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http://www.medicaldevice-network.com/contractors/consultancy_services/auersoft/press1.html Thu, 24 Apr 2008 12:22:51 GMT http://www.medicaldevice-network.com/contractors/consultancy_services/auersoft/press1.html Expanded Capabilities in VisualVault v2.8 (What's New") Core VisualVault functionality continues to strengthen and build upon prior product versions VisualVault v2.8 builds upon existing capabilities to further enhance usability, provide support for sophisticated compliance environments, and support high-volume scan and capture requirements. Customer input drives product enhancements and the following items were requested and delivered: ADMINISTRATION Connection manager: centralized control for establishing access to remote data sources and queries. Allows secure control by administrators, yet allows easy configuration for business analysts. DOCUMENT LIBRARY Powerful index/search engine: VisualVault search has been significantly upgraded with a scalable document indexing engine. The search engine natively supports over 130 file types and is also capable of indexing many other file formats. For optimal performance, the search and indexing services may be installed on separate servers. A single search and indexing engine is capable of supporting multiple VisualVault repositories. Advanced search: Millions of documents can be searched in seconds and improved search filter controls now support the use of parentheses to group boolean combinations. Enhanced user-defined index fields: Now supporting field types of: text, numeric, date, multi-line text and drop-down. Drop-down lists can be connected to external data sources or populated by configuring a centralized list manager. Vault statistics: Review the full repository statistics including status of active, archived documents and indexing jobs. QuickRoute workflow: Use this feature within forms to provide one click access to manual workflow routing. This capability allows you to retain flexibility without losing the continuity of automated workflow processes and audit trails. Conditional forms: Dynamically determine the presentation of form fields determined by field value selection or security rights. Those familiar with the logic engine for conditional workflow will easily use this tool for configuring conditional views of forms. All those forms with 'Internal Use Only'? Now you can ensure only the right stakeholders can read and edit selected form content. Password enabled digital signature stamps: Established for 21 CFR Part 11 and other compliance environments, VisualVault form signature stamps can now be configured to require secondary authentication during the signature process. QuickRoute workflow: Use this feature to provide one click access to workflow routing. This capability allows you to retain flexibility without losing the continuity of automated workflow processes and audit trails. Password enabled tasks: Workflow tasks may now be configured to require secondary authentication prior to approval voting or task completion. Scan - capture: Kofax Release Script - A Kofax Ascent release script for VisualVault ensures the highest level of integration for customers using Kofax Ascent for scanning, image capture, and automated OCR processes. http://www.medicaldevice-network.com/contractors/manufacturing/suntech-medical/press1.html Wed, 23 Apr 2008 14:56:26 GMT http://www.medicaldevice-network.com/contractors/manufacturing/suntech-medical/press1.html SunTech Medical Launches Hemodialysis OEM NIBP Technology SunTech Medical launches their Advantage™ HDM (Hemodialysis Monitoring) OEM Non-invasive Blood Pressure (OEM NIBP) technology designed specifically for monitoring blood pressure during hemodialysis. This application-specific technology recently achieved an A rating for both systolic and diastolic blood pressure measurement according to the British Hypertension Society (BHS) protocol. SunTech Medical recognized the need to address concerns over the accuracy of automated blood pressure measurements on hemodialysis patients. In response, they investigated an oscillometric blood pressure technology for End-Stage Renal Disease (ESRD) patients during hemodialysis. The results provide a break-through in clinical-grade accuracy for non-invasive automated blood pressure measurement on ESRD patients. Although recommended, current validation protocols and guidelines do not require blood pressure monitors to be validated on specific patient populations. Consequently, most are validated on readily available healthy volunteers. In this regard, special efforts were made by focusing not only on ESRD patients, but in the environment for which the technology was intended by performing the evaluation during dialysis treatment. This makes SunTech Medical the only current provider of OEM NIBP technology validated for use during hemodialysis treatment. SunTech Medical wishes to thank the patients and staff at Dr. Georges-L. Dumont Regional Hospital Nephrology Center (Moncton, New Brunswick, Canada). The study was approved by both Health Canada and the Hospital's ethics review board. All subjects were adult volunteers with ESRD currently receiving hemodialysis treatment. http://www.medicaldevice-network.com/contractors/testing/zwick/press5.html Thu, 17 Apr 2008 16:24:16 GMT http://www.medicaldevice-network.com/contractors/testing/zwick/press5.html Zwick to Attend 5th Asian Forum for Materials Testing The growing demand for advanced materials testing systems in the Asia-Pacific region is a positive trend that prepares organisations in the region to enter the global arena. The Zwick Roell Group aims to promote and enhance this growth by showcasing testing systems ranging from universal testing machines to the latest generation of materials testing software at the Asian Forum for Materials Testing. The 5th Asian Forum for Materials Testing will take place from 28 to 29 May in Seoul, Korea. Lectures and presentations by prominent industry leaders and Zwick Roell industry experts complement the exhibition, giving visitors a well-rounded perspective of materials testing in the industry today. This year's focus on the plastics, metals and automotive industries promises to bring advanced and innovative technology to the forefront. Zwick's intelligent and reliable software, testXpert II, will form a thread for every machine to run test procedures, collect and analyse test results. The introduction of the latest products for the plastics testing industry includes the HIT range of pendulum impact testers, MFlow melt flow indexers and the HIT230F drop weight impact tester. Our flagship series of Allround Universal Testing Machines and extensive range of extensometry will continue to be the highlight for organizations needing high resolution and high repeatability. Testing experts and specialists will be on