cheaper to fabricate than a similar laminated device. Computer-aided design and three-dimensional printing proved to be an effective method for designing, testing and fabricating a unique assistive device. Clinical relevance CAD and 3D printing techniques can enable devices to be designed, tested and fabricated cheaper than when using traditional techniques. This may lead to improvements in quality and accessibility.

All-inkjet-printed flexible ZnO micro photodetector for a wearable UV monitoring device

NASA Astrophysics Data System (ADS)

Tran, Van-Thai; Wei, Yuefan; Yang, Hongyi; Zhan, Zhaoyao; Du, Hejun

2017-03-01

Fabrication of small-sized patterns of inorganic semiconductor onto flexible substrates is a major concern when manufacturing wearable devices for measuring either biometric or environmental parameters. In this study, micro-sized flexible ZnO UV photodetectors have been thoroughly prepared by a facile inkjet printing technology and followed with heat treatments. A simple ink recipe of zinc acetate precursor solution was investigated. It is found that the substrate temperature during zinc precursor ink depositing has significant effects on ZnO pattern shape, film morphology, and crystallization. The device fabricated from the additive manufacturing approach has good bendability, Ohmic contact, short response time as low as 0.3 s, and high on/off ratio of 3525. We observed the sensor’s dependence of response/decay time by the illuminating UV light intensity. The whole process is based on additive manufacturing which has many benefits such as rapid prototyping, saving material, being environmentally friendly, and being capable of creating high-resolution patterns. In addition, this method can be applied to flexible substrates, which makes the device more applicable for applications requiring flexibility such as wearable devices. The proposed all-inkjet-printing approach for a micro-sized ZnO UV photodetector would significantly simplify the fabrication process of micro-sized inorganic semiconductor-based devices. A potential application is real-time monitoring of UV light exposure to warn users about unsafe direct sunlight to implement suitable avoidance solutions.

Non- contacting capacitive diagnostic device

DOEpatents

Ellison, Timothy

2005-07-12

A non-contacting capacitive diagnostic device includes a pulsed light source for producing an electric field in a semiconductor or photovoltaic device or material to be evaluated and a circuit responsive to the electric field. The circuit is not in physical contact with the device or material being evaluated and produces an electrical signal characteristic of the electric field produced in the device or material. The diagnostic device permits quality control and evaluation of semiconductor or photovoltaic device properties in continuous manufacturing processes.

Direct printing of micro/nanostructures by femtosecond laser excitation of nanocrystals

NASA Astrophysics Data System (ADS)

Shou, Wan; Pan, Heng

2017-02-01

Direct writing using single or multiple energized beams (e.g. laser, ion or electron beams) provides high feature resolution (<1μm) compared with other solution-based printing methods (e.g. inkjet printing). There have been extensive researches on micro/nano additive manufacturing methods employing laser (or optical) and ion/electron beams. Many of these processes utilize specially designed photosensitive materials consisting of additives and effective components. Due to the presence of additive (such as polymer and binders), the effective components are relatively low resulting in high threshold for device operation. In order to direct print functional devices at low cost, there has been extensive research on laser processing of pre-synthesized nanomaterials for non-polymer functional device manufacturing. Pre-synthesized nanocrystals can have better control in the stoichiometry and crystallinity. In addition, pre-synthesis process enjoys the flexibility in material choice since a variety of materials can be synthesized. Femtosecond laser assembly and deposition of nanomaterials can be a feasible 3D micro/nano additive manufacturing approach, although mechanisms leading to assembly and deposition have not been fully understood. In this paper, we propose a mechanism for 2D and 3D deposition of nanocrystals by laser excitation with moderate peak intensities(1011-1012 W/cm2). It is postulated that laser induced charging is responsible for the deposition. The scheme paves the way for laser selective electrophoretic deposition as a micro/nanoscale additive manufacturing approach.

A Novel 2-D Programmable Photonic Time Delay Device for MM-Wave Signal Processing Applications

NASA Technical Reports Server (NTRS)

Yao, X.; Maleki, L.

1994-01-01

We describe a novel programmable photonic true time delay device that has the properties of low loss, inherent two dimensionality with a packing density exceeding 25 lines/cm super 2, virtually infinite bandwidth, and is easy to manufacture.

Towards roll-to-roll manufacturing of polymer photonic devices

NASA Astrophysics Data System (ADS)

Subbaraman, Harish; Lin, Xiaohui; Ling, Tao; Guo, L. Jay; Chen, Ray T.

2014-03-01

Traditionally, polymer photonic devices are fabricated using clean-room processes such as photolithography, e-beam lithography, reactive ion etching (RIE) and lift-off methods etc, which leads to long fabrication time, low throughput and high cost. We have utilized a novel process for fabricating polymer photonic devices using a combination of imprinting and ink jet printing methods, which provides high throughput on a variety of rigid and flexible substrates with low cost. We discuss the manufacturing challenges that need to be overcome in order to realize true implementation of roll-to-roll manufacturing of flexible polymer photonic systems. Several metrology and instrumentation challenges involved such as availability of particulate-free high quality substrate, development and implementation of high-speed in-line and off-line inspection and diagnostic tools with adaptive control for patterned and unpatterned material films, development of reliable hardware, etc need to be addressed and overcome in order to realize a successful manufacturing process. Due to extreme resolution requirements compared to print media, the burden of software and hardware tools on the throughput also needs to be carefully determined. Moreover, the effect of web wander and variations in web speed need to accurately be determined in the design of the system hardware and software. In this paper, we show the realization of solutions for few challenges, and utilizing these solutions for developing a high-rate R2R dual stage ink-jet printer that can provide alignment accuracy of <10μm at a web speed of 5m/min. The development of a roll-to-roll manufacturing system for polymer photonic systems opens limitless possibilities for the deployment of high performance components in a variety of applications including communication, sensing, medicine, agriculture, energy, lighting etc.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian; Munafo, Paul M. (Technical Monitor)

2002-01-01

NASA's Space Launch Initiative (SLI) is an effort to research and develop the technologies needed to build a second-generation reusable launch vehicle. It is required that this new launch vehicle be 100 times safer and 10 times cheaper to operate than current launch vehicles. Part of the SLI includes the development of reusable composite and metallic cryotanks. The size of these reusable tanks is far greater than anything ever developed and exceeds the design limits of current manufacturing tools. Several design and manufacturing approaches have been formulated, but many factors must be weighed during the selection process. Among these factors are tooling reachability, cycle times, feasibility, and facility impacts. The manufacturing process simulation capabilities available at NASA's Marshall Space Flight Center have played a key role in down selecting between the various manufacturing approaches. By creating 3-D manufacturing process simulations, the varying approaches can be analyzed in a virtual world before any hardware or infrastructure is built. This analysis can detect and eliminate costly flaws in the various manufacturing approaches. The simulations check for collisions between devices, verify that design limits on joints are not exceeded, and provide cycle times which aid in the development of an optimized process flow. In addition, new ideas and concerns are often raised after seeing the visual representation of a manufacturing process flow. The output of the manufacturing process simulations allows for cost and safety comparisons to be performed between the various manufacturing approaches. This output helps determine which manufacturing process options reach the safety and cost goals of the SLI.

Manufacturing conditioned roughness and wear of biomedical oxide ceramics for all-ceramic knee implants

PubMed Central

2013-01-01

Background Ceramic materials are used in a growing proportion of hip joint prostheses due to their wear resistance and biocompatibility properties. However, ceramics have not been applied successfully in total knee joint endoprostheses to date. One reason for this is that with strict surface quality requirements, there are significant challenges with regard to machining. High-toughness bioceramics can only be machined by grinding and polishing processes. The aim of this study was to develop an automated process chain for the manufacturing of an all-ceramic knee implant. Methods A five-axis machining process was developed for all-ceramic implant components. These components were used in an investigation of the influence of surface conformity on wear behavior under simplified knee joint motion. Results The implant components showed considerably reduced wear compared to conventional material combinations. Contact area resulting from a variety of component surface shapes, with a variety of levels of surface conformity, greatly influenced wear rate. Conclusions It is possible to realize an all-ceramic knee endoprosthesis device, with a precise and affordable manufacturing process. The shape accuracy of the component surfaces, as specified by the design and achieved during the manufacturing process, has a substantial influence on the wear behavior of the prosthesis. This result, if corroborated by results with a greater sample size, is likely to influence the design parameters of such devices. PMID:23988155

Manufacturing conditioned roughness and wear of biomedical oxide ceramics for all-ceramic knee implants.

PubMed

Turger, Anke; Köhler, Jens; Denkena, Berend; Correa, Tomas A; Becher, Christoph; Hurschler, Christof

2013-08-29

Ceramic materials are used in a growing proportion of hip joint prostheses due to their wear resistance and biocompatibility properties. However, ceramics have not been applied successfully in total knee joint endoprostheses to date. One reason for this is that with strict surface quality requirements, there are significant challenges with regard to machining. High-toughness bioceramics can only be machined by grinding and polishing processes. The aim of this study was to develop an automated process chain for the manufacturing of an all-ceramic knee implant. A five-axis machining process was developed for all-ceramic implant components. These components were used in an investigation of the influence of surface conformity on wear behavior under simplified knee joint motion. The implant components showed considerably reduced wear compared to conventional material combinations. Contact area resulting from a variety of component surface shapes, with a variety of levels of surface conformity, greatly influenced wear rate. It is possible to realize an all-ceramic knee endoprosthesis device, with a precise and affordable manufacturing process. The shape accuracy of the component surfaces, as specified by the design and achieved during the manufacturing process, has a substantial influence on the wear behavior of the prosthesis. This result, if corroborated by results with a greater sample size, is likely to influence the design parameters of such devices.

A research factory for polymer microdevices: muFac

NASA Astrophysics Data System (ADS)

Anthony, Brian W.; Hardt, David E.; Hale, Melinda; Zarrouati, Nadege

2010-02-01

As part of our research on the manufacturing science of micron scale polymer-based devices, an automated production cell has been developed to explore its use in a volume manufacturing environment. This "micro-factory" allows the testing of models and hardware that have resulted from research on material characterization and simulation, tooling and equipment design and control, and process control and metrology. More importantly it has allowed us to identify the problems that exist between and within unit-processes. This paper details our efforts to produce basic micro-fluidic products in high volume at acceptable production rates and quality levels. The device chosen for our first product is a simple binary micromixer with 40×50 micron channel cross section manufactured by embossing of PMMA. The processes in the cell include laser cutting and drilling, hot embossing, thermal bonding and high-speed inspection of the components. Our goal is to create a "lights-out" factory that can make long production runs (e.g. an 8 hour shift) at high rates (Takt time of less than 3 minutes) with consistent quality. This contrasts with device foundries where prototypes in limited quantities but with high variety are the goal. Accordingly, rate and yield are dominant factors in this work, along with the need for precise material handling strategies. Production data will be presented to include process run charts, sampled functional testing of the products and measures of the overall system throughput.

Technology CAD for integrated circuit fabrication technology development and technology transfer

NASA Astrophysics Data System (ADS)

Saha, Samar

2003-07-01

In this paper systematic simulation-based methodologies for integrated circuit (IC) manufacturing technology development and technology transfer are presented. In technology development, technology computer-aided design (TCAD) tools are used to optimize the device and process parameters to develop a new generation of IC manufacturing technology by reverse engineering from the target product specifications. While in technology transfer to manufacturing co-location, TCAD is used for process centering with respect to high-volume manufacturing equipment of the target manufacturing equipment of the target manufacturing facility. A quantitative model is developed to demonstrate the potential benefits of the simulation-based methodology in reducing the cycle time and cost of typical technology development and technology transfer projects over the traditional practices. The strategy for predictive simulation to improve the effectiveness of a TCAD-based project, is also discussed.

Applications of laser ablation to microengineering

NASA Astrophysics Data System (ADS)

Gower, Malcolm C.; Rizvi, Nadeem H.

2000-08-01

Applications of pulsed laser ablation to the manufacture of micro- electro-mechanical systems (MEMS) and micro-opto-electro-mechanical systems (MOEMS) devices are presented. Laser ablative processes used to manufacture a variety of microsystems technology (MST) components in the computer peripheral, sensing and biomedical industries are described together with a view of some future developments.

Method for anisotropic etching in the manufacture of semiconductor devices

NASA Technical Reports Server (NTRS)

Koontz, Steven L. (Inventor); Cross, Jon B. (Inventor)

1993-01-01

Hydrocarbon polymer coatings used in microelectronic manufacturing processes are anisotropically etched by hyperthermal atomic oxygen beams (translational energies of 0.2 to 20 eV, preferably 1 to 10 eV). Etching with hyperthermal oxygen atom species obtains highly anisotropic etching with sharp boundaries between etched and mask protected areas.

Method for anisotropic etching in the manufacture of semiconductor devices

DOEpatents

Koontz, Steven L.; Cross, Jon B.

1993-01-01

Hydrocarbon polymer coatings used in microelectronic manufacturing processes are anisotropically etched by atomic oxygen beams (translational energies of 0.2-20 eV, preferably 1-10 eV). Etching with hyperthermal (kinetic energy>1 eV) oxygen atom species obtains highly anisotropic etching with sharp boundaries between etched and mask-protected areas.

Hydrophilic Polymer Embolism: Implications for Manufacturing, Regulation, and Postmarket Surveillance of Coated Intravascular Medical Devices.

PubMed

Mehta, Rashi I; Mehta, Rupal I

2018-03-19

Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.

21 CFR 820.200 - Servicing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... reports with appropriate statistical methodology in accordance with § 820.100. (c) Each manufacturer who... chapter shall automatically consider the report a complaint and shall process it in accordance with the... device serviced; (2) Any device identification(s) and control number(s) used; (3) The date of service; (4...

21 CFR 814.20 - Application.

Code of Federal Regulations, 2014 CFR

2014-04-01

... laboratory studies and on clinical investigations involving human subjects. A PMA shall be submitted in six... physical and performance characteristics of the device. A brief description of the manufacturing process... and, if known, the history of the marketing of the device by any other person. (v) Summary of studies...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bell, Nelson S.; Sarobol, Pylin; Cook, Adam

There is a rising interest in developing functional electronics using additively manufactured components. Considerations in materials selection and pathways to forming hybrid circuits and devices must demonstrate useful electronic function; must enable integration; and must complement the complex shape, low cost, high volume, and high functionality of structural but generally electronically passive additively manufactured components. This article reviews several emerging technologies being used in industry and research/development to provide integration advantages of fabricating multilayer hybrid circuits or devices. First, we review a maskless, noncontact, direct write (DW) technology that excels in the deposition of metallic colloid inks for electrical interconnects.more » Second, we review a complementary technology, aerosol deposition (AD), which excels in the deposition of metallic and ceramic powder as consolidated, thick conformal coatings and is additionally patternable through masking. As a result, we show examples of hybrid circuits/devices integrated beyond 2-D planes, using combinations of DW or AD processes and conventional, established processes.« less

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, S.P.; Chamberlin, R.

1997-10-07

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells. 13 figs.

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, Scot P.; Chamberlin, Rhodes

1999-02-09

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells.

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, S.P.; Chamberlin, R.

1999-02-09

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells. 13 figs.

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, Scot P.; Chamberlin, Rhodes

1997-10-07

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells.

Materials and processing approaches for foundry-compatible transient electronics.

PubMed

Chang, Jan-Kai; Fang, Hui; Bower, Christopher A; Song, Enming; Yu, Xinge; Rogers, John A

2017-07-11

Foundry-based routes to transient silicon electronic devices have the potential to serve as the manufacturing basis for "green" electronic devices, biodegradable implants, hardware secure data storage systems, and unrecoverable remote devices. This article introduces materials and processing approaches that enable state-of-the-art silicon complementary metal-oxide-semiconductor (CMOS) foundries to be leveraged for high-performance, water-soluble forms of electronics. The key elements are ( i ) collections of biodegradable electronic materials (e.g., silicon, tungsten, silicon nitride, silicon dioxide) and device architectures that are compatible with manufacturing procedures currently used in the integrated circuit industry, ( ii ) release schemes and transfer printing methods for integration of multiple ultrathin components formed in this way onto biodegradable polymer substrates, and ( iii ) planarization and metallization techniques to yield interconnected and fully functional systems. Various CMOS devices and circuit elements created in this fashion and detailed measurements of their electrical characteristics highlight the capabilities. Accelerated dissolution studies in aqueous environments reveal the chemical kinetics associated with the underlying transient behaviors. The results demonstrate the technical feasibility for using foundry-based routes to sophisticated forms of transient electronic devices, with functional capabilities and cost structures that could support diverse applications in the biomedical, military, industrial, and consumer industries.

Materials and processing approaches for foundry-compatible transient electronics

NASA Astrophysics Data System (ADS)

Chang, Jan-Kai; Fang, Hui; Bower, Christopher A.; Song, Enming; Yu, Xinge; Rogers, John A.

2017-07-01

Foundry-based routes to transient silicon electronic devices have the potential to serve as the manufacturing basis for “green” electronic devices, biodegradable implants, hardware secure data storage systems, and unrecoverable remote devices. This article introduces materials and processing approaches that enable state-of-the-art silicon complementary metal-oxide-semiconductor (CMOS) foundries to be leveraged for high-performance, water-soluble forms of electronics. The key elements are (i) collections of biodegradable electronic materials (e.g., silicon, tungsten, silicon nitride, silicon dioxide) and device architectures that are compatible with manufacturing procedures currently used in the integrated circuit industry, (ii) release schemes and transfer printing methods for integration of multiple ultrathin components formed in this way onto biodegradable polymer substrates, and (iii) planarization and metallization techniques to yield interconnected and fully functional systems. Various CMOS devices and circuit elements created in this fashion and detailed measurements of their electrical characteristics highlight the capabilities. Accelerated dissolution studies in aqueous environments reveal the chemical kinetics associated with the underlying transient behaviors. The results demonstrate the technical feasibility for using foundry-based routes to sophisticated forms of transient electronic devices, with functional capabilities and cost structures that could support diverse applications in the biomedical, military, industrial, and consumer industries.

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

DOE Office of Scientific and Technical Information (OSTI.GOV)

Connor, Michael J.; Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California; Marshall, Deborah C.

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact).more » Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer–user training may help mitigate these events.« less

Technology-design-manufacturing co-optimization for advanced mobile SoCs

NASA Astrophysics Data System (ADS)

Yang, Da; Gan, Chock; Chidambaram, P. R.; Nallapadi, Giri; Zhu, John; Song, S. C.; Xu, Jeff; Yeap, Geoffrey

2014-03-01

How to maintain the Moore's Law scaling beyond the 193 immersion resolution limit is the key question semiconductor industry needs to answer in the near future. Process complexity will undoubtfully increase for 14nm node and beyond, which brings both challenges and opportunities for technology development. A vertically integrated design-technologymanufacturing co-optimization flow is desired to better address the complicated issues new process changes bring. In recent years smart mobile wireless devices have been the fastest growing consumer electronics market. Advanced mobile devices such as smartphones are complex systems with the overriding objective of providing the best userexperience value by harnessing all the technology innovations. Most critical system drivers are better system performance/power efficiency, cost effectiveness, and smaller form factors, which, in turns, drive the need of system design and solution with More-than-Moore innovations. Mobile system-on-chips (SoCs) has become the leading driver for semiconductor technology definition and manufacturing. Here we highlight how the co-optimization strategy influenced architecture, device/circuit, process technology and package, in the face of growing process cost/complexity and variability as well as design rule restrictions.

Enabling Microfluidics: From Clean Rooms to Makerspaces

DTIC Science & Technology

2016-09-30

anyone can make 133 and rapidly scale to bulk manufacturing . To enable others to take part in this type of product 134 design and development, we...cost molds for a fee; however, the 77 design process is slowed down waiting for molds to be manufactured and shipped. While 78 PDMS devices may be...finished prototype into a commercial product . An example of a rapid 101 prototyping method amenable to scaled-up manufacturing is laser cutting. Figure

Medical devices manufactured from latex: European regulatory initiatives.

PubMed

De Jong, W H; Geertsma, R E; Tinkler, J J B

2002-05-01

In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities. Copyright 2002 Elsevier Science (USA).

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

40 CFR 63.7143 - What definitions apply to this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants Other... capture and transport PM to a control device. Control device means the air pollution control equipment used to reduce PM emissions released to the atmosphere from one or more process operations at an LMP...

Abatement of waste gases and water during the processes of semiconductor fabrication.

PubMed

Wen, Rui-mei; Liang, Jun-wu

2002-10-01

The purpose of this article is to examine the methods and equipment for abating waste gases and water produced during the manufacture of semiconductor materials and devices. Three separating methods and equipment are used to control three different groups of electronic wastes. The first group includes arsine and phosphine emitted during the processes of semiconductor materials manufacture. The abatement procedure for this group of pollutants consists of adding iodates, cupric and manganese salts to a multiple shower tower (MST) structure. The second group includes pollutants containing arsenic, phosphorus, HF, HCl, NO2, and SO3 emitted during the manufacture of semiconductor materials and devices. The abatement procedure involves mixing oxidants and bases in an oval column with a separator in the middle. The third group consists of the ions of As, P and heavy metals contained in the waste water. The abatement procedure includes adding CaCO3 and ferric salts in a flocculation-sedimentation compact device equipment. Test results showed that all waste gases and water after the abatement procedures presented in this article passed the discharge standards set by the State Environmental Protection Administration of China.

Acoustic biosensors.

PubMed

Fogel, Ronen; Limson, Janice; Seshia, Ashwin A

2016-06-30

Resonant and acoustic wave devices have been researched for several decades for application in the gravimetric sensing of a variety of biological and chemical analytes. These devices operate by coupling the measurand (e.g. analyte adsorption) as a modulation in the physical properties of the acoustic wave (e.g. resonant frequency, acoustic velocity, dissipation) that can then be correlated with the amount of adsorbed analyte. These devices can also be miniaturized with advantages in terms of cost, size and scalability, as well as potential additional features including integration with microfluidics and electronics, scaled sensitivities associated with smaller dimensions and higher operational frequencies, the ability to multiplex detection across arrays of hundreds of devices embedded in a single chip, increased throughput and the ability to interrogate a wider range of modes including within the same device. Additionally, device fabrication is often compatible with semiconductor volume batch manufacturing techniques enabling cost scalability and a high degree of precision and reproducibility in the manufacturing process. Integration with microfluidics handling also enables suitable sample pre-processing/separation/purification/amplification steps that could improve selectivity and the overall signal-to-noise ratio. Three device types are reviewed here: (i) bulk acoustic wave sensors, (ii) surface acoustic wave sensors, and (iii) micro/nano-electromechanical system (MEMS/NEMS) sensors. © 2016 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

3D printing technologies for electrochemical energy storage

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, Feng; Wei, Min; Viswanathan, Vilayanur V.

Fabrication of electrodes and electrolytes play an important role in promoting the performance of electrochemical energy storage (EES) devices such as batteries and supercapacitors. Traditional fabrication techniques have limited capability in controlling the geometry and architecture of the electrode and solid-state electrolytes, which would otherwise compromise the performance. 3D printing, a disruptive manufacturing technology, has emerged as an innovative approach to fabricating EES devices from nanoscale to macroscale and from nanowatt to megawatt, providing great opportunities to accurately control device geometry (e.g., dimension, porosity, morphology) and structure with enhanced specific energy and power densities. Moreover, the additive manufacturing nature ofmore » 3D printing provides excellent controllability of the electrode thickness with much simplified process in a cost effective manner. With the unique spatial and temporal material manipulation capability, 3D printing can integrate multiple nanomaterials in the same print, and multi-functional EES devices (including functional gradient devices) can be fabricated. Herein, we review recent advances in 3D printing of EES devices. We focused on two major 3D printing technologies including direct writing and inkjet printing. The direct material deposition characteristics of these two processes enable them to print on a variety of flat substrates, even a conformal one, well suiting them to applications such as wearable devices and on-chip integrations. Other potential 3D printing techniques such as freeze nano-printing, stereolithography, fused deposition modeling, binder jetting, laminated object manufacturing, and metal 3D printing are also introduced. The advantages and limitations of each 3D printing technology are extensively discussed. More importantly, we provide a perspective on how to integrate the emerging 3D printing with existing technologies to create structures over multiple length scale from macro to nano for EES applications.« less

3D printing technologies for electrochemical energy storage

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, Feng; Wei, Min; Viswanathan, Vilayanur V.

We present that fabrication and assembly of electrodes and electrolytes play an important role in promoting the performance of electrochemical energy storage (EES) devices such as batteries and supercapacitors. Traditional fabrication techniques have limitations in controlling the geometry and architecture of the electrode and solid-state electrolytes, which would otherwise compromise the performance. 3D printing, a disruptive manufacturing technology, has emerged as an innovative approach to fabricating EES devices from nanoscale to macroscale, providing great opportunities to accurately control device geometry (e.g., dimension, porosity, and morphology) and structure with enhanced specific energy and power densities. Moreover, the “additive” manufacturing nature ofmore » 3D printing provides excellent controllability of the electrode thickness with much simplified process in a cost effective manner. Additionally, with the unique spatial and temporal material manipulation capability, 3D printing can integrate multiple nano-materials in the same print, and multi-functional EES devices (including functional gradient devices) can be fabricated. Herein, we review recent advances in 3D printing of EES devices. We focus on two major 3D printing technologies including direct writing and inkjet printing. The direct material deposition characteristics of these two processes enable them to print on a variety of flat substrates, even a conformal one, well suiting them to applications such as wearable devices and on-chip integrations. Other potential 3D printing techniques such as freeze nano-printing, stereolithography, fused deposition modeling, binder jetting, laminated object manufacturing, and metal 3D printing are also introduced. The advantages and limitations of each 3D printing technology are extensively discussed. More importantly, we provide a perspective on how to integrate the emerging 3D printing with existing technologies to create structures over multiple length scale from nano to macro for EES applications.« less

3D printing technologies for electrochemical energy storage

DOE PAGES

Zhang, Feng; Wei, Min; Viswanathan, Vilayanur V.; ...

2017-08-24

We present that fabrication and assembly of electrodes and electrolytes play an important role in promoting the performance of electrochemical energy storage (EES) devices such as batteries and supercapacitors. Traditional fabrication techniques have limitations in controlling the geometry and architecture of the electrode and solid-state electrolytes, which would otherwise compromise the performance. 3D printing, a disruptive manufacturing technology, has emerged as an innovative approach to fabricating EES devices from nanoscale to macroscale, providing great opportunities to accurately control device geometry (e.g., dimension, porosity, and morphology) and structure with enhanced specific energy and power densities. Moreover, the “additive” manufacturing nature ofmore » 3D printing provides excellent controllability of the electrode thickness with much simplified process in a cost effective manner. Additionally, with the unique spatial and temporal material manipulation capability, 3D printing can integrate multiple nano-materials in the same print, and multi-functional EES devices (including functional gradient devices) can be fabricated. Herein, we review recent advances in 3D printing of EES devices. We focus on two major 3D printing technologies including direct writing and inkjet printing. The direct material deposition characteristics of these two processes enable them to print on a variety of flat substrates, even a conformal one, well suiting them to applications such as wearable devices and on-chip integrations. Other potential 3D printing techniques such as freeze nano-printing, stereolithography, fused deposition modeling, binder jetting, laminated object manufacturing, and metal 3D printing are also introduced. The advantages and limitations of each 3D printing technology are extensively discussed. More importantly, we provide a perspective on how to integrate the emerging 3D printing with existing technologies to create structures over multiple length scale from nano to macro for EES applications.« less

Water soluble nano-scale transient material germanium oxide for zero toxic waste based environmentally benign nano-manufacturing

NASA Astrophysics Data System (ADS)

Almuslem, A. S.; Hanna, A. N.; Yapici, T.; Wehbe, N.; Diallo, E. M.; Kutbee, A. T.; Bahabry, R. R.; Hussain, M. M.

2017-02-01

In the recent past, with the advent of transient electronics for mostly implantable and secured electronic applications, the whole field effect transistor structure has been dissolved in a variety of chemicals. Here, we show simple water soluble nano-scale (sub-10 nm) germanium oxide (GeO2) as the dissolvable component to remove the functional structures of metal oxide semiconductor devices and then reuse the expensive germanium substrate again for functional device fabrication. This way, in addition to transiency, we also show an environmentally friendly manufacturing process for a complementary metal oxide semiconductor (CMOS) technology. Every year, trillions of complementary metal oxide semiconductor (CMOS) electronics are manufactured and billions are disposed, which extend the harmful impact to our environment. Therefore, this is a key study to show a pragmatic approach for water soluble high performance electronics for environmentally friendly manufacturing and bioresorbable electronic applications.

Ge/IIIV fin field-effect transistor common gate process and numerical simulations

NASA Astrophysics Data System (ADS)

Chen, Bo-Yuan; Chen, Jiann-Lin; Chu, Chun-Lin; Luo, Guang-Li; Lee, Shyong; Chang, Edward Yi

2017-04-01

This study investigates the manufacturing process of thermal atomic layer deposition (ALD) and analyzes its thermal and physical mechanisms. Moreover, experimental observations and computational fluid dynamics (CFD) are both used to investigate the formation and deposition rate of a film for precisely controlling the thickness and structure of the deposited material. First, the design of the TALD system model is analyzed, and then CFD is used to simulate the optimal parameters, such as gas flow and the thermal, pressure, and concentration fields, in the manufacturing process to assist the fabrication of oxide-semiconductors and devices based on them, and to improve their characteristics. In addition, the experiment applies ALD to grow films on Ge and GaAs substrates with three-dimensional (3-D) transistors having high electric performance. The electrical analysis of dielectric properties, leakage current density, and trapped charges for the transistors is conducted by high- and low-frequency measurement instruments to determine the optimal conditions for 3-D device fabrication. It is anticipated that the competitive strength of such devices in the semiconductor industry will be enhanced by the reduction of cost and improvement of device performance through these optimizations.

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Process tool monitoring and matching using interferometry technique

NASA Astrophysics Data System (ADS)

Anberg, Doug; Owen, David M.; Mileham, Jeffrey; Lee, Byoung-Ho; Bouche, Eric

2016-03-01

The semiconductor industry makes dramatic device technology changes over short time periods. As the semiconductor industry advances towards to the 10 nm device node, more precise management and control of processing tools has become a significant manufacturing challenge. Some processes require multiple tool sets and some tools have multiple chambers for mass production. Tool and chamber matching has become a critical consideration for meeting today's manufacturing requirements. Additionally, process tools and chamber conditions have to be monitored to ensure uniform process performance across the tool and chamber fleet. There are many parameters for managing and monitoring tools and chambers. Particle defect monitoring is a well-known and established example where defect inspection tools can directly detect particles on the wafer surface. However, leading edge processes are driving the need to also monitor invisible defects, i.e. stress, contamination, etc., because some device failures cannot be directly correlated with traditional visualized defect maps or other known sources. Some failure maps show the same signatures as stress or contamination maps, which implies correlation to device performance or yield. In this paper we present process tool monitoring and matching using an interferometry technique. There are many types of interferometry techniques used for various process monitoring applications. We use a Coherent Gradient Sensing (CGS) interferometer which is self-referencing and enables high throughput measurements. Using this technique, we can quickly measure the topography of an entire wafer surface and obtain stress and displacement data from the topography measurement. For improved tool and chamber matching and reduced device failure, wafer stress measurements can be implemented as a regular tool or chamber monitoring test for either unpatterned or patterned wafers as a good criteria for improved process stability.

New possibilities using additive manufacturing with materials that are difficult to process and with complex structures

NASA Astrophysics Data System (ADS)

Olsson, Anders; Hellsing, Maja S.; Rennie, Adrian R.

2017-05-01

Additive manufacturing (or 3D printing) opens the possibility of creating new designs and manufacturing objects with new materials rapidly and economically. Particularly for use with polymers and polymer composites, simple printers can make high quality products, and these can be produced easily in offices, schools and in workshops and laboratories. This technology has opened a route for many to test ideas or to make custom devices. It is possible to easily manufacture complex geometries that would be difficult or even impossible to create with traditional methods. Naturally this technology has attracted attention in many fields that include the production of medical devices and prostheses, mechanical engineering as well as basic sciences. Materials that are highly problematic to machine can be used. We illustrate process developments with an account of the production of printer parts to cope with polymer fillers that are hard and abrasive; new nozzles with ruby inserts designed for such materials are durable and can be used to print boron carbide composites. As with other materials, complex parts can be printed using boron carbide composites with fine structures, such as screw threads and labels to identify materials. General ideas about design for this new era of manufacturing customised parts are presented.

Cell/tissue processing information system for regenerative medicine.

PubMed

Iwayama, Daisuke; Yamato, Masayuki; Tsubokura, Tetsuya; Takahashi, Minoru; Okano, Teruo

2016-11-01

When conducting clinical studies of regenerative medicine, compliance to good manufacturing practice (GMP) is mandatory, and thus much time is needed for manufacturing and quality management. It is therefore desired to introduce the manufacturing execution system (MES), which is being adopted by factories manufacturing pharmaceutical products. Meanwhile, in manufacturing human cell/tissue processing autologous products, it is necessary to protect patients' personal information, prevent patients from being identified and obtain information for cell/tissue identification. We therefore considered it difficult to adopt conventional MES to regenerative medicine-related clinical trials, and so developed novel software for production/quality management to be used in cell-processing centres (CPCs), conforming to GMP. Since this system satisfies the requirements of regulations in Japan and the USA for electronic records and electronic signatures (ER/ES), the use of ER/ES has been allowed, and the risk of contamination resulting from the use of recording paper has been eliminated, thanks to paperless operations within the CPC. Moreover, to reduce the risk of mix-up and cross-contamination due to contact during production, we developed a touchless input device with built-in radio frequency identification (RFID) reader-writer devices and optical sensors. The use of this system reduced the time to prepare and issue manufacturing instructions by 50% or more, compared to the conventional handwritten system. The system contributes to producing more large-scale production and to reducing production costs for cell and tissue products in regenerative medicine. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

Insertion of lithium into electrochromic devices after completion

DOEpatents

Berland, Brian Spencer; Lanning, Bruce Roy; Frey, Jonathan Mack; Barrett, Kathryn Suzanne; DuPont, Paul Damon; Schaller, Ronald William

2015-12-22

The present disclosure describes methods of inserting lithium into an electrochromic device after completion. In the disclosed methods, an ideal amount of lithium can be added post-fabrication to maximize or tailor the free lithium ion density of a layer or the coloration range of a device. Embodiments are directed towards a method to insert lithium into the main device layers of an electrochromic device as a post-processing step after the device has been manufactured. In an embodiment, the methods described are designed to maximize the coloration range while compensating for blind charge loss.

Standards for Lithotripter Performance

NASA Astrophysics Data System (ADS)

Schultheiss, Reiner; Doerffel, Michael

2008-09-01

Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.

40 CFR 60.611 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... From the Synthetic Organic Chemical Manufacturing Industry (SOCMI) Air Oxidation Unit Processes § 60... given them. Air Oxidation Reactor means any device or process vessel in which one or more organic... compounds. Ammoxidation and oxychlorination reactions are included in this definition. Air Oxidation Reactor...

40 CFR 60.611 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... From the Synthetic Organic Chemical Manufacturing Industry (SOCMI) Air Oxidation Unit Processes § 60... given them. Air Oxidation Reactor means any device or process vessel in which one or more organic... compounds. Ammoxidation and oxychlorination reactions are included in this definition. Air Oxidation Reactor...

40 CFR 60.611 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... From the Synthetic Organic Chemical Manufacturing Industry (SOCMI) Air Oxidation Unit Processes § 60... given them. Air Oxidation Reactor means any device or process vessel in which one or more organic... compounds. Ammoxidation and oxychlorination reactions are included in this definition. Air Oxidation Reactor...

40 CFR 60.611 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... From the Synthetic Organic Chemical Manufacturing Industry (SOCMI) Air Oxidation Unit Processes § 60... given them. Air Oxidation Reactor means any device or process vessel in which one or more organic... compounds. Ammoxidation and oxychlorination reactions are included in this definition. Air Oxidation Reactor...

21 CFR 807.81 - When a premarket notification submission is required.

Code of Federal Regulations, 2010 CFR

2010-04-01

... equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the...

76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CDRH: Anastacia Bilek, Center for Devices and Radiological Health, Food and Drug Administration, 10903... PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH,'' that...

An Easy to Manufacture Micro Gas Preconcentrator for Chemical Sensing Applications.

PubMed

McCartney, Mitchell M; Zrodnikov, Yuriy; Fung, Alexander G; LeVasseur, Michael K; Pedersen, Josephine M; Zamuruyev, Konstantin O; Aksenov, Alexander A; Kenyon, Nicholas J; Davis, Cristina E

2017-08-25

We have developed a simple-to-manufacture microfabricated gas preconcentrator for MEMS-based chemical sensing applications. Cavities and microfluidic channels were created using a wet etch process with hydrofluoric acid, portions of which can be performed outside of a cleanroom, instead of the more common deep reactive ion etch process. The integrated heater and resistance temperature detectors (RTDs) were created with a photolithography-free technique enabled by laser etching. With only 28 V DC (0.1 A), a maximum heating rate of 17.6 °C/s was observed. Adsorption and desorption flow parameters were optimized to be 90 SCCM and 25 SCCM, respectively, for a multicomponent gas mixture. Under testing conditions using Tenax TA sorbent, the device was capable of measuring analytes down to 22 ppb with only a 2 min sample loading time using a gas chromatograph with a flame ionization detector. Two separate devices were compared by measuring the same chemical mixture; both devices yielded similar peak areas and widths (fwhm: 0.032-0.033 min), suggesting reproducibility between devices.

FDA, CE mark or something else?-Thinking fast and slow.

PubMed

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Enhancing Critical Infrastructure and Key Resources (CIKR) Level-0 Physical Process Security Using Field Device Distinct Native Attribute Features

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lopez, Juan; Liefer, Nathan C.; Busho, Colin R.

Here, the need for improved Critical Infrastructure and Key Resource (CIKR) security is unquestioned and there has been minimal emphasis on Level-0 (PHY Process) improvements. Wired Signal Distinct Native Attribute (WS-DNA) Fingerprinting is investigated here as a non-intrusive PHY-based security augmentation to support an envisioned layered security strategy. Results are based on experimental response collections from Highway Addressable Remote Transducer (HART) Differential Pressure Transmitter (DPT) devices from three manufacturers (Yokogawa, Honeywell, Endress+Hauer) installed in an automated process control system. Device discrimination is assessed using Time Domain (TD) and Slope-Based FSK (SB-FSK) fingerprints input to Multiple Discriminant Analysis, Maximum Likelihood (MDA/ML)more » and Random Forest (RndF) classifiers. For 12 different classes (two devices per manufacturer at two distinct set points), both classifiers performed reliably and achieved an arbitrary performance benchmark of average cross-class percent correct of %C > 90%. The least challenging cross-manufacturer results included near-perfect %C ≈ 100%, while the more challenging like-model (serial number) discrimination results included 90%< %C < 100%, with TD Fingerprinting marginally outperforming SB-FSK Fingerprinting; SB-FSK benefits from having less stringent response alignment and registration requirements. The RndF classifier was most beneficial and enabled reliable selection of dimensionally reduced fingerprint subsets that minimize data storage and computational requirements. The RndF selected feature sets contained 15% of the full-dimensional feature sets and only suffered a worst case %CΔ = 3% to 4% performance degradation.« less

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Manufacture and distribution of sources or devices... SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Generally Licensed Items § 32.74 Manufacture and distribution of sources or devices containing byproduct material for...