hand to answer questions on every aspect of testing. From the critical machine selection stage to precision calibration services for existing machines, there is something for everyone. The Asian Forum for Materials Testing promises to be a must-attend event for everyone who conducts mechanical testing whether in research and development or in quality Control and is interested to gain the latest knowledge in this field. http://www.medicaldevice-network.com/contractors/consultancy_services/irc/press3.html Thu, 17 Apr 2008 16:19:24 GMT http://www.medicaldevice-network.com/contractors/consultancy_services/irc/press3.html IRC Expands Clinical Trial Capability to Asia In addition to IRC's realtionship with Korea Testing Laboratories (KTL) headquartered in Seoul, Korea, IRC has entered into an agreement with LSK Biopartners enabling services for clinical studies and cliical trial managment. This union enables our clients to conduct clinical trials in a truly global environment with high quality expertise. http://www.medicaldevice-network.com/contractors/consultancy_services/irc/press2.html Thu, 17 Apr 2008 16:18:32 GMT http://www.medicaldevice-network.com/contractors/consultancy_services/irc/press2.html IRC Re-Structures Its Organization to Include CRO Services Although IRC has provided has traditionally offered consulting service for client's requiring clinical trials for their products, IRC has now added to its staff to provide improved services in a highly cost effective and extremely competitive approach. As an alternative to large organizations, we provide the kind of personalized and responsive service to help minimize delays and to help keep cost to a minimum without sacrificing the clinical science required. http://www.medicaldevice-network.com/contractors/consultancy_services/irc/press1.html Thu, 17 Apr 2008 16:16:34 GMT http://www.medicaldevice-network.com/contractors/consultancy_services/irc/press1.html FDA Mandates Appointment of US Agent for All Foreign Manufacturers The US Food and Drug Administration has updated regulations which requiring all foreign manufacturers of medical devices and other FDA regulated products to designate and appoint a US Agent to represent the manufacturer with the FDA. The US Agent must be a US resident with a formal business address in the United States. As the premiere US Agent service, IRC has been serving foreign manufacturers for over ten plus years. Our experience and expertise in translating your needs and meeting your objectives is unparalleled. We offer a wide variety of services as US Agent, from simple representation to enhanced consultation. http://www.medicaldevice-network.com/contractors/electronics/schurter/press12.html Thu, 17 Apr 2008 11:20:30 GMT http://www.medicaldevice-network.com/contractors/electronics/schurter/press12.html Piezo Switches with Seal-Tight Protection Meet Highest Standard Class IP69K. By achieving the seal-tight protection class of IP69K, SCHURTER is extending the spectrum of potential applications for its already tried-and-tested PSE family of piezo switches. The qualification test was carried out using a high-pressure vapor stream at 90 Bar and a temperature of 80°C. The hermetically sealed piezo switches can now be used in areas, which are regularly disinfected or cleaned using high-pressure cleaners. This renders them ideal for use in applications exposed to high levels of dirt and grime such as food processing, commercial cooking and transportation. Besides the extraordinarily long lifetime of more than 20 million switching cycles, SCHURTER piezo switches also reveal a high level of robustness due to their stainless steel or aluminum housing. The following mounting diameters are available as standard: 16, 19, 22, 24, 27 and 30 mm. Other mounting diameters, materials, colors and shapes are possible, according to individual design requirements. Point or ring illumination is offered in mounting sizes 22 mm and up. This feature can be used to illuminate the actuating surface in a continuous mode or to display the switch position on or off. Laser lettering is available and done in house to minimize lead times. A broad range of standard legends and symbols are available. Customer-specific inscriptions are also available. http://www.medicaldevice-network.com/contractors/material-solutions/mactac/press4.html Wed, 16 Apr 2008 15:20:52 GMT http://www.medicaldevice-network.com/contractors/material-solutions/mactac/press4.html MACtac Medical Products Improves Adhesive for Surgical Drape Applications New adhesive platform offers better performance, expanded fabric and film compatibility - while lowering healthcare costs MACtac Medical Products has introduced its enhanced line of single-coated and double-coated pressure-sensitive adhesive systems, specifically designed for use in surgical drape application. MACtac Medical Products' expanded platform features three categories of adhesion: maximum hold, medium hold and gentle hold. Through this platform converters can rely on MACtac for superior performing adhesive systems that are tested according to ISO 10993-5/-10 standards for cytotoxicity, skin irritation and skin sensitization. Converters are seeing an increased demand for optimal adhesion in drape-to-drape and drape-to-patient application as end users seek to lower the risk of surgical site infections (SSI). With an estimated 500,000 SSIs each year, US health providers are constantly looking for ways to lower costs. MACtac's pressure-sensitive adhesive systems help with this, isolating the surgical site by providing a barrier that creates a sterile field - all without sacrificing patient comfort during removal. "Healthcare providers are pressured to decrease spending while improving patient care," said Aaron Smith, technical marketing manager, MACtac Medical Products. “Our new surgical drape adhesive assists customers with their budget and patient comfort requirements - and offers the ability to customize for specific applications." MACtac's expanded platform increases the variety of substrates converters are able to work with, including spunlace, SMS, Kraton, and PE and EVA films. "We not only understand the level of performance our customers need in today's medical market, but their ability to work within a diverse product line as well," Smith said. "MACtac Medical Products' dedication to continuous improvement enables us to provide OEMs and converters alike with the level of quality they require from their supply chain partners." MACtac is a leading global supplier of pressure sensitive adhesives. Founded on personal service, technical support, quality assurance, custom capabilities and supply chain efficiency, MACtac is dedicated to providing superior quality to its customers. Headquartered in Stow, Ohio, MACtac is a subsidiary of the Bemis Company, Inc., the largest flexible packaging supplier in North