Design, Development and Validation of the Eurostar 3000 Large Propellant Tank

NASA Astrophysics Data System (ADS)

Autric, J.-M.; Catherall, D.; Figues, C.; Brockhoff, T.; Lafranconi, R.

2004-10-01

EADS Astrium has undertaken the design and development of an enlarged propellant tank for its high modular Eurostar 3000 telecom satellites platform. The design and development activities included fracture, stress and functional analysis, the manufacturing of development models for the propellant management device, the qualification of new manufacturing processes and the optimization of the design with respect to the main requirements. The successful design and development-testing phase has allowed starting the manufacturing of the qualification model.

Materials and processing approaches for foundry-compatible transient electronics

PubMed Central

Chang, Jan-Kai; Fang, Hui; Bower, Christopher A.; Song, Enming; Yu, Xinge; Rogers, John A.

2017-01-01

Foundry-based routes to transient silicon electronic devices have the potential to serve as the manufacturing basis for “green” electronic devices, biodegradable implants, hardware secure data storage systems, and unrecoverable remote devices. This article introduces materials and processing approaches that enable state-of-the-art silicon complementary metal-oxide-semiconductor (CMOS) foundries to be leveraged for high-performance, water-soluble forms of electronics. The key elements are (i) collections of biodegradable electronic materials (e.g., silicon, tungsten, silicon nitride, silicon dioxide) and device architectures that are compatible with manufacturing procedures currently used in the integrated circuit industry, (ii) release schemes and transfer printing methods for integration of multiple ultrathin components formed in this way onto biodegradable polymer substrates, and (iii) planarization and metallization techniques to yield interconnected and fully functional systems. Various CMOS devices and circuit elements created in this fashion and detailed measurements of their electrical characteristics highlight the capabilities. Accelerated dissolution studies in aqueous environments reveal the chemical kinetics associated with the underlying transient behaviors. The results demonstrate the technical feasibility for using foundry-based routes to sophisticated forms of transient electronic devices, with functional capabilities and cost structures that could support diverse applications in the biomedical, military, industrial, and consumer industries. PMID:28652373

Improved Method of Manufacturing SiC Devices

NASA Technical Reports Server (NTRS)

Okojie, Robert S.

2005-01-01

The phrase, "common-layered architecture for semiconductor silicon carbide" ("CLASSiC") denotes a method of batch fabrication of microelectromechanical and semiconductor devices from bulk silicon carbide. CLASSiC is the latest in a series of related methods developed in recent years in continuing efforts to standardize SiC-fabrication processes. CLASSiC encompasses both institutional and technological innovations that can be exploited separately or in combination to make the manufacture of SiC devices more economical. Examples of such devices are piezoresistive pressure sensors, strain gauges, vibration sensors, and turbulence-intensity sensors for use in harsh environments (e.g., high-temperature, high-pressure, corrosive atmospheres). The institutional innovation is to manufacture devices for different customers (individuals, companies, and/or other entities) simultaneously in the same batch. This innovation is based on utilization of the capability for fabrication, on the same substrate, of multiple SiC devices having different functionalities (see figure). Multiple customers can purchase shares of the area on the same substrate, each customer s share being apportioned according to the customer s production-volume requirement. This makes it possible for multiple customers to share costs in a common foundry, so that the capital equipment cost per customer in the inherently low-volume SiC-product market can be reduced significantly. One of the technological innovations is a five-mask process that is based on an established set of process design rules. The rules provide for standardization of the fabrication process, yet are flexible enough to enable multiple customers to lay out masks for their portions of the SiC substrate to provide for simultaneous batch fabrication of their various devices. In a related prior method, denoted multi-user fabrication in silicon carbide (MUSiC), the fabrication process is based largely on surface micromachining of poly SiC. However, in MUSiC one cannot exploit the superior sensing, thermomechanical, and electrical properties of single-crystal 6H-SiC or 4H-SiC. As a complement to MUSiC, the CLASSiC five-mask process can be utilized to fabricate multiple devices in bulk single-crystal SiC of any polytype. The five-mask process makes fabrication less complex because it eliminates the need for large-area deposition and removal of sacrificial material. Other innovations in CLASSiC pertain to selective etching of indium tin oxide and aluminum in connection with multilayer metallization. One major characteristic of bulk micromachined microelectromechanical devices is the presence of three-dimensional (3D) structures. Any 3D recesses that already exist at a given step in a fabrication process usually make it difficult to apply a planar coat of photoresist for metallization and other subsequent process steps. To overcome this difficulty, the CLASSiC process includes a reversal of part of the conventional flow: Metallization is performed before the recesses are etched.

A comprehensive review of select smart polymeric and gel actuators for soft mechatronics and robotics applications: fundamentals, freeform fabrication, and motion control

NASA Astrophysics Data System (ADS)

Carrico, James D.; Tyler, Tom; Leang, Kam K.

2017-10-01

Smart polymeric and gel actuators change shape or size in response to stimuli like electricity, heat, or light. These smart polymeric- and gel-based actuators are compliant and well suited for development of soft mechatronic and robotic devices. This paper provides a thorough review of select smart polymeric and gel actuator materials where an automated and freeform fabrication process, like 3D printing, is exploited to create custom shaped monolithic devices. In particular, the advantages and limitations, examples of applications, manufacturing and fabrication techniques, and methods for actuator control are discussed. Finally, a rigorous comparison and analysis of some of the advantages and limitations, as well as manufacturing processes, for these materials, are presented.

[Requirements for CE-marking of apps and wearables].

PubMed

Berensmann, Michael; Gratzfeld, Markus

2018-03-01

Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive 93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. Once the conformity assessment procedure has been finished successfully, the manufacturer attaches the CE-marking to the product. This assures that all requirements of the directive have been fulfilled and the manufacturer is therefore authorized to put the product onto the market in all member states of the European union. In this article, the possible and practical conformity assessment procedures for apps and wearables are described and their implementation is outlined.For medical devices with sufficiently high-risk classification, the manufacturer has to involve a Notified Body. For the conformity assessment procedure according to annex II, the manufacturer implements a full quality management system and compiles technical documentation. These are supervised and evaluated by Notified Body audits. Especially for startups, it is important for the development of apps and wearables to implement a quality management system early and to fulfill the regulatory requirements, for example, related to the software life-cycle model. This also includes considering accompanying processes during development like risk management, usability engineering, and clinical evaluation.Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of a Notified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as class I devices, and are now upgraded to a higher class, need the approval of a notified body starting from 26 May 2020.

75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

...] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility... experience or expertise with nanotechnology. There will be a limited number of round-table participants. FDA...

75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The...

Cost effective solution using inverse lithography OPC for DRAM random contact layer

NASA Astrophysics Data System (ADS)

Jun, Jinhyuck; Hwang, Jaehee; Choi, Jaeseung; Oh, Seyoung; Park, Chanha; Yang, Hyunjo; Dam, Thuc; Do, Munhoe; Lee, Dong Chan; Xiao, Guangming; Choi, Jung-Hoe; Lucas, Kevin

2017-04-01

Many different advanced devices and design layers currently employ double patterning technology (DPT) as a means to overcome lithographic and OPC limitations at low k1 values. Certainly device layers with k1 value below 0.25 require DPT or other pitch splitting methodologies. DPT has also been used to improve patterning of certain device layers with k1 values slightly above 0.25, due to the difficulty of achieving sufficient pattern fidelity with only a single exposure. Unfortunately, this broad adoption of DPT also came with a significant increase in patterning process cost. In this paper, we discuss the development of a single patterning technology process using an integrated Inverse Lithography Technology (ILT) flow for mask synthesis. A single pattering technology flow will reduce the manufacturing cost for a k1 > 0.25 full chip random contact layer in a memory device by replacing the more expensive DPT process with ILT flow, while also maintaining good lithographic production quality and manufacturable OPC/RET production metrics. This new integrated flow consists of applying ILT to the difficult core region and traditional rule-based assist features (RBAFs) with OPC to the peripheral region of a DRAM contact layer. Comparisons of wafer results between the ILT process and the non-ILT process showed the lithographic benefits of ILT and its ability to enable a robust single patterning process for this low-k1 device layer. Advanced modeling with a negative tone develop (NTD) process achieved the accuracy levels needed for ILT to control feature shapes through dose and focus. Details of these afore mentioned results will be described in the paper.

Next step in manufacturing

NASA Astrophysics Data System (ADS)

Koenig, Jan D.

2018-04-01

Thermoelectric devices convert heat flows into electricity. Researchers recently demonstrated that thermoelectric materials can be produced in good quality by 3D printing, enabling a low-cost production process in the near future.

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

PubMed

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian

2003-01-01

NASA's Space Launch Initiative (SLI) is an effort to research and develop the technologies needed to build a second-generation reusable launch vehicle. It is required that this new launch vehicle be 100 times safer and 10 times cheaper to operate than current launch vehicles. Part of the SLI includes the development of reusable composite and metallic cryotanks. The size of these reusable tanks is far greater than anything ever developed and exceeds the design limits of current manufacturing tools. Several design and manufacturing approaches have been formulated, but many factors must be weighed during the selection process. Among these factors are tooling reachability, cycle times, feasibility, and facility impacts. The manufacturing process simulation capabilities available at NASA.s Marshall Space Flight Center have played a key role in down selecting between the various manufacturing approaches. By creating 3-D manufacturing process simulations, the varying approaches can be analyzed in a virtual world before any hardware or infrastructure is built. This analysis can detect and eliminate costly flaws in the various manufacturing approaches. The simulations check for collisions between devices, verify that design limits on joints are not exceeded, and provide cycle times which aide in the development of an optimized process flow. In addition, new ideas and concerns are often raised after seeing the visual representation of a manufacturing process flow. The output of the manufacturing process simulations allows for cost and safety comparisons to be performed between the various manufacturing approaches. This output helps determine which manufacturing process options reach the safety and cost goals of the SLI. As part of the SLI, The Boeing Company was awarded a basic period contract to research and propose options for both a metallic and a composite cryotank. Boeing then entered into a task agreement with the Marshall Space Flight Center to provide manufacturing simulation support. This paper highlights the accomplishments of this task agreement, while also introducing the capabilities of simulation software.

Wafer-level colinearity monitoring for TFH applications

NASA Astrophysics Data System (ADS)

Moore, Patrick; Newman, Gary; Abreau, Kelly J.

2000-06-01

Advances in thin film head (TFH) designs continue to outpace those in the IC industry. The transition to giant magneto resistive (GMR) designs is underway along with the push toward areal densities in the 20 Gbit/inch2 regime and beyond. This comes at a time when the popularity of the low-cost personal computer (PC) is extremely high, and PC prices are continuing to fall. Consequently, TFH manufacturers are forced to deal with pricing pressure in addition to technological demands. New methods of monitoring and improving yield are required along with advanced head designs. TFH manufacturing is a two-step process. The first is a wafer-level process consisting of manufacturing devices on substrates using processes similar to those in the IC industry. The second half is a slider-level process where wafers are diced into 'rowbars' containing many heads. Each rowbar is then lapped to obtain the desired performance from each head. Variation in the placement of specific layers of each device on the bar, known as a colinearity error, causes a change in device performance and directly impacts yield. The photolithography tool and process contribute to colinearity errors. These components include stepper lens distortion errors, stepper stage errors, reticle fabrication errors, and CD uniformity errors. Currently, colinearity is only very roughly estimated during wafer-level TFH production. An absolute metrology tool, such as a Nikon XY, could be used to quantify colinearity with improved accuracy, but this technique is impractical since TFH manufacturers typically do not have this type of equipment at the production site. More importantly, this measurement technique does not provide the rapid feedback needed in a high-volume production facility. Consequently, the wafer-fab must rely on resistivity-based measurements from slider-fab to quantify colinearity errors. The feedback of this data may require several weeks, making it useless as a process diagnostic. This study examines a method of quickly estimating colinearity at the wafer-level with a test reticle and metrology equipment routinely found in TFH facilities. Colinearity results are correlated to slider-fab measurements on production devices. Stepper contributions to colinearity are estimated, and compared across multiple steppers and stepper generations. Multiple techniques of integrating this diagnostic into production are investigated and discussed.

Thin film solar cell configuration and fabrication method

DOEpatents

Menezes, Shalini

2009-07-14

A new photovoltaic device configuration based on an n-copper indium selenide absorber and a p-type window is disclosed. A fabrication method to produce this device on flexible or rigid substrates is described that reduces the number of cell components, avoids hazardous materials, simplifies the process steps and hence the costs for high volume solar cell manufacturing.

All fiber cladding mode stripper with uniform heat distribution and high cladding light loss manufactured by CO2 laser ablation

NASA Astrophysics Data System (ADS)

Jebali, M. A.; Basso, E. T.

2018-02-01

Cladding mode strippers are primarily used at the end of a fiber laser cavity to remove high-power excess cladding light without inducing core loss and beam quality degradation. Conventional manufacturing methods of cladding mode strippers include acid etching, abrasive blasting or laser ablation. Manufacturing of cladding mode strippers using laser ablation consist of removing parts of the cladding by fused silica ablation with a controlled penetration and shape. We present and characterize an optimized cladding mode stripper design that increases the cladding light loss with a minimal device length and manufacturing time. This design reduces the localized heat generation by improving the heat distribution along the device. We demonstrate a cladding mode stripper written on a 400um fiber with cladding light loss of 20dB, with less than 0.02dB loss in the core and minimal heating of the fiber and coating. The manufacturing process of the designed component is fully automated and takes less than 3 minutes with a very high throughput yield.

Enhanced clinical-scale manufacturing of TCR transduced T-cells using closed culture system modules.

PubMed

Jin, Jianjian; Gkitsas, Nikolaos; Fellowes, Vicki S; Ren, Jiaqiang; Feldman, Steven A; Hinrichs, Christian S; Stroncek, David F; Highfill, Steven L

2018-01-24

Genetic engineering of T-cells to express specific T cell receptors (TCR) has emerged as a novel strategy to treat various malignancies. More widespread utilization of these types of therapies has been somewhat constrained by the lack of closed culture processes capable of expanding sufficient numbers of T-cells for clinical application. Here, we evaluate a process for robust clinical grade manufacturing of TCR gene engineered T-cells. TCRs that target human papillomavirus E6 and E7 were independently tested. A 21 day process was divided into a transduction phase (7 days) and a rapid expansion phase (14 days). This process was evaluated using two healthy donor samples and four samples obtained from patients with epithelial cancers. The process resulted in ~ 2000-fold increase in viable nucleated cells and high transduction efficiencies (64-92%). At the end of culture, functional assays demonstrated that these cells were potent and specific in their ability to kill tumor cells bearing target and secrete large quantities of interferon and tumor necrosis factor. Both phases of culture were contained within closed or semi-closed modules, which include automated density gradient separation and cell culture bags for the first phase and closed GREX culture devices and wash/concentrate systems for the second phase. Large-scale manufacturing using modular systems and semi-automated devices resulted in highly functional clinical-grade TCR transduced T-cells. This process is now in use in actively accruing clinical trials and the NIH Clinical Center and can be utilized at other cell therapy manufacturing sites that wish to scale-up and optimize their processing using closed systems.

From space qualified fiber optic gyroscope to generic fiber optic solutions available for space application

NASA Astrophysics Data System (ADS)

Buret, Thomas; Ramecourt, David; Napolitano, Fabien

2017-11-01

The aim of this article is to present how the qualification of the Fiber Optic Gyroscope technology from IXSEA has been achieved through the qualification of a large range of optical devices and related manufacturing processes. These qualified optical devices and processes, that are now fully mastered by IXSEA through vertical integration of the technology, can be used for other space optical sensors. The example of the SWARM project will be discussed.

Devices for monitoring content of microparticles and bacterium in injection solutions in pharmaceutical production

NASA Astrophysics Data System (ADS)

Bilyi, Olexander I.; Getman, Vasyl B.; Konyev, Fedir A.; Sapunkov, Olexander; Sapunkov, Pavlo G.

2001-06-01

The devices for monitoring of parameters of efficiency of water solutions filtration, which are based on the analysis of scattered light by microparticles are considered in this article. The efficiency of using of devices in pharmaceutics in technological processes of manufacturing medical injection solutions is shown. The examples of monitoring of contents of bacterial cultures Pseudomonas aeruginosa, Escherichia coli, and Micrococcus luteus in water solutions of glucose are indicated.

Thin glass substrates for mobile applications

NASA Astrophysics Data System (ADS)

Mauch, Reiner H.; Wegener, Holger; Kruse, Anke; Hildebrand, Norbert

2000-10-01

Flat panel displays play an important role as the visual interface for today's electronic devices (Notebook computers, PDA's, pagers, mobile phones, etc.). Liquid Crystal Display's are dominating the market. While for higher resolution displays active matrix displays like Thin Film Transistor LCD's are used, portable devices are mainly using Super Twisted Nematic (STN) displays. Based on the application, STN displays for mobile applications require thinner glass substrates with improved surface quality at a lower cost. The requirements and trends for STN glass substrates are identified and discussed. Different glass manufacturing processes are used today for the manufacture of these substrates. Advantages and disadvantages of the different glass substrate types are presented and discussed.

Manufacturing considerations for AMLCD cockpit displays

NASA Astrophysics Data System (ADS)

Luo, Fang-Chen

1995-06-01

AMLCD cockpit displays need to meet more stringent requirements compared with AMLCD commercial displays in areas such as environmental conditions, optical performance and device reliability. Special considerations are required for the manufacturing of AMLCD cockpit displays in each process step to address these issues. Some examples are: UV stable polarizers, wide-temperature LC material, strong LC glue seal, ESS test system, gray scale voltage EEPROM, etc.

The Effect of the Elimination of Micromotion and Tissue Strain on Intracortical Device Performance

DTIC Science & Technology

2016-10-01

promise for translation into the clinic. SMP-based probes are compatible with reliable manufacturing practices. 15. SUBJECT TERMS Intracortical probe...addition, the fabrication approaches used to create these test structures take advantage of industrial level manufacturing processes such that...Ravikumar et al. (2014) “The Effect of Residual Endotoxin Contamination on the Neuroinflammatory Response to Sterilized Intracortical Microelectrodes” J

Integrated manufacturing approach to attain benchmark team performance

NASA Astrophysics Data System (ADS)

Chen, Shau-Ron; Nguyen, Andrew; Naguib, Hussein

1994-09-01

A Self-Directed Work Team (SDWT) was developed to transfer a polyimide process module from the research laboratory to our wafer fab facility for applications in IC specialty devices. The SDWT implemented processes and tools based on the integration of five manufacturing strategies for continuous improvement. These were: Leadership Through Quality (LTQ), Total Productive Maintenance (TMP), Cycle Time Management (CTM), Activity-Based Costing (ABC), and Total Employee Involvement (TEI). Utilizing these management techniques simultaneously, the team achieved six sigma control of all critical parameters, increased Overall Equipment Effectiveness (OEE) from 20% to 90%, reduced cycle time by 95%, cut polyimide manufacturing cost by 70%, and improved its overall team member skill level by 33%.

Integrated intelligent sensor for the textile industry

NASA Astrophysics Data System (ADS)

Peltie, Philippe; David, Dominique

1996-08-01

A new sensor has been developed for pantyhose inspection. Unlike a first complete inspection machine devoted to post- manufacturing control of the whole panty, this sensor will be directly integrated on currently existing manufacturing machines, and will combine advantages of miniaturization is to design an intelligent, compact and very cheap product, which should be integrated without requiring any modifications of host machines. The sensor part was designed to achieve closed acquisition, and various solutions have been explored to maintain adequate depth of field. The illumination source will be integrated in the device. The processing part will include correction facilities and electronic processing. Finally, high-level information will be output in order to interface directly with the manufacturing machine automate.

Probabilistic distributions of pinhole defects in atomic layer deposited films on polymeric substrates

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yersak, Alexander S., E-mail: alexander.yersak@colorado.edu; Lee, Yung-Cheng

Pinhole defects in atomic layer deposition (ALD) coatings were measured in an area of 30 cm{sup 2} in an ALD reactor, and these defects were represented by a probabilistic cluster model instead of a single defect density value with number of defects over area. With the probabilistic cluster model, the pinhole defects were simulated over a manufacturing scale surface area of ∼1 m{sup 2}. Large-area pinhole defect simulations were used to develop an improved and enhanced design method for ALD-based devices. A flexible thermal ground plane (FTGP) device requiring ALD hermetic coatings was used as an example. Using a single defectmore » density value, it was determined that for an application with operation temperatures higher than 60 °C, the FTGP device would not be possible. The new probabilistic cluster model shows that up to 40.3% of the FTGP would be acceptable. With this new approach the manufacturing yield of ALD-enabled or other thin film based devices with different design configurations can be determined. It is important to guide process optimization and control and design for manufacturability.« less

A solution for exposure tool optimization at the 65-nm node and beyond

NASA Astrophysics Data System (ADS)

Itai, Daisuke

2007-03-01

As device geometries shrink, tolerances for critical dimension, focus, and overlay control decrease. For the stable manufacture of semiconductor devices at (and beyond) the 65nm node, both performance variability and drift in exposure tools are no longer negligible factors. With EES (Equipment Engineering System) as a guidepost, hopes of improving productivity of semiconductor manufacturing are growing. We are developing a system, EESP (Equipment Engineering Support Program), based on the concept of EES. The EESP system collects and stores large volumes of detailed data generated from Canon lithographic equipment while product is being manufactured. It uses that data to monitor both equipment characteristics and process characteristics, which cannot be examined without this system. The goal of EESP is to maximize equipment capabilities, by feeding the result back to APC/FDC and the equipment maintenance list. This was a collaborative study of the system's effectiveness at the device maker's factories. We analyzed the performance variability of exposure tools by using focus residual data. We also attempted to optimize tool performance using the analyzed results. The EESP system can make the optimum performance of exposure tools available to the device maker.

Design and manufacturing of patient-specific orthodontic appliances by computer-aided engineering techniques.

PubMed

Barone, Sandro; Neri, Paolo; Paoli, Alessandro; Razionale, Armando Viviano

2018-01-01

Orthodontic treatments are usually performed using fixed brackets or removable oral appliances, which are traditionally made from alginate impressions and wax registrations. Among removable devices, eruption guidance appliances are used for early orthodontic treatments in order to intercept and prevent malocclusion problems. Commercially available eruption guidance appliances, however, are symmetric devices produced using a few standard sizes. For this reason, they are not able to meet all the specific patient's needs since the actual dental anatomies present various geometries and asymmetric conditions. In this article, a computer-aided design-based methodology for the design and manufacturing of a patient-specific eruption guidance appliances is presented. The proposed approach is based on the digitalization of several steps of the overall process: from the digital reconstruction of patients' anatomies to the manufacturing of customized appliances. A finite element model has been developed to evaluate the temporomandibular joint disks stress level caused by using symmetric eruption guidance appliances with different teeth misalignment conditions. The developed model can then be used to guide the design of a patient-specific appliance with the aim at reducing the patient discomfort. At this purpose, two different customization levels are proposed in order to face both arches and single tooth misalignment issues. A low-cost manufacturing process, based on an additive manufacturing technique, is finally presented and discussed.

[Risk management for medical devices].

PubMed

Xie, Ying-jie; Xu, Xing-gang

2007-07-01

Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management.

78 FR 5443 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... mean hourly income for workers in sales and related occupations according to the latest figures from... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes...

78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

PubMed

Ashar, B S; Dang, J M; Krause, D; Luke, M C

2011-12-01

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

Simple solution to the medical instrumentation software problem

NASA Astrophysics Data System (ADS)

Leif, Robert C.; Leif, Suzanne B.; Leif, Stephanie H.; Bingue, E.

1995-04-01

Medical devices now include a substantial software component, which is both difficult and expensive to produce and maintain. Medical software must be developed according to `Good Manufacturing Practices', GMP. Good Manufacturing Practices as specified by the FDA and ISO requires the definition and compliance to a software processes which ensures quality products by specifying a detailed method of software construction. The software process should be based on accepted standards. US Department of Defense software standards and technology can both facilitate the development and improve the quality of medical systems. We describe the advantages of employing Mil-Std-498, Software Development and Documentation, and the Ada programming language. Ada provides the very broad range of functionalities, from embedded real-time to management information systems required by many medical devices. It also includes advanced facilities for object oriented programming and software engineering.

Post-marketing surveillance and vigilance for medical devices: the European approach.

PubMed

Randall, H

2001-01-01

The extent to which the medical device manufacturers are responsible for actively monitoring the performance of their products after they have successfully passed the rigorous pre-market approval process has always been a matter of diverse opinion. Within Europe, the law is unhelpfully vague on this point. While there are some comparatively clear obligations for reporting incidents to the authorities (known as the 'vigilance system'), little detail is given on how diligently the manufacturer should try to find out about such incidents. In the early stages of the European Community Directives covering medical devices, there was much emphasis upon formulating guidance to help interpret the vigilance reporting requirements. It is, however, only recently that attention has turned to attempting to clarify what is expected from post-marketing surveillance (PMS) in its broader sense. This article discuses both the vigilance and PMS processes and outlines the currently available European, and particularly UK, guidance documents which are aimed at promoting a more level playing field across industry where these activities are concerned. In particular, it explains the principle differences between vigilance and post-marketing surveillance: the former being the reporting of adverse incidents by manufacturers to the regulatory authorities and their subsequent sharing of key incident data between each other; the latter being the process by which information on overall devise performance is captured, analysed and acted upon. Nevertheless, it is still a struggle to gain widespread appreciation that these two activities are not in fact one and the same.

Poly(lactic-co-glycolic acid) devices: Production and applications for sustained protein delivery.

PubMed

Lee, Parker W; Pokorski, Jonathan K

2018-03-13

Injectable or implantable poly(lactic-co-glycolic acid) (PLGA) devices for the sustained delivery of proteins have been widely studied and utilized to overcome the necessity of repeated administrations for therapeutic proteins due to poor pharmacokinetic profiles of macromolecular therapies. These devices can come in the form of microparticles, implants, or patches depending on the disease state and route of administration. Furthermore, the release rate can be tuned from weeks to months by controlling the polymer composition, geometry of the device, or introducing additives during device fabrication. Slow-release devices have become a very powerful tool for modern medicine. Production of these devices has initially focused on emulsion-based methods, relying on phase separation to encapsulate proteins within polymeric microparticles. Process parameters and the effect of additives have been thoroughly researched to ensure protein stability during device manufacturing and to control the release profile. Continuous fluidic production methods have also been utilized to create protein-laden PLGA devices through spray drying and electrospray production. Thermal processing of PLGA with solid proteins is an emerging production method that allows for continuous, high-throughput manufacturing of PLGA/protein devices. Overall, polymeric materials for protein delivery remain an emerging field of research for the creation of single administration treatments for a wide variety of disease. This review describes, in detail, methods to make PLGA devices, comparing traditional emulsion-based methods to emerging methods to fabricate protein-laden devices. This article is categorized under: Biology-Inspired Nanomaterials > Protein and Virus-Based Structures Implantable Materials and Surgical Technologies > Nanomaterials and Implants Biology-Inspired Nanomaterials > Peptide-Based Structures. © 2018 Wiley Periodicals, Inc.

Additive Manufacturing Design Considerations for Liquid Engine Components

NASA Technical Reports Server (NTRS)

Whitten, Dave; Hissam, Andy; Baker, Kevin; Rice, Darron

2014-01-01

The Marshall Space Flight Center's Propulsion Systems Department has gained significant experience in the last year designing, building, and testing liquid engine components using additive manufacturing. The department has developed valve, duct, turbo-machinery, and combustion device components using this technology. Many valuable lessons were learned during this process. These lessons will be the focus of this presentation. We will present criteria for selecting part candidates for additive manufacturing. Some part characteristics are 'tailor made' for this process. Selecting the right parts for the process is the first step to maximizing productivity gains. We will also present specific lessons we learned about feature geometry that can and cannot be produced using additive manufacturing machines. Most liquid engine components were made using a two-step process. The base part was made using additive manufacturing and then traditional machining processes were used to produce the final part. The presentation will describe design accommodations needed to make the base part and lessons we learned about which features could be built directly and which require the final machine process. Tolerance capabilities, surface finish, and material thickness allowances will also be covered. Additive Manufacturing can produce internal passages that cannot be made using traditional approaches. It can also eliminate a significant amount of manpower by reducing part count and leveraging model-based design and analysis techniques. Information will be shared about performance enhancements and design efficiencies we experienced for certain categories of engine parts.

Standard cell electrical and physical variability analysis based on automatic physical measurement for design-for-manufacturing purposes

NASA Astrophysics Data System (ADS)

Shauly, Eitan; Parag, Allon; Khmaisy, Hafez; Krispil, Uri; Adan, Ofer; Levi, Shimon; Latinski, Sergey; Schwarzband, Ishai; Rotstein, Israel

2011-04-01

A fully automated system for process variability analysis of high density standard cell was developed. The system consists of layout analysis with device mapping: device type, location, configuration and more. The mapping step was created by a simple DRC run-set. This database was then used as an input for choosing locations for SEM images and for specific layout parameter extraction, used by SPICE simulation. This method was used to analyze large arrays of standard cell blocks, manufactured using Tower TS013LV (Low Voltage for high-speed applications) Platforms. Variability of different physical parameters like and like Lgate, Line-width-roughness and more as well as of electrical parameters like drive current (Ion), off current (Ioff) were calculated and statistically analyzed, in order to understand the variability root cause. Comparison between transistors having the same W/L but with different layout configurations and different layout environments (around the transistor) was made in terms of performances as well as process variability. We successfully defined "robust" and "less-robust" transistors configurations, and updated guidelines for Design-for-Manufacturing (DfM).

A manufacturable process integration approach for graphene devices

NASA Astrophysics Data System (ADS)

Vaziri, Sam; Lupina, Grzegorz; Paussa, Alan; Smith, Anderson D.; Henkel, Christoph; Lippert, Gunther; Dabrowski, Jarek; Mehr, Wolfgang; Östling, Mikael; Lemme, Max C.

2013-06-01

In this work, we propose an integration approach for double gate graphene field effect transistors. The approach includes a number of process steps that are key for future integration of graphene in microelectronics: bottom gates with ultra-thin (2 nm) high-quality thermally grown SiO2 dielectrics, shallow trench isolation between devices and atomic layer deposited Al2O3 top gate dielectrics. The complete process flow is demonstrated with fully functional GFET transistors and can be extended to wafer scale processing. We assess, through simulation, the effects of the quantum capacitance and band bending in the silicon substrate on the effective electric fields in the top and bottom gate oxide. The proposed process technology is suitable for other graphene-based devices such as graphene-based hot electron transistors and photodetectors.

77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration... Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological... regarding good manufacturing practices governing the methods used in, and the facilities and controls used...

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

Code of Federal Regulations, 2010 CFR

2010-04-01

... containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. 801.63... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

Code of Federal Regulations, 2013 CFR

2013-04-01

... containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. 801.63... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

Code of Federal Regulations, 2012 CFR

2012-04-01

... containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. 801.63... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

Code of Federal Regulations, 2014 CFR

2014-04-01

... containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. 801.63... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

Code of Federal Regulations, 2011 CFR

2011-04-01

... containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. 801.63... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...

47 CFR 15.124 - DTV transition notices by manufacturers of televisions and related devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false DTV transition notices by manufacturers of televisions and related devices. 15.124 Section 15.124 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES Unintentional Radiators § 15.124 DTV transition notices by manufacturers...

Process-Based Cost Modeling of Photonics Manufacture: The Cost Competitiveness of Monolithic Integration of a 1550-nm DFB Laser and an Electroabsorptive Modulator on an InP Platform

NASA Astrophysics Data System (ADS)

Fuchs, Erica R. H.; Bruce, E. J.; Ram, R. J.; Kirchain, Randolph E.

2006-08-01

The monolithic integration of components holds promise to increase network functionality and reduce packaging expense. Integration also drives down yield due to manufacturing complexity and the compounding of failures across devices. Consensus is lacking on the economically preferred extent of integration. Previous studies on the cost feasibility of integration have used high-level estimation methods. This study instead focuses on accurate-to-industry detail, basing a process-based cost model of device manufacture on data collected from 20 firms across the optoelectronics supply chain. The model presented allows for the definition of process organization, including testing, as well as processing conditions, operational characteristics, and level of automation at each step. This study focuses on the cost implications of integration of a 1550-nm DFB laser with an electroabsorptive modulator on an InP platform. Results show the monolithically integrated design to be more cost competitive over discrete component options regardless of production scale. Dominant cost drivers are packaging, testing, and assembly. Leveraging the technical detail underlying model projections, component alignment, bonding, and metal-organic chemical vapor deposition (MOCVD) are identified as processes where technical improvements are most critical to lowering costs. Such results should encourage exploration of the cost advantages of further integration and focus cost-driven technology development.

Engineered TPEs: new materials of choice for health care?

PubMed

Decordier, J M

1992-03-01

Engineered thermoplastic elastomers (ETPEs) are a relatively young, fast-growing generation of products and have an important strategic influence on both the rubber and plastics market. Much has been written about the increasing usage of plastics in the design and manufacture of medical devices, and today we may add ETPEs to this list, with significant benefits possible for the plastics industry manufacturing elastomeric parts using plastics processing technology.

Techniques of Final Preseal Visual Inspection

NASA Technical Reports Server (NTRS)

Anstead, R. J.

1975-01-01

A dissertation is given on the final preseal visual inspection of microcircuit devices to detect manufacturing defects and reduce failure rates in service. The processes employed in fabricating monolithic integrated circuits and hybrid microcircuits, various failure mechanisms resulting from deficiencies in those processes, and the rudiments of performing final inspection are outlined.

Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study.

PubMed

Telfer, S; Woodburn, J; Collier, A; Cavanagh, P R

2017-07-26

Integration of objective biomechanical measures of foot function into the design process for insoles has been shown to provide enhanced plantar tissue protection for individuals at-risk of plantar ulceration. The use of virtual simulations utilizing numerical modeling techniques offers a potential approach to further optimize these devices. In a patient population at-risk of foot ulceration, we aimed to compare the pressure offloading performance of insoles that were optimized via numerical simulation techniques against shape-based devices. Twenty participants with diabetes and at-risk feet were enrolled in this study. Three pairs of personalized insoles: one based on shape data and subsequently manufactured via direct milling; and two were based on a design derived from shape, pressure, and ultrasound data which underwent a finite element analysis-based virtual optimization procedure. For the latter set of insole designs, one pair was manufactured via direct milling, and a second pair was manufactured through 3D printing. The offloading performance of the insoles was analyzed for forefoot regions identified as having elevated plantar pressures. In 88% of the regions of interest, the use of virtually optimized insoles resulted in lower peak plantar pressures compared to the shape-based devices. Overall, the virtually optimized insoles significantly reduced peak pressures by a mean of 41.3kPa (p<0.001, 95% CI [31.1, 51.5]) for milled and 40.5kPa (p<0.001, 95% CI [26.4, 54.5]) for printed devices compared to shape-based insoles. The integration of virtual optimization into the insole design process resulted in improved offloading performance compared to standard, shape-based devices. ISRCTN19805071, www.ISRCTN.org. Copyright © 2017 Elsevier Ltd. All rights reserved.

Methods utilized in evaluating the profitability of commercial space processing

NASA Technical Reports Server (NTRS)

Bloom, H. L.; Schmitt, P. T.

1976-01-01

Profitability analysis is applied to commercial space processing on the basis of business concept definition and assessment and the relationship between ground and space functions. Throughput analysis is demonstrated by analysis of the space manufacturing of surface acoustic wave devices. The paper describes a financial analysis model for space processing and provides key profitability measures for space processed isoenzymes.

Outsourcing to win.

PubMed

Fink, Paul; Skeen, James

2007-01-01

The decision to outsource the manufacture of an entire device can be difficult, yet the advantages of this business strategy are huge. The important elements of the process are examined here so that companies can adopt this approach with confidence.

40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must...

40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must...

Flexible manufacturing for photonics device assembly

NASA Technical Reports Server (NTRS)

Lu, Shin-Yee; Pocha, Michael D.; Strand, Oliver T.; Young, K. David

1994-01-01

The assembly of photonics devices such as laser diodes, optical modulators, and opto-electronics multi-chip modules (OEMCM), usually requires the placement of micron size devices such as laser diodes, and sub-micron precision attachment between optical fibers and diodes or waveguide modulators (usually referred to as pigtailing). This is a very labor intensive process. Studies done by the opto-electronics (OE) industry have shown that 95 percent of the cost of a pigtailed photonic device is due to the use of manual alignment and bonding techniques, which is the current practice in industry. At Lawrence Livermore National Laboratory, we are working to reduce the cost of packaging OE devices through the use of automation. Our efforts are concentrated on several areas that are directly related to an automated process. This paper will focus on our progress in two of those areas, in particular, an automated fiber pigtailing machine and silicon micro-technology compatible with an automated process.

A laboratory evaluation of four quality control devices for radiographic processing.

PubMed

Rushton, V E; Horner, K

1994-08-01

Quality assurance programmes for radiographic processing traditionally employ expensive sensitometric and densitometric techniques. However cheap and simple devices for monitoring radiographic processing are available. The aim of this study was to make a comparison of four such devices in terms of their ability to detect variations in radiographic density of clinical significance. Three of the devices are commercially available while the fourth is easily manufactured from waste materials. Ideal bitewing exposure times were selected for four different kilovoltage/film speed combinations. Phantom bitewing radiographs, exposed using these exposure times, were processed using a variety of times and developer temperatures to simulate variations in radiographic quality due to inadequate processing conditions. Test films, produced using the four monitoring devices, were exposed and processed under identical conditions. The phantom bitewings were judged to have 'acceptable' quality when the optical density of that part of the film not showing calcified structures was within +/- 0.5 of that of the film processed under optimal conditions. The efficacy of the monitoring devices in indicating the adequacy of processing was assessed by a comparison of their readings with those made from the phantom bitewings. None of the monitoring devices was ideal for all the kilovoltage/film speed combinations tested, but the homemade device proved to be the most generally effective. We conclude that guidelines to dentists on radiographic quality assurance should include reference to and details of this simple device.

47 CFR 2.807 - Statutory exceptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Carriers transporting radiofrequency devices without trading in them. (b) Radiofrequency devices manufactured solely for export. (c) The manufacture, assembly, or installation of radiofrequency devices for... device shall be operated if it causes harmful interference to radio communications. (d) Radiofrequency...

Thermodynamic analysis of resources used in manufacturing processes.

PubMed

Gutowski, Timothy G; Branham, Matthew S; Dahmus, Jeffrey B; Jones, Alissa J; Thiriez, Alexandre

2009-03-01

In this study we use a thermodynamic framework to characterize the material and energy resources used in manufacturing processes. The analysis and data span a wide range of processes from "conventional" processes such as machining, casting, and injection molding, to the so-called "advanced machining" processes such as electrical discharge machining and abrasive waterjet machining, and to the vapor-phase processes used in semiconductor and nanomaterials fabrication. In all, 20 processes are analyzed. The results show that the intensity of materials and energy used per unit of mass of material processed (measured either as specific energy or exergy) has increased by at least 6 orders of magnitude over the past several decades. The increase of material/energy intensity use has been primarily a consequence of the introduction of new manufacturing processes, rather than changes in traditional technologies. This phenomenon has been driven by the desire for precise small-scale devices and product features and enabled by stable and declining material and energy prices over this period. We illustrate the relevance of thermodynamics (including exergy analysis) for all processes in spite of the fact that long-lasting focus in manufacturing has been on product quality--not necessarily energy/material conversion efficiency. We promote the use of thermodynamics tools for analysis of manufacturing processes within the context of rapidly increasing relevance of sustainable human enterprises. We confirm that exergy analysis can be used to identify where resources are lost in these processes, which is the first step in proposing and/or redesigning new more efficient processes.

Optimization Manufacture of Virus- and Tumor-Specific T Cells

PubMed Central

Lapteva, Natalia; Vera, Juan F.

2011-01-01

Although ex vivo expanded T cells are currently widely used in pre-clinical and clinical trials, the complexity of manufacture remains a major impediment for broader application. In this review we discuss current protocols for the ex vivo expansion of virus- and tumor-specific T cells and describe our experience in manufacture optimization using a gas-permeable static culture flask (G-Rex). This innovative device has revolutionized the manufacture process by allowing us to increase cell yields while decreasing the frequency of cell manipulation and in vitro culture time. It is now being used in good manufacturing practice (GMP) facilities for clinical cell production in our institution as well as many others in the US and worldwide. PMID:21915183

Fabrication and performance of pressure-sensing device consisting of electret film and organic semiconductor

NASA Astrophysics Data System (ADS)

Kodzasa, Takehito; Nobeshima, Daiki; Kuribara, Kazunori; Uemura, Sei; Yoshida, Manabu

2017-04-01

We propose a new concept of a pressure-sensitive device that consists of an organic electret film and an organic semiconductor. This device exhibits high sensitivity and selectivity against various types of pressure. The sensing mechanism of this device originates from a modulation of the electric conductivity of the organic semiconductor film induced by the interaction between the semiconductor film and the charged electret film placed face to face. It is expected that a complicated sensor array will be fabricated by using a roll-to-roll manufacturing system, because this device can be prepared by an all-printing and simple lamination process without high-level positional adjustment for printing processes. This also shows that this device with a simple structure is suitable for application to a highly flexible device array sheet for an Internet of Things (IoT) or wearable sensing system.

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

Image change detection systems, methods, and articles of manufacture

DOEpatents

Jones, James L.; Lassahn, Gordon D.; Lancaster, Gregory D.

2010-01-05

Aspects of the invention relate to image change detection systems, methods, and articles of manufacture. According to one aspect, a method of identifying differences between a plurality of images is described. The method includes loading a source image and a target image into memory of a computer, constructing source and target edge images from the source and target images to enable processing of multiband images, displaying the source and target images on a display device of the computer, aligning the source and target edge images, switching displaying of the source image and the target image on the display device, to enable identification of differences between the source image and the target image.

Solution-Processable Transparent Conductive Hole Injection Electrode for OLED SSL

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pschenitzka, Florian; Mathai, Mathew; Torke, Terri

2012-07-15

An interconnected network of silver nanowires has been used as transparent anode in OLED devices. This layer was deposited by spin-coating and slot-die coating from an aqueous nanowire suspension. The sheet resistance of the film was 10ohms/sq with a transmission (including the glass substrate) of higher than 85%. The first phase of the project focused on the implementation of this nanowire layer with a hole-injection-layer (HIL) which has been developed at Plextronics and has been shown to provide good stability and efficiency in conventional OLED devices. We modified the HIL solution such that it coated reasonably well with suitable surfacemore » morphology so that actual devices can be manufactured. During the second phase we investigated the hole-injection and stability of hole-onlydevices. We determined that the use of the nanowire network as anode does not introduce an additional degradation mechanism since the observed device characteristics did not differ from those made with ITO anode. We then proceeded to make actual OLED devices with this nanowire / HIL stack and achieved device characteristics similar state-of-the-art OLED devices with a single junction. In order to gain traction with potential OLED manufacturers, we decided to contract Novaled to prepare large-area demonstrators for us. For these devices, we used an allevaporated stack, i.e. we did use Novaled's HIL material instead of Plextronics. We successfully fabricated demonstrators with an area of 25cm2 with a double or triple junction stack. Minor stack optimizations were necessary to achieve efficacies and lifetime equivalent with ITO devices made with the same devices stack. Due to the reduced microcavity effect, the color of the emitted light is significantly more stable with respect to the viewing angle compared to ITO devices. This fact in conjunction with the promise of lower production cost due to the elimination of the ITO sputtering process and the direct patterning of the anode layer are the obvious advantages of this technology. The project has shown that this nanowire technology is a viable option to achieve OLED devices with good lifetime and efficiency and we are currently working with manufacturers to utilize this technology in a production setting.« less

A Silicon Nanocrystal Schottky Junction Solar Cell produced from Colloidal Silicon Nanocrystals

PubMed Central

2010-01-01

Solution-processed semiconductors are seen as a promising route to reducing the cost of the photovoltaic device manufacture. We are reporting a single-layer Schottky photovoltaic device that was fabricated by spin-coating intrinsic silicon nanocrystals (Si NCs) from colloidal suspension. The thin-film formation process was based on Si NCs without any ligand attachment, exchange, or removal reactions. The Schottky junction device showed a photovoltaic response with a power conversion efficiency of 0.02%, a fill factor of 0.26, short circuit-current density of 0.148 mA/cm2, and open-circuit voltage of 0.51 V. PMID:20676200

Inkjet 3D printing of UV and thermal cure silicone elastomers for dielectric elastomer actuators

NASA Astrophysics Data System (ADS)

McCoul, David; Rosset, Samuel; Schlatter, Samuel; Shea, Herbert

2017-12-01

Dielectric elastomer actuators (DEAs) are an attractive form of electromechanical transducer, possessing high energy densities, an efficient design, mechanical compliance, high speed, and noiseless operation. They have been incorporated into a wide variety of devices, such as microfluidic systems, cell bioreactors, tunable optics, haptic displays, and actuators for soft robotics. Fabrication of DEA devices is complex, and the majority are inefficiently made by hand. 3D printing offers an automated and flexible manufacturing alternative that can fabricate complex, multi-material, integrated devices consistently and in high resolution. We present a novel additive manufacturing approach to DEA devices in which five commercially available, thermal and UV-cure DEA silicone rubber materials have been 3D printed with a drop-on-demand, piezoelectric inkjet system. Using this process, 3D structures and high-quality silicone dielectric elastomer membranes as thin as 2 μm have been printed that exhibit mechanical and actuation performance at least as good as conventionally blade-cast membranes. Printed silicone membranes exhibited maximum tensile strains of up to 727%, and DEAs with printed silicone dielectrics were actuated up to 6.1% area strain at a breakdown strength of 84 V μm-1 and also up to 130 V μm-1 at 2.4% strain. This approach holds great potential to manufacture reliable, high-performance DEA devices with high throughput.

A Manufacturing Cost and Supply Chain Analysis of SiC Power Electronics Applicable to Medium-Voltage Motor Drives

DOE Office of Scientific and Technical Information (OSTI.GOV)

Horowitz, Kelsey; Remo, Timothy; Reese, Samantha

Wide bandgap (WBG) semiconductor devices are increasingly being considered for use in certain power electronics applications, where they can improve efficiency, performance, footprint, and, potentially, total system cost compared to systems using traditional silicon (Si) devices. Silicon carbide (SiC) devices in particular -- which are currently more mature than other WBG devices -- are poised for growth in the coming years. Today, the manufacturing of SiC wafers is concentrated in the United States, and chip production is split roughly equally between the United States, Japan, and Europe. Established contract manufacturers located throughout Asia typically carry out manufacturing of WBG powermore » modules. We seek to understand how global manufacturing of SiC components may evolve over time by illustrating the regional cost drivers along the supply chain and providing an overview of other factors that influence where manufacturing is sited. We conduct this analysis for a particular case study where SiC devices are used in a medium-voltage motor drive.« less

A fully roll-to-roll gravure-printed carbon nanotube-based active matrix for multi-touch sensors

PubMed Central

Lee, Wookyu; Koo, Hyunmo; Sun, Junfeng; Noh, Jinsoo; Kwon, Kye-Si; Yeom, Chiseon; Choi, Younchang; Chen, Kevin; Javey, Ali; Cho, Gyoujin

2015-01-01

Roll-to-roll (R2R) printing has been pursued as a commercially viable high-throughput technology to manufacture flexible, disposable, and inexpensive printed electronic devices. However, in recent years, pessimism has prevailed because of the barriers faced when attempting to fabricate and integrate thin film transistors (TFTs) using an R2R printing method. In this paper, we report 20 × 20 active matrices (AMs) based on single-walled carbon nanotubes (SWCNTs) with a resolution of 9.3 points per inch (ppi) resolution, obtained using a fully R2R gravure printing process. By using SWCNTs as the semiconducting layer and poly(ethylene terephthalate) (PET) as the substrate, we have obtained a device yield above 98%, and extracted the key scalability factors required for a feasible R2R gravure manufacturing process. Multi-touch sensor arrays were achieved by laminating a pressure sensitive rubber onto the SWCNT-TFT AM. This R2R gravure printing system overcomes the barriers associated with the registration accuracy of printing each layer and the variation of the threshold voltage (Vth). By overcoming these barriers, the R2R gravure printing method can be viable as an advanced manufacturing technology, thus enabling the high-throughput production of flexible, disposable, and human-interactive cutting-edge electronic devices based on SWCNT-TFT AMs. PMID:26635237

Design and implementation of a portal for the medical equipment market: MEDICOM.

PubMed

Palamas, S; Kalivas, D; Panou-Diamandi, O; Zeelenberg, C; van Nimwegen, C

2001-01-01

The MEDICOM (Medical Products Electronic Commerce) Portal provides the electronic means for medical-equipment manufacturers to communicate online with their customers while supporting the Purchasing Process and Post Market Surveillance. The Portal offers a powerful Internet-based search tool for finding medical products and manufacturers. Its main advantage is the fast, reliable and up-to-date retrieval of information while eliminating all unrelated content that a general-purpose search engine would retrieve. The Universal Medical Device Nomenclature System (UMDNS) registers all products. The Portal accepts end-user requests and generates a list of results containing text descriptions of devices, UMDNS attribute values, and links to manufacturer Web pages and online catalogues for access to more-detailed information. Device short descriptions are provided by the corresponding manufacturer. The Portal offers technical support for integration of the manufacturers Web sites with itself. The network of the Portal and the connected manufacturers sites is called the MEDICOM system. To establish an environment hosting all the interactions of consumers (health care organizations and professionals) and providers (manufacturers, distributors, and resellers of medical devices). The Portal provides the end-user interface, implements system management, and supports database compatibility. The Portal hosts information about the whole MEDICOM system (Common Database) and summarized descriptions of medical devices (Short Description Database); the manufacturers servers present extended descriptions. The Portal provides end-user profiling and registration, an efficient product-searching mechanism, bulletin boards, links to on-line libraries and standards, on-line information for the MEDICOM system, and special messages or advertisements from manufacturers. Platform independence and interoperability characterize the system design. Relational Database Management Systems are used for the system s databases. The end-user interface is implemented using HTML, Javascript, Java applets, and XML documents. Communication between the Portal and the manufacturers servers is implemented using a CORBA interface. Remote administration of the Portal is enabled by dynamically-generated HTML interfaces based on XML documents. A representative group of users evaluated the system. The aim of the evaluation was validation of the usability of all of MEDICOM s functionality. The evaluation procedure was based on ISO/IEC 9126 Information technology - Software product evaluation - Quality characteristics and guidelines for their use. The overall user evaluation of the MEDICOM system was very positive. The MEDICOM system was characterized as an innovative concept that brings significant added value to medical-equipment commerce. The eventual benefits of the MEDICOM system are (a) establishment of a worldwide-accessible marketplace between manufacturers and health care professionals that provides up-to-date and high-quality product information in an easy and friendly way and (b) enhancement of the efficiency of marketing procedures and after-sales support.

Design and Implementation of a Portal for the Medical Equipment Market: MEDICOM

PubMed Central

Kalivas, Dimitris; Panou-Diamandi, Ourania; Zeelenberg, Cees; van Nimwegen, Chris

2001-01-01

Background The MEDICOM (Medical Products Electronic Commerce) Portal provides the electronic means for medical-equipment manufacturers to communicate online with their customers while supporting the Purchasing Process and Post Market Surveillance. The Portal offers a powerful Internet-based search tool for finding medical products and manufacturers. Its main advantage is the fast, reliable and up-to-date retrieval of information while eliminating all unrelated content that a general-purpose search engine would retrieve. The Universal Medical Device Nomenclature System (UMDNS) registers all products. The Portal accepts end-user requests and generates a list of results containing text descriptions of devices, UMDNS attribute values, and links to manufacturer Web pages and online catalogues for access to more-detailed information. Device short descriptions are provided by the corresponding manufacturer. The Portal offers technical support for integration of the manufacturers' Web sites with itself. The network of the Portal and the connected manufacturers' sites is called the MEDICOM system. Objective To establish an environment hosting all the interactions of consumers (health care organizations and professionals) and providers (manufacturers, distributors, and resellers of medical devices). Methods The Portal provides the end-user interface, implements system management, and supports database compatibility. The Portal hosts information about the whole MEDICOM system (Common Database) and summarized descriptions of medical devices (Short Description Database); the manufacturers' servers present extended descriptions. The Portal provides end-user profiling and registration, an efficient product-searching mechanism, bulletin boards, links to on-line libraries and standards, on-line information for the MEDICOM system, and special messages or advertisements from manufacturers. Platform independence and interoperability characterize the system design. Relational Database Management Systems are used for the system's databases. The end-user interface is implemented using HTML, Javascript, Java applets, and XML documents. Communication between the Portal and the manufacturers' servers is implemented using a CORBA interface. Remote administration of the Portal is enabled by dynamically-generated HTML interfaces based on XML documents. A representative group of users evaluated the system. The aim of the evaluation was validation of the usability of all of MEDICOM's functionality. The evaluation procedure was based on ISO/IEC 9126 Information technology - Software product evaluation - Quality characteristics and guidelines for their use. Results The overall user evaluation of the MEDICOM system was very positive. The MEDICOM system was characterized as an innovative concept that brings significant added value to medical-equipment commerce. Conclusions The eventual benefits of the MEDICOM system are (a) establishment of a worldwide-accessible marketplace between manufacturers and health care professionals that provides up-to-date and high-quality product information in an easy and friendly way and (b) enhancement of the efficiency of marketing procedures and after-sales support. PMID:11772547

Robust, low-noise, polarization-maintaining mode-locked Er-fiber laser with a planar lightwave circuit (PLC) device as a multi-functional element.

PubMed

Kim, Chur; Kwon, Dohyeon; Kim, Dohyun; Choi, Sun Young; Cha, Sang Jun; Choi, Ki Sun; Yeom, Dong-Il; Rotermund, Fabian; Kim, Jungwon

2017-04-15

We demonstrate a new planar lightwave circuit (PLC)-based device, integrated with a 980/1550 wavelength division multiplexer, an evanescent-field-interaction-based saturable absorber, and an output tap coupler, which can be employed as a multi-functional element in mode-locked fiber lasers. Using this multi-functional PLC device, we demonstrate a simple, robust, low-noise, and polarization-maintaining mode-locked Er-fiber laser. The measured full-width at half-maximum bandwidth is 6 nm centered at 1555 nm, corresponding to 217 fs transform-limited pulse duration. The measured RIN and timing jitter are 0.22% [10 Hz-10 MHz] and 6.6 fs [10 kHz-1 MHz], respectively. Our results show that the non-gain section of mode-locked fiber lasers can be easily implemented as a single PLC chip that can be manufactured by a wafer-scale fabrication process. The use of PLC processes in mode-locked lasers has the potential for higher manufacturability of low-cost and robust fiber and waveguide lasers.

78 FR 58305 - Honeywell International, Inc.; Analysis of Agreement Containing Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

..., formulas, patterns, devices, manufacturing processes, or customer names. If you want the Commission to give... barcode scanners, barcode printers, RFID systems and voice recognition systems. III. Scan Engines The...

78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... medicines at home, and dialysis machines in outpatient centers. The specific risks to patients and the best... impacted your manufacturing site? What were the lessons learned during the recovery process as you returned...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

Advanced Research Deposition System (ARDS) for processing CdTe solar cells

NASA Astrophysics Data System (ADS)

Barricklow, Keegan Corey

CdTe solar cells have been commercialized at the Gigawatt/year level. The development of volume manufacturing processes for next generation CdTe photovoltaics (PV) with higher efficiencies requires research systems with flexibility, scalability, repeatability and automation. The Advanced Research Deposition Systems (ARDS) developed by the Materials Engineering Laboratory (MEL) provides such a platform for the investigation of materials and manufacturing processes necessary to produce the next generation of CdTe PV. Limited by previous research systems, the ARDS was developed to provide process and hardware flexibility, accommodating advanced processing techniques, and capable of producing device quality films. The ARDS is a unique, in-line process tool with nine processing stations. The system was designed, built and assembled at the Materials Engineering Laboratory. Final assembly, startup, characterization and process development are the focus of this research. Many technical challenges encountered during the startup of the ARDS were addressed in this research. In this study, several hardware modifications needed for the reliable operation of the ARDS were designed, constructed and successfully incorporated into the ARDS. The effect of process condition on film properties for each process step was quantified. Process development to achieve 12% efficient baseline solar cell required investigation of discrete processing steps, troubleshooting process variation, and developing performance correlations. Subsequent to this research, many advances have been demonstrated with the ARDS. The ARDS consistently produces devices of 12% +/-.5% by the process of record (POR). The champion cell produced to date utilizing the ARDS has an efficiency of 16.2% on low cost commercial sodalime glass and utilizes advanced films. The ARDS has enabled investigation of advanced concepts for processing CdTe devices including, Plasma Cleaning, Plasma Enhanced Closed Space Sublimation (PECSS), Electron Reflector (ER) using Cd1-xMgxTe (CMT) structure and alternative device structures. The ARDS has been instrumental in the collaborative research with many institutions.

Nanoparticle chemisorption printing technique for conductive silver patterning with submicron resolution

PubMed Central

Yamada, Toshikazu; Fukuhara, Katsuo; Matsuoka, Ken; Minemawari, Hiromi; Tsutsumi, Jun'ya; Fukuda, Nobuko; Aoshima, Keisuke; Arai, Shunto; Makita, Yuichi; Kubo, Hitoshi; Enomoto, Takao; Togashi, Takanari; Kurihara, Masato; Hasegawa, Tatsuo

2016-01-01

Silver nanocolloid, a dense suspension of ligand-encapsulated silver nanoparticles, is an important material for printing-based device production technologies. However, printed conductive patterns of sufficiently high quality and resolution for industrial products have not yet been achieved, as the use of conventional printing techniques is severely limiting. Here we report a printing technique to manufacture ultrafine conductive patterns utilizing the exclusive chemisorption phenomenon of weakly encapsulated silver nanoparticles on a photoactivated surface. The process includes masked irradiation of vacuum ultraviolet light on an amorphous perfluorinated polymer layer to photoactivate the surface with pendant carboxylate groups, and subsequent coating of alkylamine-encapsulated silver nanocolloids, which causes amine–carboxylate conversion to trigger the spontaneous formation of a self-fused solid silver layer. The technique can produce silver patterns of submicron fineness adhered strongly to substrates, thus enabling manufacture of flexible transparent conductive sheets. This printing technique could replace conventional vacuum- and photolithography-based device processing. PMID:27091238

Modelling of double air-bridged structured inductor implemented by a GaAs integrated passive device manufacturing process

NASA Astrophysics Data System (ADS)

Li, Yang; Yao, Zhao; Zhang, Chun-Wei; Fu, Xiao-Qian; Li, Zhi-Ming; Li, Nian-Qiang; Wang, Cong

2017-05-01

In order to provide excellent performance and show the development of a complicated structure in a module and system, this paper presents a double air-bridge-structured symmetrical differential inductor based on integrated passive device technology. Corresponding to the proposed complicated structure, a new manufacturing process fabricated on a high-resistivity GaAs substrate is described in detail. Frequency-independent physical models are presented with lump elements and the results of skin effect-based measurements. Finally, some key features of the inductor are compared; good agreement between the measurements and modeled circuit fully verifies the validity of the proposed modeling approach. Meanwhile, we also present a comparison of different coil turns for inductor performance. The proposed work can provide a good solution for the design, fabrication, modeling, and practical application of radio-frequency modules and systems.

Piezoresistive Sensor with High Elasticity Based on 3D Hybrid Network of Sponge@CNTs@Ag NPs.

PubMed

Zhang, Hui; Liu, Nishuang; Shi, Yuling; Liu, Weijie; Yue, Yang; Wang, Siliang; Ma, Yanan; Wen, Li; Li, Luying; Long, Fei; Zou, Zhengguang; Gao, Yihua

2016-08-31

Pressure sensors with high elasticity are in great demand for the realization of intelligent sensing, but there is a need to develope a simple, inexpensive, and scalable method for the manufacture of the sensors. Here, we reported an efficient, simple, facile, and repeatable "dipping and coating" process to manufacture a piezoresistive sensor with high elasticity, based on homogeneous 3D hybrid network of carbon nanotubes@silver nanoparticles (CNTs@Ag NPs) anchored on a skeleton sponge. Highly elastic, sensitive, and wearable sensors are obtained using the porous structure of sponge and the synergy effect of CNTs/Ag NPs. Our sensor was also tested for over 2000 compression-release cycles, exhibiting excellent elasticity and cycling stability. Sensors with high performance and a simple fabrication process are promising devices for commercial production in various electronic devices, for example, sport performance monitoring and man-machine interfaces.

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

Warpage Measurement of Thin Wafers by Reflectometry

NASA Astrophysics Data System (ADS)

Ng, Chi Seng; Asundi, Anand Krishna

To cope with advances in the electronic and portable devices, electronic packaging industries have employed thinner and larger wafers to produce thinner packages/ electronic devices. As the thickness of the wafer decrease (below 250um), there is an increased tendency for it to warp. Large stresses are induced during manufacturing processes, particularly during backside metal deposition. The wafers bend due to these stresses. Warpage results from the residual stress will affect subsequent manufacturing processes. For example, warpage due to this residual stresses lead to crack dies during singulation process which will severely reorient the residual stress distributions, thus, weakening the mechanical and electrical properties of the singulated die. It is impossible to completely prevent the residual stress induced on thin wafers during the manufacturing processes. Monitoring of curvature/flatness is thus necessary to ensure reliability of device and its uses. A simple whole-field curvature measurement system using a novel computer aided phase shift reflection grating method has been developed and this project aims to take it to the next step for residual stress and full field surface shape measurement. The system was developed from our earlier works on Computer Aided Moiré Methods and Novel Techniques in Reflection Moiré, Experimental Mechanics (1994) in which novel structured light approach was shown for surface slope and curvature measurement. This method uses similar technology but coupled with a novel phase shift system to accurately measure slope and curvature. In this study, slope of the surface were obtain using the versatility of computer aided reflection grating method to manipulate and generate gratings in two orthogonal directions. The curvature and stress can be evaluated by performing a single order differentiation on slope data.

An improved method for characterizing photoresist lithographic and defectivity performance for sub-20nm node lithography

NASA Astrophysics Data System (ADS)

Amblard, Gilles; Purdy, Sara; Cooper, Ryan; Hockaday, Marjory

2016-03-01

The overall quality and processing capability of lithographic materials are critical for ensuring high device yield and performance at sub-20nm technology nodes in a high volume manufacturing environment. Insufficient process margin and high line width roughness (LWR) cause poor manufacturing control, while high defectivity causes product failures. In this paper, we focus on the most critical layer of a sub-20nm technology node LSI device, and present an improved method for characterizing both lithographic and post-patterning defectivity performance of state-of-the-art immersion photoresists. Multiple formulations from different suppliers were used and compared. Photoresists were tested under various process conditions, and multiple lithographic metrics were investigated (depth of focus, exposure dose latitude, line width roughness, etc.). Results were analyzed and combined using an innovative approach based on advanced software, providing clearer results than previously available. This increased detail enables more accurate performance comparisons among the different photoresists. Post-patterning defectivity was also quantified, with defects reviewed and classified using state-of-the-art inspection tools. Correlations were established between the lithographic and post-patterning defectivity performances for each material, and overall ranking was established among the photoresists, enabling the selection of the best performer for implementation in a high volume manufacturing environment.

Device overlay method for high volume manufacturing

NASA Astrophysics Data System (ADS)

Lee, Honggoo; Han, Sangjun; Kim, Youngsik; Kim, Myoungsoo; Heo, Hoyoung; Jeon, Sanghuck; Choi, DongSub; Nabeth, Jeremy; Brinster, Irina; Pierson, Bill; Robinson, John C.

2016-03-01

Advancing technology nodes with smaller process margins require improved photolithography overlay control. Overlay control at develop inspection (DI) based on optical metrology targets is well established in semiconductor manufacturing. Advances in target design and metrology technology have enabled significant improvements in overlay precision and accuracy. One approach to represent in-die on-device as-etched overlay is to measure at final inspection (FI) with a scanning electron microscope (SEM). Disadvantages to this approach include inability to rework, limited layer coverage due to lack of transparency, and higher cost of ownership (CoO). A hybrid approach is investigated in this report whereby infrequent DI/FI bias is characterized and the results are used to compensate the frequent DI overlay results. The bias characterization is done on an infrequent basis, either based on time or triggered from change points. On a per-device and per-layer basis, the optical target overlay at DI is compared with SEM on-device overlay at FI. The bias characterization results are validated and tracked for use in compensating the DI APC controller. Results of the DI/FI bias characterization and sources of variation are presented, as well as the impact on the DI correctables feeding the APC system. Implementation details in a high volume manufacturing (HVM) wafer fab will be reviewed. Finally future directions of the investigation will be discussed.

RapidNAM: generative manufacturing approach of nasoalveolar molding devices for presurgical cleft lip and palate treatment.

PubMed

Bauer, Franz Xaver; Schönberger, Markus; Gattinger, Johannes; Eblenkamp, Markus; Wintermantel, Erich; Rau, Andrea; Güll, Florian Dieter; Wolff, Klaus-Dietrich; Loeffelbein, Denys J

2017-08-28

Nasoalveolar molding (NAM) is an accepted treatment strategy in presurgical cleft therapy. The major drawbacks of the treatment listed in the literature relate to the time of the treatment and the coordination of the required interdisciplinary team of therapists, parents, and patients. To overcome these limitations, we present the automated RapidNAM concept that facilitates the design and manufacturing process of NAM devices, and that allows the virtual modification and subsequent manufacture of the devices in advance, with a growth prediction factor adapted to the patient's natural growth. The RapidNAM concept involves (i) the prediction of three trajectories that envelope the fragmented alveolar segments with the goal to mimic a harmonic arch, (ii) the extrusion from the larger toward the smaller alveolar segment along the envelope curves toward the harmonic upper alveolar arch, and (iii) the generation of the NAM device with a ventilation hole, fixation pin, and fixation points for the nasal stents. A feasibility study for a vector-based approach was successfully conducted for unilateral and bilateral cleft lip and palate (CLP) patients. A comparison of the modified target models with the reference target models showed similar results. For further improvement, the number of landmarks used to modify the models was increased by a curve-based approach.

Automated Cell Enrichment of Cytomegalovirus-specific T cells for Clinical Applications using the Cytokine-capture System.

PubMed

Kumaresan, Pappanaicken; Figliola, Mathew; Moyes, Judy S; Huls, M Helen; Tewari, Priti; Shpall, Elizabeth J; Champlin, Richard; Cooper, Laurence J N

2015-10-05

The adoptive transfer of pathogen-specific T cells can be used to prevent and treat opportunistic infections such as cytomegalovirus (CMV) infection occurring after allogeneic hematopoietic stem-cell transplantation. Viral-specific T cells from allogeneic donors, including third party donors, can be propagated ex vivo in compliance with current good manufacturing practice (cGMP), employing repeated rounds of antigen-driven stimulation to selectively propagate desired T cells. The identification and isolation of antigen-specific T cells can also be undertaken based upon the cytokine capture system of T cells that have been activated to secrete gamma-interferon (IFN-γ). However, widespread human application of the cytokine capture system (CCS) to help restore immunity has been limited as the production process is time-consuming and requires a skilled operator. The development of a second-generation cell enrichment device such as CliniMACS Prodigy now enables investigators to generate viral-specific T cells using an automated, less labor-intensive system. This device separates magnetically labeled cells from unlabeled cells using magnetic activated cell sorting technology to generate clinical-grade products, is engineered as a closed system and can be accessed and operated on the benchtop. We demonstrate the operation of this new automated cell enrichment device to manufacture CMV pp65-specific T cells obtained from a steady-state apheresis product obtained from a CMV seropositive donor. These isolated T cells can then be directly infused into a patient under institutional and federal regulatory supervision. All the bio-processing steps including removal of red blood cells, stimulation of T cells, separation of antigen-specific T cells, purification, and washing are fully automated. Devices such as this raise the possibility that T cells for human application can be manufactured outside of dedicated good manufacturing practice (GMP) facilities and instead be produced in blood banking facilities where staff can supervise automated protocols to produce multiple products.

Development of manufacturing methods for the production of superconductive devices. Final technical documentary report, 28 Jun 1965--27 Jun 1969. [Plasma arc process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haid, D.A.; Fietz, W.A.

1969-06-01

The effort to scale-up the plasma-arc process to produce large solenoids and saddle coils is described. Large coils (up to 16-/sup 3///sub 4/ in. and 41-in. length) of three different configurations, helical, ''pancake'' and ''saddle,'' were fabricated using the plasma arc process.

Additive manufacturing of microfluidic glass chips

NASA Astrophysics Data System (ADS)

Kotz, F.; Helmer, D.; Rapp, B. E.

2018-02-01

Additive manufacturing has gained great interest in the microfluidic community due to the numerous channel designs which can be tested in the early phases of a lab-on-a-chip device development. High resolution additive manufacturing like microstereolithography is largely associated with polymers. Polymers are at a disadvantage compared to other materials due to their softness and low chemical resistance. Whenever high chemical and thermal resistance combined with high optical transparency is needed, glasses become the material of choice. However, glasses are difficult to structure at the microscale requiring hazardous chemicals for etching processes. In this work we present additive manufacturing and high resolution patterning of microfluidic chips in transparent fused silica glass using stereolithography and microlithography. We print an amorphous silica nanocomposite at room temperature using benchtop stereolithography printers and a custom built microlithography system based on a digital mirror device. Using microlithography we printed structures with tens of micron resolution. The printed part is then converted to a transparent fused silica glass using thermal debinding and sintering. Printing of a microfluidic chip can be done within 30 minutes. The heat treatment can be done within two days.

78 FR 21950 - Bosley, Inc., a Corporation, and Aderans America Holdings, Inc., a Corporation, and Aderans Co...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-12

... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes... recognition. Bosley is the largest such manager in the United States. For at least four years, the chief...

Need low-cost networking? Consider DeviceNet

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moss, W.H.

1996-11-01

The drive to reduce production costs and optimize system performance in manufacturing facilities causes many end users to invest in network solutions. Because of distinct differences between the way tasks are performed and the way data are handled for various applications, it is clear than more than one network will be needed in most facilities. What is not clear is which network is most appropriate for a given application. The information layer is the link between automation and information environments via management information systems (MISs) and manufacturing execution systems (MESs) and manufacturing execution systems (MESs). Here the market has chosenmore » a de facto standard in Ethernet, primarily transmission control protocol/internet protocol (TCP/IP) and secondarily manufacturing messaging system (MMS). There is no single standard at the device layer. However, the DeviceNet communication standard has made strides to reach this goal. This protocol eliminates expensive hardwiring and provides improved communication between devices and important device-level diagnostics not easily accessible or available through hardwired I/O interfaces. DeviceNet is a low-cost communications link connecting industrial devices to a network. Many original equipment manufacturers and end users have chosen the DeviceNet platform for several reasons, but most frequently because of four key features: interchangeability; low cost; advanced diagnostics; insert devices under power.« less

Hot Melt Extruded and Injection Moulded Dosage Forms: Recent Research and Patents.

PubMed

Major, Ian; McConville, Christopher

2015-01-01

Hot Melt Extrusion (HME) and Injection Moulding (IM) are becoming more prevalent in the drug delivery field due to their continuous nature and advantages over current pharmaceutical manufacturing techniques. Hot melt extrusion (HME) is a process that involves the use of at least one reciprocating screw to force a thermoplastic resin along a heated barrel and through a die, while injection moulding is a forming process were molten polymer is forced at high pressure to enter a mould. HME offers a number of advantages over conventional pharmaceutical manufacturing techniques such as increased solubility and bioavailability of poorly water soluble drugs, a solvent free and continuous process, improved content uniformity and flexibility in manufacture. Injection moulding (IM) has been recognised as a rapid and versatile manufacturing technique, which has the advantages of being a continuous process, which is easily scaled up by the use of larger equipment and moulds. However, despite their advantages and the significant number of publications and patents on HME and IM drug delivery devices there are very few marketed formulations. These marketed products range from oral dosage forms which improve bioavailability and reduce pill burden to vaginal rings which provide long-term controlled release thus improving patient compliance. The patenting strategy for IM and HME seems to be focused towards patenting the finished product, more so than patenting the manufacturing process. This is probably due to the fact that the IM and HME processes have already been patented. HME is a process where raw materials (i.e. polymer, plasticizer, drug etc.) are mixed and pumped along by a rotating screw(s) at elevated temperatures through a die to produce a product of uniform shape. IM is similar to HME except that the raw materials are pushed into a mould which is set at lower temperatures. Interest in the use of HME and IM within the pharmaceutical industry is growing with as steady increase in the number of HME patents being issued and with more than 10 products, ranging from oral dosage forms to implantable devices, currently on the market. Therefore, this review of HME and IM is important to the scientific community to further understand and advance these novel and exciting manufacturing techniques.

Solution-Processed Cu2Se Nanocrystal Films with Bulk-Like Thermoelectric Performance.

PubMed

Forster, Jason D; Lynch, Jared J; Coates, Nelson E; Liu, Jun; Jang, Hyejin; Zaia, Edmond; Gordon, Madeleine P; Szybowski, Maxime; Sahu, Ayaskanta; Cahill, David G; Urban, Jeffrey J

2017-06-05

Thermoelectric power generation can play a key role in a sustainable energy future by converting waste heat from power plants and other industrial processes into usable electrical power. Current thermoelectric devices, however, require energy intensive manufacturing processes such as alloying and spark plasma sintering. Here, we describe the fabrication of a p-type thermoelectric material, copper selenide (Cu 2 Se), utilizing solution-processing and thermal annealing to produce a thin film that achieves a figure of merit, ZT, which is as high as its traditionally processed counterpart, a value of 0.14 at room temperature. This is the first report of a fully solution-processed nanomaterial achieving performance equivalent to its bulk form and represents a general strategy to reduce the energy required to manufacture advanced energy conversion and harvesting materials.

Current Radiation Issues for Programmable Elements and Devices

NASA Technical Reports Server (NTRS)

Katz, R.; Wang, J. J.; Koga, R.; LaBel, A.; McCollum, J.; Brown, R.; Reed, R. A.; Cronquist, B.; Crain, S.; Scott, T.;

Approximately 800-nm-Thick Pinhole-Free Perovskite Films via Facile Solvent Retarding Process for Efficient Planar Solar Cells.

PubMed

Yuan, Zhongcheng; Yang, Yingguo; Wu, Zhongwei; Bai, Sai; Xu, Weidong; Song, Tao; Gao, Xingyu; Gao, Feng; Sun, Baoquan

2016-12-21

Device performance of organometal halide perovskite solar cells significantly depends on the quality and thickness of perovskite absorber films. However, conventional deposition methods often generate pinholes within ∼300 nm-thick perovskite films, which are detrimental to the large area device manufacture. Here we demonstrated a simple solvent retarding process to deposit uniform pinhole free perovskite films with thicknesses up to ∼800 nm. Solvent evaporation during the retarding process facilitated the components separation in the mixed halide perovskite precursors, and hence the final films exhibited pinhole free morphology and large grain sizes. In addition, the increased precursor concentration after solvent-retarding process led to thick perovskite films. Based on the uniform and thick perovskite films prepared by this convenient process, a champion device efficiency up to 16.8% was achieved. We believe that this simple deposition procedure for high quality perovskite films around micrometer thickness has a great potential in the application of large area perovskite solar cells and other optoelectronic devices.

Building devices from colloidal quantum dots.

PubMed

Kagan, Cherie R; Lifshitz, Efrat; Sargent, Edward H; Talapin, Dmitri V

2016-08-26

The continued growth of mobile and interactive computing requires devices manufactured with low-cost processes, compatible with large-area and flexible form factors, and with additional functionality. We review recent advances in the design of electronic and optoelectronic devices that use colloidal semiconductor quantum dots (QDs). The properties of materials assembled of QDs may be tailored not only by the atomic composition but also by the size, shape, and surface functionalization of the individual QDs and by the communication among these QDs. The chemical and physical properties of QD surfaces and the interfaces in QD devices are of particular importance, and these enable the solution-based fabrication of low-cost, large-area, flexible, and functional devices. We discuss challenges that must be addressed in the move to solution-processed functional optoelectronic nanomaterials. Copyright © 2016, American Association for the Advancement of Science.

French Sizing of Medical Devices is not Fit for Purpose

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kibriya, Nabil, E-mail: nabskib@yahoo.co.uk; Hall, Rebecca; Powell, Steven

PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels ofmore » interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.« less

Recent advances in low-cost microfluidic platforms for diagnostic applications.

PubMed

Tomazelli Coltro, Wendell Karlos; Cheng, Chao-Min; Carrilho, Emanuel; de Jesus, Dosil Pereira

2014-08-01

The use of inexpensive materials and cost-effective manufacturing processes for mass production of microfluidic devices is very attractive and has spurred a variety of approaches. Such devices are particularly suited for diagnostic applications in limited resource settings. This review describes the recent and remarkable advances in the use of low-cost substrates for the development of microfluidic devices for diagnostics and clinical assays. Thus, a plethora of new and improved fabrication methods, designs, capabilities, detections, and applications of microfluidic devices fabricated with paper, plastic, and threads are covered. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Overlay Tolerances For VLSI Using Wafer Steppers

NASA Astrophysics Data System (ADS)

Levinson, Harry J.; Rice, Rory

1988-01-01

In order for VLSI circuits to function properly, the masking layers used in the fabrication of those devices must overlay each other to within the manufacturing tolerance incorporated in the circuit design. The capabilities of the alignment tools used in the masking process determine the overlay tolerances to which circuits can be designed. It is therefore of considerable importance that these capabilities be well characterized. Underestimation of the overlay accuracy results in unnecessarily large devices, resulting in poor utilization of wafer area and possible degradation of device performance. Overestimation will result in significant yield loss because of the failure to conform to the tolerances of the design rules. The proper methodology for determining the overlay capabilities of wafer steppers, the most commonly used alignment tool for the production of VLSI circuits, is the subject of this paper. Because cost-effective manufacturing process technology has been the driving force of VLSI, the impact on productivity is a primary consideration in all discussions. Manufacturers of alignment tools advertise the capabilities of their equipment. It is notable that no manufacturer currently characterizes his aligners in a manner consistent with the requirements of producing very large integrated circuits, as will be discussed. This has resulted in the situation in which the evaluation and comparison of the capabilities of alignment tools require the attention of a lithography specialist. Unfortunately, lithographic capabilities must be known by many other people, particularly the circuit designers and the managers responsible for the financial consequences of the high prices of modern alignment tools. All too frequently, the designer or manager is confronted with contradictory data, one set coming from his lithography specialist, and the other coming from a sales representative of an equipment manufacturer. Since the latter generally attempts to make his merchandise appear as attractive as possible, the lithographer is frequently placed in the position of having to explain subtle issues in order to justify his decisions. It is the purpose of this paper to provide that explanation.