America. http://www.medicaldevice-network.com/contractors/testing/zwick/press4.html Mon, 14 Apr 2008 19:04:31 GMT http://www.medicaldevice-network.com/contractors/testing/zwick/press4.html testXpo 2008 - 5th Asian Forum for Materials Testing The growing demand for advanced materials testing systems in the Asia-Pacific region is a positive trend that prepares organisations in the region to enter the global arena. The Zwick Roell Group aims to promote and enhance this growth by showcasing testing systems ranging from universal testing machines to the latest generation of materials testing software at the Asian Forum for Materials Testing. The 5th Asian Forum for Materials Testing will take place from 28 to 29 May in Seoul, Korea. Lectures and presentations by prominent industry leaders and Zwick Roell industry experts complement the exhibition, giving visitors a well-rounded perspective of materials testing in the industry today. This year's focus on the plastics, metals and automotive industries promises to bring advanced and innovative technology to the forefront. Zwick's intelligent and reliable software, testXpert® II, will form a thread for every machine to run test procedures, collect and analyse test results. The introduction of the latest products for the plastics testing industry includes the HIT range of pendulum impact testers, MFlow melt flow indexers and the HIT230F drop weight impact tester. Our flagship series of Allround Universal Testing Machines and extensive range of extensometry will continue to be the highlight for organizations needing high resolution and high repeatability. Testing experts and specialists will be on hand to answer questions on every aspect of testing. From the critical machine selection stage to precision calibration services for existing machines, there is something for everyone. The Asian Forum for Materials Testing promises to be a must-attend event for everyone who conducts mechanical testing whether in research and development or in quality control and is interested to gain the latest knowledge in this field. http://www.medicaldevice-network.com/contractors/contract-services/tyco-electrics/press2.html Fri, 11 Apr 2008 09:44:47 GMT http://www.medicaldevice-network.com/contractors/contract-services/tyco-electrics/press2.html Low Friction STERILENE Cable Jacket from Tyco Electronics Eliminates Surface Tackiness of Silicone Tyco Electronics has recently introduced autoclaveable cable assemblies fabricated from STERILENE-enhanced silicone for surgical video and power tools. This latest innovation in material technology eliminates the surface tackiness of silicone and appeals to end-users in hospitals and clinics, by providing a cleaner look and smoother feel. Precision interconnect cable assemblies with STERILENE-enhanced silicone cable jackets maintain their smooth feel, flexibility and strength after repeated autoclave sterilization. Even after being subjected to 1,000 autoclave cycles, 500 Sterrad (100) cycles and 1,000 Steris (System 1) cycles, biocompatible STERILENE-enhanced silicone jacketed cables show no measurable degradation in jacket lubricity or electrical and mechanical properties. The new cable jackets slip comfortably over gloved hands, scrubs and surgical drape. This extra degree of cable manoeuvrability makes it easier to manipulate hand-held surgical devices that are linked by cables to controllers or power sources. STERILENE-enhanced silicone is available on precision interconnect pre-engineered BASIS cable assemblies as well as on custom cable assemblies. http://www.medicaldevice-network.com/contractors/contract-services/tyco-electrics/press1.html Tue, 08 Apr 2008 12:21:38 GMT http://www.medicaldevice-network.com/contractors/contract-services/tyco-electrics/press1.html Reliable, Low Cost Medical Connector for Disposable or Re-Useable Applications from Tyco Electronics Tyco Electronics introduces its rugged, user-friendly and sterilisable medical CPC connector for use in applications such as surgical power instruments, RF and ultrasound ablation and EP monitors used in the operating room. Available with 5, 6, 7 or 10 contact positions, the devices are very cost-effective and benefit from a robust self-latching mechanism which is secure under axial and torsional loads. CPC medical connectors feature a grip area with push-pull action, gold-plated contacts for a reliable connection, MEDLOC II enhanced latch release and a black or grey lightweight housing which is resistant to shock, drop and chemically induced cracking. Sterilisation is possible by autoclave and EtO and by STERRAD and CIDEX+ disinfectants. The components can be overmoulded with silicone in a single step (without potting/sealing) or customisable PVC flex reliefs added for cable strain and flex protection. Integral colour coded cable collets for mating polarisation are also available. Accommodating cables with outside diameters from 2.7mm up to 6.5mm, CPC medical connectors feature an operating voltage of 300VAC, current ratings from 3A up to 7A (depending on the number of contact positions), a durability of 2,500 mating cycles and an operating temperature range from -50°C up to +170°C. http://www.medicaldevice-network.com/contractors/mechanics/aerotech/press6.html Mon, 07 Apr 2008 17:10:20 GMT http://www.medicaldevice-network.com/contractors/mechanics/aerotech/press6.html Updated Laser and Medical Automation Solutions Brochure Available in German Aerotech is now offering its completely updated and redesigned brochure titled Automation Solutions for Laser Processing, Medical Device Manufacturing, and Life Sciences in German. The brochure features our latest advanced systems and components used in laser processing and medical applications, including the LaserTurn™ 1, 2, and 5, as well as systems for laser cutting, welding, ablation, and marking. Of course, we've also included an expansive line of motion systems and components specifically designed for the medical industry, including those for stent, guidewire, catheter, cannulae, hypotube, and endoscope manufacturing, hermetic seam welding, IOL and contact lens manufacturing, DNA and proteomics research, and much more. http://www.medicaldevice-network.com/contractors/mechanics/aerotech/press5.html Mon, 07 Apr 2008 17:08:56 GMT http://www.medicaldevice-network.com/contractors/mechanics/aerotech/press5.html Aerotech Introduces ALAR Series Direct-Drive Rotary Stages Aerotech's ALAR series direct-drive rotary stages provide superior angular positioning and velocity control with exceptionally large apertures. With the combination of a large aperture and direct-drive motor, the ALAR series makes worm-drive large aperture stages a thing of the past. Advantage ALAR Now customers can get large aperture rotary stages with zero backlash, and no gear wear or gear vibration as is commonly seen in worm-drive stages. The other added benefit is that direct