Drug Delivery for Peripheral Nerve Regeneration

DTIC Science & Technology

2015-11-01

components are shown in Figure 2. The solvent casting method was used for manufacturing devices, with the 75/25 PLGA pellets dissolved in acetone at a...bottom-up process that minimizes wrinkling of the sheet as it expands and contracts. Following 4 hours on a hot plate, the sheet was submerged into...glass transition temperature (40-60°C), eliminating many traditional sterilization methods like autoclaving. We evaluated deformation of the device

Development of microtitre plates for electrokinetic assays

NASA Astrophysics Data System (ADS)

Burt, J. P. H.; Goater, A. D.; Menachery, A.; Pethig, R.; Rizvi, N. H.

2007-02-01

Electrokinetic processes have wide ranging applications in microsystems technology. Their optimum performance at micro and nano dimensions allows their use both as characterization and diagnostic tools and as a means of general particle manipulation. Within analytical studies, measurement of the electrokinesis of biological cells has the sensitivity and selectivity to distinguish subtle differences between cell types and cells undergoing changes and is gaining acceptance as a diagnostic tool in high throughput screening for drug discovery applications. In this work the development and manufacture of an electrokinetic-based microtitre plate is described. The plate is intended to be compatible with automated sample loading and handling systems. Manufacturing of the microtitre plate, which employs indium tin oxide microelectrodes, has been entirely undertaken using excimer and ultra-fast pulsed laser micromachining due to its flexibility in materials processing and accuracy in microstructuring. Laser micromachining has the ability to rapidly realize iterations in device prototype design while also having the capability to be scaled up for large scale manufacture. Device verification is achieved by the measurement of the electrorotation and dielectrophoretic properties of yeast cells while the flexibility of the developed microtitre plate is demonstrated by the selective separation of live yeast from polystyrene microbeads.

High volume fabrication of laser targets using MEMS techniques

NASA Astrophysics Data System (ADS)

Spindloe, C.; Arthur, G.; Hall, F.; Tomlinson, S.; Potter, R.; Kar, S.; Green, J.; Higginbotham, A.; Booth, N.; Tolley, M. K.

2016-04-01

The latest techniques for the fabrication of high power laser targets, using processes developed for the manufacture of Micro-Electro-Mechanical System (MEMS) devices are discussed. These laser targets are designed to meet the needs of the increased shot numbers that are available in the latest design of laser facilities. Traditionally laser targets have been fabricated using conventional machining or coarse etching processes and have been produced in quantities of 10s to low 100s. Such targets can be used for high complexity experiments such as Inertial Fusion Energy (IFE) studies and can have many complex components that need assembling and characterisation with high precision. Using the techniques that are common to MEMS devices and integrating these with an existing target fabrication capability we are able to manufacture and deliver targets to these systems. It also enables us to manufacture novel targets that have not been possible using other techniques. In addition, developments in the positioning systems that are required to deliver these targets to the laser focus are also required and a system to deliver the target to a focus of an F2 beam at 0.1Hz is discussed.

Manufacturability: from design to SPC limits through "corner-lot" characterization

NASA Astrophysics Data System (ADS)

Hogan, Timothy J.; Baker, James C.; Wesneski, Lisa; Black, Robert S.; Rothenbury, Dave

2004-12-01

Texas Instruments" Digital Micro-mirror Device, is used in a wide variety of optical display applications ranging from fixed and portable projectors to high-definition television (HDTV) to digital cinema projection systems. A new DMD pixel architecture, called "FTP", was designed and qualified by Texas Instruments DLPTMTM Group in 2003 to meet increased performance objectives for brightness and contrast ratio. Coordination between design, test and fabrication groups was required to balance pixel performance requirements and manufacturing capability. "Corner Lot" designed experiments (DOE) were used to verify "fabrication space" available for the pixel design. The corner lot technique allows confirmation of manufacturability projections early in the design/qualification cycle. Through careful design and analysis of the corner-lot DOE, a balance of critical dimension (cd) "budgets" is possible so that specification and process control limits can be established that meet both customer and factory requirements. The application of corner-lot DOE is illustrated in a case history of the DMD "FTP" pixel. The process for balancing test parameter requirements with multiple critical dimension budgets is shown. MEMS/MOEMS device design and fabrication can use similar techniques to achieve agressive design-to-qualification goals.

Manufacturability: from design to SPC limits through "corner-lot" characterization

NASA Astrophysics Data System (ADS)

Hogan, Timothy J.; Baker, James C.; Wesneski, Lisa; Black, Robert S.; Rothenbury, Dave

2005-01-01

Texas Instruments" Digital Micro-mirror Device, is used in a wide variety of optical display applications ranging from fixed and portable projectors to high-definition television (HDTV) to digital cinema projection systems. A new DMD pixel architecture, called "FTP", was designed and qualified by Texas Instruments DLPTMTM Group in 2003 to meet increased performance objectives for brightness and contrast ratio. Coordination between design, test and fabrication groups was required to balance pixel performance requirements and manufacturing capability. "Corner Lot" designed experiments (DOE) were used to verify "fabrication space" available for the pixel design. The corner lot technique allows confirmation of manufacturability projections early in the design/qualification cycle. Through careful design and analysis of the corner-lot DOE, a balance of critical dimension (cd) "budgets" is possible so that specification and process control limits can be established that meet both customer and factory requirements. The application of corner-lot DOE is illustrated in a case history of the DMD "FTP" pixel. The process for balancing test parameter requirements with multiple critical dimension budgets is shown. MEMS/MOEMS device design and fabrication can use similar techniques to achieve agressive design-to-qualification goals.

Additive technology of soluble mold tooling for embedded devices in composite structures: A study on manufactured tolerances

NASA Astrophysics Data System (ADS)

Roy, Madhuparna

Composite textiles have found widespread use and advantages in various industries and applications. The constant demand for high quality products and services requires companies to minimize their manufacturing costs, and delivery time in order to compete in general and niche marketplaces. Advanced manufacturing methods aim to provide economical methods of mold production. Creation of molding and tooling options for advanced composites encompasses a large portion of the fabrication time, making it a costly process and restraining factor. This research discusses a preliminary investigation into the use of soluble polymer compounds and additive manufacturing to fabricate soluble molds. These molds suffer from dimensional errors due to several factors, which have also been characterized. The basic soluble mold of a composite is 3D printed to meet the desired dimensions and geometry of holistic structures or spliced components. The time taken to dissolve the mold depends on the rate of agitation of the solvent. This process is steered towards enabling the implantation of optoelectronic devices within the composite to provide sensing capability for structural health monitoring. The shape deviation of the 3D printed mold is also studied and compared to its original dimensions to optimize the dimensional quality to produce dimensionally accurate parts. Mechanical tests were performed on compact tension (CT) resin samples prepared from these 3D printed molds and revealed crack propagation towards an embedded intact optical fiber.

Additive manufacturing of titanium alloys in the biomedical field: processes, properties and applications.

PubMed

Trevisan, Francesco; Calignano, Flaviana; Aversa, Alberta; Marchese, Giulio; Lombardi, Mariangela; Biamino, Sara; Ugues, Daniele; Manfredi, Diego

2018-04-01

The mechanical properties and biocompatibility of titanium alloy medical devices and implants produced by additive manufacturing (AM) technologies - in particular, selective laser melting (SLM), electron beam melting (EBM) and laser metal deposition (LMD) - have been investigated by several researchers demonstrating how these innovative processes are able to fulfil medical requirements for clinical applications. This work reviews the advantages given by these technologies, which include the possibility to create porous complex structures to improve osseointegration and mechanical properties (best match with the modulus of elasticity of local bone), to lower processing costs, to produce custom-made implants according to the data for the patient acquired via computed tomography and to reduce waste.

Advanced plasma etch technologies for nanopatterning

NASA Astrophysics Data System (ADS)

Wise, Rich

2013-10-01

Advances in patterning techniques have enabled the extension of immersion lithography from 65/45 nm through 14/10 nm device technologies. A key to this increase in patterning capability has been innovation in the subsequent dry plasma etch processing steps. Multiple exposure techniques, such as litho-etch-litho-etch, sidewall image transfer, line/cut mask, and self-aligned structures, have been implemented to solution required device scaling. Advances in dry plasma etch process control across wafer uniformity and etch selectivity to both masking materials have enabled adoption of vertical devices and thin film scaling for increased device performance at a given pitch. Plasma etch processes, such as trilayer etches, aggressive critical dimension shrink techniques, and the extension of resist trim processes, have increased the attainable device dimensions at a given imaging capability. Precise control of the plasma etch parameters affecting across-design variation, defectivity, profile stability within wafer, within lot, and across tools has been successfully implemented to provide manufacturable patterning technology solutions. IBM has addressed these patterning challenges through an integrated total patterning solutions team to provide seamless and synergistic patterning processes to device and integration internal customers. We will discuss these challenges and the innovative plasma etch solutions pioneered by IBM and our alliance partners.

Advanced plasma etch technologies for nanopatterning

NASA Astrophysics Data System (ADS)

Wise, Rich

2012-03-01

Advances in patterning techniques have enabled the extension of immersion lithography from 65/45nm through 14/10nm device technologies. A key to this increase in patterning capability has been innovation in the subsequent dry plasma etch processing steps. Multiple exposure techniques such as litho-etch-litho-etch, sidewall image transfer, line/cut mask and self-aligned structures have been implemented to solution required device scaling. Advances in dry plasma etch process control, across wafer uniformity and etch selectivity to both masking materials and have enabled adoption of vertical devices and thin film scaling for increased device performance at a given pitch. Plasma etch processes such as trilayer etches, aggressive CD shrink techniques, and the extension of resist trim processes have increased the attainable device dimensions at a given imaging capability. Precise control of the plasma etch parameters affecting across design variation, defectivity, profile stability within wafer, within lot, and across tools have been successfully implemented to provide manufacturable patterning technology solutions. IBM has addressed these patterning challenges through an integrated Total Patterning Solutions team to provide seamless and synergistic patterning processes to device and integration internal customers. This paper will discuss these challenges and the innovative plasma etch solutions pioneered by IBM and our alliance partners.

Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry.

PubMed

Geissler, Norman; Byrnes, Trevor; Lauer, Wolfgang; Radermacher, Klaus; Kotzsch, Susanne; Korb, Werner; Hölscher, Uvo M

2013-02-01

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.

40 CFR 424.21 - Specialized definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... mean megawatt hour(s) of electrical energy consumed in the smelting process (furnace power consumption). ... STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Covered Electric Furnaces and Other Smelting Operations With Wet Air Pollution Control Devices Subcategory § 424.21 Specialized definitions. For the...

40 CFR 424.21 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... mean megawatt hour(s) of electrical energy consumed in the smelting process (furnace power consumption). ... STANDARDS FERROALLOY MANUFACTURING POINT SOURCE CATEGORY Covered Electric Furnaces and Other Smelting Operations With Wet Air Pollution Control Devices Subcategory § 424.21 Specialized definitions. For the...

Challenges and Recent Developments in Hearing Aids: Part II. Feedback and Occlusion Effect Reduction Strategies, Laser Shell Manufacturing Processes, and Other Signal Processing Technologies

PubMed Central

Chung, King

2004-01-01

This is the second part of a review on the challenges and recent developments in hearing aids. Feedback and the occlusion effect pose great challenges in hearing aid design and usage. Yet, conventional solutions to feedback and the occlusion effect often create a dilemma: the solution to one often leads to the other. This review discusses the advanced signal processing strategies to reduce feedback and some new approaches to reduce the occlusion effect. Specifically, the causes of three types of feedback (acoustic, mechanical, and electromagnetic) are discussed. The strategies currently used to reduce acoustic feedback (i.e., adaptive feedback reduction algorithms using adaptive gain reduction, notch filtering, and phase cancellation strategies) and the design of new receivers that are built to reduce mechanical and electromagnetic feedback are explained. In addition, various new strategies (i.e., redesigned sound delivery devices and receiver-in-the-ear-canal hearing aid configuration) to reduce the occlusion effect are reviewed. Many manufacturers have recently adopted laser shell-manufacturing technologies to overcome problems associated with manufacturing custom hearing aid shells. The mechanisms of selected laser sintering and stereo lithographic apparatus and the properties of custom shells produced by these two processes are reviewed. Further, various new developments in hearing aid transducers, telecoils, channel-free amplification, open-platform programming options, rechargeable hearing aids, ear-level frequency modulated (FM) receivers, wireless Bluetooth FM systems, and wireless programming options are briefly explained and discussed. Finally, the applications of advanced hearing aid technologies to enhance other devices such as cochlear implants, hearing protectors, and cellular phones are discussed. PMID:15735871

Additive Manufacturing of Low Cost Upper Stage Propulsion Components

NASA Technical Reports Server (NTRS)

Protz, Christopher; Bowman, Randy; Cooper, Ken; Fikes, John; Taminger, Karen; Wright, Belinda

2014-01-01

NASA is currently developing Additive Manufacturing (AM) technologies and design tools aimed at reducing the costs and manufacturing time of regeneratively cooled rocket engine components. These Low Cost Upper Stage Propulsion (LCUSP) tasks are funded through NASA's Game Changing Development Program in the Space Technology Mission Directorate. The LCUSP project will develop a copper alloy additive manufacturing design process and develop and optimize the Electron Beam Freeform Fabrication (EBF3) manufacturing process to direct deposit a nickel alloy structural jacket and manifolds onto an SLM manufactured GRCop chamber and Ni-alloy nozzle. In order to develop these processes, the project will characterize both the microstructural and mechanical properties of the SLMproduced GRCop-84, and will explore and document novel design techniques specific to AM combustion devices components. These manufacturing technologies will be used to build a 25K-class regenerative chamber and nozzle (to be used with tested DMLS injectors) that will be tested individually and as a system in hot fire tests to demonstrate the applicability of the technologies. These tasks are expected to bring costs and manufacturing time down as spacecraft propulsion systems typically comprise more than 70% of the total vehicle cost and account for a significant portion of the development schedule. Additionally, high pressure/high temperature combustion chambers and nozzles must be regeneratively cooled to survive their operating environment, causing their design to be time consuming and costly to build. LCUSP presents an opportunity to develop and demonstrate a process that can infuse these technologies into industry, build competition, and drive down costs of future engines.

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.

PubMed

Sackner-Bernstein, Jonathan

2017-03-01

The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

A Low Temperature Co-fired Ceramics Manufactured Power Inductor Based on A Ternary Hybrid Material System

NASA Astrophysics Data System (ADS)

Xie, Yunsong; Chen, Ru

Low temperature co-fired ceramics (LTCC) is one of the most important techniques to produce circuits with high working frequency, multi-functionality and high integration. We have developed a methodology to enable a ternary hybrid material system being implemented into the LTCC manufacturing process. The co-firing sintering process can be divided into a densification and cooling process. In this method, a successful ternary hybrid material densification process is achieved by tuning the sintering profile of each material to match each other. The system integrity is maintained in the cooling process is obtained by develop a strong bonding at the interfaces of each materials. As a demonstration, we have construct a power inductor device made of the ternary material system including Ag, NiCuZn ferrite and non-magnetic ceramic. The power inductors well maintains its physical integrity after sintering. The microscopic images show no obvious sign of cracks or structural deformation. More importantly, despite the bonding between the ferrite and ceramic is enhanced by non-magnetic element diffusion, the undesired magnetic elements diffusion is effectively suppressed. The electric performance shows that the power handling capability is comparable to the current state of art device.

40 CFR Table 1 to Subpart Hhhh of... - Minimum Requirements for Monitoring and Recordkeeping

Code of Federal Regulations, 2010 CFR

2010-07-01

...-hour block averages. 2. Other process or control device parameters specified in your OMM b plan. As... value for each product manufactured during the operating day. 6. UF-to-latex ratio in the binder c For... Required if a thermal oxidizer is used to control formaldehyde emissions. b Required if process...

Using computed tomography and 3D printing to construct custom prosthetics attachments and devices.

PubMed

Liacouras, Peter C; Sahajwalla, Divya; Beachler, Mark D; Sleeman, Todd; Ho, Vincent B; Lichtenberger, John P

2017-01-01

The prosthetic devices the military uses to restore function and mobility to our wounded warriors are highly advanced, and in many instances not publically available. There is considerable research aimed at this population of young patients who are extremely active and desire to take part in numerous complex activities. While prosthetists design and manufacture numerous devices with standard materials and limb assemblies, patients often require individualized prosthetic design and/or modifications to enable them to participate fully in complex activities. Prosthetists and engineers perform research and implement digitally designs in collaboration to generate equipment for their patient's rehabilitation needs. 3D printing allows for these devices to be manufactured from an array of materials ranging from plastic to titanium alloy. Many designs require form fitting to a prosthetic socket or a complex surface geometry. Specialty items can be scanned using computed tomography and digitally reconstructed to produce a virtual 3D model the engineer can use to design the necessary features of the desired prosthetic, device, or attachment. Completed devices are tested for fit and function. Numerous custom prostheses and attachments have been successfully translated from the research domain to clinical reality, in particular, those that feature the use of computed tomography (CT) reconstructions. The purpose of this project is to describe the research pathways to implementation for the following clinical designs: sets of bilateral hockey skates; custom weightlifting prosthetic hands; and a wine glass holder. This article will demonstrate how to incorporate CT imaging and 3D printing in the design and manufacturing process of custom attachments and assistive technology devices. Even though some of these prosthesis attachments may be relatively simple in design to an engineer, they have an enormous impact on the lives of our wounded warriors.

Virtual manufacturing work cell for engineering

NASA Astrophysics Data System (ADS)

Watanabe, Hideo; Ohashi, Kazushi; Takahashi, Nobuyuki; Kato, Kiyotaka; Fujita, Satoru

1997-12-01

The life cycles of products have been getting shorter. To meet this rapid turnover, manufacturing systems must be frequently changed as well. In engineering to develop manufacturing systems, there are several tasks such as process planning, layout design, programming, and final testing using actual machines. This development of manufacturing systems takes a long time and is expensive. To aid the above engineering process, we have developed the virtual manufacturing workcell (VMW). This paper describes a concept of VMW and design method through computer aided manufacturing engineering using VMW (CAME-VMW) related to the above engineering tasks. The VMW has all design data, and realizes a behavior of equipment and devices using a simulator. The simulator has logical and physical functionality. The one simulates a sequence control and the other simulates motion control, shape movement in 3D space. The simulator can execute the same control software made for actual machines. Therefore we can verify the behavior precisely before the manufacturing workcell will be constructed. The VMW creates engineering work space for several engineers and offers debugging tools such as virtual equipment and virtual controllers. We applied this VMW to development of a transfer workcell for vaporization machine in actual manufacturing system to produce plasma display panel (PDP) workcell and confirmed its effectiveness.

Novel EUV photoresist for sub-7nm node (Conference Presentation)

NASA Astrophysics Data System (ADS)

Furukawa, Tsuyoshi; Naruoka, Takehiko; Nakagawa, Hisashi; Miyata, Hiromu; Shiratani, Motohiro; Hori, Masafumi; Dei, Satoshi; Ayothi, Ramakrishnan; Hishiro, Yoshi; Nagai, Tomoki

2017-04-01

Extreme ultraviolet (EUV) lithography has been recognized as a promising candidate for the manufacturing of semiconductor devices as LS and CH pattern for 7nm node and beyond. EUV lithography is ready for high volume manufacturing stage. For the high volume manufacturing of semiconductor devices, significant improvement of sensitivity and line edge roughness (LWR) and Local CD Uniformity (LCDU) is required for EUV resist. It is well-known that the key challenge for EUV resist is the simultaneous requirement of ultrahigh resolution (R), low line edge roughness (L) and high sensitivity (S). Especially high sensitivity and good roughness is important for EUV lithography high volume manufacturing. We are trying to improve sensitivity and LWR/LCDU from many directions. From material side, we found that both sensitivity and LWR/LCDU are simultaneously improved by controlling acid diffusion length and efficiency of acid generation using novel resin and PAG. And optimizing EUV integration is one of the good solution to improve sensitivity and LWR/LCDU. We are challenging to develop new multi-layer materials to improve sensitivity and LWR/LCDU. Our new multi-layer materials are designed for best performance in EUV lithography system. From process side, we found that sensitivity was substantially improved maintaining LWR applying novel type of chemical amplified resist (CAR) and process. EUV lithography evaluation results obtained for new CAR EUV interference lithography. And also metal containing resist is one possibility to break through sensitivity and LWR trade off. In this paper, we will report the recent progress of sensitivity and LWR/LCDU improvement of JSR novel EUV resist and process.

Micro Computer Tomography for medical device and pharmaceutical packaging analysis.

PubMed

Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

2015-04-10

Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. Copyright © 2015 Elsevier B.V. All rights reserved.

A low temperature co-fired ceramic power inductor manufactured using a glass-free ternary composite material system

NASA Astrophysics Data System (ADS)

Li, Yuanxun; Xie, Yunsong; Xie, Ru; Chen, Daming; Han, Likun; Su, Hua

2018-03-01

A glass-free ternary composite material system (CMS) manufactured employing the low temperature ( 890 ° C ) co-fired ceramic (LTCC) technique is reported. This ternary CMS consists of silver, NiCuZn ferrite, and Zn2SiO4 ceramic. The reported device fabricated from this ternary CMS is a power inductor with a nominal inductance of 1.0 μH. Three major highlights were achieved from the device and the material study. First, unlike most other LTCC methods, no glass is required to be added in either of the dielectric materials in order to co-fire the NiCuZn ferrite, Zn2SiO4 ceramic, and silver. Second, a successfully co-fired silver, NiCuZn, and Zn2SiO4 device can be achieved by optimizing the thermal shrinkage properties of both NiCuZn and Zn2SiO4, so that they have a very similar temperature shrinkage profile. We have also found that strong non-magnetic elemental diffusion occurs during the densification process, which further enhances the success rate of manufacturing co-fired devices. Last but not least, elemental mapping suggests that strong magnetic elemental diffusion between NiCuZn and Zn2SiO4 has been suppressed during the co-firing process. The investigation of electrical performance illustrates that while the ordinary binary CMS based power inductor can deal with 400 mA DC, the ternary CMS based power inductor is able to handle higher DC currents, 700 mA and 620 mA DC, according to both simulation and experiment demonstrations, respectively.

Neurovascular Modeling: Small-Batch Manufacturing of Silicone Vascular Replicas

PubMed Central

Chueh, J.Y.; Wakhloo, A.K.; Gounis, M.J.

2009-01-01

BACKGROUND AND PURPOSE Realistic, population based cerebrovascular replicas are required for the development of neuroendovascular devices. The objective of this work was to develop an efficient methodology for manufacturing realistic cerebrovascular replicas. MATERIALS AND METHODS Brain MR angiography data from 20 patients were acquired. The centerline of the vasculature was calculated, and geometric parameters were measured to describe quantitatively the internal carotid artery (ICA) siphon. A representative model was created on the basis of the quantitative measurements. Using this virtual model, we designed a mold with core-shell structure and converted it into a physical object by fused-deposit manufacturing. Vascular replicas were created by injection molding of different silicones. Mechanical properties, including the stiffness and luminal coefficient of friction, were measured. RESULTS The average diameter, length, and curvature of the ICA siphon were 4.15 ± 0.09 mm, 22.60 ± 0.79 mm, and 0.34 ± 0.02 mm-1 (average ± standard error of the mean), respectively. From these image datasets, we created a median virtual model, which was transformed into a physical replica by an efficient batch-manufacturing process. The coefficient of friction of the luminal surface of the replica was reduced by up to 55% by using liquid silicone rubber coatings. The modulus ranged from 0.67 to 1.15 MPa compared with 0.42 MPa from human postmortem studies, depending on the material used to make the replica. CONCLUSIONS Population-representative, smooth, and true-to-scale silicone arterial replicas with uniform wall thickness were successfully built for in vitro neurointerventional device-testing by using a batch-manufacturing process. PMID:19321626

75 FR 20399 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-19

..., Revision 1, ``Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed... Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material,'' was issued with a... during the review of an application to manufacture or distribute sealed sources and devices containing...

33 CFR 159.14 - Application for certification.

Code of Federal Regulations, 2010 CFR

2010-07-01

... description of the manufacturer's production quality control and inspection methods, record keeping systems pertaining to the manufacture of marine sanitation devices, and testing procedures; (2) The design for the... device; and (4) The name and address of the applicant and the manufacturing facility. (c) The...

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Ultrafast graphene and carbon nanotube film patterning by picosecond laser pulses

NASA Astrophysics Data System (ADS)

Bobrinetskiy, Ivan I.; Emelianov, Alexey V.; Otero, Nerea; Romero, Pablo M.

2016-03-01

Carbon nanomaterials is among the most promising technologies for advanced electronic applications, due to their extraordinary chemical and physical properties. Nonetheless, after more than two decades of intensive research, the application of carbon-based nanostructures in real electronic and optoelectronic devices is still a big challenge due to lack of scalable integration in microelectronic manufacturing. Laser processing is an attractive tool for graphene device manufacturing, providing a large variety of processes through direct and indirect interaction of laser beams with graphene lattice: functionalization, oxidation, reduction, etching and ablation, growth, etc. with resolution down to the nanoscale. Focused laser radiation allows freeform processing, enabling fully mask-less fabrication of devices from graphene and carbon nanotube films. This concept is attractive to reduce costs, improve flexibility, and reduce alignment operations, by producing fully functional devices in single direct-write operations. In this paper, a picosecond laser with a wavelength of 515 nm and pulse width of 30 ps is used to pattern carbon nanostructures in two ways: ablation and chemical functionalization. The light absorption leads to thermal ablation of graphene and carbon nanotube film under the fluence 60-90 J/cm2 with scanning speed up to 2 m/s. Just under the ablation energy, the two-photon absorption leads to add functional groups to the carbon lattice which change the optical properties of graphene. This paper shows the results of controlled modification of geometrical configuration and the physical and chemical properties of carbon based nanostructures, by laser direct writing.

21 CFR 803.50 - If I am a manufacturer, what reporting requirements apply to me?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING Manufacturer Reporting... become aware of information, from any source, that reasonably suggests that a device that you market: (1) May have caused or contributed to a death or serious injury; or (2) Has malfunctioned and this device...

Conduction and Narrow Escape in Dense, Disordered, Particulate-based Heterogeneous Materials

NASA Astrophysics Data System (ADS)

Lechman, Jeremy

For optimal and reliable performance, many technological devices rely on complex, disordered heterogeneous or composite materials and their associated manufacturing processes. Examples include many powder and particulate-based materials found in phyrotechnic devices for car airbags, electrodes in energy storage devices, and various advanced composite materials. Due to their technological importance and complex structure, these materials have been the subject of much research in a number of fields. Moreover, the advent of new manufacturing techniques based on powder bed and particulate process routes, the potential of functional nano-structured materials, and the additional recognition of persistent shortcomings in predicting reliable performance of high consequence applications; leading to ballooning costs of fielding and maintaining advanced technologies, should motivate renewed efforts in understanding, predicting and controlling these materials' fabrication and behavior. Our particular effort seeks to understand the link between the top-down control presented in specific non-equilibrium processes routes (i.e., manufacturing processes) and the variability and uncertainty of the end product performance. Our ultimate aim is to quantify the variability inherent in these constrained dynamical or random processes and to use it to optimize and predict resulting material properties/performance and to inform component design with precise margins. In fact, this raises a set of deep and broad-ranging issues that have been recognized and as touching the core of a major research challenge at Sandia National Laboratories. In this talk, we will give an overview of recent efforts to address aspects of this vision. In particular the case of conductive properties of packed particulate materials will be highlighted. Combining a number of existing approaches we will discuss new insights and potential directions for further development toward the stated goal. Sandia National Laboratories is a multiprogram laboratory managed and operated by Sandia Corporation, a Lockheed-Martin Company, for the U. S. Department of Energy's National Nuclear Security Administration under Contract No. DE-AC04-94AL85000.

10 CFR 32.54 - Same: Labeling of devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS... licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or.... The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing...

10 CFR 32.54 - Same: Labeling of devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS... licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or.... The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing...

Ginning

USDA-ARS?s Scientific Manuscript database

The purpose of the cotton ginning process is to separate a field crop into its salable components. It is a necessary step between the farmer and the textile manufacturer. The original gin was a simple manually operated device that took hand harvested cotton and separated fiber from the cottonseed. T...

40 CFR 60.701 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Volatile Organic Compound Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactor Processes § 60.701 Definitions. As used in.... Incinerator means an enclosed combustion device that is used for destroying organic compounds. If there is...

40 CFR 60.701 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Volatile Organic Compound Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactor Processes § 60.701 Definitions. As used in.... Incinerator means an enclosed combustion device that is used for destroying organic compounds. If there is...

Rapid and low-cost prototyping of medical devices using 3D printed molds for liquid injection molding.

PubMed

Chung, Philip; Heller, J Alex; Etemadi, Mozziyar; Ottoson, Paige E; Liu, Jonathan A; Rand, Larry; Roy, Shuvo

2014-06-27

Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications.

Solution-Processed Cu 2Se Nanocrystal Films with Bulk-Like Thermoelectric Performance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Forster, Jason D.; Lynch, Jared J.; Coates, Nelson E.

Thermoelectric power generation can play a key role in a sustainable energy future by converting waste heat from power plants and other industrial processes into usable electrical power. Current thermoelectric devices, however, require energy intensive manufacturing processes such as alloying and spark plasma sintering. Here, we describe the fabrication of a p-type thermoelectric material, copper selenide (Cu 2 Se), utilizing solution-processing and thermal annealing to produce a thin film that achieves a figure of merit, ZT, which is as high as its traditionally processed counterpart, a value of 0.14 at room temperature. This is the first report of amore » fully solution-processed nanomaterial achieving performance equivalent to its bulk form and represents a general strategy to reduce the energy required to manufacture advanced energy conversion and harvesting materials.« less

Solution-Processed Cu 2Se Nanocrystal Films with Bulk-Like Thermoelectric Performance

DOE PAGES

Forster, Jason D.; Lynch, Jared J.; Coates, Nelson E.; ...

2017-06-05

Thermoelectric power generation can play a key role in a sustainable energy future by converting waste heat from power plants and other industrial processes into usable electrical power. Current thermoelectric devices, however, require energy intensive manufacturing processes such as alloying and spark plasma sintering. Here, we describe the fabrication of a p-type thermoelectric material, copper selenide (Cu 2 Se), utilizing solution-processing and thermal annealing to produce a thin film that achieves a figure of merit, ZT, which is as high as its traditionally processed counterpart, a value of 0.14 at room temperature. This is the first report of amore » fully solution-processed nanomaterial achieving performance equivalent to its bulk form and represents a general strategy to reduce the energy required to manufacture advanced energy conversion and harvesting materials.« less

Study for identification of Beneficial Uses of Space (BUS), phase 2. Volume 2: Technical report. Book 2: Section 5, appendices A through D

NASA Technical Reports Server (NTRS)

1973-01-01

An investigation of the technology and programmatics involved in the development of four of the products selected as capable of benefitting from space manufacturing was conducted. The four activities selected are as follows: (1) levitation heating and melting of tungsten, (2) free suspension processing of oxides to form amorphous oxide materials, (3) crystals for surface wave acoustic substrates, and (4) space manufacturing of surface acoustic wave devices.

A fast and flexible method for manufacturing 3D molded interconnect devices by the use of a rapid prototyping technology

NASA Astrophysics Data System (ADS)

Amend, P.; Pscherer, C.; Rechtenwald, T.; Frick, T.; Schmidt, M.

This paper presents experimental results of manufacturing MID-prototypes by means of SLS, laser structuring and metallization. Therefore common SLS powder (PA12) doped with laser structuring additives is used. First of all the influence of the additives on the characteristic temperatures of melting and crystallization is analyzed by means of DSC. Afterwards the sintering process is carried out and optimized by experiments. Finally the generated components are qualified regarding their density, mechanical properties and surface roughness. Especially the surface quality is important for the metallization process. Therefore surface finishing techniques are investigated.

Interface and facet control during Czochralski growth of (111) InSb crystals for cost reduction and yield improvement of IR focal plane array substrates

NASA Astrophysics Data System (ADS)

Gray, Nathan W.; Perez-Rubio, Victor; Bolke, Joseph G.; Alexander, W. B.

2014-10-01

Focal plane arrays (FPAs) made on InSb wafers are the key cost-driving component in IR imaging systems. The electronic and crystallographic properties of the wafer directly determine the imaging device performance. The "facet effect" describes the non-uniform electronic properties of crystals resulting from anisotropic dopant segregation during bulk growth. When the segregation coefficient of dopant impurities changes notably across the melt/solid interface of a growing crystal the result is non-uniform electronic properties across wafers made from these crystals. The effect is more pronounced in InSb crystals grown on the (111) axis compared with other orientations and crystal systems. FPA devices made on these wafers suffer costly yield hits due to inconsistent device response and performance. Historically, InSb crystal growers have grown approximately 9-19 degree off-axis from the (111) to avoid the facet effect and produced wafers with improved uniformity of electronic properties. It has been shown by researchers in the 1960s that control of the facet effect can produce uniform small diameter crystals. In this paper, we share results employing a process that controls the facet effect when growing large diameter crystals from which 4, 5, and 6" wafers can be manufactured. The process change resulted in an increase in wafers yielded per crystal by several times, all with high crystal quality and uniform electronic properties. Since the crystals are grown on the (111) axis, manufacturing (111) oriented wafers is straightforward with standard semiconductor equipment and processes common to the high-volume silicon wafer industry. These benefits result in significant manufacturing cost savings and increased value to our customers.

Accessing microfluidics through feature-based design software for 3D printing.

PubMed

Shankles, Peter G; Millet, Larry J; Aufrecht, Jayde A; Retterer, Scott T

2018-01-01

Additive manufacturing has been a cornerstone of the product development pipeline for decades, playing an essential role in the creation of both functional and cosmetic prototypes. In recent years, the prospects for distributed and open source manufacturing have grown tremendously. This growth has been enabled by an expanding library of printable materials, low-cost printers, and communities dedicated to platform development. The microfluidics community has embraced this opportunity to integrate 3D printing into the suite of manufacturing strategies used to create novel fluidic architectures. The rapid turnaround time and low cost to implement these strategies in the lab makes 3D printing an attractive alternative to conventional micro- and nanofabrication techniques. In this work, the production of multiple microfluidic architectures using a hybrid 3D printing-soft lithography approach is demonstrated and shown to enable rapid device fabrication with channel dimensions that take advantage of laminar flow characteristics. The fabrication process outlined here is underpinned by the implementation of custom design software with an integrated slicer program that replaces less intuitive computer aided design and slicer software tools. Devices are designed in the program by assembling parameterized microfluidic building blocks. The fabrication process and flow control within 3D printed devices were demonstrated with a gradient generator and two droplet generator designs. Precise control over the printing process allowed 3D microfluidics to be printed in a single step by extruding bridge structures to 'jump-over' channels in the same plane. This strategy was shown to integrate with conventional nanofabrication strategies to simplify the operation of a platform that incorporates both nanoscale features and 3D printed microfluidics.

Accessing microfluidics through feature-based design software for 3D printing

PubMed Central

Shankles, Peter G.; Millet, Larry J.; Aufrecht, Jayde A.

2018-01-01

Additive manufacturing has been a cornerstone of the product development pipeline for decades, playing an essential role in the creation of both functional and cosmetic prototypes. In recent years, the prospects for distributed and open source manufacturing have grown tremendously. This growth has been enabled by an expanding library of printable materials, low-cost printers, and communities dedicated to platform development. The microfluidics community has embraced this opportunity to integrate 3D printing into the suite of manufacturing strategies used to create novel fluidic architectures. The rapid turnaround time and low cost to implement these strategies in the lab makes 3D printing an attractive alternative to conventional micro- and nanofabrication techniques. In this work, the production of multiple microfluidic architectures using a hybrid 3D printing-soft lithography approach is demonstrated and shown to enable rapid device fabrication with channel dimensions that take advantage of laminar flow characteristics. The fabrication process outlined here is underpinned by the implementation of custom design software with an integrated slicer program that replaces less intuitive computer aided design and slicer software tools. Devices are designed in the program by assembling parameterized microfluidic building blocks. The fabrication process and flow control within 3D printed devices were demonstrated with a gradient generator and two droplet generator designs. Precise control over the printing process allowed 3D microfluidics to be printed in a single step by extruding bridge structures to ‘jump-over’ channels in the same plane. This strategy was shown to integrate with conventional nanofabrication strategies to simplify the operation of a platform that incorporates both nanoscale features and 3D printed microfluidics. PMID:29596418

Microgravity Manufacturing Via Fused Deposition

NASA Technical Reports Server (NTRS)

Cooper, K. G.; Griffin, M. R.

2003-01-01

Manufacturing polymer hardware during space flight is currently outside the state of the art. A process called fused deposition modeling (FDM) can make this approach a reality by producing net-shaped components of polymer materials directly from a CAE model. FDM is a rapid prototyping process developed by Stratasys, Inc.. which deposits a fine line of semi-molten polymer onto a substrate while moving via computer control to form the cross-sectional shape of the part it is building. The build platen is then lowered and the process is repeated, building a component directly layer by layer. This method enables direct net-shaped production of polymer components directly from a computer file. The layered manufacturing process allows for the manufacture of complex shapes and internal cavities otherwise impossible to machine. This task demonstrated the benefits of the FDM technique to quickly and inexpensively produce replacement components or repair broken hardware in a Space Shuttle or Space Station environment. The intent of the task was to develop and fabricate an FDM system that was lightweight, compact, and required minimum power consumption to fabricate ABS plastic hardware in microgravity. The final product of the shortened task turned out to be a ground-based breadboard device, demonstrating miniaturization capability of the system.

Silicon nanowire device and method for its manufacture

DOEpatents

Okandan, Murat; Draper, Bruce L.; Resnick, Paul J.

2017-01-03

There is provided an electronic device and a method for its manufacture. The device comprises an elongate silicon nanowire less than 0.5 .mu.m in cross-sectional dimensions and having a hexagonal cross-sectional shape due to annealing-induced energy relaxation.

A case study on Simulation and Design optimization to improve Productivity in cooling tower manufacturing industry

NASA Astrophysics Data System (ADS)

Pranav Nithin, R.; Gopikrishnan, S.; Sumesh, A.

2018-02-01

Cooling towers are the heat transfer devices commonly found in industries which are used to extract the high temperature from the coolants and make it reusable in various plants. Basically, the cooling towers has Fills made of PVC sheets stacked together to increase the surface area exposure of the cooling liquid flowing through it. This paper focuses on the study in such a manufacturing plant where fills are being manufactured. The productivity using the current manufacturing method was only 6 to 8 fills per day, where the ideal capacity was of 14 fills per day. In this plant manual labor was employed in the manufacturing process. A change in the process modification designed and implemented will help the industry to increase the productivity to 14. In this paper, initially the simulation study was done using ARENA the simulation package and later the new design was done using CAD Package and validated using Ansys Mechanical APDL. It’s found that, by the implementation of the safe design the productivity can be increased to 196 Units.

FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

PubMed

Drum, Bruce

2004-01-01

The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

Real-time parameter optimization based on neural network for smart injection molding

NASA Astrophysics Data System (ADS)

Lee, H.; Liau, Y.; Ryu, K.

2018-03-01

The manufacturing industry has been facing several challenges, including sustainability, performance and quality of production. Manufacturers attempt to enhance the competitiveness of companies by implementing CPS (Cyber-Physical Systems) through the convergence of IoT(Internet of Things) and ICT(Information & Communication Technology) in the manufacturing process level. Injection molding process has a short cycle time and high productivity. This features have been making it suitable for mass production. In addition, this process is used to produce precise parts in various industry fields such as automobiles, optics and medical devices. Injection molding process has a mixture of discrete and continuous variables. In order to optimized the quality, variables that is generated in the injection molding process must be considered. Furthermore, Optimal parameter setting is time-consuming work to predict the optimum quality of the product. Since the process parameter cannot be easily corrected during the process execution. In this research, we propose a neural network based real-time process parameter optimization methodology that sets optimal process parameters by using mold data, molding machine data, and response data. This paper is expected to have academic contribution as a novel study of parameter optimization during production compare with pre - production parameter optimization in typical studies.

Accuracy of mechanical torque-limiting devices for dental implants.

PubMed

L'Homme-Langlois, Emilie; Yilmaz, Burak; Chien, Hua-Hong; McGlumphy, Edwin

2015-10-01

A common complication in implant dentistry is unintentional implant screw loosening. The critical factor in the prevention of screw loosening is the delivery of the appropriate target torque value. Mechanical torque-limiting devices (MTLDs) are the most frequently recommended devices by the implant manufacturers to deliver the target torque value to the screw. Two types of MTLDs are available: friction-style and spring-style. Limited information is available regarding the influence of device type on the accuracy of MTLDs. The purpose of this study was to determine and compare the accuracy of spring-style and friction-style MTLDs. Five MTLDs from 6 different dental implant manufacturers (Astra Tech/Dentsply, Zimmer Dental, Biohorizons, Biomet 3i, Straumann [ITI], and Nobel Biocare) (n=5 per manufacturer) were selected to determine their accuracy in delivering target torque values preset by their manufacturers. All torque-limiting devices were new and there were 3 manufacturers for the friction-style and 3 manufacturers for the spring-style. The procedure of target torque measurement was performed 10 times for each device and a digital torque gauge (Chatillon Model DFS2-R-ND; Ametek) was used to record the measurements. Statistical analysis used nonparametric tests to determine the accuracy of the MTLDs in delivering target torque values and Bonferroni post hoc tests were used to assess pairwise comparisons. Median absolute difference between delivered torque values and target torque values of friction-style and spring-style MTLDs were not significantly different (P>.05). Accuracy of Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly different than Biohorizons torque-limiting devices (P<.05). There is no difference between the accuracy of new friction-style MTLDs and new spring-style MTLDs. All MTLDs fell within ±10% of the target torque value. Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly more accurate than Biohorizons (C) torque-limiting devices (P<.05); however, all the torque-limiting devices fell within ±10% of the target torque value preset by the manufacturers. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Computers in manufacturing

NASA Astrophysics Data System (ADS)

Hudson, C. A.

1982-02-01

CAD/CAM advances and applications for enhancing productivity in industry are explored. Wide-spread use of CAD/CAM devices are projected to occur by the time period 1992-1997, resulting in a higher percentage of technicians in the manufacturing process, while the cost of computers and software will continue to fall and become more widely available. Computer aided design is becoming a commercially viable system for design and geometric modeling, engineering analysis, kinematics, and drafting, and efforts to bridge the gap between CAD and CAM are indicated, with particular attention given to layering, wherein individual monitoring of different parts of the manufacturing process can be effected without crossover of unnecessary information. The potentials and barriers to the use of robotics are described, with the added optimism that displaced workers to date have moved up to jobs of higher skill and interest.

Latest advances in the manufacturing of 3D rechargeable lithium microbatteries

NASA Astrophysics Data System (ADS)

Ferrari, Stefania; Loveridge, Melanie; Beattie, Shane D.; Jahn, Marcus; Dashwood, Richard J.; Bhagat, Rohit

2015-07-01

Recent advances in micro- and nano-electromechanical systems (MEMS/NEMS) technology have led to a niche industry of diverse small-scale devices that include microsensors, micromachines and drug-delivery systems. For these devices, there is an urgent need to develop Micro Lithium Ion Batteries (MLIBs) with dimensions on the scale 1-10 mm3 enabling on-board power delivery. Unfortunately, power limitations are inherent in planar 2D cells and only the advent of 3D designs and microarchitectures will lead to a real breakthrough in the microbattery technology. During the last few years, many efforts to optimise MLIBs were discussed in literature, both in the planar and 3D configurations. This review highlights the importance of 3D microarchitectured electrodes to fabricate batteries that can be device-integrated with exceptionally high specific power density coupled with exquisite miniaturisation. A wide literature overview is provided and recent advances in manufacturing routes to 3D-MLIBs comprising materials synthesis, device formulation, device testing are herein discussed. The advent of simple, economic and easily scalable fabrication processes such as 3D printing will have a decisive role in the growing field of micropower sources and microdevices.

Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix.

PubMed

Smirniotopoulos, Amalea

2012-01-01

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.

Optimizing the construction of devices to control inaccesible surfaces - case study

NASA Astrophysics Data System (ADS)

Niţu, E. L.; Costea, A.; Iordache, M. D.; Rizea, A. D.; Babă, Al

2017-10-01

The modern concept for the evolution of manufacturing systems requires multi-criteria optimization of technological processes and equipments, prioritizing associated criteria according to their importance. Technological preparation of the manufacturing can be developed, depending on the volume of production, to the limit of favourable economical effects related to the recovery of the costs for the design and execution of the technological equipment. Devices, as subsystems of the technological system, in the general context of modernization and diversification of machines, tools, semi-finished products and drives, are made in a multitude of constructive variants, which in many cases do not allow their identification, study and improvement. This paper presents a case study in which the multi-criteria analysis of some structures, based on a general optimization method, of novelty character, is used in order to determine the optimal construction variant of a control device. The rational construction of the control device confirms that the optimization method and the proposed calculation methods are correct and determine a different system configuration, new features and functions, and a specific method of working to control inaccessible surfaces.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

Emission factors of air toxics from semiconductor manufacturing in Korea.

PubMed

Eom, Yun-Sung; Hong, Ji-Hyung; Lee, Suk-Jo; Lee, Eun-Jung; Cha, Jun-Seok; Lee, Dae-Gyun; Bang, Sun-Ae

2006-11-01

The development of local, accurate emission factors is very important for the estimation of reliable national emissions and air quality management. For that, this study is performed for pollutants released to the atmosphere with source-specific emission tests from the semiconductor manufacturing industry. The semiconductor manufacturing industry is one of the major sources of air toxics or hazardous air pollutants (HAPs); thus, understanding the emission characteristics of the emission source is a very important factor in the development of a control strategy. However, in Korea, there is a general lack of information available on air emissions from the semiconductor industry. The major emission sources of air toxics examined from the semiconductor manufacturing industry were wet chemical stations, coating applications, gaseous operations, photolithography, and miscellaneous devices in the wafer fabrication and semiconductor packaging processes. In this study, analyses of emission characteristics, and the estimations of emission data and factors for air toxics, such as acids, bases, heavy metals, and volatile organic compounds from the semiconductor manufacturing process have been performed. The concentration of hydrogen chloride from the packaging process was the highest among all of the processes. In addition, the emission factor of total volatile organic compounds (TVOCs) for the packaging process was higher than that of the wafer fabrication process. Emission factors estimated in this study were compared with those of Taiwan for evaluation, and they were found to be of similar level in the case of TVOCs and fluorine compounds.

Process for forming pure silver ohmic contacts to N- and P-type gallium arsenide materials

DOEpatents

Hogan, S.J.

1983-03-13

Disclosed is an improved process for manufacturing gallium arsenide semiconductor devices having as its components a n-type gallium arsenide substrate layer and a p-type gallium arsenide diffused layer. The improved process comprises forming a pure silver ohmic contact to both the diffuse layer and the substrate layer wherein the n-type layer comprises a substantially low doping carrier concentration.

21 CFR 814.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... (d) Master file means a reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the... for a class III medical device, including all information submitted with or incorporated by reference...

IEEE WMED 2016 Homepage

Science.gov Websites

characterization, design, and new device technologies. This workshop will consist of invited talks, contributed and Reliability Semiconductor package reliability, Design for Manufacturability, Stacked die packaging and Novel assembly processes Microelectronic Circuit Design New product design, high-speed and/or low

Selecting a sterilisation subcontractor.

PubMed

Donawa, M

2001-03-01

Medical device manufacturers who need contract sterilisation services sometimes lack extensive knowledge of the technical aspects of sterilisation processes. For this reason, they may have problems assessing quality requirements for subcontractor sterilisation services. This article discusses important quality issues that should be considered when selecting a sterilisation subcontractor.

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety

PubMed Central

Sackner-Bernstein, Jonathan

2017-01-01

Background: The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware. PMID:27837161

Diffusion of novel healthcare technologies to resource poor settings.

PubMed

Malkin, Robert; von Oldenburg Beer, Kim

2013-09-01

A new product has completed clinical trials in a distant, resource poor hospital using a few dozen prototypes. The data looks great. The novel medical device solves a widely felt problem. The next goal is to integrate the device into the country's healthcare system and spread the device to other countries. But how? In order to be widely used, the device must be manufactured and distributed. One option is to license the intellectual property (IP) to an interested third party, if one can be found. However, it is possible to manage the manufacturing and distribution without licensing. There are at least two common means for manufacturing a novel medical device targeted to resource poor settings: (a) formal (contract) manufacturing and (b) informal (local) manufacturing. There are three primary routes to diffusion of novel medical devices in the developing world: (1) local distributors (2) direct international sales and (3) international donations. Perhaps surprisingly, the least effective mechanism is direct importation through donation. The most successful mechanism, the method used by nearly all working medical devices in resource-poor settings, is the use of contract manufacturing and a local distributor. This article is written for the biomedical innovator and entrepreneur who wishes to make a novel healthcare technology or product available and accessible to healthcare providers and patients in the developing world. There are very few documented cases and little formal research in this area. To this end, this article describes and explores the manufacturing and distribution options in order to provide insights into when and how each can be applied to scale up a novel technology to make a difference in a resource poor setting.

Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture

DOEpatents

McCown, Steven H [Rigby, ID; Derr, Kurt W [Idaho Falls, ID; Rohde, Kenneth W [Idaho Falls, ID

2012-05-08

Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture are described. According to one embodiment, a wireless device monitoring method includes accessing device configuration information of a wireless device present at a secure area, wherein the device configuration information comprises information regarding a configuration of the wireless device, accessing stored information corresponding to the wireless device, wherein the stored information comprises information regarding the configuration of the wireless device, comparing the device configuration information with the stored information, and indicating the wireless device as one of authorized and unauthorized for presence at the secure area using the comparing.

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

PubMed Central

2014-01-01

Background According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). Methods The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. Results The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. Conclusions The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers. PMID:24655818

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit.

PubMed

Höss, Angelika; Lampe, Christian; Panse, Ralf; Ackermann, Benjamin; Naumann, Jakob; Jäkel, Oliver

2014-03-21

According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.

Light-emitting block copolymers composition, process and use

DOEpatents

Ferraris, John P.; Gutierrez, Jose J.

2006-11-14

Generally, and in one form, the present invention is a composition of light-emitting block copolymer. In another form, the present invention is a process producing a light-emitting block copolymers that intends polymerizing a first di(halo-methyl) aromatic monomer compound in the presence of an anionic initiator and a base to form a polymer and contacting a second di(halo-methyl) aromatic monomer compound with the polymer to form a homopolymer or block copolymer wherein the block copolymer is a diblock, triblock, or star polymer. In yet another form, the present invention is an electroluminescent device comprising a light-emitting block copolymer, wherein the electroluminescent device is to be used in the manufacturing of optical and electrical devices.

Integrated MEMS-based variable optical attenuator and 10Gb/s receiver

NASA Astrophysics Data System (ADS)

Aberson, James; Cusin, Pierre; Fettig, H.; Hickey, Ryan; Wylde, James

2005-03-01

MEMS devices can be successfully commercialized in favour of competing technologies only if they offer an advantage to the customer in terms of lower cost or increased functionality. There are limited markets where MEMS can be manufactured cheaper than similar technologies due to large volumes: automotive, printing technology, wireless communications, etc. However, success in the marketplace can also be realized by adding significant value to a system at minimal cost or leverging MEMS technology when other solutions simply will not work. This paper describes a thermally actuated, MEMS based, variable optical attenuator that is co-packaged with existing opto-electronic devices to develop an integrated 10Gb/s SONET/SDH receiver. The configuration of the receiver opto-electronics and relatively low voltage availability (12V max) in optical systems bar the use of LCD, EO, and electro-chromic style attenuators. The device was designed and fabricated using a silicon-on-insulator (SOI) starting material. The design and performance of the device (displacement, power consumption, reliability, physical geometry) was defined by the receiver parameters geometry. This paper will describe how these design parameters (hence final device geometry) were determined in light of both the MEMS device fabrication process and the receiver performance. Reference will be made to the design tools used and the design flow which was a joint effort between the MEMS vendor and the end customer. The SOI technology offered a robust, manufacturable solution that gave the required performance in a cost-effective process. However, the singulation of the devices required the development of a new singulation technique that allowed large volumes of silicon to be removed during fabrication yet still offer high singulation yields.

3D printing of nano- and micro-structures

NASA Astrophysics Data System (ADS)

Ramasamy, Mouli; Varadan, Vijay K.

2016-04-01

Additive manufacturing or 3D printing techniques are being vigorously investigated as a replacement to the traditional and conventional methods in fabrication to bring forth cost and time effective approaches. Introduction of 3D printing has led to printing micro and nanoscale structures including tissues and organelles, bioelectric sensors and devices, artificial bones and transplants, microfluidic devices, batteries and various other biomaterials. Various microfabrication processes have been developed to fabricate micro components and assemblies at lab scale. 3D Fabrication processes that can accommodate the functional and geometrical requirements to realize complicated structures are becoming feasible through advances in additive manufacturing. This advancement could lead to simpler development mechanisms of novel components and devices exhibiting complex features. For instance, development of microstructure electrodes that can penetrate the epidermis of the skin to collect the bio potential signal may prove very effective than the electrodes that measure signal from the skin's surface. The micro and nanostructures will have to possess extraordinary material and mechanical properties for its dexterity in the applications. A substantial amount of research being pursued on stretchable and flexible devices based on PDMA, textiles, and organic electronics. Despite the numerous advantages these substrates and techniques could solely offer, 3D printing enables a multi-dimensional approach towards finer and complex applications. This review emphasizes the use of 3D printing to fabricate micro and nanostructures for that can be applied for human healthcare.

49 CFR 393.11 - Lamps and reflective devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., meet the applicable requirements of 49 CFR 571.108 (FMVSS No. 108) in effect at the time of manufacture..., meet the requirements of subpart B of part 393 in effect at the time of manufacture. (2) Exceptions... devices and electrical equipment in effect at the time of manufacture. Trailers which are equipped with...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gaynor, Whitney

OLED lighting has immense potential as aesthetically pleasing, energy-efficient general illumination. Unlike other light sources, such as incandescents, fluorescents, and inorganic LEDs, OLEDs naturally emit over a large-area surface. They are glare free, do not need to be shaded, and are cool to the touch, requiring no heatsink. The best efficiencies and lifetimes reported are on par with or better than current forms of illumination. However, the cost for OLED lighting remains high – so much so that these products are not market competitive and there is very low consumer demand. We believe that flexible, plastic-based devices will highlight themore » advantages of aesthetically-pleasing OLED lighting systems while paving the way for lowering both materials and manufacturing costs. These flexible devices require new development in substrate and support technology, which was the focus of the work reported here. The project team, led by Sinovia Technologies, has developed integrated plastic substrates to serve as supports for flexible OLED lighting. The substrates created in this project would enable large-area, flexible devices and are specified to perform three functions. They include a barrier to protect the OLED from moisture and oxygen-related degradation, a smooth, highly conductive transparent electrode to enable large-area device operation, and a light scattering layer to improve emission efficiency. Through the course of this project, integrated substrates were fabricated, characterized, evaluated for manufacturing feasibility and cost, and used in white OLED demonstrations to test their impact on flexible OLED lighting. Our integrated substrates meet or exceed the DOE specifications for barrier performance in water vapor and oxygen transport rates, as well as the transparency and conductivity of the anode film. We find that these integrated substrates can be manufactured in a completely roll-to-roll, high throughput process and have developed and demonstrated manufacturing methods that can produce thousands of feet of material without defects. We have evaluated the materials and manufacturing costs of these films at scale and find that they meet the current and future cost targets for bringing down the cost of OLED lighting while enabling future roll-to-roll manufacturing of the complete device. And finally, we have demonstrated that the inherent light-scattering properties of our films enhance white OLED emission efficiency from 20% to 50% depending on the metric. This work has shown that these substrates can be created, manufactured, and will perform as needed to enable flexible OLED lighting to enter the marketplace.« less

Flexible devices: from materials, architectures to applications

NASA Astrophysics Data System (ADS)

Zou, Mingzhi; Ma, Yue; Yuan, Xin; Hu, Yi; Liu, Jie; Jin, Zhong

2018-01-01

Flexible devices, such as flexible electronic devices and flexible energy storage devices, have attracted a significant amount of attention in recent years for their potential applications in modern human lives. The development of flexible devices is moving forward rapidly, as the innovation of methods and manufacturing processes has greatly encouraged the research of flexible devices. This review focuses on advanced materials, architecture designs and abundant applications of flexible devices, and discusses the problems and challenges in current situations of flexible devices. We summarize the discovery of novel materials and the design of new architectures for improving the performance of flexible devices. Finally, we introduce the applications of flexible devices as key components in real life. Project supported by the National Key R&D Program of China (Nos. 2017YFA0208200, 2016YFB0700600, 2015CB659300), the National Natural Science Foundation of China (Nos. 21403105, 21573108), and the Fundamental Research Funds for the Central Universities (No. 020514380107).

Printable Functional Chips Based on Nanoparticle Assembly.

PubMed

Huang, Yu; Li, Wenbo; Qin, Meng; Zhou, Haihua; Zhang, Xingye; Li, Fengyu; Song, Yanlin

2017-01-01

With facile manufacturability and modifiability, impressive nanoparticles (NPs) assembly applications were performed for functional patterned devices, which have attracted booming research attention due to their increasing applications in high-performance optical/electrical devices for sensing, electronics, displays, and catalysis. By virtue of easy and direct fabrication to desired patterns, high throughput, and low cost, NPs assembly printing is one of the most promising candidates for the manufacturing of functional micro-chips. In this review, an overview of the fabrications and applications of NPs patterned assembly by printing methods, including inkjet printing, lithography, imprinting, and extended printing techniques is presented. The assembly processes and mechanisms on various substrates with distinct wettabilities are deeply discussed and summarized. Via manipulating the droplet three phase contact line (TCL) pinning or slipping, the NPs contracted in ink are controllably assembled following the TCL, and generate novel functional chips and correlative integrate devices. Finally, the perspective of future developments and challenges is presented and widely exhibited. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Crystal growth and materials research in photovoltaics: progress and challenges

NASA Astrophysics Data System (ADS)

Surek, Thomas

2005-02-01

Photovoltaics (PV) is solar electric power—a semiconductor-based technology that converts sunlight to electricity. Three decades of research has led to the discovery of new materials and devices and new processing techniques for low-cost manufacturing. This has resulted in improved sunlight-to-electricity conversion efficiencies, improved outdoor reliability, and lower module and system costs. The manufacture and sale of PV has grown into a $5 billion industry worldwide, with more than 740 megawatts of PV modules shipped in 2003. This paper reviews the significant progress that has occurred in PV materials and devices research over the past 30 years, focusing on the advances in crystal growth and materials research, and examines the challenges to reaching the ultimate potential of current-generation (crystalline silicon), next-generation (thin films and concentrators), and future-generation PV technologies. The latter includes innovative materials and device concepts that hold the promise of significantly higher conversion efficiencies and/or much lower costs.

A CMOS-Compatible Poly-Si Nanowire Device with Hybrid Sensor/Memory Characteristics for System-on-Chip Applications

PubMed Central

Chen, Min-Cheng; Chen, Hao-Yu; Lin, Chia-Yi; Chien, Chao-Hsin; Hsieh, Tsung-Fan; Horng, Jim-Tong; Qiu, Jian-Tai; Huang, Chien-Chao; Ho, Chia-Hua; Yang, Fu-Liang

2012-01-01

This paper reports a versatile nano-sensor technology using “top-down” poly-silicon nanowire field-effect transistors (FETs) in the conventional Complementary Metal-Oxide Semiconductor (CMOS)-compatible semiconductor process. The nanowire manufacturing technique reduced nanowire width scaling to 50 nm without use of extra lithography equipment, and exhibited superior device uniformity. These n type polysilicon nanowire FETs have positive pH sensitivity (100 mV/pH) and sensitive deoxyribonucleic acid (DNA) detection ability (100 pM) at normal system operation voltages. Specially designed oxide-nitride-oxide buried oxide nanowire realizes an electrically Vth-adjustable sensor to compensate device variation. These nanowire FETs also enable non-volatile memory application for a large and steady Vth adjustment window (>2 V Programming/Erasing window). The CMOS-compatible manufacturing technique of polysilicon nanowire FETs offers a possible solution for commercial System-on-Chip biosensor application, which enables portable physiology monitoring and in situ recording. PMID:22666012

Bio-composites from mycelium reinforced agricultural substrates

USDA-ARS?s Scientific Manuscript database

There is a need for biodegradable alternatives to the inert plastics and expanded foams currently used in in manufacturing processes and device components. The material focused on in this report is a bio-composite patented by Ecovative Design, LLC. The bio-composite utilizes the fungus mycelium to i...

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.

Single Crystal DMs for Space-Based Observatories

NASA Astrophysics Data System (ADS)

Bierden, Paul

We propose to demonstrate the feasibility of a new manufacturing process for large aperture, high-actuator count microelectromechanical deformable mirrors (MEMS-DMs). These DMs are designed to fill a critical technology gap in NASA s plan for high- contrast space-based exoplanet observatories. We will manufacture a prototype DM with a continuous mirror facesheet, having an active aperture of 50mm diameter, supported by 2040 electrostatic actuators (50 across the diameter of the active aperture), spaced at a pitch of 1mm. The DM will be manufactured using silicon microfabrication tools. The strategic motivation for the proposed project is to advance MEMS DMs as an enabling technology in NASA s rapidly emerging program for extrasolar planet exploration. That goal is supported by an Astro2010 white paper on Technologies for Direct Optical Imaging of Exoplanets, which concluded that DMs are a critical component for all proposed internal coronagraph instrument concepts. That white paper pointed to great strides made by DM developers in the past decade, and acknowledged the components made by Boston Micromachines Corporation to be the most notable MEMS-based technology option. The principal manufacturing innovation in this project will be assembly of the DM through fusion bonding of three separate single crystal silicon wafers comprising the device s substrate, actuator array, and facesheet. The most significant challenge of this project will be to develop processes that allow reliable fusion bonds between multiple compliant silicon layers while yielding an optically flat surface and a robust electromechanical system. The compliance of the DM, which is required for its electromechanical function, will make it challenging to achieve the intimate, planar contact that is generally needed for success in fusion bonding. The manufacturing approach will use photolithography and reactive ion etching to pattern structural layers. Three wafer-scale devices will be patterned and etched independently: one for the substrate and fixed electrode layer, one for the actuator layer, and one for the mirror layer. Subsequently, each of these wafers will be bonded through a thermal fusion process to the others. In an innovative new processing technique, we will employ sacrificial oxide pillars to add temporary support to the otherwise compliant device structures. These pillars will be dissolved after assembly. The result will be a stress-free, single crystal silicon device with broadly expanded design space for geometric parameters such as actuator pitch, mirror diameter, array size, and actuator gap. Consequently, this approach will allow us to make devices with characteristics that are needed for some important NASA applications in space-based coronography, especially where larger array sizes, greater actuator pitch, and better optical surface quality are needed. The significance of this work is that it will provide a technology platform that meets or exceeds the superb optical performance that has been demonstrated in conventional pizezoelectrically actuated DMs, while retaining the advantages in cost, repeatability, and thermal insensitivity that have been demonstrated in the newer generation of MEMS electrostatically actuated DMs. The shift to bonded single-crystal structures will eliminate the single biggest drawback in previously reported NASA-fielded MEMS DM technology: device susceptibility to stress-induced scalloping and print through artifacts resulting from polycrystalline thin film surface micromachining. With single crystal structures bonded at atomic scales, uncorrected surface topography can be controlled to subnanometer levels, enabling the advancement of NASA s next-generation space-based coronagraphs.

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2013 CFR

2013-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2010 CFR

2010-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2012 CFR

2012-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2014 CFR

2014-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2011 CFR

2011-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

Materials, Structures and Manufacturing: An Integrated Approach to Develop Expandable Structures

NASA Technical Reports Server (NTRS)

Belvin, W. Keith; Zander, Martin E.; Sleight, Daid W.; Connell, John; Holloway, Nancy; Palmieri, Frank

2012-01-01

Membrane dominated space structures are lightweight and package efficiently for launch; however, they must be expanded (deployed) in-orbit to achieve the desired geometry. These expandable structural systems include solar sails, solar power arrays, antennas, and numerous other large aperture devices that are used to collect, reflect and/or transmit electromagnetic radiation. In this work, an integrated approach to development of thin-film damage tolerant membranes is explored using advanced manufacturing. Bio-inspired hierarchical structures were printed on films using additive manufacturing to achieve improved tear resistance and to facilitate membrane deployment. High precision, robust expandable structures can be realized using materials that are both space durable and processable using additive manufacturing. Test results show this initial work produced higher tear resistance than neat film of equivalent mass. Future research and development opportunities for expandable structural systems designed using an integrated approach to structural design, manufacturing, and materials selection are discussed.

Comparison of roll-to-roll replication approaches for microfluidic and optical functions in lab-on-a-chip diagnostic devices

NASA Astrophysics Data System (ADS)

Brecher, Christian; Baum, Christoph; Bastuck, Thomas

2015-03-01

Economically advantageous microfabrication technologies for lab-on-a-chip diagnostic devices substituting commonly used glass etching or injection molding processes are one of the key enablers for the emerging market of microfluidic devices. On-site detection in fields of life sciences, point of care diagnostics and environmental analysis requires compact, disposable and highly functionalized systems. Roll-to-roll production as a high volume process has become the emerging fabrication technology for integrated, complex high technology products within recent years (e.g. fuel cells). Differently functionalized polymer films enable researchers to create a new generation of lab-on-a-chip devices by combining electronic, microfluidic and optical functions in multilayer architecture. For replication of microfluidic and optical functions via roll-to-roll production process competitive approaches are available. One of them is to imprint fluidic channels and optical structures of micro- or nanometer scale from embossing rollers into ultraviolet (UV) curable lacquers on polymer substrates. Depending on dimension, shape and quantity of those structures there are alternative manufacturing technologies for the embossing roller. Ultra-precise diamond turning, electroforming or casting polymer materials are used either for direct structuring or manufacturing of roller sleeves. Mastering methods are selected for application considering replication quality required and structure complexity. Criteria for the replication quality are surface roughness and contour accuracy. Structure complexity is evaluated by shapes producible (e.g. linear, circular) and aspect ratio. Costs for the mastering process and structure lifetime are major cost factors. The alternative replication approaches are introduced and analyzed corresponding to the criteria presented. Advantages and drawbacks of each technology are discussed and exemplary applications are presented.

Low cost microfluidic device based on cotton threads for electroanalytical application.

PubMed

Agustini, Deonir; Bergamini, Márcio F; Marcolino-Junior, Luiz Humberto

2016-01-21

Microfluidic devices are an interesting alternative for performing analytical assays, due to the speed of analyses, reduced sample, reagent and solvent consumption and less waste generation. However, the high manufacturing costs still prevent the massive use of these devices worldwide. Here, we present the construction of a low cost microfluidic thread-based electroanalytical device (μTED), employing extremely cheap materials and a manufacturing process free of equipment. The microfluidic channels were built with cotton threads and the estimated cost per device was only $0.39. The flow of solutions (1.12 μL s(-1)) is generated spontaneously due to the capillary forces, eliminating the use of any pumping system. To demonstrate the analytical performance of the μTED, a simultaneous determination of acetaminophen (ACT) and diclofenac (DCF) was performed by multiple pulse amperometry (MPA). A linear dynamic range (LDR) of 10 to 320 μmol L(-1) for both species, a limit of detection (LOD) and a limit of quantitation (LOQ) of 1.4 and 4.7 μmol L(-1) and 2.5 and 8.3 μmol L(-1) for ACT and DCF, respectively, as well as an analytical frequency of 45 injections per hour were reached. Thus, the proposed device has shown potential to extend the use of microfluidic analytical devices, due to its simplicity, low cost and good analytical performance.

Semitransparent organic photovoltaic modules with Ag nanowire top electrodes

NASA Astrophysics Data System (ADS)

Guo, Fei; Kubis, Peter; Przybilla, Thomas; Spiecker, Erdmann; Forberich, Karen; Brabec, Christoph J.

2014-10-01

Semitransparent organic photovoltaic (OPV) cells are promising for applications in transparent architectures where their opaque counterparts are not suitable. Manufacturing of large-area modules without performance losses compared to their lab-scale devices is a key step towards practical applications of this PV technology. In this paper, we report the use of solution-processed silver nanowires as top electrodes and fabricate semitransparent OPV modules based on ultra-fast laser scribing. Through a rational choice of device architecture in combination with high-precision laser patterning, we demonstrate efficient semitransparent modules with comparable performance as compared to the reference devices.

Conductivity based on selective etch for GaN devices and applications thereof

DOEpatents

Zhang, Yu; Sun, Qian; Han, Jung

2015-12-08

This invention relates to methods of generating NP gallium nitride (GaN) across large areas (>1 cm.sup.2) with controlled pore diameters, pore density, and porosity. Also disclosed are methods of generating novel optoelectronic devices based on porous GaN. Additionally a layer transfer scheme to separate and create free-standing crystalline GaN thin layers is disclosed that enables a new device manufacturing paradigm involving substrate recycling. Other disclosed embodiments of this invention relate to fabrication of GaN based nanocrystals and the use of NP GaN electrodes for electrolysis, water splitting, or photosynthetic process applications.

Perforation patterned electrical interconnects

DOEpatents

Frey, Jonathan

2014-01-28

This disclosure describes systems and methods for increasing the usable surface area of electrical contacts within a device, such as a thin film solid state device, through the implementation of electrically conductive interconnects. Embodiments described herein include the use of a plurality of electrically conductive interconnects that penetrate through a top contact layer, through one or more multiple layers, and into a bottom contact layer. The plurality of conductive interconnects may form horizontal and vertical cross-sectional patterns. The use of lasers to form the plurality of electrically conductive interconnects from reflowed layer material further aids in the manufacturing process of a device.

Impact of Hearing Aid Technology on Outcomes in Daily Life I: the Patients’ Perspective

PubMed Central

Cox, Robyn M; Johnson, Jani A; Xu, Jingjing

2016-01-01

Objectives One of the challenges facing hearing care providers when recommending hearing aids is the choice of device technology level. Major manufacturers market families of hearing aids that are described as spanning the range from basic technology to premium technology. Premium technology hearing aids include acoustical processing capabilities (features) that are not found in basic technology instruments. These premium features are intended to yield improved hearing in daily life compared to basic-feature devices. However, independent research that establishes the incremental effectiveness of premium-feature devices compared to basic-feature devices is lacking. This research was designed to explore reported differences in hearing abilities for adults using premium-feature and basic-feature hearing aids in their daily lives. Design This was a single-blinded, repeated, crossover trial in which the participants were blinded. All procedures were carefully controlled to limit researcher bias. Forty-five participants used carefully fitted bilateral hearing aids for one month and then provided data to describe the hearing improvements or deficiencies noted in daily life. Typical participants were 70 years old with mild to moderate adult-onset hearing loss bilaterally. Each participant used 4 pairs of hearing aids: premium- and basic-feature devices from brands marketed by each of two major manufacturers. Participants were blinded about the devices they used and about the research questions. Results All of the outcomes were designed to capture the participant’s point of view about the benefits of the hearing aids. Three types of data were collected: change in hearing-related quality of life, extent of agreement with six positively worded statements about everyday hearing with the hearing aids, and reported preferences between the premium- and basic-feature devices from each brand as well as across all four research hearing aids combined. None of these measures yielded a statistically significant difference in outcomes between premium- and basic-feature devices. Participants did not report better outcomes with premium processing with any measure. Conclusions It could reasonably be asserted that the patient’s perspective is the gold standard for hearing aid effectiveness. While the acoustical processing provided by premium features can potentially improve scores on tests conducted in contrived conditions in a laboratory, or on specific items in a questionnaire, this does not ensure that the processing will be of noteworthy benefit when the hearing aid is used in the real world challenges faced by the patient. If evidence suggests the patient cannot detect that premium features yield improvements over basic features in daily life, what is the responsibility of the provider in recommending hearing aid technology level? In the current research, there was no evidence to suggest that premium-feature devices yielded better outcomes than basic-feature devices from the patient’s point of view. All of the research hearing aids were substantially, but equally, helpful. Further research is needed on this topic with other hearing aids and other manufacturers. In the meantime, providers should insist on scientifically credible independent evidence to support effectiveness claims for any hearing help devices. PMID:26881981

78 FR 43887 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... manufacturers and applicable group purchasing organizations (GPOs) of covered drugs, devices, biologicals, or..., applicable manufacturers of covered drugs, devices, biologicals, and medical supplies are required to submit...

Nanomanufacturing : nano-structured materials made layer-by-layer.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cox, James V.; Cheng, Shengfeng; Grest, Gary Stephen

Large-scale, high-throughput production of nano-structured materials (i.e. nanomanufacturing) is a strategic area in manufacturing, with markets projected to exceed $1T by 2015. Nanomanufacturing is still in its infancy; process/product developments are costly and only touch on potential opportunities enabled by growing nanoscience discoveries. The greatest promise for high-volume manufacturing lies in age-old coating and imprinting operations. For materials with tailored nm-scale structure, imprinting/embossing must be achieved at high speeds (roll-to-roll) and/or over large areas (batch operation) with feature sizes less than 100 nm. Dispersion coatings with nanoparticles can also tailor structure through self- or directed-assembly. Layering films structured with thesemore » processes have tremendous potential for efficient manufacturing of microelectronics, photovoltaics and other topical nano-structured devices. This project is designed to perform the requisite R and D to bring Sandia's technology base in computational mechanics to bear on this scale-up problem. Project focus is enforced by addressing a promising imprinting process currently being commercialized.« less

Research and Development Strategies in the Semiconductor Industry

NASA Astrophysics Data System (ADS)

Bowling, Allen

2003-03-01

In the 21st Century semiconductor industry, there is a critical balance between internally funded semiconductor research and development (R) and externally funded R. External R may include jointly-funded research collaborations/partnerships with other device manufacturers, jointly-funded consortia-based R, and individually-funded research programs at universities and other contract research locations. Each of these approaches has merits and each has costs. There is a critical balance between keeping the internal research and development pipeline filled and keeping it from being overspent. To meet both competitive schedule and cost goals, a semiconductor device manufacturer must decide on a model for selection of internal versus external R. Today, one of the most critical decisions is whether or not to do semiconductor research and development on 300 mm silicon wafers. Equipment suppliers are doing first development on 300 mm equipment. So, for the device manufacturer, there is a balance between the cost of doing development on 300 mm wafers and the development time schedule driven by equipment availability. In the face of these cost and schedule elements, device manufacturers are looking to consortia such as SEMATECH, SRC, and SRC MARCO for early development and screening of new materials and device structure approaches. This also causes much more close development collaboration between device manufacturer and equipment supplier. Many device manufacturers are also making use of direct contract research with universities and other contract-research organizations, such as IMEC, LETI, and other government-funded research organizations around the world. To get the most out of these external research interactions, the company must develop a strategy for management and technology integration of external R.

Regulatory aspects of noninvasive glucose measurements.

PubMed

Gutman, Steve; Bernhardt, Patricia; Pinkos, Arleen; Moxey-Mims, Marva; Knott, Thomas; Cooper, Jean

2002-01-01

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.

A fluid collection system for dermal wounds in clinical investigations

PubMed Central

Klopfer, Michael; Li, G.-P.; Widgerow, Alan; Bachman, Mark

2016-01-01

In this work, we demonstrate the use of a thin, self adherent, and clinically durable patch device that can collect fluid from a wound site for analysis. This device is manufactured from laminated silicone layers using a novel all-silicone double-molding process. In vitro studies for flow and delivery were followed by a clinical demonstration for exudate collection efficiency from a clinically presented partial thickness burn. The demonstrated utility of this device lends itself for use as a research implement used to clinically sample wound exudate for analysis. This device can serve as a platform for future integration of wearable technology into wound monitoring and care. The demonstrated fabrication method can be used for devices requiring thin membrane construction. PMID:27051470

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture

DOEpatents

West, Phillip B [Idaho Falls, ID; Novascone, Stephen R [Idaho Falls, ID; Wright, Jerry P [Idaho Falls, ID

2012-05-29

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture are described. According to one embodiment, an earth analysis method includes engaging a device with the earth, analyzing the earth in a single substantially lineal direction using the device during the engaging, and providing information regarding a subsurface feature of the earth using the analysis.

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture

DOEpatents

West, Phillip B [Idaho Falls, ID; Novascone, Stephen R [Idaho Falls, ID; Wright, Jerry P [Idaho Falls, ID

2011-09-27

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture are described. According to one embodiment, an earth analysis method includes engaging a device with the earth, analyzing the earth in a single substantially lineal direction using the device during the engaging, and providing information regarding a subsurface feature of the earth using the analysis.

Assessing new developments in the pre-market regulatory process of medical devices in the People's Republic of China.

PubMed

Zhang, Shixuan; Kriza, Christine; Kolominsky-Rabas, Peter L

2014-09-01

The objective of this paper is to provide a systematic overview of the Chinese medical device registration processes, identify challenges and suggest how these can be addressed. In addition, the paper will outline the impact of new policies and regulations since the restructuring of the China FDA. A systematic review was performed for journal articles between the year of 2009 and 2013 in the following databases: PubMed, ScienceDirect and Zhongguozhiwang. The review has identified 184 papers which were potentially relevant. Seventeen articles were included in the review, which highlights the challenges and opportunities related to the medical device registration process. In order to understand the actual impact of the regulation environment and its policies including the lack of regulatory guidance regular assessment updates are crucial. The results of this paper are aimed at informing regulatory bodies, health policy decision makers, national and international Health Technology Assessment networks as well as medical devices manufacturers.

More than a device: today's medical technology companies provide value through service.

PubMed

McCoy, Fred

2003-01-01

When physicians implant cardiac rhythm management devices, they establish a long-term relationship with those devices and with the manufacturers of those devices. The therapeutic value that each device will provide to its patient is enhanced throughout the life of the device by the services that the manufacturer provides. Services are provided prior to, during and long after implantation. Services include physician and allied health professional training, quality assurance programs, therapy outreach initiatives, on site technical support during device implantation and follow-up, technical service expertise and customer service support. The costs of these services are substantial. When assessed on a per device basis, the service costs may actually exceed the costs of manufacture. Further, the costs of these services are rising. Over the past five years, the number of implanted cardiac rhythm management devices has doubled. Industry field forces have tripled in size. Clearly, industry is dedicated to providing service as a critical element in achieving excellent patient outcomes.