drive is significantly faster than worm drive, so testing can be completed in less time. In production settings, this equates to faster testing, lower cost manufacturing, and higher profits. From the standpoint of system accuracy and repeatability, the stage will maintain its performance over time with no need for maintenance because there are no gears to wear out. With higher accuracy and no backlash, customers can produce more accurate products because their test system is now more accurate. Applications Applications for the ALAR include single and multi-axis electro-optic sensor testing, missile seeker testing, antenna testing, inertial navigation device testing, photonic component alignment, high-accuracy laser machining, and precision wafer inspection. These include testing in vacuum to 10-6torr. These rotary stages can also be configured as multiaxis gimbals. High Speed Conventional worm-drive rotaries with similar apertures and payload capacity only operate to 15rpm or less. These direct-drive stages have been tested to 85rpm continuous rotation - over five times faster than worm drives. Superior Mechanical Design Angular contact bearings are used to maximize performance with respect to wobble, moment stiffness, and rotating friction. A precision-machined shaft further minimizes wobble. The design incorporates integral connections that minimize cable issues. The ALAR works especially well in applications that require 360° continuous motion, but have limited space. The stage is 65mm-160mm tall and provides smooth motion without travel restrictions. Brushless Direct-Drive To maximize positioning performance, the ALAR series utilizes Aerotech's brushless, slotless motors. This motor has all of the advantages of a brushless direct-drive motor - no brushes to wear, no gear trains to maintain, and high acceleration and high speeds. Since it is a slotless, ironless design, there is zero cogging, meaning there is absolutely no torque ripple. This makes the ALAR ideal for applications requiring outstanding contoured motion, smooth scan velocity, or precise incremental steps. High Payload Capacity and Large Moment Load Stiffness The ALAR comes in two different configurations. The standard profile (SP) unit has high payload capacity and high moment load stiffness so it can handle applications where its rotation axis is parallel or perpendicular to gravity and the payload center of gravity is cantilevered away from the stage. The low profile (LP) unit has high payload capacity and is good for applications where the axis of rotation is parallel to gravity. Both the SP and LP units have the same aperture options and motor options. Either SP or LP stages can handle between 300lb-1,000lb of axial load. Accurate Positioning Performance is assured with encoder line counts from 31,000 to 74,000 per rev, resulting in resolutions from 0.02 arc sec/count to 0.009 arc sec/count. The motor and high-performance rotary encoder are directly coupled to a common shaft. The absence of gear trains and mechanical couplings means no position errors caused by hysteresis, windup, or backlash. As a result, accuracy of ±3.9 arc sec and bi-directional repeatability of ±0.5 arc sec is attainable. Flexible Configurations Aerotech manufactures a wide range of servo amplifiers and advanced controllers to provide a complete, integrated package. http://www.medicaldevice-network.com/contractors/embedded/texas-instruments/press17.html Tue, 25 Mar 2008 11:32:14 GMT http://www.medicaldevice-network.com/contractors/embedded/texas-instruments/press17.html Ti Unveils Industry's First Family of Complete Analog Front Ends for Superior Ultrasound Systems First device offers 50% smaller size, 20% less power consumption, 40% less noise for sharper images in portable equipment. Extending its high-performance analog expertise in the medical imaging market, Texas Instruments (TI) (NYSE: TXN) today introduced a family of fully integrated Analog Front Ends (AFEs) for portable to high-end ultrasound diagnostic equipment. TI's AFE58xx family will allow the design of innovative ultrasound systems with superior image quality and reduced power consumption. The first device, the AFE5805, addresses the specific needs of the portable ultrasound market with nearly 50% space savings, 20% lower power consumption and 40% less noise than existing integrated solutions. Aging populations, rising healthcare costs and increased demand in emerging economies have created a rapidly growing need for innovative medical solutions such as portable and affordable ultrasound equipment to be used in doctors' offices, ambulances, mobile triage situations and remote regions. Frost & Sullivan forecasts the market for portable or hand-carried ultrasound systems to grow with a 19.2% compound annual growth rate and reach $330 million by 2010. "With the changing requirements and design complexity in the ultrasound market, manufacturers require scalable, highly integrated solutions to make ultrasound systems more accessible while further enhancing medical image quality and reducing power consumption", said Kent Novak, vice president of TI's Medical and High-Reliability business unit. "With a full roadmap of AFE58xx devices addressing all market segments, TI is saving systems cost for manufacturers and helping shape technology to improve the quality and affordability of innovative ultrasound systems." Advanced features for lower power and higher image quality The AFE5805 is a complete analog signal chain solution specifically designed for portable ultrasound systems, which require low power and small size while maintaining the highest resolution possible. By reducing component count, the AFE5805 decreases power consumption by up to 20% with 122mW per channel power efficiency and offers 40% less noise than its closest competitor. With the low noise feature of 0.85nV/rtHz at 2MHz, the AFE5805 achieves a performance suitable not only for portable equipment, but also for high channel density mid-range ultrasound systems. The device integrates eight channels of a Low-Noise Amplifier (LNA), voltage controlled attenuator, programmable gain amplifier, low-pass filter, and 12-bit, 50MSPS Analog-to-Digital Converter (ADC) with LVDS data outputs. With a 15mm by 9mm package, the AFE5805 is the smallest analog front end currently available in the market, about half the size of existing solutions. The low input voltage noise level of the on-chip LNA is key to the quality of the complete input signal path and determines the entire system performance, including the high resolution. Tools, support speed time-to-market Easy-to-use Evaluation Modules (EVMs), data sheet downloads and free samples from TI allow for fast and cost-effective evaluation to help customers speed the design process and penetrate the market quickly. In addition to the AFE5805, TI offers a full portfolio of integrated circuits