Efficiency improvements of offline metrology job creation

NASA Astrophysics Data System (ADS)

Zuniga, Victor J.; Carlson, Alan; Podlesny, John C.; Knutrud, Paul C.

1999-06-01

Progress of the first lot of a new design through the production line is watched very closely. All performance metrics, cycle-time, in-line measurement results and final electrical performance are critical. Rapid movement of this lot through the line has serious time-to-market implications. Having this material waiting at a metrology operation for an engineer to create a measurement job plan wastes valuable turnaround time. Further, efficient use of a metrology system is compromised by the time required to create and maintain these measurement job plans. Thus, having a method to develop metrology job plans prior to the actual running of the material through the manufacture area can significantly improve both cycle time and overall equipment efficiency. Motorola and Schlumberger have worked together to develop and test such a system. The Remote Job Generator (RJG) created job plans for new device sin a manufacturing process from an NT host or workstation, offline. This increases available system tim effort making production measurements, decreases turnaround time on job plan creation and editing, and improves consistency across job plans. Most importantly this allows job plans for new devices to be available before the first wafers of the device arrive at the tool for measurement. The software also includes a database manager which allows updates of existing job plans to incorporate measurement changes required by process changes or measurement optimization. This paper will review the result of productivity enhancements through the increased metrology utilization and decreased cycle time associated with the use of RJG. Finally, improvements in process control through better control of Job Plans across different devices and layers will be discussed.

Single-chip microprocessor that communicates directly using light

NASA Astrophysics Data System (ADS)

Sun, Chen; Wade, Mark T.; Lee, Yunsup; Orcutt, Jason S.; Alloatti, Luca; Georgas, Michael S.; Waterman, Andrew S.; Shainline, Jeffrey M.; Avizienis, Rimas R.; Lin, Sen; Moss, Benjamin R.; Kumar, Rajesh; Pavanello, Fabio; Atabaki, Amir H.; Cook, Henry M.; Ou, Albert J.; Leu, Jonathan C.; Chen, Yu-Hsin; Asanović, Krste; Ram, Rajeev J.; Popović, Miloš A.; Stojanović, Vladimir M.

2015-12-01

Data transport across short electrical wires is limited by both bandwidth and power density, which creates a performance bottleneck for semiconductor microchips in modern computer systems—from mobile phones to large-scale data centres. These limitations can be overcome by using optical communications based on chip-scale electronic-photonic systems enabled by silicon-based nanophotonic devices8. However, combining electronics and photonics on the same chip has proved challenging, owing to microchip manufacturing conflicts between electronics and photonics. Consequently, current electronic-photonic chips are limited to niche manufacturing processes and include only a few optical devices alongside simple circuits. Here we report an electronic-photonic system on a single chip integrating over 70 million transistors and 850 photonic components that work together to provide logic, memory, and interconnect functions. This system is a realization of a microprocessor that uses on-chip photonic devices to directly communicate with other chips using light. To integrate electronics and photonics at the scale of a microprocessor chip, we adopt a ‘zero-change’ approach to the integration of photonics. Instead of developing a custom process to enable the fabrication of photonics, which would complicate or eliminate the possibility of integration with state-of-the-art transistors at large scale and at high yield, we design optical devices using a standard microelectronics foundry process that is used for modern microprocessors. This demonstration could represent the beginning of an era of chip-scale electronic-photonic systems with the potential to transform computing system architectures, enabling more powerful computers, from network infrastructure to data centres and supercomputers.

Single-chip microprocessor that communicates directly using light.

PubMed

Sun, Chen; Wade, Mark T; Lee, Yunsup; Orcutt, Jason S; Alloatti, Luca; Georgas, Michael S; Waterman, Andrew S; Shainline, Jeffrey M; Avizienis, Rimas R; Lin, Sen; Moss, Benjamin R; Kumar, Rajesh; Pavanello, Fabio; Atabaki, Amir H; Cook, Henry M; Ou, Albert J; Leu, Jonathan C; Chen, Yu-Hsin; Asanović, Krste; Ram, Rajeev J; Popović, Miloš A; Stojanović, Vladimir M

2015-12-24

Data transport across short electrical wires is limited by both bandwidth and power density, which creates a performance bottleneck for semiconductor microchips in modern computer systems--from mobile phones to large-scale data centres. These limitations can be overcome by using optical communications based on chip-scale electronic-photonic systems enabled by silicon-based nanophotonic devices. However, combining electronics and photonics on the same chip has proved challenging, owing to microchip manufacturing conflicts between electronics and photonics. Consequently, current electronic-photonic chips are limited to niche manufacturing processes and include only a few optical devices alongside simple circuits. Here we report an electronic-photonic system on a single chip integrating over 70 million transistors and 850 photonic components that work together to provide logic, memory, and interconnect functions. This system is a realization of a microprocessor that uses on-chip photonic devices to directly communicate with other chips using light. To integrate electronics and photonics at the scale of a microprocessor chip, we adopt a 'zero-change' approach to the integration of photonics. Instead of developing a custom process to enable the fabrication of photonics, which would complicate or eliminate the possibility of integration with state-of-the-art transistors at large scale and at high yield, we design optical devices using a standard microelectronics foundry process that is used for modern microprocessors. This demonstration could represent the beginning of an era of chip-scale electronic-photonic systems with the potential to transform computing system architectures, enabling more powerful computers, from network infrastructure to data centres and supercomputers.

Pure silver ohmic contacts to N- and P- type gallium arsenide materials

DOEpatents

Hogan, Stephen J.

1986-01-01

Disclosed is an improved process for manufacturing gallium arsenide semiconductor devices having as its components an n-type gallium arsenide substrate layer and a p-type gallium arsenide diffused layer. The improved process comprises forming a pure silver ohmic contact to both the diffused layer and the substrate layer, wherein the n-type layer comprises a substantially low doping carrier concentration.

Using the scanning electron microscope on the production line to assure quality semiconductors

NASA Technical Reports Server (NTRS)

Adolphsen, J. W.; Anstead, R. J.

1972-01-01

The use of the scanning electron microscope to detect metallization defects introduced during batch processing of semiconductor devices is discussed. A method of determining metallization integrity was developed which culminates in a procurement specification using the scanning microscope on the production line as a quality control tool. Batch process control of the metallization operation is monitored early in the manufacturing cycle.

Manufacturing process applications team (MATeam)

NASA Technical Reports Server (NTRS)

Bangs, E. R.

1980-01-01

The objectives and activities of an aerospace technology transfer group are outlined and programs in various stages of progress are described including the orbital tube flaring device, infrared proximity sensor for robot positioning, laser stripping magnet wire, infrared imaging as welding process tracking system, carbide coating of cutting tools, nondestructive fracture toughness testing of titanium welds, portable solar system for agricultural applications, and an anerobic methane gas generator.

3D Printing in Zero-G ISS Technology Demonstration

NASA Technical Reports Server (NTRS)

Johnston, Mallory M.; Werkheiser, Mary J.; Cooper, Kenneth G.; Snyder, Michael P.; Edmunson, Jennifer E.

2014-01-01

The National Aeronautics and Space Administration (NASA) has a long term strategy to fabricate components and equipment on-demand for manned missions to the Moon, Mars, and beyond. To support this strategy, NASA and Made in Space, Inc. are developing the 3D Printing In Zero-G payload as a Technology Demonstration for the International Space Station. The 3D Printing In Zero-G experiment will be the first machine to perform 3D printing in space. The greater the distance from Earth and the longer the mission duration, the more difficult resupply becomes; this requires a change from the current spares, maintenance, repair, and hardware design model that has been used on the International Space Station up until now. Given the extension of the ISS Program, which will inevitably result in replacement parts being required, the ISS is an ideal platform to begin changing the current model for resupply and repair to one that is more suitable for all exploration missions. 3D Printing, more formally known as Additive Manufacturing, is the method of building parts/ objects/tools layer-by-layer. The 3D Print experiment will use extrusion-based additive manufacturing, which involves building an object out of plastic deposited by a wire-feed via an extruder head. Parts can be printed from data files loaded on the device at launch, as well as additional files uplinked to the device while on-orbit. The plastic extrusion additive manufacturing process is a low-energy, low-mass solution to many common needs on board the ISS. The 3D Print payload will serve as the ideal first step to proving that process in space. It is unreasonable to expect NASA to launch large blocks of material from which parts or tools can be traditionally machined, and even more unreasonable to fly up specialized manufacturing hardware to perform the entire range of function traditionally machining requires. The technology to produce parts on demand, in space, offers unique design options that are not possible through traditional manufacturing methods while offering cost-effective, high-precision, low-unit on-demand manufacturing. Thus, Additive Manufacturing capabilities are the foundation of an advanced manufacturing in space roadmap.

21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... for Communicable Disease Agents § 610.42 Restrictions on use for further manufacture of medical...

Stochastic modeling of filtrate alkalinity in water filtration devices: Transport through micro/nano porous clay based ceramic materials

USDA-ARS?s Scientific Manuscript database

Clay and plant materials such as wood are the raw materials used in manufacture of ceramic water filtration devices around the world. A step by step manufacturing procedure which includes initial mixing, molding and sintering is used. The manufactured ceramic filters have numerous pores which help i...

A manufacturer's perspective: Hewlett Packard Y2K action plan.

PubMed

Rapp, W N

1999-01-01

Medical device manufacturers must ensure that their devices are safe and effective including investigating issues involved with the century rollover. Manufacturers must begin early to evaluate their products in order to allow time to correct and distribute these product corrections and communicate to their customers so they can prepare for the Y2K event.

Ultra-slim flexible glass for roll-to-roll electronic device fabrication

NASA Astrophysics Data System (ADS)

Garner, Sean; Glaesemann, Scott; Li, Xinghua

2014-08-01

As displays and electronics evolve to become lighter, thinner, and more flexible, the choice of substrate continues to be critical to their overall optimization. The substrate directly affects improvements in the designs, materials, fabrication processes, and performance of advanced electronics. With their inherent benefits such as surface quality, optical transmission, hermeticity, and thermal and dimensional stability, glass substrates enable high-quality and long-life devices. As substrate thicknesses are reduced below 200 μm, ultra-slim flexible glass continues to provide these inherent benefits to high-performance flexible electronics such as displays, touch sensors, photovoltaics, and lighting. In addition, the reduction in glass thickness also allows for new device designs and high-throughput, continuous manufacturing enabled by R2R processes. This paper provides an overview of ultra-slim flexible glass substrates and how they enable flexible electronic device optimization. Specific focus is put on flexible glass' mechanical reliability. For this, a combination of substrate design and process optimizations has been demonstrated that enables R2R device fabrication on flexible glass. Demonstrations of R2R flexible glass processes such as vacuum deposition, photolithography, laser patterning, screen printing, slot die coating, and lamination have been made. Compatibility with these key process steps has resulted in the first demonstration of a fully functional flexible glass device fabricated completely using R2R processes.

You're a What? Automation Technician

ERIC Educational Resources Information Center

Mullins, John

2010-01-01

Many people think of automation as laborsaving technology, but it sure keeps Jim Duffell busy. Defined simply, automation is a technique for making a device run or a process occur with minimal direct human intervention. But the functions and technologies involved in automated manufacturing are complex. Nearly all functions, from orders coming in…

77 FR 16224 - Billion Auto, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... Social Security number, date of birth, driver's license number or other state identification number or... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes... advertised, the rate be stated as an ``annual percentage rate'' using that term or the abbreviation ``APR...

Managing the Manpower Aspects of Applying Micro-Electronics Technology.

ERIC Educational Resources Information Center

Thornton, P.; Routledge, C.

1980-01-01

Outlines major effects that the application of micro-electronics devices in products/processes and in office systems will have on future manpower and skill requirements in manufacturing organizations. Identifies the type of problems these changes will pose for manpower managers. Provides general guidelines for the successful management of these…

40 CFR 60.560 - Applicability and designation of affected facilities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (including expandable polystyrene) manufacturing processes, the affected facilities are each group of...) shall be used to determine the control of emissions from the facility. Table 2—Maximum Uncontrolled... rate of a vent stream to the atmosphere that would occur in the absence of any add-on control devices...

40 CFR 60.560 - Applicability and designation of affected facilities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (including expandable polystyrene) manufacturing processes, the affected facilities are each group of...) shall be used to determine the control of emissions from the facility. Table 2—Maximum Uncontrolled... rate of a vent stream to the atmosphere that would occur in the absence of any add-on control devices...

Evaluation of mycelium reinforced agricultural fiber biocomposites for diverse applications

USDA-ARS?s Scientific Manuscript database

There is a genuine need for new biodegradable alternatives to the inert plastics and expanded foams that are common in both manufacturing processes and device componentry. The material emphasized in this report is a bio-composite patented by Ecovative Design, LLC. The bio-composite utilizes fungus m...

77 FR 13326 - Carpenter Technology Corporation and Latrobe Specialty Metals, Inc.; Analysis of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

... established sales and marketing network in the United States that will allow it to be immediately competitive... making sure that your comment does not include any sensitive personal information, like anyone's Social... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes...

77 FR 50057 - Premerger Notification; Reporting and Waiting Period Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-20

... statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. If you want... an exclusive license to all of B's patent rights for all veterinary indications. B retains all patent... veterinary indications is an asset acquisition because A is receiving all rights to the patent for a...

76 FR 70451 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

... commodities to keep records that substantiate ``cents off,'' ``introductory offer,'' and/or ``economy size... United States, 2010, U.S. Department of Labor, U.S. Bureau of Labor Statistics (May 2011) (``BLS National... information such as costs, sales statistics, inventories, formulas, patterns devices, manufacturing processes...

Silicone substrate with in situ strain relief for stretchable thin-film transistors

NASA Astrophysics Data System (ADS)

Graz, Ingrid M.; Cotton, Darryl P. J.; Robinson, Adam; Lacour, Stéphanie P.

2011-03-01

We have manufactured stretchable thin-film transistors and interconnects directly onto an engineered silicone matrix with localized and graded mechanical compliance. The fabrication only involves planar and standard processing. Brittle active device materials are patterned on non deformable elastomer regions (strain <1% at all times) while interconnects run smoothly from "stiff" to "soft" elastomer. Pentacene thin-film transistors sustain applied strain up to 13% without electrical degradation and mechanical fracture. This integrated approach opens promising options for the manufacture of physically adaptable and transformable circuitry.

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2011 CFR

2011-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2012 CFR

2012-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2010 CFR

2010-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

40 CFR 60.256 - Continuous monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... device is to be certified by the manufacturer to be accurate within ±1 inch water gauge. (B) A monitoring device for the continuous measurement of the water supply pressure to the control equipment. The monitoring device is to be certified by the manufacturer to be accurate within ±5 percent of design water...

Digital capture, design, and manufacturing of an extraoral device for a clarinet player with Bell's palsy.

PubMed

Aita-Holmes, Cynthia; Liacouras, Peter; Wilson, William O; Grant, Gerald T

2015-08-01

An extraoral device was fabricated to assist a clarinet player with Bell's palsy. The device was fabricated by using stereophotogrammetry, digital design, and additive manufacturing technologies. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

FDA use of international standards in the premarket review process.

PubMed

Rechen, E; Barth, D J; Marlowe, D; Kroger, L

1998-01-01

"This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European conformity assessment procedures with the new 510(k) paradigm will appear in an upcoming issue of BI&T.

Study of thermo-fluidic behavior of micro-droplet in inkjet-based micro manufacturing processes

NASA Astrophysics Data System (ADS)

Das, Raju; Mahapatra, Abhijit; Ball, Amit Kumar; Roy, Shibendu Shekhar; Murmu, Naresh Chandra

2017-06-01

Inkjet printing technology, a maskless, non-contact patterning operation, which has been a revelation in the field of micro and nano manufacturing for its use in the selective deposition of desired materials. It is becoming an exciting alternative technology such as lithography to print functional material on to a substrate. Selective deposition of functional materials on desired substrates is a basic requirement in many of the printing based micro and nano manufacturing operations like the fabrication of microelectronic devices, solar cell, Light-emitting Diode (LED) research fields like pharmaceutical industries for drug discovery purposes and in biotechnology to make DNA microarrays. In this paper, an attempt has been made to design and develop an indigenous Electrohydrodynamic Inkjet printing system for micro fabrication and to study the interrelationships between various thermos-fluidic parameters of the ink material in the printing process. The effect of printing process parameters on printing performance characteristics has also been studied. And the applicability of the process has also been experimentally demonstrated. The experimentally found results were quite satisfactory and accordance to its applicability.

Metalorganic chemical vapor deposition of AlGaAs and InGaP heterojunction bipolar transistors

NASA Astrophysics Data System (ADS)

Pan, N.; Welser, R. E.; Lutz, C. R.; DeLuca, P. M.; Han, B.; Hong, K.

2001-05-01

Heterojunction bipolar transistors (HBT) are now beginning to be widely incorporated as power amplifiers, laser drivers, multiplexers, clock data recovery circuits, as well as transimpedance and broadband amplifiers in high performance millimeter wave circuits (MMICs). The increasing acceptance of this device is principally due to advancements in metalorganic chemical vapor deposition (MOCVD), device processing, and circuit design technologies. Many of the DC electrical characteristics of large area devices can be directly correlated to the DC performance of small area RF devices. A precise understanding of the growth parameters and their relationship to device characteristics is critical for ensuring the high degree of reproducibility required for low cost high-yield volume manufacturing. Significant improvements in the understanding of the MOCVD growth process have been realized through the implementation of statistical process control on the key HBT device parameters. This tool has been successfully used to maintain the high quality of the device characteristics in high-volume production of 4″ GaAs-based HBTs. There is a growing demand to migrate towards 6″ diameter wafer size due to the potential cost reductions and increased volume production that can be realized. Preliminary results, indicating good heterostructure layer characteristics, demonstrate the feasibility of 6″ InGaP-based HBT devices.

Collection, Measurement and Treatment of Microorganism Using Dielectrophoretic Micro Devices

NASA Astrophysics Data System (ADS)

Uchida, Satoshi

Constant monitoring of manufacturing processes has been essential in food industry because of global expansion of microbial infection. Micro-scale dielectrophoretic method is an attractive technique for direct operation and quantitative detection of bioparticles. The electrical system is capable of rapid and simple treatments corresponding to severe legal control for food safety. In this paper, newly developed techniques are reviewed for bacterial concentration, detection and sterilization using dielectrophoresis in a micro reactor. The perspective to an integrated micro device of those components is also discussed.

Automated fiber pigtailing machine

DOEpatents

Strand, Oliver T.; Lowry, Mark E.

1999-01-01

The Automated Fiber Pigtailing Machine (AFPM) aligns and attaches optical fibers to optoelectonic (OE) devices such as laser diodes, photodiodes, and waveguide devices without operator intervention. The so-called pigtailing process is completed with sub-micron accuracies in less than 3 minutes. The AFPM operates unattended for one hour, is modular in design and is compatible with a mass production manufacturing environment. This machine can be used to build components which are used in military aircraft navigation systems, computer systems, communications systems and in the construction of diagnostics and experimental systems.

An investigation into the feasibility of locating portable medical devices using radio frequency identification devices and technology.

PubMed

Britton, J

2007-01-01

Portable medical devices represent an important resource for assisting healthcare delivery. The movement of portable devices often results in them being unavailable when needed. Tracking equipment using radiofrequency identification technology/devices (RFID) may provide a promising solution to the problems encountered in locating portable equipment. An RFID technology trial was undertaken at Royal Alexandra Hospital, Paisley. This involved the temporary installation of three active readers and attaching actively transmitting radio frequency tags to different portable medical devices. The active readers and computer system were linked using a bespoke data network. Tags and readers from two separate manufacturers were tested. Reliability difficulties were encountered when testing the technology from the first manufacturer, probably due to the casing of the medical device interfering with the signal from the tag. Improved results were obtained when using equipment from the second manufacturer with an overall error rate of 12.3%. Tags from this manufacturer were specifically designed to overcome problems observed with the first system tested. Findings from this proof of concept trial suggest that RFID technology could be used to track the location of equipment in a hospital.

Vacuum-free laminated top electrode with conductive tapes for scalable manufacturing of efficient perovskite solar cells

DOE PAGES

Shao, Yuchuan; Wang, Qi; Dong, Qingfeng; ...

2015-06-25

The efficiency of organometal trihalide perovskites (OTP) solar cells have reached that parity of single crystal silicon, and its nature abundant raw material and solution-process capability promise a bright future for commercialization. However, the vacuum based techniques for metal electrode deposition and additional encapsulation layer increase the cost of the perovskite solar cells dramatically and impede their commercialization process. Here, we report a vacuum-free low temperature lamination technique to fabricate the top electrode by commercial conductive tapes (C-tape). The simple fabrication method yields good quality contact and high efficiency device of 12.7%. The C-tapes also encapsulated the devices effectively, resultingmore » in greatly improved device stability. As a result, the combination of lamination of electrodes and encapsulation layers into a single step significantly reduce the cost of device fabrication.« less

Fibre laser cutting of polycaprolactone sheet for stents manufacturing: A feasibility study

NASA Astrophysics Data System (ADS)

Guerra, Antonio J.; Farjas, Jordi; Ciurana, Joaquim

2017-10-01

The role of the stent is temporary and it is limited to the intervention and shortly thereafter. Bioresorbable polymer stents were introduced to overcome this problem, making the stent manufacturing process rather difficult considering the complexity of the material. The stent forecast sale makes constant technology development necessary on this field. The adaptation of the laser manufacturing industry to these new materials is costly, thus further studies employing different sorts of lasers are necessary. This paper aims to explore the feasibility of 1.08 μm wavelength fibre laser to cut polycaprolactone sheet, which is especially interesting for long-term implantable devices, such as stents. The laser cut samples were analysed by Differential Scanning Calorimetry (DSC), Tensile Stress Test, and Optical Microscopy in order to study the effects of the laser process over the workpiece. The parameters measured were: taper angle, dimensional precision, material structure changes and mechanical properties changes. Results showed a dimensional precision above 95.75% with a taper angle lower than 0.033°. The laser ablation process has exhibited a minor influence upon material properties. Results exhibit the feasibility of fibre laser to cut polycaprolactone, making the fibre laser an alternative to manufacture stents.

Integration of fluidic jet actuators in composite structures

NASA Astrophysics Data System (ADS)

Schueller, Martin; Lipowski, Mathias; Schirmer, Eckart; Walther, Marco; Otto, Thomas; Geßner, Thomas; Kroll, Lothar

2015-04-01

Fluidic Actuated Flow Control (FAFC) has been introduced as a technology that influences the boundary layer by actively blowing air through slots or holes in the aircraft skin or wind turbine rotor blade. Modern wing structures are or will be manufactured using composite materials. In these state of the art systems, AFC actuators are integrated in a hybrid approach. The new idea is to directly integrate the active fluidic elements (such as SJAs and PJAs) and their components in the structure of the airfoil. Consequently, the integration of such fluidic devices must fit the manufacturing process and the material properties of the composite structure. The challenge is to integrate temperature-sensitive active elements and to realize fluidic cavities at the same time. The transducer elements will be provided for the manufacturing steps using roll-to-roll processes. The fluidic parts of the actuators will be manufactured using the MuCell® process that provides on the one hand the defined reproduction of the fluidic structures and, on the other hand, a high light weight index. Based on the first design concept, a demonstrator was developed in order to proof the design approach. The output velocity on the exit was measured using a hot-wire anemometer.

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

PubMed Central

Chung, Philip; Heller, J. Alex; Etemadi, Mozziyar; Ottoson, Paige E.; Liu, Jonathan A.; Rand, Larry; Roy, Shuvo

2014-01-01

Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications. PMID:24998993

Monolithic amorphous silicon modules on continuous polymer substrate

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grimmer, D.P.

This report examines manufacturing monolithic amorphous silicon modules on a continuous polymer substrate. Module production costs can be reduced by increasing module performance, expanding production, and improving and modifying production processes. Material costs can be reduced by developing processes that use a 1-mil polyimide substrate and multilayers of low-cost material for the front encapsulant. Research to speed up a-Si and ZnO deposition rates is needed to improve throughputs. To keep throughput rates compatible with depositions, multibeam fiber optic delivery systems for laser scribing can be used. However, mechanical scribing systems promise even higher throughputs. Tandem cells and production experience canmore » increase device efficiency and stability. Two alternative manufacturing processes are described: (1) wet etching and sheet handling and (2) wet etching and roll-to-roll fabrication.« less

Continuous and pulsed laser high power beam combiner for additive manufacturing applications

NASA Astrophysics Data System (ADS)

Bassignana, Marta; Califano, Alessio; Pescarmona, Francesco; Braglia, Andrea; Perrone, Guido

2018-02-01

Laser-based additive manufacturing (AM) from metal powders is emerging as the new industrial revolution, although current fabrication approaches still require long mechanical post-processing to improve the final surface quality and meet the design tolerances. To overcome this limitation, the next generation machines are expected to complement laser AM with laser ablation (LA) to implement surface finishing and micro texturing already during the device growth process. With this aim, a new beam combiner to allow the real-time interchange of additive and subtractive processes using the same scanner head has been designed. Extensive tests have been carried out using a 6 kW continuous-wave laser similar to that used for the metal powder fusion and a nanosecond 100W pulsed source similar to that used for laser ablation.

Manufacturing polymer light emitting diode with high luminance efficiency by solution process

NASA Astrophysics Data System (ADS)

Kim, Miyoung; Jo, SongJin; Yang, Ho Chang; Yoon, Dang Mo; Kwon, Jae-Taek; Lee, Seung-Hyun; Choi, Ju Hwan; Lee, Bum-Joo; Shin, Jin-Koog

2012-06-01

While investigating polymer light emitting diodes (polymer-LEDs) fabricated by solution process, surface roughness influences electro-optical (E-O) characteristics. We expect that E-O characteristics such as luminance and power efficiency related to surface roughness and layer thickness of emitting layer with poly-9-Vinylcarbazole. In this study, we fabricated polymer organic light emitting diodes by solution process which guarantees easy, eco-friendly and low cost manufacturing for flexible display applications. In order to obtain high luminescence efficiency, E-O characteristics of these devices by varying parameters for printing process have been investigated. Therefore, we optimized process condition for polymer-LEDs by adjusting annealing temperatures of emission, thickness of emission layer showing efficiency (10.8 cd/A) at 10 mA/cm2. We also checked wavelength dependent electroluminescence spectrum in order to find the correlation between the variation of efficiency and the thickness of the layer.

Scaling Properties of Algorithms in Nanotechnology

NASA Technical Reports Server (NTRS)

Saini, Subhash; Bailey, David H.; Chancellor, Marisa K. (Technical Monitor)

1996-01-01

At the present time, several technologies are pressing the limits of microminiature manufacturing. In semiconductor technology, for example, the Intel Pentium Pro (which is used in the Department of Energy's ASCI 'red' parallel supercomputer system) and the DEC Alpha 21164 (which is used in the CRAY T3E) both are fabricated using 0.35 micron process technology. Recently Texas Instruments (TI) announced the availability of 0.25 micron technology chips by the end of 1996 and plans to have 0.18 micron devices in production within two years. However, some significant challenges lie down the road. These include the skyrocketing cost of manufacturing plants, the 0.1 micron foreseeable limit of the photolithography process, quantum effects, data communication bandwidth limitations, heat dissipation, and others. Some related microminiature technologies include micro-electromechanical systems (MEMS), opto-electronic devices, quantum computing, biological computing, and others. All of these technologies require the fabrication of devices whose sizes are approaching the nanometer level. As such they are often collectively referred to with the name 'nanotechnology'. Clearly nanotechnology in this general sense is destined to be a very important technology of the 21st century. The ultimate dream in this arena is 'molecular nanotechnology', in other words the fabrication of devices and materials with most or all atoms and molecules in a pre-programmed position, possibly placed there by 'nano-robots'. This futuristic capability will probably not be achieved for at least two decades. However, it appears that somewhat less ambitious variations of molecular nanotechnology, such as devices and materials based on 'buckyballs' and 'nanotubes' may be realized significantly sooner, possibly within ten years or so. Even at the present time, semiconductor devices are approaching the regime where quantum chemical effects must be considered in design.

Rapid Thermal Processing (RTP) of semiconductors in space

NASA Technical Reports Server (NTRS)

Anderson, T. J.; Jones, K. S.

1993-01-01

The progress achieved on the project entitled 'Rapid Thermal Processing of Semiconductors in Space' for a 12 month period of activity ending March 31, 1993 is summarized. The activity of this group is being performed under the direct auspices of the ROMPS program. The main objective of this program is to develop and demonstrate the use of advanced robotics in space with rapid thermal process (RTP) of semiconductors providing the test technology. Rapid thermal processing is an ideal processing step for demonstration purposes since it encompasses many of the characteristics of other processes used in solid state device manufacturing. Furthermore, a low thermal budget is becoming more important in existing manufacturing practice, while a low thermal budget is critical to successful processing in space. A secondary objective of this project is to determine the influence of microgravity on the rapid thermal process for a variety of operating modes. In many instances, this involves one or more fluid phases. The advancement of microgravity processing science is an important ancillary objective.

Optimization of Processing and Modeling Issues for Thin Film Solar Cell Devices Including Concepts for The Development of Polycrystalline Multijunctions: Annual Report; 24 August 1998-23 August 1999

DOE Office of Scientific and Technical Information (OSTI.GOV)

Birkmire, R.W.; Phillips, J.E.; Shafarman, W.N.

2000-08-25

This report describes results achieved during phase 1 of a three-phase subcontract to develop and understand thin-film solar cell technology associated to CuInSe{sub 2} and related alloys, a-Si and its alloys, and CdTe. Modules based on all these thin films are promising candidates to meet DOE long-range efficiency, reliability, and manufacturing cost goals. The critical issues being addressed under this program are intended to provide the science and engineering basis for the development of viable commercial processes and to improve module performance. The generic research issues addressed are: (1) quantitative analysis of processing steps to provide information for efficient commercial-scalemore » equipment design and operation; (2) device characterization relating the device performance to materials properties and process conditions; (3) development of alloy materials with different bandgaps to allow improved device structures for stability and compatibility with module design; (4) development of improved window/heterojunction layers and contacts to improve device performance and reliability; and (5) evaluation of cell stability with respect to illumination, temperature, and ambient and with respect to device structure and module encapsulation.« less

Fiber-based wearable electronics: a review of materials, fabrication, devices, and applications.

PubMed

Zeng, Wei; Shu, Lin; Li, Qiao; Chen, Song; Wang, Fei; Tao, Xiao-Ming

2014-08-20

Fiber-based structures are highly desirable for wearable electronics that are expected to be light-weight, long-lasting, flexible, and conformable. Many fibrous structures have been manufactured by well-established lost-effective textile processing technologies, normally at ambient conditions. The advancement of nanotechnology has made it feasible to build electronic devices directly on the surface or inside of single fibers, which have typical thickness of several to tens microns. However, imparting electronic functions to porous, highly deformable and three-dimensional fiber assemblies and maintaining them during wear represent great challenges from both views of fundamental understanding and practical implementation. This article attempts to critically review the current state-of-arts with respect to materials, fabrication techniques, and structural design of devices as well as applications of the fiber-based wearable electronic products. In addition, this review elaborates the performance requirements of the fiber-based wearable electronic products, especially regarding the correlation among materials, fiber/textile structures and electronic as well as mechanical functionalities of fiber-based electronic devices. Finally, discussions will be presented regarding to limitations of current materials, fabrication techniques, devices concerning manufacturability and performance as well as scientific understanding that must be improved prior to their wide adoption. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Mid-infrared photodetectors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guyot-Sionnest, Philippe; Keuleyan, Sean E.; Lhuillier, Emmanuel

2016-04-19

Nanoparticles, methods of manufacture, devices comprising the nanoparticles, methods of their manufacture, and methods of their use are provided herein. The nanoparticles and devices having photoabsorptions in the range of 1.7 .mu.m to 12 .mu.m and can be used as photoconductors, photodiodes, phototransistors, charge-coupled devices (CCD), luminescent probes, lasers, thermal imagers, night-vision systems, and/or photodetectors.

24 CFR 3280.404 - Standard for egress windows and devices for use in manufactured homes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Standard for egress windows and... SAFETY STANDARDS Testing § 3280.404 Standard for egress windows and devices for use in manufactured homes..., construction, and installation of windows and approved devices intended to be used as an emergency exit during...

OPC for curved designs in application to photonics on silicon

NASA Astrophysics Data System (ADS)

Orlando, Bastien; Farys, Vincent; Schneider, Loïc.; Cremer, Sébastien; Postnikov, Sergei V.; Millequant, Matthieu; Dirrenberger, Mathieu; Tiphine, Charles; Bayle, Sébastian; Tranquillin, Céline; Schiavone, Patrick

2016-03-01

Today's design for photonics devices on silicon relies on non-Manhattan features such as curves and a wide variety of angles with minimum feature size below 100nm. Industrial manufacturing of such devices requires optimized process window with 193nm lithography. Therefore, Resolution Enhancement Techniques (RET) that are commonly used for CMOS manufacturing are required. However, most RET algorithms are based on Manhattan fragmentation (0°, 45° and 90°) which can generate large CD dispersion on masks for photonic designs. Industrial implementation of RET solutions to photonic designs is challenging as most currently available OPC tools are CMOS-oriented. Discrepancy from design to final results induced by RET techniques can lead to lower photonic device performance. We propose a novel sizing algorithm allowing adjustment of design edge fragments while preserving the topology of the original structures. The results of the algorithm implementation in the rule based sizing, SRAF placement and model based correction will be discussed in this paper. Corrections based on this novel algorithm were applied and characterized on real photonics devices. The obtained results demonstrate the validity of the proposed correction method integrated in Inscale software of Aselta Nanographics.

Charge Splitting In Situ Recorder (CSIR) for Real-Time Examination of Plasma Charging Effect in FinFET BEOL Processes

NASA Astrophysics Data System (ADS)

Tsai, Yi-Pei; Hsieh, Ting-Huan; Lin, Chrong Jung; King, Ya-Chin

2017-09-01

A novel device for monitoring plasma-induced damage in the back-end-of-line (BEOL) process with charge splitting capability is first-time proposed and demonstrated. This novel charge splitting in situ recorder (CSIR) can independently trace the amount and polarity of plasma charging effects during the manufacturing process of advanced fin field-effect transistor (FinFET) circuits. Not only does it reveal the real-time and in situ plasma charging levels on the antennas, but it also separates positive and negative charging effect and provides two independent readings. As CMOS technologies push for finer metal lines in the future, the new charge separation scheme provides a powerful tool for BEOL process optimization and further device reliability improvements.

Microelectromechanical Systems

NASA Technical Reports Server (NTRS)

Gabriel, Kaigham J.

1995-01-01

Micro-electromechanical systems (MEMS) is an enabling technology that merges computation and communication with sensing and actuation to change the way people and machines interact with the physical world. MEMS is a manufacturing technology that will impact widespread applications including: miniature inertial measurement measurement units for competent munitions and personal navigation; distributed unattended sensors; mass data storage devices; miniature analytical instruments; embedded pressure sensors; non-invasive biomedical sensors; fiber-optics components and networks; distributed aerodynamic control; and on-demand structural strength. The long term goal of ARPA's MEMS program is to merge information processing with sensing and actuation to realize new systems and strategies for both perceiving and controlling systems, processes, and the environment. The MEMS program has three major thrusts: advanced devices and processes, system design, and infrastructure.

Low-temperature technique for thick film resist stabilization and curing

NASA Astrophysics Data System (ADS)

Minter, Jason P.; Wong, Selmer S.; Marlowe, Trey; Ross, Matthew F.; Narcy, Mark E.; Livesay, William R.

1999-06-01

For a range of thick film photoresist applications, including MeV ion implant processing, thin film head manufacturing, and microelectromechanical systems processing, there is a need for a low-temperature method for resist stabilization and curing. Traditional methods of stabilizing or curing resist films have relied on thermal cycling, which may not be desirable due to device temperature limitations or thermally-induced distortion of the resist features.

Portable Device Slices Thermoplastic Prepregs

NASA Technical Reports Server (NTRS)

Taylor, Beverly A.; Boston, Morton W.; Wilson, Maywood L.

1993-01-01

Prepreg slitter designed to slit various widths rapidly by use of slicing bar holding several blades, each capable of slicing strip of preset width in single pass. Produces material evenly sliced and does not contain jagged edges. Used for various applications in such batch processes involving composite materials as press molding and autoclaving, and in such continuous processes as pultrusion. Useful to all manufacturers of thermoplastic composites, and in slicing B-staged thermoset composites.

Reducing bottom anti-reflective coating (BARC) defects: optimizing and decoupling the filtration and dispense process

NASA Astrophysics Data System (ADS)

Brakensiek, Nickolas L.; Martin, Gary; Simmons, Sean; Batchelder, Traci

2006-03-01

Semiconductor device manufacturing is one of the cleanest manufacturing operations that can be found in the world today. It has to be that way; a particle on a wafer today can kill an entire device, which raises the costs, and therefore reduces the profits, of the manufacturing company in two ways: it must produce extra wafers to make up for the lost die, and it has less product to sell. In today's state-of-the-art fab, everything is filtered to the lowest pore size available. This practice is fairly easy for gases because a gas molecule is very small compared to the pore size of the filter. Filtering liquids, especially photochemicals such as photoresists and BARCs, can be much harder because the molecules that form the polymers used to manufacture the photochemicals are approaching the filter pore size. As a result, filters may plug up, filtration rates may drop, pressure drops across the filter may increase, or a filter may degrade. These conditions can then cause polymer shearing, microbubble formation, gel particle formation, and BARC chemical changes to occur before the BARC reaches the wafer. To investigate these possible interactions, an Entegris(R) IntelliGen(R) pump was installed on a TEL Mk8 TM track to see if the filtration process would have an effect on the BARC chemistry and coating defects. Various BARC chemicals such as DUV112 and DUV42P were pumped through various filter media having a variety of pore sizes at different filtration rates to investigate the interaction between the dispense process and the filtration process. The IntelliGen2 pump has the capability to filter the BARC independent of the dispense process. By using a designed experiment to look at various parameters such as dispense rate, filtration rate, and dispense volume, the effects of the complete pump system can be learned, and appropriate conditions can be applied to yield the cleanest BARC coating process. Results indicate that filtration rate and filter pore size play a dramatic role in the defect density on a coated wafer with the actual dispense properties such as dispense wafer speed and dispense time playing a lesser role.

Mask-less patterning of organic light emitting diodes using electrospray and selective biasing on pixel electrodes

NASA Astrophysics Data System (ADS)

Lee, Sangyeob; Koo, Hyun; Cho, Sunghwan

2015-04-01

Wet process of soluble organic light emitting diode (OLED) materials has attracted much attention due to its potential as a large-area manufacturing process with high productivity. Electrospray (ES) deposition is one of candidates of organic thin film formation process for OLED. However, to fabricate red, green, and blue emitters for color display, a fine metal mask is required during spraying emitter materials. We demonstrate a mask-less color pixel patterning process using ES of soluble OLED materials and selective biasing on pixel electrodes and a spray nozzle. We show red and green line patterns of OLED materials. It was found that selective patterning can be allowed by coulomb repulsion between nozzle and pixel. Furthermore, we fabricated blue fluorescent OLED devices by vacuum evaporation and ES processes. The device performance of ES processed OLED showed nearly identical current-voltage characteristics and slightly lower current efficiency compared to vacuum processed OLED.

Development of low-cost technology for the next generation of high efficiency solar cells composed of earth abundant elements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Agrawal, Rakesh

2014-09-28

The development of renewable, affordable, and environmentally conscious means of generating energy on a global scale represents a grand challenge of our time. Due to the “permanence” of radiation from the sun, solar energy promises to remain a viable and sustainable power source far into the future. Established single-junction photovoltaic technologies achieve high power conversion efficiencies (pce) near 20% but require complicated manufacturing processes that prohibit the marriage of large-scale throughput (e.g. on the GW scale), profitability, and quality control. Our approach to this problem begins with the synthesis of nanocrystals of semiconductor materials comprising earth abundant elements and characterizedmore » by material and optoelectronic properties ideal for photovoltaic applications, namely Cu2ZnSn(S,Se)4 (CZTSSe). Once synthesized, such nanocrystals are formulated into an ink, coated onto substrates, and processed into completed solar cells in such a way that enables scale-up to high throughput, roll-to-roll manufacturing processes. This project aimed to address the major limitation to CZTSSe solar cell pce’s – the low open-circuit voltage (Voc) reported throughout literature for devices comprised of this material. Throughout the project significant advancements have been made in fundamental understanding of the CZTSSe material and device limitations associated with this material system. Additionally, notable improvements have been made to our nanocrystal based processing technique to alleviate performance limitations due to the identified device limitations. Notably, (1) significant improvements have been made in reducing intra- and inter-nanoparticle heterogeneity, (2) improvements in device performance have been realized with novel cation substitution in Ge-alloyed CZTGeSSe absorbers, (3) systematic analysis of absorber sintering has been conducted to optimize the selenization process for large grain CZTSSe absorbers, (4) novel electrical characterization analysis techniques have been developed to identify significant limitations to traditional electrical characterization of CZTSSe devices, and (5) the developed electrical analysis techniques have been used to identify the role that band gap and electrostatic potential fluctuations have in limiting device performance for this material system. The device modeling and characterization of CZTSSe undertaken with this project have significant implications for the CZTSSe research community, as the identified limitations due to potential fluctuations are expected to be a performance limitation to high-efficiency CZTSSe devices fabricated from all current processing techniques. Additionally, improvements realized through enhanced absorber processing conditions to minimize nanoparticle and large-grain absorber heterogeneity are suggested to be beneficial processing improvements which should be applied to CZTSSe devices fabricated from all processing techniques. Ultimately, our research has indicated that improved performance for CZTSSe will be achieved through novel absorber processing which minimizes defect formation, elemental losses, secondary phase formation, and compositional uniformity in CZTSSe absorbers; we believe this novel absorber processing can be achieved through nanocrystal based processing of CZTSSe which is an active area of research at the conclusion of this award. While significant fundamental understanding of CZTSSe and the performance limitations associated with this material system, as well as notable improvements in the processing of nanocrystal based CZTSSe absorbers, have been achieved under this project, the limitation of two years of research funding towards our goals prevents further significant advancements directly identified through pce. improvements relative to those reported herein. As the characterization and modeling subtask of this project has been the main driving force for understanding device limitations, the conclusions of this analysis have just recently been applied to the processing of nanocrystal based CZTSSe absorbers -- with notable success. We expect the notable fundamental understanding of device limitations and absorber sintering achieved under this project will lead to significant improvements in device performance for CZTSSe devices in the near future for devices fabricated from a variety of processing techniques« less

Regulatory issues for computerized electrocardiographic devices.

PubMed

Muni, Neal I; Ho, Charles; Mallis, Elias

2004-01-01

Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a "clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.

49 CFR Appendix A to Part 221 - Procedures for Approval of Rear End Marking Devices

Code of Federal Regulations, 2011 CFR

2011-10-01

... description of the device including the type, luminance description, size of lens, manufacturer and catalog number, lamp manufacturer, lamp type and model number, and any auxiliary optics used. (2) A certification...

49 CFR Appendix A to Part 221 - Procedures for Approval of Rear End Marking Devices

Code of Federal Regulations, 2010 CFR

2010-10-01

... description of the device including the type, luminance description, size of lens, manufacturer and catalog number, lamp manufacturer, lamp type and model number, and any auxiliary optics used. (2) A certification...

3D printed Lego®-like modular microfluidic devices based on capillary driving.

PubMed

Nie, Jing; Gao, Qing; Qiu, Jing-Jiang; Sun, Miao; Liu, An; Shao, Lei; Fu, Jian-Zhong; Zhao, Peng; He, Yong

2018-03-12

The field of how to rapidly assemble microfluidics with modular components continuously attracts researchers' attention, however, extra efforts must be devoted to solving the problems of leaking and aligning between individual modules. This paper presents a novel type of modular microfluidic device, driven by capillary force. There is no necessity for a strict seal or special alignment, and its open structures make it easy to integrate various stents and reactants. The key rationale for this method is to print different functional modules with a low-cost three-dimensional (3D) printer, then fill the channels with capillary materials and assemble them with plugs like Lego ® bricks. This rapidly reconstructed modular microfluidic device consists of a variety of common functional modules and other personalized modules, each module having a unified standard interface for easy assembly. As it can be printed by a desktop 3D printer, the manufacturing process is simple and efficient, with controllable regulation of the flow channel scale. Through diverse combinations of different modules, a variety of different functions can be achieved, without duplicating the manufacturing process. A single module can also be taken out for testing and analysis. What's more, combined with basic circuit components, it can serve as a low-cost Lego ® -like modular microfluidic circuits. As a proof of concept, the modular microfluidic device has been successfully demonstrated and used for stent degradation and cell cultures, revealing the potential use of this method in both chemical and biological research.

78 FR 14963 - Foreign-Trade Zone 163-Ponce, Puerto Rico; Authorization of Production Activity; Zimmer...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-80-2012] Foreign-Trade Zone 163--Ponce, Puerto Rico; Authorization of Production Activity; Zimmer Manufacturing BV (Medical Devices); Ponce, Puerto... Subzone 163A, in Ponce, Puerto Rico. The notification was processed in accordance with the regulations of...

77 FR 16228 - Key Hyundai of Manchester, LLC; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... Social Security number, date of birth, driver's license number or other state identification number or... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes... consumer credit. It also requires that if any finance charge is advertised, the rate be stated as an...

78 FR 10574 - Premerger Notification; Reporting and Waiting Period Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

..., patterns, devices, manufacturing processes, or customer names. If you would like the Commission to give... service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release... of a tender offer under Sec. 801.30, that the intention to make the tender offer has been publicly...

Equipment and Supplies For Collecting, Processing, Storing, and Testing Forest Tree Seed

Treesearch

F.T. Bonner

1977-01-01

This publication is a directory of information on equipment and supplies used in handling and treating tree seed. The use of each device is briefly described. Specifications such as size, capacity, or model number are given. Manufacturers' or suppliers' names are listed, and users of the equipment are identified.

77 FR 68784 - Standard Test Procedures Approval Process for Respirators To Be Used in Wildland Fire-Fighting...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... regulations allow. Because manufacturers have not yet developed respiratory protection for this occupational...-approved filtering facepiece respirators which are not designed for this use, or no respiratory protection... respiratory protective devices designed for the inhalation hazards of this occupational setting. On July 10...

Update On The Development, Testing, And Manufacture Of High Density LEU-Foil Targets For The Production Of Mo-99

DOE Office of Scientific and Technical Information (OSTI.GOV)

Creasy, John T

2015-05-12

This project has the objective to reduce and/or eliminate the use of HEU in commerce. Steps in the process include developing a target testing methodology that is bounding for all Mo-99 target irradiators, establishing a maximum target LEU-foil mass, developing a LEU-foil target qualification document, developing a bounding target failure analysis methodology (failure in reactor containment), optimizing safety vs. economics (goal is to manufacture a safe, but relatively inexpensive target to offset the inherent economic disadvantage of using LEU in place of HEU), and developing target material specifications and manufacturing QC test criteria. The slide presentation is organized under themore » following topics: Objective, Process Overview, Background, Team Structure, Key Achievements, Experiment and Activity Descriptions, and Conclusions. The High Density Target project has demonstrated: approx. 50 targets irradiated through domestic and international partners; proof of concept for two front end processing methods; fabrication of uranium foils for target manufacture; quality control procedures and steps for manufacture; multiple target assembly techniques; multiple target disassembly devices; welding of targets; thermal, hydraulic, and mechanical modeling; robust target assembly parametric studies; and target qualification analysis for insertion into very high flux environment. The High Density Target project has tested and proven several technologies that will benefit current and future Mo-99 producers.« less

Towards sustainable design for single-use medical devices.

PubMed

Hanson, Jacob J; Hitchcock, Robert W

2009-01-01

Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit.

Improving overlay control through proper use of multilevel query APC

NASA Astrophysics Data System (ADS)

Conway, Timothy H.; Carlson, Alan; Crow, David A.

2003-06-01

Many state-of-the-art fabs are operating with increasingly diversified product mixes. For example, at Cypress Semiconductor, it is not unusual to be concurrently running multiple technologies and many devices within each technology. This diverse product mix significantly increases the difficulty of manually controlling overlay process corrections. As a result, automated run-to-run feedforward-feedback control has become a necessary and vital component of manufacturing. However, traditional run-to-run controllers rely on highly correlated historical events to forecast process corrections. For example, the historical process events typically are constrained to match the current event for exposure tool, device, process level and reticle ID. This narrowly defined process stream can result in insufficient data when applied to lowvolume or new-release devices. The run-to-run controller implemented at Cypress utilizes a multi-level query (Level-N) correlation algorithm, where each subsequent level widens the search criteria for available historical data. The paper discusses how best to widen the search criteria and how to determine and apply a known bias to account for tool-to-tool and device-to-device differences. Specific applications include offloading lots from one tool to another when the first tool is down for preventive maintenance, utilizing related devices to determine a default feedback vector for new-release devices, and applying bias values to account for known reticle-to-reticle differences. In this study, we will show how historical data can be leveraged from related devices or tools to overcome the limitations of narrow process streams. In particular, this paper discusses how effectively handling narrow process streams allows Cypress to offload lots from a baseline tool to an alternate tool.

Fabrication of multilayered conductive polymer structures via selective visible light photopolymerization

NASA Astrophysics Data System (ADS)

Cullen, Andrew T.; Price, Aaron D.

2017-04-01

Electropolymerization of pyrrole is commonly employed to fabricate intrinsically conductive polymer films that exhibit desirable electromechanical properties. Due to their monolithic nature, electroactive polypyrrole films produced via this process are typically limited to simple linear or bending actuation modes, which has hindered their application in complex actuation tasks. This initiative aims to develop the specialized fabrication methods and polymer formulations required to realize three-dimensional conductive polymer structures capable of more elaborate actuation modes. Our group has previously reported the application of the digital light processing additive manufacturing process for the fabrication of three-dimensional conductive polymer structures using ultraviolet radiation. In this investigation, we further expand upon this initial work and present an improved polymer formulation designed for digital light processing additive manufacturing using visible light. This technology enables the design of novel electroactive polymer sensors and actuators with enhanced capabilities and brings us one step closer to realizing more advanced electroactive polymer enabled devices.

Polyimide-Epoxy Composites with Superior Bendable Properties for Application in Flexible Electronics

NASA Astrophysics Data System (ADS)

Lee, Sangyoup; Yoo, Taewon; Han, Youngyu; Kim, Hanglim; Han, Haksoo

2017-08-01

The need for flexible electronics with outstanding bending properties is increasing due to the demand for wearable devices and next-generation flexible or rollable smartphones. In addition, the requirements for flexible or rigid-flexible electronics are sharply increasing to achieve the design of space-saving electronic devices. In this regard, coverlay (CL) film is a key material used in the bending area of flexible electronics, albeit infrequently. Because flexible electronics undergo folding and unfolding numerous times, CL films with superior mechanical and bending properties are required so that the bending area can endure such severe stress. However, because current CL films are only used for a designated bending area in the flexible electronics panel, their highly complicated and expensive manufacturing procedure is a disadvantage. In addition, the thickness of CL films must be decreased to satisfy the ongoing requirement for increasingly thin products. However, due to the limitations of the two-layer structure of existing CL films, the manufacturing process cannot be made more cost effective by simply applying more thin film onto the board. To address this problem, we have developed liquid coverlay inks (LCIs) with superior bendable properties, in comparison with CL films, when applied onto flexible electronics using a screen-printing method. The results show that LCIs have the potential to become one of the leading candidates to replace existing CL films because of their lower cost and faster manufacturing process.

Communications device identification methods, communications methods, wireless communications readers, wireless communications systems, and articles of manufacture

DOEpatents

Steele, Kerry D [Kennewick, WA; Anderson, Gordon A [Benton City, WA; Gilbert, Ronald W [Morgan Hill, CA

2011-02-01

Communications device identification methods, communications methods, wireless communications readers, wireless communications systems, and articles of manufacture are described. In one aspect, a communications device identification method includes providing identification information regarding a group of wireless identification devices within a wireless communications range of a reader, using the provided identification information, selecting one of a plurality of different search procedures for identifying unidentified ones of the wireless identification devices within the wireless communications range, and identifying at least some of the unidentified ones of the wireless identification devices using the selected one of the search procedures.

PERFORMANCE EVALUATION OF TYPE I MARINE SANITATION DEVICES

EPA Science Inventory

This performance test was designed to evaluate the effectiveness of two Type I Marine Sanitation Devices (MSDs): the Electro Scan Model EST 12, manufactured by Raritan Engineering Company, Inc., and the Thermopure-2, manufactured by Gross Mechanical Laboratories, Inc. Performance...

New method of 2-dimensional metrology using mask contouring

NASA Astrophysics Data System (ADS)

Matsuoka, Ryoichi; Yamagata, Yoshikazu; Sugiyama, Akiyuki; Toyoda, Yasutaka

2008-10-01

We have developed a new method of accurately profiling and measuring of a mask shape by utilizing a Mask CD-SEM. The method is intended to realize high accuracy, stability and reproducibility of the Mask CD-SEM adopting an edge detection algorithm as the key technology used in CD-SEM for high accuracy CD measurement. In comparison with a conventional image processing method for contour profiling, this edge detection method is possible to create the profiles with much higher accuracy which is comparable with CD-SEM for semiconductor device CD measurement. This method realizes two-dimensional metrology for refined pattern that had been difficult to measure conventionally by utilizing high precision contour profile. In this report, we will introduce the algorithm in general, the experimental results and the application in practice. As shrinkage of design rule for semiconductor device has further advanced, an aggressive OPC (Optical Proximity Correction) is indispensable in RET (Resolution Enhancement Technology). From the view point of DFM (Design for Manufacturability), a dramatic increase of data processing cost for advanced MDP (Mask Data Preparation) for instance and surge of mask making cost have become a big concern to the device manufacturers. This is to say, demands for quality is becoming strenuous because of enormous quantity of data growth with increasing of refined pattern on photo mask manufacture. In the result, massive amount of simulated error occurs on mask inspection that causes lengthening of mask production and inspection period, cost increasing, and long delivery time. In a sense, it is a trade-off between the high accuracy RET and the mask production cost, while it gives a significant impact on the semiconductor market centered around the mask business. To cope with the problem, we propose the best method of a DFM solution using two-dimensional metrology for refined pattern.

Design of an automatic production monitoring system on job shop manufacturing

NASA Astrophysics Data System (ADS)

Prasetyo, Hoedi; Sugiarto, Yohanes; Rosyidi, Cucuk Nur

2018-02-01

Every production process requires monitoring system, so the desired efficiency and productivity can be monitored at any time. This system is also needed in the job shop type of manufacturing which is mainly influenced by the manufacturing lead time. Processing time is one of the factors that affect the manufacturing lead time. In a conventional company, the recording of processing time is done manually by the operator on a sheet of paper. This method is prone to errors. This paper aims to overcome this problem by creating a system which is able to record and monitor the processing time automatically. The solution is realized by utilizing electric current sensor, barcode, RFID, wireless network and windows-based application. An automatic monitoring device is attached to the production machine. It is equipped with a touch screen-LCD so that the operator can use it easily. Operator identity is recorded through RFID which is embedded in his ID card. The workpiece data are collected from the database by scanning the barcode listed on its monitoring sheet. A sensor is mounted on the machine to measure the actual machining time. The system's outputs are actual processing time and machine's capacity information. This system is connected wirelessly to a workshop planning application belongs to the firm. Test results indicated that all functions of the system can run properly. This system successfully enables supervisors, PPIC or higher level management staffs to monitor the processing time quickly with a better accuracy.

Additive Biotech-Chances, challenges, and recent applications of additive manufacturing technologies in biotechnology.

PubMed

Krujatz, Felix; Lode, Anja; Seidel, Julia; Bley, Thomas; Gelinsky, Michael; Steingroewer, Juliane

2017-10-25

The diversity and complexity of biotechnological applications are constantly increasing, with ever expanding ranges of production hosts, cultivation conditions and measurement tasks. Consequently, many analytical and cultivation systems for biotechnology and bioprocess engineering, such as microfluidic devices or bioreactors, are tailor-made to precisely satisfy the requirements of specific measurements or cultivation tasks. Additive manufacturing (AM) technologies offer the possibility of fabricating tailor-made 3D laboratory equipment directly from CAD designs with previously inaccessible levels of freedom in terms of structural complexity. This review discusses the historical background of these technologies, their most promising current implementations and the associated workflows, fabrication processes and material specifications, together with some of the major challenges associated with using AM in biotechnology/bioprocess engineering. To illustrate the great potential of AM, selected examples in microfluidic devices, 3D-bioprinting/biofabrication and bioprocess engineering are highlighted. Copyright © 2017 Elsevier B.V. All rights reserved.

Editorial: Photovoltaic Materials and Devices 2014

DOE PAGES

Sopori, Bhushan; Rupnowski, Peter; Shet, Sudhakar; ...

2014-12-22

An ever increasing demand on energy has fostered many new generation technologies, which include photovoltaics. In recent years, photovoltaic industry has grown very rapidly. The installed capacity of PV for 2013 was about 37 GW and 2014 sales are expected to be around 45 GW. However, there has been excess production for last several years, which is responsible in part for the low prices (about 60 c/W). To lower the PV energy costs further, a major strategy appears to be going to high efficiency solar cells. This approach is favored (over lower cost/lower efficiency) because cell efficiency has a verymore » large influence on the acceptable manufacturing cost of a PV module. Hence, the PV industry is moving toward developing processes and equipment to manufacture solar cells that can yield efficiencies >20%. Therefore, further research is needed within existing technologies to accomplish these objectives. Likewise, research will continue to seek new materials and devices.« less

A laser-based technology for fabricating a soda-lime glass based microfluidic device for circulating tumour cell capture.

PubMed

Nieto, Daniel; Couceiro, Ramiro; Aymerich, Maria; Lopez-Lopez, Rafael; Abal, Miguel; Flores-Arias, María Teresa

2015-10-01

We developed a laser-based technique for fabricating microfluidic microchips on soda-lime glass substrates. The proposed methodology combines a laser direct writing, as a manufacturing tool for the fabrication of the microfluidics structures, followed by a post-thermal treatment with a CO2 laser. This treatment will allow reshaping and improving the morphological (roughness) and optical qualities (transparency) of the generated microfluidics structures. The use of lasers commonly implemented for material processing makes this technique highly competitive when compared with other glass microstructuring approaches. The manufactured chips were tested with tumour cells (Hec 1A) after being functionalized with an epithelial cell adhesion molecule (EpCAM) antibody coating. Cells were successfully arrested on the pillars after being flown through the device giving our technology a translational application in the field of cancer research. Copyright © 2015 Elsevier B.V. All rights reserved.

Printed batteries and conductive patterns in technical textiles

NASA Astrophysics Data System (ADS)

Willert, Andreas; Meuser, Carmen; Baumann, Reinhard R.

2018-05-01

Various applications of functional devices need a tailored and reliable supply of electrical energy. Batteries are electrochemical systems that deliver energy for functional devices and applications. Due to the common use, several rigid types of batteries have been standardized. To fully integrate the battery into a product that is bendable, free in geometry and less than 1 mm thick, printing of power adaptable batteries is a challenging area of research. Therefore, the well-known zinc-manganese system, which is very promising due to its environmental sustainability and its simplicity, has been used to manufacture battery solutions on a new kind of substrate: technical textiles. Another challenge is the deposition of conductive patterns. At present, embroidery with metallic yarn is the only possibility to provide conducting paths on technical textiles, a time-consuming and elaborate process. Screen printed conductive pathways will generate a new momentum in the manufacturing of conductivity on textiles.

Method of Manufacturing a Light Emitting, Photovoltaic or Other Electronic Apparatus and System

NASA Technical Reports Server (NTRS)

Blanchard, Richard A. (Inventor); Lewandowski, Mark Allan (Inventor); Frazier, Donald Odell (Inventor); Ray, William Johnstone (Inventor); Fuller, Kirk A. (Inventor); Lowenthal, Mark David (Inventor); Shotton, Neil O. (Inventor)

2014-01-01

The present invention provides a method of manufacturing an electronic apparatus, such as a lighting device having light emitting diodes (LEDs) or a power generating device having photovoltaic diodes. The exemplary method includes depositing a first conductive medium within a plurality of channels of a base to form a plurality of first conductors; depositing within the plurality of channels a plurality of semiconductor substrate particles suspended in a carrier medium; forming an ohmic contact between each semiconductor substrate particle and a first conductor; converting the semiconductor substrate particles into a plurality of semiconductor diodes; depositing a second conductive medium to form a plurality of second conductors coupled to the plurality of semiconductor diodes; and depositing or attaching a plurality of lenses suspended in a first polymer over the plurality of diodes. In various embodiments, the depositing, forming, coupling and converting steps are performed by or through a printing process.

Method of Manufacturing a Light Emitting, Photovoltaic or Other Electronic Apparatus and System

NASA Technical Reports Server (NTRS)

Lowenthal, Mark D. (Inventor); Shotton, Neil O. (Inventor); Lewandowski, Mark Allan (Inventor); Frazier, Donald Odell (Inventor); Ray, William Johnstone (Inventor); Blanchard, Richard A. (Inventor); Fuller, Kirk A. (Inventor)

2013-01-01

The present invention provides a method of manufacturing an electronic apparatus, such as a lighting device having light emitting diodes (LEDs) or a power generating device having photovoltaic diodes. The exemplary method includes forming at least one first conductor coupled to a base; coupling a plurality of substrate particles to the at least one first conductor; converting the plurality of substrate particles into a plurality of diodes; forming at least one second conductor coupled to the plurality of spherical diodes; and depositing or attaching a plurality of substantially spherical lenses suspended in a first polymer, with the lenses and the suspending polymer having different indices of refraction. In some embodiments, the lenses and diodes have a ratio of mean diameters or lengths between about 10:1 and 2:1. In various embodiments, the forming, coupling and converting steps are performed by or through a printing process.

Method of manufacturing a light emitting, photovoltaic or other electronic apparatus and system

NASA Technical Reports Server (NTRS)

Fuller, Kirk A. (Inventor); Frazier, Donald Odell (Inventor); Blanchard, Richard A. (Inventor); Lowenthal, Mark D. (Inventor); Lewandowski, Mark Allan (Inventor); Ray, William Johnstone (Inventor); Shotton, Neil O. (Inventor)

2012-01-01

The present invention provides a method of manufacturing an electronic apparatus, such as a lighting device having light emitting diodes (LEDs) or a power generating device having photovoltaic diodes. The exemplary method includes depositing a first conductive medium within a plurality of channels of a base to form a plurality of first conductors; depositing within the plurality of channels a plurality of semiconductor substrate particles suspended in a carrier medium; forming an ohmic contact between each semiconductor substrate particle and a first conductor; converting the semiconductor substrate particles into a plurality of semiconductor diodes; depositing a second conductive medium to form a plurality of second conductors coupled to the plurality of semiconductor diodes; and depositing or attaching a plurality of lenses suspended in a first polymer over the plurality of diodes. In various embodiments, the depositing, forming, coupling and converting steps are performed by or through a printing process.

Method of Manufacturing a Light Emitting, Photovoltaic or Other Electronic Apparatus and System

NASA Technical Reports Server (NTRS)

Blanchard, Richard A. (Inventor); Fuller, Kirk A. (Inventor); Ray, William Johnstone (Inventor); Shotton, Neil O. (Inventor); Frazier, Donald Odell (Inventor); Lowenthal, Mark D. (Inventor); Lewandowski, Mark Allan (Inventor)

2013-01-01

The present invention provides a method of manufacturing an electronic apparatus, such as a lighting device having light emitting diodes (LEDs) or a power generating device having photovoltaic diodes. The exemplary method includes forming at least one first conductor coupled to a base; coupling a plurality of substantially spherical substrate particles to the at least one first conductor; converting the substrate particles into a plurality of substantially spherical diodes; forming at least one second conductor coupled to the substantially spherical diodes; and depositing or attaching a plurality of substantially spherical lenses suspended in a first polymer. The lenses and the suspending polymer have different indices of refraction. In some embodiments, the lenses and diodes have a ratio of mean diameters or lengths between about 10:1 and 2:1. In various embodiments, the forming, coupling and converting steps are performed by or through a printing process.

Silicon Chemical Vapor Deposition Process Using a Half-Inch Silicon Wafer for Minimal Manufacturing System

NASA Astrophysics Data System (ADS)

Li, Ning; Habuka, Hitoshi; Ikeda, Shin-ichi; Hara, Shiro

A chemical vapor deposition reactor for producing thin silicon films was designed and developed for achieving a new electronic device production system, the Minimal Manufacturing, using a half-inch wafer. This system requires a rapid process by a small footprint reactor. This was designed and verified by employing the technical issues, such as (i) vertical gas flow, (ii) thermal operation using a highly concentrated infrared flux, and (iii) reactor cleaning by chlorine trifluoride gas. The combination of (i) and (ii) could achieve a low heating power and a fast cooling designed by the heat balance of the small wafer placed at a position outside of the reflector. The cleaning process could be rapid by (iii). The heating step could be skipped because chlorine trifluoride gas was reactive at any temperature higher than room temperature.

A DRM based on renewable broadcast encryption

NASA Astrophysics Data System (ADS)

Ramkumar, Mahalingam; Memon, Nasir

2005-07-01

We propose an architecture for digital rights management based on a renewable, random key pre-distribution (KPD) scheme, HARPS (hashed random preloaded subsets). The proposed architecture caters for broadcast encryption by a trusted authority (TA) and by "parent" devices (devices used by vendors who manufacture compliant devices) for periodic revocation of devices. The KPD also facilitates broadcast encryption by peer devices, which permits peers to distribute content, and efficiently control access to the content encryption secret using subscription secrets. The underlying KPD also caters for broadcast authentication and mutual authentication of any two devices, irrespective of the vendors manufacturing the device, and thus provides a comprehensive solution for securing interactions between devices taking part in a DRM system.

InGaAsSb Detectors' Characterization for 2-Micron CO2 Lidar/DIAL Applications

NASA Technical Reports Server (NTRS)

Refaat, Tamer F.; Abedin, M. Nurul; Koch, Grady J.; Singh, Upendra N.

2003-01-01

Recent interest in monitoring atmospheric CO2 focuses attention on infrared remote sensing using the 2-micron lidar/differential absorption lidar (DIAL) technique. Quantum detectors are critical components in this technique, and many research efforts concentrate on developing such devices for the 2-micron wavelength. Characterization results of InGaAsSb quantum detectors for the 2-micron wavelength range are presented, including experimental setup and procedure. Detectors are prototype devices manufactured by using separate absorption and multiplication (SAM) structures. Characterization experiments include V-I measurements, spectral response and its variation with bias voltage and temperature, noise measurements, noise-equivalent-power (NEP) and detectivity calculations, and signal-to-noise ratio (SNR) estimation. A slight increase in the output signal occurred with increased bias voltage and was associated with a noise level increase. Cooling down the detectors reduces noise and shifts the cutoff wavelength to shorter values. Further improvement in the design and manufacturing process, by increasing the device gain and lowering its noise level, is necessary to meet the required CO2 lidar/DIAL specifications.

Readability of "Dear Patient" device advisory notification letters created by a device manufacturer.

PubMed

Mueller, Luke A; Sharma, Arjun; Ottenberg, Abigale L; Mueller, Paul S

2013-04-01

In 2006, the Heart Rhythm Society (HRS) recommended that cardiovascular implantable electronic device (CIED) manufacturers use advisory notification letters to communicate with affected patients. To evaluate the readability of the HRS sample "patient device advisory notification" letter and those created by 1 CIED manufacturer. The HRS sample letter and 25 Boston Scientific Corporation letters dated from 2005 through 2011 were evaluated by using 6 readability tests. Readability (Flesch-Kincaid score) of the HRS sample letter was grade level 12.5, and median readability of the device manufacturer letters was grade level 12.8 (range 10.8-18.9). Similar results were obtained by using other readability scales. No letters had readability scores at the National Work Group on Literacy and Health's recommended reading level-fifth grade; the letters' readability exceeded this recommended level by an average of 7.7 grades (95% confidence interval 6.9-8.5; P<.001). Likewise, no letters had readability scores at the average reading level of US adults-eighth grade; the letters' readability exceeded this level by an average of 4.7 grades (95% confidence interval 3.9-5.5; P< .001). The readability of the HRS sample letter and those created by a CIED manufacturer significantly exceeded the recommended and average US adults' reading skill levels. Such letters are unlikely to be informative to many patients. CIED manufacturers should ensure that advisory letters are comprehensible to most affected patients. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Plasma jet printing for flexible substrates

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gandhiraman, Ram P.; Singh, Eric; Diaz-Cartagena, Diana C.

2016-03-21

Recent interest in flexible electronics and wearable devices has created a demand for fast and highly repeatable printing processes suitable for device manufacturing. Robust printing technology is critical for the integration of sensors and other devices on flexible substrates such as paper and textile. An atmospheric pressure plasma-based printing process has been developed to deposit different types of nanomaterials on flexible substrates. Multiwalled carbon nanotubes were deposited on paper to demonstrate site-selective deposition as well as direct printing without any type of patterning. Plasma-printed nanotubes were compared with non-plasma-printed samples under similar gas flow and other experimental conditions and foundmore » to be denser with higher conductivity. The utility of the nanotubes on the paper substrate as a biosensor and chemical sensor was demonstrated by the detection of dopamine, a neurotransmitter, and ammonia, respectively.« less

Factors Influencing the Decision to Proceed to Firmware Upgrades to Implanted Pacemakers for Cybersecurity Risk Mitigation.

PubMed

Saxon, Leslie A; Varma, Niraj; Epstein, Laurence M; Ganz, Leonard I; Epstein, Andrew E

2018-05-10

In August 2017, the first major recall for cybersecurity vulnerabilities in pacemakers capable of remote connectivity was released that impacted 465,000 United States patients. 1,2 The FDA approved a firmware update designed by the manufacturer of the devices as a remediation (Abbott , formally St. Jude Medical). The recall was in response to the public disclosure of vulnerability by an investment firm and produced in a lab environment that could allow an unauthorized party in close proximity to a patient to impact the performance of the device or modify device settings via radio frequency communication. 3 While an exploit has not occurred in a patient and requires a high degree of resources and skill to execute, if accomplished, it could pose a significant risk to device safety and essential performance and cause patient harm. The FDA defines this as an uncontrolled vulnerability. 2 The recall recommendations were coordinated between the FDA, the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT), a division of Homeland Security that responds to and coordinates disclosure of critical infrastructure cybersecurity vulnerabilities and Abbott. 1 All parties urged caution and shared decision making between patient and clinician as to whether to have the device firmware update, a process that requires a clinic visit to implement with a device programmer. The manufacturer bench tested the firmware update but the only prior experience with an implanted device firmware updates was a 2012 ICD firmware update that demonstrated a 0.197% risk of device back-up mode pacing after the upgrade was performed.

Characterization of printed planar electromagnetic coils using digital extrusion and roll-to-roll flexographic processes

NASA Astrophysics Data System (ADS)

Rickard, Scott

Electromagnets are a crucial component in a wide range of more complex electrical devices due to their ability to turn electrical energy into mechanical energy and vice versa. The trend for electronics becoming smaller and lighter has led to increased interest in using flat, planar electromagnetic coils, which have been shown to perform better at scaled down sizes. The two-dimensional geometry of a planar electromagnetic coil yields itself to be produced by a roll-to-roll additive manufacturing process. The emergence of the printed electronics field, which uses traditional printing processes to pattern functional inks, has led to new methods of mass-producing basic electrical components. The ability to print a planar electromagnetic coil using printed electronics could rival the traditional subtractive and semi-subtractive PCB process of manufacturing. The ability to print lightweight planar electromagnetic coils on flexible substrates could lead to their inclusion into intelligent packaging applications and could have specific use in actuating devices, transformers, and electromagnetic induction applications such as energy harvesting or wireless charging. In attempts to better understand the limitations of printing planar electromagnetic coils, the effect that the design parameters of the planar coils have on the achievable magnetic field strength were researched. A comparison between prototyping methods of digital extrusion and manufacturing scale flexographic printing are presented, discussing consistency in the printed coils and their performance in generating magnetic fields. A method to predict the performance of these planar coils is introduced to allow for design within required needs of an application. Results from the research include a demonstration of a printed coil being used in a flat speaker design, working off of actuating principles.

Technological innovations for a sustainable business model in the semiconductor industry

NASA Astrophysics Data System (ADS)

Levinson, Harry J.

2014-09-01

Increasing costs of wafer processing, particularly for lithographic processes, have made it increasingly difficult to achieve simultaneous reductions in cost-per-function and area per device. Multiple patterning techniques have made possible the fabrication of circuit layouts below the resolution limit of single optical exposures but have led to significant increases in the costs of patterning. Innovative techniques, such as self-aligned double patterning (SADP) have enabled good device performance when using less expensive patterning equipment. Other innovations have directly reduced the cost of manufacturing. A number of technical challenges must be overcome to enable a return to single-exposure patterning using short wavelength optical techniques, such as EUV patterning.

High-coercivity FePt nanoparticle assemblies embedded in silica thin films.

PubMed

Yan, Q; Purkayastha, A; Singh, A P; Li, H; Li, A; Ramanujan, R V; Ramanath, G

2009-01-14

The ability to process assemblies using thin film techniques in a scalable fashion would be a key to transmuting the assemblies into manufacturable devices. Here, we embed FePt nanoparticle assemblies into a silica thin film by sol-gel processing. Annealing the thin film composite at 650 degrees C transforms the chemically disordered fcc FePt phase into the fct phase, yielding magnetic coercivity values H(c)>630 mT. The positional order of the particles is retained due to the protection offered by the silica host. Such films with assemblies of high-coercivity magnetic particles are attractive for realizing new types of ultra-high-density data storage devices and magneto-composites.

Advanced metal lift-off process using electron-beam flood exposure of single-layer photoresist

NASA Astrophysics Data System (ADS)

Minter, Jason P.; Ross, Matthew F.; Livesay, William R.; Wong, Selmer S.; Narcy, Mark E.; Marlowe, Trey

1999-06-01

In the manufacture of many types of integrated circuit and thin film devices, it is desirable to use a lift-of process for the metallization step to avoid manufacturing problems encountered when creating metal interconnect structures using plasma etch. These problems include both metal adhesion and plasma etch difficulties. Key to the success of the lift-off process is the creation of a retrograde or undercut profile in the photoresists before the metal deposition step. Until now, lift-off processing has relied on costly multi-layer photoresists schemes, image reversal, and non-repeatable photoresist processes to obtain the desired lift-off profiles in patterned photoresist. This paper present a simple, repeatable process for creating robust, user-defined lift-off profiles in single layer photoresist using a non-thermal electron beam flood exposure. For this investigation, lift-off profiles created using electron beam flood exposure of many popular photoresists were evaluated. Results of lift-off profiles created in positive tone AZ7209 and ip3250 are presented here.

Pulsed excimer laser processing for cost-effective solar cells

NASA Technical Reports Server (NTRS)

Wong, David C.

1985-01-01

The application of excimer laser in the fabrication of photovoltaic devices was investigated extensively. Processes included junction formation, laser assisted chemical vapor deposition metallization, and laser assisted chemical vapor deposition surface passivation. Results demonstrated that implementation of junction formation by laser annealing in production is feasible because of excellent control in junction depth and quality. Both metallization and surface passivation, however, were found impractical to be considered for manufacturing at this stage.

BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

PubMed

Bruzzi, M S; Linehan, J H

2013-09-01

In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.

A fast and efficient method for device level layout analysis

NASA Astrophysics Data System (ADS)

Dong, YaoQi; Zou, Elaine; Pang, Jenny; Huang, Lucas; Yang, Legender; Zhang, Chunlei; Du, Chunshan; Hu, Xinyi; Wan, Qijian

2017-03-01

There is an increasing demand for device level layout analysis, especially as technology advances. The analysis is to study standard cells by extracting and classifying critical dimension parameters. There are couples of parameters to extract, like channel width, length, gate to active distance, and active to adjacent active distance, etc. for 14nm technology, there are some other parameters that are cared about. On the one hand, these parameters are very important for studying standard cell structures and spice model development with the goal of improving standard cell manufacturing yield and optimizing circuit performance; on the other hand, a full chip device statistics analysis can provide useful information to diagnose the yield issue. Device analysis is essential for standard cell customization and enhancements and manufacturability failure diagnosis. Traditional parasitic parameters extraction tool like Calibre xRC is powerful but it is not sufficient for this device level layout analysis application as engineers would like to review, classify and filter out the data more easily. This paper presents a fast and efficient method based on Calibre equation-based DRC (eqDRC). Equation-based DRC extends the traditional DRC technology to provide a flexible programmable modeling engine which allows the end user to define grouped multi-dimensional feature measurements using flexible mathematical expressions. This paper demonstrates how such an engine and its programming language can be used to implement critical device parameter extraction. The device parameters are extracted and stored in a DFM database which can be processed by Calibre YieldServer. YieldServer is data processing software that lets engineers query, manipulate, modify, and create data in a DFM database. These parameters, known as properties in eqDRC language, can be annotated back to the layout for easily review. Calibre DesignRev can create a HTML formatted report of the results displayed in Calibre RVE which makes it easy to share results among groups. This method has been proven and used in SMIC PDE team and SPICE team.

Automated fiber pigtailing machine

DOEpatents

Strand, O.T.; Lowry, M.E.

1999-01-05

The Automated Fiber Pigtailing Machine (AFPM) aligns and attaches optical fibers to optoelectronic (OE) devices such as laser diodes, photodiodes, and waveguide devices without operator intervention. The so-called pigtailing process is completed with sub-micron accuracies in less than 3 minutes. The AFPM operates unattended for one hour, is modular in design and is compatible with a mass production manufacturing environment. This machine can be used to build components which are used in military aircraft navigation systems, computer systems, communications systems and in the construction of diagnostics and experimental systems. 26 figs.

What do you mean you can't sterilize it? The reusable medical device matrix.