for ultrasound systems including high performance DSPs, DaVinci™ digital media processors, OMAP™ application processors, high-speed data converters and amplifiers, power management, clocks and interface devices. To download TI's latest Medical Applications Guide, please visit www.ti.com/Medical. Pricing, packaging and availability The AFE5805 is available in a 15mm x 9mm, 135-pin BGA package with a suggested retail price of $75 each in 100-unit quantities. Samples and EVMs are available now, with volume production scheduled for June 2008. http://www.medicaldevice-network.com/contractors/material-solutions/mactac/press3.html Mon, 17 Mar 2008 14:51:10 GMT http://www.medicaldevice-network.com/contractors/material-solutions/mactac/press3.html MACtac® Medical Products Expands Its Adhesive Platform New platform features three categories designed for increased customization, continuous quality There is nothing more important to successful product engineering than quality at every stop along your supply chain. This is magnified in the medical industry when you consider the large number of products that come into direct contact with patients. A primary component in ensuring product quality is selecting the right Pressure-Sensitive Adhesive (PSA), something medical device OEMs and converters carefully consider. Whether the need is gentle removal (from sensitive skin) or aggressive hold (for extended wear), MACtac Medical Products' expanded adhesive platform features three categories of adhesion: extreme durability, medium hold and gentle hold. From these three adhesive categories, a designer can specify the precise adhesion strength, quick tack, gentle peel off from skin, breathability, shear strength and clean removability that works best for their application. The custom-matched adhesive can be coated on foams, films and fabrics to meet customers' diverse specifications. For more than 25 years, the healthcare industry has relied on MACtac for superior performing adhesive systems that are tested according to ISO 10993-5/-10 standards for cytotoxicity, skin irritation and skin sensitization. MACtac's reliable three to five day lead-times ensure that you not only get the product that you need, but you get it when you need it. "Our overall goal is to ensure customer peace of mind," said Rob Zachrich, vice president, MACtac Medical Products. "By providing customers with a single source for all their PSA needs, we are able to conveniently meet their product, logistics and most importantly, quality needs." Serving a variety of market applications, MACtac medical-grade adhesives are suitable for medical device assembly in direct and non-direct skin contact applications, such as disposable electrode adhesive systems, surgical drape constructions and wound dressing adhesive systems. All MACtac Medical Products' adhesives are suitable for sustained skin contact with third-party biocompatibility documentation, and are stable after EtO or gamma sterilization. MACtac is a leading global supplier of pressure sensitive adhesives. Founded on personal service, technical support, quality assurance, custom capabilities and supply chain efficiency, MACtac is dedicated to providing superior quality to its customers. Headquartered in Stow, Ohio, MACtac is a subsidiary of the Bemis Company, Inc., the largest flexible packaging supplier in North America. http://www.medicaldevice-network.com/contractors/testing/tinius-olsen Fri, 09 May 2008 00:00:00 GMT http://www.medicaldevice-network.com/contractors/testing/tinius-olsen Tinius Olsen Tinius Olsen is one of the world's foremost specialist manufacturers and suppliers of testing machines for the medical device industry. Our machines are designed for use in research and quality-control departments to measure, prove and check the physical strength and performance of both materials – be they metals, composites, polymers, rubbers or adhesives – and finished components. A complete series of physical tests are available that include measuring tension, shear, compression, flexure / bending, puncture / burst, tear, peel and frictional strengths, melt flow, impact resistance, stiffness, deflection temperature under load, Vicat penetration, and torsion strength. All such tests are designed and implemented by Tinius Olsen in accordance with key international industrial testing standards including ISO, EN, ASTM, DIN, BS and JIS. Additionally, tests may be devised to put the final product, or even interim production pieces, through a sequence of tests to best replicate the final application of that part. STATIC HYDRAULIC MATERIALS TESTING MACHINES Super "L" testing machines are rugged tension and compression hydraulic machines proven in thousands of demanding applications worldwide. Available with digital readout and optional servo and computer control systems, their maximum frame capacity is 150kN (30,000lb/ft). TENSION AND COMPRESSION TESTING MACHINES These rugged electromechanical tension and compression testing machines feature Tinius Olsen strain-gage load cell force measuring systems. We offer a choice of two-screw or four-screw load frames and maximum frame capacities start from 60kN (12,000lb/ft) for these special application machines. HIGH-FORCE ELECTROMECHANICAL MATERIALS TESTING MACHINES These rugged electromechanical testing machines are designed to test metals, composites, rigid reinforced plastics, webbing, etc. for tension, compression, flexure, shear, tear and peel. These machines feature high-precision interchangeable load cells, superior pre-loaded ballscrews and powerful drive systems that mean they can easily tackle the most challenging of applications. HORIZONTAL TENSILE TESTERS For maximum tensile testing throughput and capability, Tinius Olsen offers a range of horizontal tensile testing machines in capacities of 5kN (1,000lb/ft), 25kN (5,000lb/ft), 150kN (30,000lb/ft) and 300kN (60,000lb/ft). Our horizontal testing machines offer unique benefits over vertically oriented testers by allowing a range of accessories to be mounted next to the machine that can turn it into a fully automatic testing station. The unique horizontal extensometer that is typically supplied incorporates pneumatic controls that automatically lowers the arms prior to the test and raises the arms at the end of the test. Friction-free air bearings on the extensometer provide accurate strain measurement through fracture. TORSION TESTERS For maximum torsion testing versatility and capability, Tinius Olsen offers a full range of torsion testing machines in capacities from 1,000Nm to 30,000Nm. These unique torsion testers provide loading and weighing capabilities in both directions of rotation. This feature makes it possible to conveniently determine not only the ultimate torque load of a specimen, but how that specimen behaves under conditions of continuous or intermittent torque loading in both