PubMed

Stephens, Anne; Assang, AnnMarie

2010-12-01

Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable Medical Device (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medical devices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it begins with proper cleaning and processing of the surgical instruments. Surgical site infections can increase the length of stay and the cost of the patients' hospitalization, as well as increased risk, morbidity and even mortality. 1 Today's patients are far more informed than they were in the past. They can gather information from the internet as well as from television, radio, and print media. This knowledge empowers the patient to expect that their healthcare providers are practicing due diligence. It is the ethical duty and responsibility of nurses to provide safe, competent care while protecting the rights of the patient and being accountable to the professional governing bodies. In other words, we are advocates for both our patients and the healthcare system.2 Using both new and innovative instruments in the OR was, in the past, as simple as a surgeon requesting an instrument, the perioperative nurse ordering the instrument and CPD processing it for use in the OR. That is no longer the case. With a wide range of more complex instrumentation and an increasing focus on sterilization strategies, healthcare facilities have had to adopt a more rigorous approach. There are many challenges in the world of sterile processing. A common one, faced on a regular basis, is the provision of vague, inaccurate reprocessing recommendations from the medical device manufacturer. Canadian centres are not able to meet European standards for reprocessing. European cycles, often referred to as "Fractionated Steam Cycles", are different than the pre-vacuum steam cycles run in Canada.

DOE Office of Scientific and Technical Information (OSTI.GOV)

MANI,SEETHAMBAL S.; FLEMING,JAMES G.; WALRAVEN,JEREMY A.

Two major problems associated with Si-based MEMS (MicroElectroMechanical Systems) devices are stiction and wear. Surface modifications are needed to reduce both adhesion and friction in micromechanical structures to solve these problems. In this paper, the authors present a CVD (Chemical Vapor Deposition) process that selectively coats MEMS devices with tungsten and significantly enhances device durability. Tungsten CVD is used in the integrated-circuit industry, which makes this approach manufacturable. This selective deposition process results in a very conformal coating and can potentially address both stiction and wear problems confronting MEMS processing. The selective deposition of tungsten is accomplished through the siliconmore » reduction of WF{sub 6}. The self-limiting nature of the process ensures consistent process control. The tungsten is deposited after the removal of the sacrificial oxides to minimize stress and process integration problems. The tungsten coating adheres well and is hard and conducting, which enhances performance for numerous devices. Furthermore, since the deposited tungsten infiltrates under adhered silicon parts and the volume of W deposited is less than the amount of Si consumed, it appears to be possible to release adhered parts that are contacted over small areas such as dimples. The wear resistance of tungsten coated parts has been shown to be significantly improved by microengine test structures.« less

Effects of Build Orientation on Surface Morphology and Bone Cell Activity of Additively Manufactured Ti6Al4V Specimens.

PubMed

Weißmann, Volker; Drescher, Philipp; Seitz, Hermann; Hansmann, Harald; Bader, Rainer; Seyfarth, Anika; Klinder, Annett; Jonitz-Heincke, Anika

2018-05-29

Additive manufacturing of lightweight or functional structures by selective laser beam (SLM) or electron beam melting (EBM) is widespread, especially in the field of medical applications. SLM and EBM processes were applied to prepare Ti6Al4V test specimens with different surface orientations (0°, 45° and 90°). Roughness measurements of the surfaces were conducted and cell behavior on these surfaces was analyzed. Hence, human osteoblasts were seeded on test specimens to determine cell viability (metabolic activity, live-dead staining) and gene expression of collagen type 1 (Col1A1), matrix metalloprotease (MMP) 1 and its natural inhibitor, TIMP1, after 3 and 7 days. The surface orientation of specimens during the manufacturing process significantly influenced the roughness. Surface roughness showed significant impact on cellular viability, whereas differences between the time points day 3 and 7 were not found. Collagen type 1 mRNA synthesis rates in human osteoblasts were enhanced with increasing roughness. Both manufacturing techniques further influenced the induction of bone formation process in the cell culture. Moreover, the relationship between osteoblastic collagen type 1 mRNA synthesis rates and specimen orientation during the building process could be characterized by functional formulas. These findings are useful in the designing of biomedical applications and medical devices.

40 CFR 211.211 - Compliance with labeling requirement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ABATEMENT PROGRAMS PRODUCT NOISE LABELING Hearing Protective Devices § 211.211 Compliance with labeling requirement. (a) All hearing protective devices manufactured after the effective date of this regulation, and... comply with the Labeled Values of mean attenuation. (b) A manufacturer must take into account both...

3D printed disposable optics and lab-on-a-chip devices for chemical sensing with cell phones

NASA Astrophysics Data System (ADS)

Comina, G.; Suska, A.; Filippini, D.

2017-02-01

Digital manufacturing (DM) offers fast prototyping capabilities and great versatility to configure countless architectures at affordable development costs. Autonomous lab-on-a-chip (LOC) devices, conceived as only disposable accessory to interface chemical sensing to cell phones, require specific features that can be achieved using DM techniques. Here we describe stereo-lithography 3D printing (SLA) of optical components and unibody-LOC (ULOC) devices using consumer grade printers. ULOC devices integrate actuation in the form of check-valves and finger pumps, as well as the calibration range required for quantitative detection. Coupling to phone camera readout depends on the detection approach, and includes different types of optical components. Optical surfaces can be locally configured with a simple polishing-free post-processing step, and the representative costs are 0.5 US$/device, same as ULOC devices, both involving fabrication times of about 20 min.

Material selection for climbing hardware using the example of a belay device

NASA Astrophysics Data System (ADS)

Semenov, E.; Schwanitz, S.; Odenwald, S.

2017-03-01

The aim of the research project was to design a novel climbing belay device. The present article describes the details of the therefor performed material selection. Literature research on the materials used in commercially available belay devices revealed a lack of definite information. Thus, a pilot x-ray fluorescence (XRF) test was performed on a small sample of common aluminium belay devices. It revealed the use of a variety of different alloy systems. The selection process continued by compiling a thorough list of constraints and objectives for this safety related piece of sports equipment. Different material options including non-aluminium-materials were discussed. The final material choice was a high strength aluminium alloy with a T6 thermal treatment. The device was designed and calculated by use of CAD and FEM software respectively, aiming to reduce weight. After manufacturing the strength, usability and friction properties of the device have been successfully tested.

Using CORBA to integrate manufacturing cells to a virtual enterprise

NASA Astrophysics Data System (ADS)

Pancerella, Carmen M.; Whiteside, Robert A.

1997-01-01

It is critical in today's enterprises that manufacturing facilities are not isolated from design, planning, and other business activities and that information flows easily and bidirectionally between these activities. It is also important and cost-effective that COTS software, databases, and corporate legacy codes are well integrated in the information architecture. Further, much of the information generated during manufacturing must be dynamically accessible to engineering and business operations both in a restricted corporate intranet and on the internet. The software integration strategy in the Sandia Agile Manufacturing Testbed supports these enterprise requirements. We are developing a CORBA-based distributed object software system for manufacturing. Each physical machining device is a CORBA object and exports a common IDL interface to allow for rapid and dynamic insertion, deletion, and upgrading within the manufacturing cell. Cell management CORBA components access manufacturing devices without knowledge of any device-specific implementation. To support information flow from design to planning data is accessible to machinists on the shop floor. CORBA allows manufacturing components to be easily accessible to the enterprise. Dynamic clients can be created using web browsers and portable Java GUI's. A CORBA-OLE adapter allows integration to PC desktop applications. Other commercial software can access CORBA network objects in the information architecture through vendor API's.

Proceedings, Conference on New Processes for Braille Manufacture (American Printing House for the Blind, Louisville, Kentucky, February 8-9, 1968).

ERIC Educational Resources Information Center

Massachusetts Inst. of Tech., Cambridge. Sensory Aids Evaluation and Development Center.

The proceedings include papers on computer translated braille (grade 2, display devices, recent developments), the new braille translation program and research at the American Printing House for the Blind, the braille electric typewriter, the Massachusetts Institute of Technology braille embosser, the braille reader, and braille transmission for…

A Statistical Representation of Pyrotechnic Igniter Output

NASA Astrophysics Data System (ADS)

Guo, Shuyue; Cooper, Marcia

2017-06-01

The output of simplified pyrotechnic igniters for research investigations is statistically characterized by monitoring the post-ignition external flow field with Schlieren imaging. Unique to this work is a detailed quantification of all measurable manufacturing parameters (e.g., bridgewire length, charge cavity dimensions, powder bed density) and associated shock-motion variability in the tested igniters. To demonstrate experimental precision of the recorded Schlieren images and developed image processing methodologies, commercial exploding bridgewires using wires of different parameters were tested. Finally, a statistically-significant population of manufactured igniters were tested within the Schlieren arrangement resulting in a characterization of the nominal output. Comparisons between the variances measured throughout the manufacturing processes and the calculated output variance provide insight into the critical device phenomena that dominate performance. Sandia National Laboratories is a multi-mission laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Corporation, for the U.S. Department of Energy's NNSA under contract DE-AC04-94AL85000.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hung, Cheng-Hung

The main objective of this project was to develop a low-cost integrated substrate for rigid OLED solid-state lighting produced at a manufacturing scale. The integrated substrates could include combinations of soda lime glass substrate, light extraction layer, and an anode layer (i.e., Transparent Conductive Oxide, TCO). Over the 3 + year course of the project, the scope of work was revised to focus on the development of a glass substrates with an internal light extraction (IEL) layer. A manufacturing-scale float glass on-line particle embedding process capable of producing an IEL glass substrate having a thickness of less than 1.7mm andmore » an area larger than 500mm x 400mm was demonstrated. Substrates measuring 470mm x 370mm were used in the OLED manufacturing process for fabricating OLED lighting panels in single pixel devices as large as 120.5mm x 120.5mm. The measured light extraction efficiency (calculated as external quantum efficiency, EQE) for on-line produced IEL samples (>50%) met the project’s initial goal.« less

Low-Cost Manufacturing of Bioresorbable Conductors by Evaporation-Condensation-Mediated Laser Printing and Sintering of Zn Nanoparticles.

PubMed

Shou, Wan; Mahajan, Bikram K; Ludwig, Brandon; Yu, Xiaowei; Staggs, Joshua; Huang, Xian; Pan, Heng

2017-07-01

Currently, bioresorbable electronic devices are predominantly fabricated by complex and expensive vacuum-based integrated circuit (IC) processes. Here, a low-cost manufacturing approach for bioresorbable conductors on bioresorbable polymer substrates by evaporation-condensation-mediated laser printing and sintering of Zn nanoparticle is reported. Laser sintering of Zn nanoparticles has been technically difficult due to the surface oxide on nanoparticles. To circumvent the surface oxide, a novel approach is discovered to print and sinter Zn nanoparticle facilitated by evaporation-condensation in confined domains. The printing process can be performed on low-temperature substrates in ambient environment allowing easy integration on a roll-to-roll platform for economical manufacturing of bioresorbable electronics. The fabricated Zn conductors show excellent electrical conductivity (≈1.124 × 10 6 S m -1 ), mechanical durability, and water dissolvability. Successful demonstration of strain gauges confirms the potential application in various environmentally friendly sensors and circuits. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Fine pitch thermosonic wire bonding: analysis of state-of-the-art manufacturing capability

NASA Astrophysics Data System (ADS)

Cavasin, Daniel

1995-09-01

A comprehensive process characterization was performed at the Motorola plastic package assembly site in Selangor, Malaysia, to document the current fine pitch wire bond process capability, using state-of-the-art equipment, in an actual manufacturing environment. Two machines, representing the latest technology from two separate manufacturers, were operated one shift per day for five days, bonding a 132 lead Plastic Quad Flat Pack. Using a test device specifically designed for fine pitch wire bonding, the bonding programs were alternated between 107 micrometers and 92 micrometers pad pitch, running each pitch for a total of 1600 units per machine. Wire, capillary type, and related materials were standardized and commercially available. A video metrology measurement system, with a demonstrated six sigma repeatability band width of 0.51 micrometers , was utilized to measure the bonded units for bond dimensions and placement. Standard Quality Assurance (QA) metrics were also performed. Results indicate that state-of-the-art thermosonic wire bonding can achieve acceptable assembly yields at these fine pad pitches.

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

PubMed

1998-11-03

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

The FDA role in contact lens development and safety.

PubMed

Lippman, R E

1990-01-01

The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS)

An integrated optics microfluidic device for detecting single DNA molecules.

PubMed

Krogmeier, Jeffrey R; Schaefer, Ian; Seward, George; Yantz, Gregory R; Larson, Jonathan W

2007-12-01

A fluorescence-based integrated optics microfluidic device is presented, capable of detecting single DNA molecules in a high throughput and reproducible manner. The device integrates microfluidics for DNA stretching with two optical elements for single molecule detection (SMD): a plano-aspheric refractive lens for fluorescence excitation (illuminator) and a solid parabolic reflective mirror for fluorescence collection (collector). Although miniaturized in size, both optical components were produced and assembled onto the microfluidic device by readily manufacturable fabrication techniques. The optical resolution of the device is determined by the small and relatively low numerical aperture (NA) illuminator lens (0.10 effective NA, 4.0 mm diameter) that delivers excitation light to a diffraction limited 2.0 microm diameter spot at full width half maximum within the microfluidic channel. The collector (0.82 annular NA, 15 mm diameter) reflects the fluorescence over a large collection angle, representing 71% of a hemisphere, toward a single photon counting module in an infinity-corrected scheme. As a proof-of-principle experiment for this simple integrated device, individual intercalated lambda-phage DNA molecules (48.5 kb) were stretched in a mixed elongational-shear microflow, detected, and sized with a fluorescence signal to noise ratio of 9.9 +/-1.0. We have demonstrated that SMD does not require traditional high numerical aperture objective lenses and sub-micron positioning systems conventionally used in many applications. Rather, standard manufacturing processes can be combined in a novel way that promises greater accessibility and affordability for microfluidic-based single molecule applications.

Origin of vertical orientation in two-dimensional metal halide perovskites and its effect on photovoltaic performance.

PubMed

Chen, Alexander Z; Shiu, Michelle; Ma, Jennifer H; Alpert, Matthew R; Zhang, Depei; Foley, Benjamin J; Smilgies, Detlef-M; Lee, Seung-Hun; Choi, Joshua J

2018-04-06

Thin films based on two-dimensional metal halide perovskites have achieved exceptional performance and stability in numerous optoelectronic device applications. Simple solution processing of the 2D perovskite provides opportunities for manufacturing devices at drastically lower cost compared to current commercial technologies. A key to high device performance is to align the 2D perovskite layers, during the solution processing, vertical to the electrodes to achieve efficient charge transport. However, it is yet to be understood how the counter-intuitive vertical orientations of 2D perovskite layers on substrates can be obtained. Here we report a formation mechanism of such vertically orientated 2D perovskite in which the nucleation and growth arise from the liquid-air interface. As a consequence, choice of substrates can be liberal from polymers to metal oxides depending on targeted application. We also demonstrate control over the degree of preferential orientation of the 2D perovskite layers and its drastic impact on device performance.

Atomic layer deposited oxide films as protective interface layers for integrated graphene transfer

NASA Astrophysics Data System (ADS)

Cabrero-Vilatela, A.; Alexander-Webber, J. A.; Sagade, A. A.; Aria, A. I.; Braeuninger-Weimer, P.; Martin, M.-B.; Weatherup, R. S.; Hofmann, S.

2017-12-01

The transfer of chemical vapour deposited graphene from its parent growth catalyst has become a bottleneck for many of its emerging applications. The sacrificial polymer layers that are typically deposited onto graphene for mechanical support during transfer are challenging to remove completely and hence leave graphene and subsequent device interfaces contaminated. Here, we report on the use of atomic layer deposited (ALD) oxide films as protective interface and support layers during graphene transfer. The method avoids any direct contact of the graphene with polymers and through the use of thicker ALD layers (≥100 nm), polymers can be eliminated from the transfer-process altogether. The ALD film can be kept as a functional device layer, facilitating integrated device manufacturing. We demonstrate back-gated field effect devices based on single-layer graphene transferred with a protective Al2O3 film onto SiO2 that show significantly reduced charge trap and residual carrier densities. We critically discuss the advantages and challenges of processing graphene/ALD bilayer structures.

Normative Databases for Imaging Instrumentation.

PubMed

Realini, Tony; Zangwill, Linda M; Flanagan, John G; Garway-Heath, David; Patella, Vincent M; Johnson, Chris A; Artes, Paul H; Gaddie, Ian B; Fingeret, Murray

2015-08-01

To describe the process by which imaging devices undergo reference database development and regulatory clearance. The limitations and potential improvements of reference (normative) data sets for ophthalmic imaging devices will be discussed. A symposium was held in July 2013 in which a series of speakers discussed issues related to the development of reference databases for imaging devices. Automated imaging has become widely accepted and used in glaucoma management. The ability of such instruments to discriminate healthy from glaucomatous optic nerves, and to detect glaucomatous progression over time is limited by the quality of reference databases associated with the available commercial devices. In the absence of standardized rules governing the development of reference databases, each manufacturer's database differs in size, eligibility criteria, and ethnic make-up, among other key features. The process for development of imaging reference databases may be improved by standardizing eligibility requirements and data collection protocols. Such standardization may also improve the degree to which results may be compared between commercial instruments.

Fabricating specialised orthopaedic implants using additive manufacturing

NASA Astrophysics Data System (ADS)

Unwin, Paul

2014-03-01

It has been hypothesised that AM is ideal for patient specific orthopaedic implants such as those used in bone cancer treatment, that can rapidly build structures such as lattices for bone and tissues to in-grow, that would be impossible using current conventional subtractive manufacturing techniques. The aim of this study was to describe the adoption of AM (direct metal laser sintering and electron beam melting) into the design manufacturing and post-manufacturing processes and the early clinical use. Prior to the clinical use of AM implants, extensive metallurgical and mechanical testing of both laser and electron beam fabrications were undertaken. Concurrently, post-manufacturing processes evaluated included hipping, cleaning and coating treatments. The first clinical application of a titanium alloy mega-implant was undertaken in November 2010. A 3D model of the pelvic wing implant was designed from CT scans. Novel key features included extensive lattice structures at the bone interfaces and integral flanges to fix the implant to the bone. The pelvic device was implanted with the aid of navigation and to date the patient remains active. A further 18 patient specific mega-implants have now been implanted. The early use of this advanced manufacturing route for patient specific implants has been very encouraging enabling the engineer to produce more advanced and anatomical conforming implants. However, there are a new set of design, manufacturing and regulatory challenges that require addressing to permit this technique to be used more widely. This technology is changing the design and manufacturing paradigm for the fabrication of specialised orthopaedic implants.

Electromagnetic field tapering using all-dielectric gradient index materials.

PubMed

Yi, Jianjia; Piau, Gérard-Pascal; de Lustrac, André; Burokur, Shah Nawaz

2016-07-28

The concept of transformation optics (TO) is applied to control the flow of electromagnetic fields between two sections of different dimensions through a tapering device. The broadband performance of the field taper is numerically and experimentally validated. The taper device presents a graded permittivity profile and is fabricated through three-dimensional (3D) polyjet printing technology using low-cost all-dielectric materials. Calculated and measured near-field mappings are presented in order to validate the proposed taper. A good qualitative agreement is obtained between full-wave simulations and experimental tests. Such all-dielectric taper paves the way to novel types of microwave devices that can be easily fabricated through low-cost additive manufacturing processes.

Hand-Held Devices Detect Explosives and Chemical Agents

NASA Technical Reports Server (NTRS)

2010-01-01

Ion Applications Inc., of West Palm Beach, Florida, partnered with Ames Research Center through Small Business Innovation Research (SBIR) agreements to develop a miniature version ion mobility spectrometer (IMS). While NASA was interested in the instrument for detecting chemicals during exploration of distant planets, moons, and comets, the company has incorporated the technology into a commercial hand-held IMS device for use by the military and other public safety organizations. Capable of detecting and identifying molecules with part-per-billion sensitivity, the technology now provides soldiers with portable explosives and chemical warfare agent detection. The device is also being adapted for detecting drugs and is employed in industrial processes such as semiconductor manufacturing.

Optical radiation hazards of laser welding processes. Part 1: Neodymium-YAG laser.

PubMed

Rockwell, R J; Moss, C E

1983-08-01

High power laser devices are being used for numerous metalworking processes such as welding, cutting and heat treating. Such laser devices are totally enclosed either by the manufacturer or the end-user. When this is done, the total laser system is usually certified by the manufacturer following the federal requirements of the Code of Federal Regulations (CFR) 1040.10 and 10.40.11 as a Class I laser system. Similarly, the end-user may also reclassify an enclosed high-power laser into the Class I category following the requirements of the American National Standards Institute (ANSI) Z-136.1 (1980) standard. There are, however, numerous industrial laser applications where Class IV systems are required to be used in an unenclosed manner. In such applications, there is concern for both ocular and skin hazards caused by direct and scattered laser radiation, as well as potential hazards caused by the optical radiation created by the laser beam's interaction with the metal (i.e. the plume radiation). Radiant energy measurements are reported for both the scattered laser radiation and the resultant plume radiations which were produced during typical unenclosed Class IV Neodymium-YAG laser welding processes. Evaluation of the plume radiation was done with both radiometric and spectroradiometric measurement equipment. The data obtained were compared to applicable safety standards.

Advanced hole patterning technology using soft spacer materials (Conference Presentation)

NASA Astrophysics Data System (ADS)

Park, Jong Keun; Hustad, Phillip D.; Aqad, Emad; Valeri, David; Wagner, Mike D.; Li, Mingqi

2017-03-01

A continuing goal in integrated circuit industry is to increase density of features within patterned masks. One pathway being used by the device manufacturers for patterning beyond the 80nm pitch limitation of 193 immersion lithography is the self-aligned spacer double patterning (SADP). Two orthogonal line space patterns with subsequent SADP can be used for contact holes multiplication. However, a combination of two immersion exposures, two spacer deposition processes, and two etch processes to reach the desired dimensions makes this process expensive and complicated. One alternative technique for contact hole multiplication is the use of an array of pillar patterns. Pillars, imaged with 193 immersion photolithography, can be uniformly deposited with spacer materials until a hole is formed in the center of 4 pillars. Selective removal of the pillar core gives a reversal of phases, a contact hole where there was once a pillar. However, the highly conformal nature of conventional spacer materials causes a problem with this application. The new holes, formed between 4 pillars, by this method have a tendency to be imperfect and not circular. To improve the contact hole circularity, this paper presents the use of both conventional spacer material and soft spacer materials. Application of soft spacer materials can be achieved by an existing coating track without additional cost burden to the device manufacturers.

Effect of Back Contact and Rapid Thermal Processing Conditions on Flexible CdTe Device Performance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mahabaduge, Hasitha; Meysing, D. M.; Rance, Will L.

Flexible CdTe solar cells on ultra-thin glass substrates can enable new applications that require high specific power, unique form-factors, and low manufacturing costs. To be successful, these cells must be cost competitive, have high efficiency, and have high reliability. Here we present back contact processing conditions that enabled us to achieve over 16% efficiency on flexible Corning (R) Willow (R) Glass substrates. We used co-evaporated ZnTe:Cu and Au as our back contact and used rapid thermal processing (RTP) to activate the back contact. Both the ZnTe to Cu ratio and the RTP activation temperature provide independent control over the devicemore » performance. We have investigated the influence of various RTP conditions to Cu activation and distribution. Current density-voltage, capacitance-voltage measurements along with device simulations were used to examine the device performance in terms of ZnTe to Cu ratio and rapid thermal activation temperature.« less

Standardization of reliability reporting for cochlear implants: an interim report.

PubMed

Backous, Douglas D; Watson, Stacey D

2007-04-01

To propose a standard definition of "out of specification" for cochlear implants and a paradigm for inclusion of category C of the ISO standard 5841-2:2000 for reporting in cumulative survival statistics. A standard definition of "out of specification" and consistent reporting by manufacturers of cochlear implants will create a fair and consistent representation of cumulative survival. This will allow discernment of differences between manufacturers for reliability and for detection of trends in reliability between model types from the same manufacturer. Three separate meetings with representatives of the three manufacturers of cochlear implants marketed in the United States were staged over a 13-mo period. Standard questions, created by the authors, were addressed by each representative to determine the current state of device reliability reporting. Results were presented to clinicians at the William House Cochlear Implant study Group and the Implantable devices sub-committee of the American Academy of Otolaryngology (2004, 2005) and at the 8th International Cochlear Implant Conference (2004) for feedback. After assimilation of feedback by all parties, the standard was written and reviewed by representatives from each manufacturer for accuracy of data. A complaint-driven standard was developed. A "cochlear implant" as an internal device placed and skin closed in surgery. An internal device is "out of specification" when one or more technical characteristics is outside the limits of normal function and results in explantation or non-use by the patient." Children will be reported separately from adults, each model of device will be reported on annually, a minimum of 200 devices must be in each model group for Cumulative Survival Reporting (CSR). Confidence limits are set at 95%. Explants will be determined to be "biological" or "technical." Technical explants are included in CSR reports. Devices failing to meet specifications set by the manufacturer, not in use but still in situ due to patient choice not to be re-implanted are considered category C and included in CSR reports. Implants that cannot be classified at explant are placed in an "under investigation" category while evaluation is completed. If no classification is made by 6 months, these devices will be included in the CSR report. Notification to the implant center regarding "in" or "out of specification" will be made within 60 d of the explant arriving at the manufacturer with final root cause of failure reported to centers when complete. Information will be passed on to patients by members of the implant team. A standardized form will be created to provide the manufacturers with necessary patient information to guide reliability analysis, including performance after re-implant. The standard for reliability reporting described in this paper improves patient care by presenting data which are understandable to clinicians delivering cochlear implant services. It fosters fair and accurate reporting without discriminating or granting perceived advantage to any manufacturer. This standard provides a basis for reporting research related to or including device reliability in the medical literature.

Comparative alternative materials assessment to screen toxicity hazards in the life cycle of CIGS thin film photovoltaics.

PubMed

Eisenberg, Daniel A; Yu, Mengjing; Lam, Carl W; Ogunseitan, Oladele A; Schoenung, Julie M

2013-09-15

Copper-indium-gallium-selenium-sulfide (CIGS) thin film photovoltaics are increasingly penetrating the market supply for consumer solar panels. Although CIGS is attractive for producing less greenhouse gas emissions than fossil-fuel based energy sources, CIGS manufacturing processes and solar cell devices use hazardous materials that should be carefully considered in evaluating and comparing net environmental benefits of energy products. Through this research, we present a case study on the toxicity hazards associated with alternative materials selection for CIGS manufacturing. We applied two numeric models, The Green Screen for Safer Chemicals and the Toxic Potential Indicator. To improve the sensitivity of the model outputs, we developed a novel, life cycle thinking based hazard assessment method that facilitates the projection of hazards throughout material life cycles. Our results show that the least hazardous CIGS solar cell device and manufacturing protocol consist of a titanium substrate, molybdenum metal back electrode, CuInS₂ p-type absorber deposited by spray pyrolysis, ZnS buffer deposited by spray ion layer gas reduction, ZnO:Ga transparent conducting oxide (TCO) deposited by sputtering, and the encapsulant polydimethylsiloxane. Copyright © 2013 Elsevier B.V. All rights reserved.

Direct Laser Writing-Based Programmable Transfer Printing via Bioinspired Shape Memory Reversible Adhesive.

PubMed

Huang, Yin; Zheng, Ning; Cheng, Zhiqiang; Chen, Ying; Lu, Bingwei; Xie, Tao; Feng, Xue

2016-12-28

Flexible and stretchable electronics offer a wide range of unprecedented opportunities beyond conventional rigid electronics. Despite their vast promise, a significant bottleneck lies in the availability of a transfer printing technique to manufacture such devices in a highly controllable and scalable manner. Current technologies usually rely on manual stick-and-place and do not offer feasible mechanisms for precise and quantitative process control, especially when scalability is taken into account. Here, we demonstrate a spatioselective and programmable transfer strategy to print electronic microelements onto a soft substrate. The method takes advantage of automated direct laser writing to trigger localized heating of a micropatterned shape memory polymer adhesive stamp, allowing highly controlled and spatioselective switching of the interfacial adhesion. This, coupled to the proper tuning of the stamp properties, enables printing with perfect yield. The wide range adhesion switchability further allows printing of hybrid electronic elements, which is otherwise challenging given the complex interfacial manipulation involved. Our temperature-controlled transfer printing technique shows its critical importance and obvious advantages in the potential scale-up of device manufacturing. Our strategy opens a route to manufacturing flexible electronics with exceptional versatility and potential scalability.

Development of lightweight THUNDER with fiber composite layers

NASA Astrophysics Data System (ADS)

Yoon, Kwang J.; Shin, Sukjoon; Kim, Jusik; Park, Hoon C.; Kwak, Moon K.

2000-06-01

This paper is concerned with design, manufacturing and performance test of lightweight THUNDER using a top fiber composite layer with near-zero CTE, a PZT ceramic wafer and a bottom glass/epoxy layer with high CTE. The main point of this design is to replace the heavy metal layers of THUNDER by the lightweight fiber reinforced plastic layers without losing capabilities to generate high force and displacement. It is possible to save weight up to about 30 percent if we replace the metallic backing materials by the light fiber composite layer. We can also have design flexibility by selecting the fiber direction and the size of prepreg layers. In addition to the lightweight advantage and design flexibility, the proposed device can be manufactured without adhesive layers when we use epoxy resin prepreg system. Glass/epoxy prepregs, a ceramic wafer with electrode surfaces, and a graphite/epoxy prepreg were simply stacked and cured at an elevated temperature by following autoclave bagging process. It was found that the manufactured composite laminate device had a sufficient curvature after detaching form a flat mold. From experimental actuation tests, it was observed that the developed actuator could generate larger actuation displacement than THUNDER.

High strength fused silica flexures manufactured by femtosecond laser

NASA Astrophysics Data System (ADS)

Bellouard, Yves; Said, Ali A.; Dugan, Mark; Bado, Philippe

2009-02-01

Flexures are mechanical elements used in micro- and precision-engineering to precisely guide the motion of micro-parts. They consist of slender bodies that deform elastically upon the application of a force. Although counter-intuitive at first, fused silica is an attractive material for flexure. Pending that the machining process does not introduce surface flaws that would lead to catastrophic failure, the material has a theoretically high ultimate tensile strength of several GPa. We report on high-aspect ratio fused silica flexures manufactured by femtosecond laser combined with chemical etching. Notch-hinges with thickness as small as twenty microns and aspect ratios comparable to aspect ratios obtained by Deep- Reactive-Ion-Etching (DRIE) were fabricated and tested under different loading conditions. Multiple fracture tests were performed for various loading conditions and the cracks morphologies were analyzed using Scanning Electron Microscopy. The manufactured elements show outstanding mechanical properties with flexural strengths largely exceeding those obtained with other technologies and materials. Fused silica flexures offer a mean to combine integrated optics with micro-mechanics in a single monolithic substrate. Waveguides and mechanical elements can be combined in a monolithic devices opening new opportunities for integrated opto-mechatronics devices.

The economic impact of battery longevity in implantable cardioverter-defibrillators for cardiac resynchronization therapy: the hospital and healthcare system perspectives.

PubMed

Landolina, Maurizio; Morani, Giovanni; Curnis, Antonio; Vado, Antonello; D'Onofrio, Antonio; Bianchi, Valter; Stabile, Giuseppe; Crosato, Martino; Petracci, Barbara; Ceriotti, Carlo; Bontempi, Luca; Morosato, Martina; Ballari, Gian Paolo; Gasparini, Maurizio

2017-08-01

Patients receiving cardiac resynchronization therapy defibrillators (CRT-Ds) are likely to undergo one or more device replacements, mainly for battery depletion. We assessed the economic impact of battery depletion on the overall cost of CRT-D treatment from the perspectives of the healthcare system and the hospital. We also compared devices of different generations and from different manufacturers in terms of therapy cost. We analysed data on 1792 CRT-Ds implanted in 1399 patients in 9 Italian centres. We calculated the replacement probability and the total therapy cost over 6 years, stratified by device generation and manufacturer. Public tariffs from diagnosis-related groups were used together with device prices and hospitalization costs. Generators were from 3 manufacturers: Boston Scientific (667, 37%), Medtronic (973, 54%), and St Jude Medical (152, 9%). The replacement probability at 6 years was 83 and 68% for earlier- and recent-generation devices, respectively. The need for replacement increased total therapy costs by more than 50% over the initial implantation cost for hospitals and by more than 30% for healthcare system. The improved longevity of recent-generation CRT-Ds reduced the therapy cost by ∼6% in both perspectives. Among recent-generation CRT-Ds, the replacement probability of devices from different manufacturers ranged from 12 to 70%. Consequently, the maximum difference in therapy cost between manufacturers was 40% for hospitals and 19% for the healthcare system. Differences in CRT-D longevity strongly affect the overall therapy cost. While the use of recent-generation devices has reduced the cost, significant differences exist among currently available systems. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Objective and perceptual comparisons of two bluetooth hearing aid assistive devices.

PubMed

Clark, Jackie L; Pustejovsky, Carmen; Vanneste, Sven

2017-08-01

With the advent of Bluetooth technology, many of the assistive listening devices for hearing have become manufacturer specific, with little objective information about the performance provided. Thirty native English-speaking adults (mean age 29.8) with normal hearing were tested pseudo-randomly with two major hearing aid manufacturers' proprietary Bluetooth connectivity devices paired to the accompanying manufacturer's specific hearing aids. Sentence recognition performance was objectively measured for each system with signals transmitted via a land-line to the same iPhone in two conditions. There was a significant effect of participant's performance according to listening condition. There was no significant effect between device manufacturers according to listening condition, but there was a significant effect in participant's perception of "quality of sound". Despite differences in signal transmission for each devise, when worn by participants both the systems performed equally. In fact, participants expressed personal preferences for specific technology that was largely due to their perceived quality of sound while listening to recorded signals. While further research is necessary to investigate other measures of benefit for Bluetooth connectivity devices, preliminary data suggest that in order to ensure comfort and compatibility, not only should objective measures of the patient benefit be completed, but also assessing the patient's perception of benefit is equally important. Implications for Rehabilitation All professionals who work with individuals with hearing loss, become aware of the differences in the multiple choices for assistive technology readily available for hearing loss. With the ever growing dispensing of Bluetooth connectivity devices coupled to hearing aids, there is an increased burden to determine whether performance differences could exist between manufacturers. There is a growing need to investigate other measures of benefit for Bluetooth hearing aid connectivity devices that not only include objective measures, but also patient perception of benefit.

Antimicrobial Peptides in Biomedical Device Manufacturing.

PubMed

Riool, Martijn; de Breij, Anna; Drijfhout, Jan W; Nibbering, Peter H; Zaat, Sebastian A J

2017-01-01

Over the past decades the use of medical devices, such as catheters, artificial heart valves, prosthetic joints, and other implants, has grown significantly. Despite continuous improvements in device design, surgical procedures, and wound care, biomaterial-associated infections (BAI) are still a major problem in modern medicine. Conventional antibiotic treatment often fails due to the low levels of antibiotic at the site of infection. The presence of biofilms on the biomaterial and/or the multidrug-resistant phenotype of the bacteria further impair the efficacy of antibiotic treatment. Removal of the biomaterial is then the last option to control the infection. Clearly, there is a pressing need for alternative strategies to prevent and treat BAI. Synthetic antimicrobial peptides (AMPs) are considered promising candidates as they are active against a broad spectrum of (antibiotic-resistant) planktonic bacteria and biofilms. Moreover, bacteria are less likely to develop resistance to these rapidly-acting peptides. In this review we highlight the four main strategies, three of which applying AMPs, in biomedical device manufacturing to prevent BAI. The first involves modification of the physicochemical characteristics of the surface of implants. Immobilization of AMPs on surfaces of medical devices with a variety of chemical techniques is essential in the second strategy. The main disadvantage of these two strategies relates to the limited antibacterial effect in the tissue surrounding the implant. This limitation is addressed by the third strategy that releases AMPs from a coating in a controlled fashion. Lastly, AMPs can be integrated in the design and manufacturing of additively manufactured/3D-printed implants, owing to the physicochemical characteristics of the implant material and the versatile manufacturing technologies compatible with antimicrobials incorporation. These novel technologies utilizing AMPs will contribute to development of novel and safe antimicrobial medical devices, reducing complications and associated costs of device infection.

Antimicrobial Peptides in Biomedical Device Manufacturing

NASA Astrophysics Data System (ADS)

Riool, Martijn; de Breij, Anna; Drijfhout, Jan W.; Nibbering, Peter H.; Zaat, Sebastian A. J.

2017-08-01

Over the past decades the use of medical devices, such as catheters, artificial heart valves, prosthetic joints and other implants, has grown significantly. Despite continuous improvements in device design, surgical procedures and wound care, biomaterial-associated infections (BAI) are still a major problem in modern medicine. Conventional antibiotic treatment often fails due to the low levels of antibiotic at the site of infection. The presence of biofilms on the biomaterial and/or the multidrug-resistant phenotype of the bacteria further impair the efficacy of antibiotic treatment. Removal of the biomaterial is then the last option to control the infection. Clearly, there is a pressing need for alternative strategies to prevent and treat BAI. Synthetic antimicrobial peptides (AMPs) are considered promising candidates as they are active against a broad spectrum of (antibiotic-resistant) planktonic bacteria and biofilms. Moreover, bacteria are less likely to develop resistance to these rapidly-acting peptides. In this review we highlight the four main strategies, three of which applying AMPs, in biomedical device manufacturing to prevent BAI. The first involves modification of the physicochemical characteristics of the surface of implants. Immobilization of AMPs on surfaces of medical devices with a variety of chemical techniques is essential in the second strategy. The main disadvantage of these two strategies relates to the limited antibacterial effect in the tissue surrounding the implant. This limitation is addressed by the third strategy that releases AMPs from a coating in a controlled fashion. Lastly, AMPs can be integrated in the design and manufacturing of additively manufactured / 3D-printed implants, owing to the physicochemical characteristics of the implant material and the versatile manufacturing technologies compatible with antimicrobials incorporation. These novel technologies utilizing AMPs will contribute to development of novel and safe antimicrobial medical devices, reducing complications and associated costs of device infection.

Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports.

PubMed

Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rohit; Adelstein, Evan; Jain, Sandeep; Saba, Samir

2017-03-01

Cardiac resynchronization therapy (CRT) is an important treatment for heart failure that requires constant ventricular pacing, placing a high energy burden on CRT defibrillators (CRT-D). Longer battery life reduces the need for device changes and associated complications, thereby affecting patient outcomes and cost of care. We therefore investigated the time to battery depletion of CRT-D from different manufacturers and compared these results with manufacturers' published product performance reports (PPRs). All CRT-D recipients at our institution between January 2008 and December 2010 were included in this study cohort. The patients were followed up to the endpoint of battery depletion and were otherwise censored at the time of death, last follow-up, or device removal for any reason other than battery depletion. A total of 621 patients [173 Boston Scientific (BSC), 391 Medtronic (MDT), and 57 St. Jude Medical (SJM)] were followed up for a median of 3.7 (IQR 1.6-5.0) years, during which time 253 (41%) devices were replaced for battery depletion. Compared with MDT devices, battery depletion was 85 and 54% less likely to happen with BSC and SJM devices, respectively (P < 0.001 for pairwise comparisons). Product performance reports from all manufacturers significantly overestimated battery longevity by more than 20% 6 years after device implantation. Large differences in CRT-D battery longevity exist between manufacturers. Industry-published PPRs significantly overestimate device longevity. These data have important implications to patients, healthcare professionals, hospitals, and third-party payers. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.