directions. BENCHTOP MATERIALS-TESTING MACHINES Tinius Olsen's line of benchtop materials-testing machines are designed to test a wide spectrum of materials – including metals, plastics, rubber, textiles, paper, yarn, wire, adhesives, ceramics, timber, foils, composites and finished components – for tension, compression, flexure or shear. MELT INDEXERS (EXTRUSION PLASTOMETER) Tinius Olsen has two models of melt indexer to meet almost every need. We offer either our MP200 low-cost, procedure-A-only (of ASTM D1238) model, or our more familiar, flexible, model MP600. The MP600 is an advanced melt indexing system that allows easy, modular upgrading from its basic capabilities with accessory packages for more automated testing, including control of multiple units from a single PC and automatic flow rate measurements using up to three different loads in one test. IMPACT-TESTING SYSTEMS Tinius Olsen manufactures a range of different pendulum impact testers that can be easily changed from a Charpy configuration to an Izod configuration. These testers come in a couple of capacities and are designed primarily for either plastics or metals impact-testing. http://www.medicaldevice-network.com/contractors/contract-services/tyco-electrics Tue, 22 Apr 2008 00:00:00 GMT http://www.medicaldevice-network.com/contractors/contract-services/tyco-electrics TYCO Electronics Tyco Electronics Ltd. is a leading global provider of engineered electronic components, network solutions, wireless systems and undersea telecommunication systems, with fiscal 2007 sales of US$13.5 billion to customers in more than 150 countries. We design, manufacture and market products for customers in industries from automotive, appliance and aerospace and defence to telecommunications, computers and consumer electronics. With approximately 8,000 engineers and worldwide manufacturing, sales and customer service capabilities, Tyco Electronics' commitment is our customers' advantage. MEDICAL ELECTRONICS SOLUTIONS BROUGHT TO LIFE Tyco Electronics is a leader in cutting-edge medical technology and provides advanced products including calibrators, specialist cable and wire, medical grade tubing, labelling products, fibre optic, wireless components and touch screen. Medical electronics continues to provide remarkable benefits to patients and care givers alike. As medical applications require advanced electronic solutions with higher speeds, sophistication, and reliability you will find Tyco Electronics designs to meet your needs. Our expanding line of products are utilised throughout the medical industry in cardiovascular ultrasound imaging equipment, biomedical chemical analyzer (blood analyzer) equipment, telemetry systems, and copper and fibre optic based local area networks. Measurements can't drift. Signals can't be distorted. Interconnects can't be a performance-throttling bottleneck. The newest requirements in instrumentation and test equipment demand even higher speeds, more flexible packaging, and new levels of precision. System chip test and networking test solutions that can deliver reliable and repeatable measurements from design verification, to manufacturing test, to in-field system test relative to CDMA, W-CDMA, TDMA, GSM, ADSL, ISDN, and D SLAM are entering the marketplace on a daily basis. TURNKEY ELECTRONIC MEDICAL COMPONENT SOLUTIONS Tyco Electronics is a turnkey medical solution provider, developing innovative products, technologies and manufacturing processes to assist medical device market leaders. Our ability to serve your present and future requirements are realised through the synergies of a strong R&D program, expertise in materials science, product design and process engineering, and our network of knowledgeable application engineers, sales representatives and customer service personnel. We want to help you make your next generation of products successful. To find out more, please contact our product information centre. http://www.medicaldevice-network.com/contractors/embedded/intertech Tue, 15 Apr 2008 00:00:00 GMT http://www.medicaldevice-network.com/contractors/embedded/intertech Intertech Intertech Engineering Associates is a leader in medical device design, development, verification, validation, consulting and training. Intertech is a Massachusetts-based corporation that has been providing a variety of services to the medical device industry since 1982. We help clients to design, develop and validate their products, manage their projects, and build their own internal expertise and training infrastructure. MEDICAL DEVICE DESIGN Our 25-year focus on the medical device industry has made Intertech&squo;s experienced engineers keenly aware of the regulatory challenges its clients face with new product design and development. This has enabled the company to apply its software and electronics engineering experience in ways that helps clients navigate their projects through the regulatory stages. Intertech&squo;s design control policies and procedures are traceable to regulations and guidelines from the FDA. Our expertise in software validation is widely recognized within the industry. The company is a leader in helping manufacturers with the validation of quality and production system software (21CFR820.70i). MEDICAL DEVICE SOFTWARE AND ELECTRONICS Intertech&squo;s technical expertise is centered on medical device software and the electronics that support it. Additionally, Intertech is skilled in software and product validation, regulatory compliance, and the management of requirements, projects and product risk. MEDICAL DEVICE SOFTWARE TRAINING Customised on and off-site training is available, which can run from 1hr seminars to multi-day workshops. Intertech currently has training programs on Developing Compliant Medical Device Software, Validation of Medical Device Software, Dealing with GUI Requirements, Software Risk Management, and Validation of Production and Quality System Software. Intertech has also collaborated with AAMI to present the AAMI software validation class. MEDICAL DEVICE DEVELOPMENT ADVICE The depth of Intertech&squo;s involvement is tailored to the demands of a client&squo;s situation. Intertech advises and trains clients seeking to broaden their knowledge base, or will lead by example and work with clients to advance their schedules and reduce project risk. Projects range from supplementing the client&squo;s staffing in a specific discipline to full turn-key design, development and validation. Intertech offers four levels of services: evaluations and assessments, training, consulting and coaching, and hands-on engineering. MEDICAL DEVICE ASSESSMENTS Intertech provides this level of services to clients who want in-depth project status assessment and detailed recommendations for services needed. At this level, Intertech may conduct a demonstrative &squo;friendly audit&squo; or assist in technical or regulatory due diligence on acquisitions or investments. Intertech prides itself on leading the client&squo;s staff by example and actively contributing to projects. This approach supplements consultative advice on how to best address problems and deficiencies. Intertech&squo;s hands-on services include reviews, project management, requirements development, traceability analysis, software development and implementation, and electronics design and development. DEVICE VALIDATION CONSULTING Intertech forms consultative relationships with clients working through their first device development project. Additionally, the company assists those attempting to create or streamline SOPs for device development and validation. This level of service may benefit clients who have employees not from the regulated medical device industry who are experiencing difficulty adapting to the regulated environment. Intertech will help avoid regulatory compliance problems by developing an engineering process, periodically reviewing progress, or acting as an on-call expert resource. Our projects have spanned a range of biomedical fields including audiology, cardiology, dialysis, medication delivery and 3D imaging. Clients include Fortune 500 medical device manufacturers and large international companies. Intertech also works with small companies and has successfully contributed to launching several venture-funded startups. Intertech has been a regular contributor to industry workgroups and standards committees on software risk management and validation. Intertech employees are actively conducting workshops at national and international tradeshows, to supplement corporate training offerings. Intertech&squo;s expertise in risk management, product development, validation, and project management is shared in numerous trade publications. Intertech contributes to the editorial advisory boards of three industry publications. http://www.medicaldevice-network.com/projects/cslp/ Tue, 04 Mar 2008 00:00:00 GMT http://www.medicaldevice-network.com/projects/cslp/ Fracture Mode Analysis of a Cervical Spine Locking Plate (CSLP) We have only performed non-destructive analysis on the fractured CSLP pieces to determine only the fracture mode. We performed initial low magnification stereomicroscope examination on both fracture pieces of the locking plate at 50X magnification. One half of the fractured locking plate piece was examined in the Scanning Electron Microscope (SEM) to determine the fracture mode and crack initiation areas. The fine features on the fracture are analyzed to determine the fracture mode (e.g. fatigue, overload, embrittlement, etc.). RESULTS An overall view of the fractured CSLP is shown in Figure 1. Note that the piece fractured in two halves. This view is from the top surface of the plate on which the identification markings were present. Note that adjacent to the center hole, the writing CSLP is present and the piece fractured through the letter “C”. An overall view of the opposite surface of the CSLP is presented in Figure 2. An overall view of the fracture surfaces of the left-hand side piece in Figure 1 is presented in Figure 3. The two black arrows at the corners point to the approximate crack initiation areas. The red arrows point to the overall crack propagation directions on the surfaces. An SEM view of the fracture surface on the left-hand side in Figure 3 is displayed in Figure 4. The arrow points to the crack origin area at the corner. Note that there were some semielliptical shaped or clam-shaped markings on the fracture which emanated from the origin. These markings are called “beach marks” and are typically associated with a progressive type of fracture or with a fracture which progresses with time. These are macrocrack arrest markings during the progression of the crack. A higher magnification view of the origin area is presented in Figure 5, arrow. Note that there was post-fracture damage present right at the corner and on some areas of the fracture which is evidenced by the smooth appearing areas. A higher magnification view of the area marked “x” in Figure 4 is presented in Figure 6. The small arrows on the fracture surface identified some fatigue striation type parallel markings which indicate that the crack after initiation progressed, most likely, under cyclic loading. These are microcrack arrest markings. The overall features associated with the fracture can be typically related to the fatigue failure of a titanium alloy. There were many secondary microcracks observed which is also associated with fatigue failure of titanium alloys. FINDINGS AND DISCUSSION Our non-destructive fracture mode analysis of the failed Cervical Spine Locking Plate (CSLP) indicated that the fracture initiated on the opposite sides of the middle hole area of the plate at the corner of the hole and top surface (the surface which is towards the outside of the spine when assembled). It appeared that after initiation, the cracks propagated in a progressive manner with cyclic type loading or intermittent loading condition. Typically fatigue failures of unalloyed titanium depends on grain size, interstitial contents, degree of cold work, surface finish, etc. There can be many chemical and microstructural contributions also. http://www.medicaldevice-network.com/projects/nanon/ Thu, 11 Oct 2007 00:00:00 GMT http://www.medicaldevice-network.com/projects/nanon/ Bringing Silicone Rubber to New Levels Nanon has over the last few years developed four unique technologies, able to assist the medical device industry to extend the possibilities with silicone rubber. The technologies are able to tailor-make the silicone surface as well as the bulk - without compromising the physical properties. ColdCuring™: Removes volatiles to parts-per-million level Safe to 'post cure' in combinations with thermoplastic materials Avoids slit healing - also after gamma sterilizations SiliCO2ne Impregnation™: Impregnates substances like oils, drugs, fragrances etc. into the silicone rubber matrix Creates a lubricious surface Softplasma™ polymerization: Creates a chemical bond between silicone and your material Creates biocompatible and medical coatings (i.e. PVP) Softfeel™: Creates a soft surface by adding a clear varnish on top of the silicone rubber COLDCURING™ This process is based on the use of the properties and advantages of the liquid CO2 as solvent &dash; this is the new alternative to the standard post-curing method used for years within the silicone rubber industry &dash; without any rejecting of volatiles to the environment. SAVING TIME AND BEING MORE EFFECTIVE To fulfill food grade and medical grade silicone, the process needs about 50 minutes to reach below the 0.5% of volatiles. For applications requiring materials with very low out gassing level, it is possible to reduce the content of volatiles much more: the amount of cyclic siloxanes D4-D20 can be reduced to below 0.005% (50ppm). On top of that, ColdCuring™ can extract volatiles from two component-molded products - silicone and thermoplastic materials. GAMMA-STERILISATION The wellknown re-polymerisation effect on silicone parts will not take place, which means no slit or cut-healing occur. For medical devices, Nanon has proven that Coldcuring prevents slit-healing of silicone during gamma sterilization. WORLDCLASS DOCUMENTATION The worldwide leaders in suppling silicone rubber have tested and documented the features of the process. SILICO2NE IMPREGNATION™ This process is also based on the use of liquid carbon dioxide. Whereas ColdCuring™ removes volatiles and residues from silicone rubber, SiliCO2ne Impregnation™ adds compound inside the materials. The liquid CO2 acts as a carrier for bringing the compound inside the materials. For instance it is possible to impregnate a lubricant in 100% of the silicone rubber material, creating lubricious silicone materials with anti-static, low friction and anti-electrostatic properties. Other relevant to introduce could be heat-sensitive drugs, fragrance or active compounds. POLYMERIZATIONS INSIDE SILICONE RUBBER The process is also able to add a monomer, which is polymerized inside the silicone rubber, creating an interpenetrating polymer network (IPN). The IPN brings new surface and bulk properties to the silicone such as hydrophilicity or antimicrobial effects. SOFTPLASMA™ POLYMERIZATION Is a unique process creating permanent coating on difficult materials, in particular Silicone. Thin layers (nanoscale) coatings are created on top of the substrate surface with the desired chemical functions. By applying this technology it is possible to create a 'silicone-like' coating onto polymers and metals without using solvent based primer. From this a silicone rubber can be over molded or extruded on the coated substrate. The silicone over-molding application offered by Softplasma™ is especially relevant for bonding thermoplastics, such as poly-amide, poly-carbonate and Poly-ethylene with silicone. Our plasma coating can also be a "stand-alone" coating suitable for medical devices in silicone rubber. Today specially designed coatings have been developed which Decrease adsorption of blood components and thus enhance blood compatibility Resist bacterial attachment and biofilm formation on the device surface Dramatically increase hydrophilicity Activate the surface for additional chemical treatment or drug binding SOFTFEEL™ The main application in Bonding To Silicone is the SoftFeel™, a polyurethane coated silicone membrane. The polyurethane paint procures a soft feel and combined with the silicone rubber, the switch becomes flexible and smooth and allows a diffused backside illumination. Since 2000 Nanon's technology has helped Mercedes to obtain this comfort. Today is also includes Seat and Citroen. SILICONE EXPERTISE Nanon has a Silicone Technology Center with unique solutions and an extensive research pipeline in Copenhagen. Applications cover among others medical devices, automotive components and baby care products. Contact us to see which level we are able to bring your silicone product to. http://www.medicaldevice-network.com/projects/optoelectronics/ Tue, 10 Apr 2007 00:00:00 GMT http://www.medicaldevice-network.com/projects/optoelectronics/ Optoelectronics, Nanophotonics, Laser Technology and Micro Manufacturing Laser Competence Centre Finland (LCC Finland) covers the whole development chain including technology oriented basic research, end users' application development, system integration and testing of lasers as well as training aspects. The objective is to adapt new laser technologies to the needs of industry so that the companies can experiment and develop their products and their processes by utilising the know-how and hardware of the centre. Laser Pilot Factory (LPF), an application laboratory of LCC Finland, has been running for one full year at Tampere University of Technology (TUT). It has been proven to be a successful concept: new type of lasers were tested and evolved, new applications found and nurtured. This service model has clearly met the demand from industry. The most important single factor here is the fruitful co-operation between industrial end-users and laser development partners in LCC Finland. ULTRA SHORT PULSE FIBRE LASER HITS RECORD SPEEDS LPF has been in the front line of application development for an ultra short pulse fibre laser. LPF is running now the 3rd generation of Corelase X-lase ultra short pulse fibre lasers and the current version fits in many needs in modern manufacturing. The most promising applications are found in laser surface structuring and thin-film ablation. LASER SURFACE STRUCTURING Precise surface structuring of steel or specialized hard coatings is a promising application for an ultra short pulse fibre laser. Precise grooves and shapes with minimal thermal effect offer a competing advantage for functional surfaces. Challenges lie in processing speed, process parameters and design of micro shapes. THIN FILM GROOVING High repetition rate and relatively high power allow very high processing speed for a thin film removal for an ultra short pulse fibre laser. Removal speed typical clearly exceeds 2m/s. This high speed is already a challenge for a workpiece manipulation. Typically laser power and removal speed can be adjusted so that it removes cleanly just the required layer. MEDICAL APPLICATIONS By laser machining micro-grooves and holes to the implant/product it is possible to manufacture biodegradable filters and other applications e.g. to guide nerve tissue growth. In addition, it is possible to coat implants to protect the implant structures or use the coating as a drug carrier, change surface topography to enhance cell proliferation or improve corrosion resistance and wear resistance. Scalpels, bone saws, microsurgical instruments and implants are typical examples of laser machined applications. Laser cutting has also been used for cutting stents and needles. For example in stent production, cutting stent implants to desired shapes becomes difficult due to the decreasing diameter of the desired tubes. Very small cutting width, small heat affected zone and the damage free interior of tubes during laser machining are challenges in stent production. Typical stent materials are stainless steel, cobalt and chrome alloys, nitinol, tantalum, platinum and niobium, but nowadays biodegradable polymers have also been used. Laser joining as a manufacturing method has been used for hermetically seal pacemakers, defibrillators and neural stimulation devices. Various biomaterials have been successfully joined together by means of laser joining e.g. polymer-polymer, glass-metal and polymer-metal. In the future many potential applications for laser joining will rise in the field of biomedical sector.