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By Sherrie Conroy, Director of Content
The leaders from nine medical technology associations worldwide have signed the “Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs),” in an effort to further advance ethical behavior globally. The agreement was first signed in 2010 by the AdvaMed; Eucomed, the European medical technology industry association; and, the European Diagnostic Manufacturers Association (EDMA), in an effort to advance their longstanding work to promote ethical collaborations among companies and HCPs globally. It now includes six additional industry associations. The signing took place during a ceremony held at the 2011 International Medical Device Industry Compliance Conference in London. The nine associations’ leaders who have signed the agreement represent the following organizations: AdvaMed, Eucomed, EDMA, COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), IMEDA (International Medical Devices Manufacturers Association), MEDEC (Canadian medical technology industry association), MTAA (Medical Technology Association of Australia), Medical Technology Association of New Zealand, and SAMED (South African Medical Device Industry Association).
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The European Diagnostic Manufacturers Association (EDMA) and Eucomed, the European medical technology industry association, confirmed their commitment to continuing to collaborate on the development of robust, globally consistent regulatory systems that will facilitate access to innovative, safe, effective, and high-quality, clinically beneficial medical technologies for the benefit of patients worldwide. The announcement came after what Eucomed called "the outcomes of the constructive discussions that took place at the last Global Harmonization Task Force (GHTF) Steering Committee," which was held May 11-13 in Brisbane, Australia. During the three-day summit, Eucomed says it became apparent that GHTF members appreciated the work of the GHTF Steering Committee over the past decades. There has also been a useful exchange of views on desirable elements of future forum. Philippe Jacon, EDMA ad interim director general, said, “I am particularly pleased with the outcomes of the GHTF Steering Committee as the planned work was taken further, and the support for existing GHTF guidance was reaffirmed.”
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Buy American. Right from Apple.
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 Apple Rubber manufactures medical grade silicone parts and seals right in the USA. Providing the highest quality standards with no shipping issues. We’ll customize a sealing solution to meet your exact needs, no matter the shape or size.
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Styron, a global materials company established in June 2010, plans to change its company name to Trinseo. The name change will be fully effective in all countries later in 2011; the company will continue to do business as Styron until that time. "We believe that the new name of Trinseo will position the company better for future growth and greater potential as a global materials company," explains Chris Pappas, president and CEO of Styron. "The name Styron is strongly tied to the styrenics chain, particularly polystyrene and styrene monomer, which are an important part of our company, but we are much more than that.” Pappas says the new name of Trinseo is meant to communicate that the company is “a leader in a broader range of businesses, products, and technologies,” and that the name underscores the company’s commitment to growth.
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MD&M East • June 7-9, 2011 • Javits Convention Center •
New York, NY
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 Plan now to attend MD&M East— Regardless of what stage your device is in the product development life cycle, you'll gain immediate, hands-on access to hundreds of qualified knowledgeable suppliers. They understand your strict development requirements and have the expertise and resources you need to bring that new medical device to market on-time and on-budget. Learn more and register at:
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Momentive Performance Materials Inc and Specialty Silicone Fabricators (SSF) are collaborating to develop combination products for medical devices manufacturers. Focusing on the fast-growing market of combination devices with active pharmaceutical ingredients (APIs), the collaboration brings together Momentive Performance Materials’ advanced silicone elastomer technology with SSF expertise in silicone extrusion and medical device assembly. The collaboration leverages Momentive Performance Materials’ advanced ultraviolet (UV) elastomer cure technology, which typically offers fast cure of specialized silicone products at room temperature. According to the Momentive, specialty silicone products featuring the UV cure technology, such as Addisil UV 60 EX elastomer, are excellent candidates to consider in the manufacture of medical devices where lower temperatures are required for heat-sensitive APIs and other materials. Momentive says the new technology can provide a number of other benefits as well, including production output with high purity and low levels of extractables.
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Designed for batch-size and full-run production applications, a direct metal laser-sintering system (DMLS) can manufacture functional parts for prototypes and finished products. The M 280 from EOS of North America, Novi, MI, provides precision manufacturing capabilities for a range of materials using either nitrogen or argon protective atmospheres. Within these atmospheres, the DMLS system can process light metals, tooling steel, and such super alloys as titanium, aluminum, cobalt chrome, and Iconel. To maintain consistent and accurate performance, the machine is equipped with either a 200- or 400W solid-state laser for targeted radiation, as well as laser power monitoring to control the building process. Optional features that can be added to the machine at any time include part property profiles for standardized production and integrated process chain management modules.
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Liquid silicone rubber (LSR) thin-walled diaphragms are molded to offer high strength and flexibility features for healthcare applications. The custom injection-molded LSR diaphragm sealing devices from Minnesota Rubber and Plastics, Minneapolis, are designed to offer improved functionality and cost efficiency compared with similar components that were molded of lesser-grade compounds. Designed for seal applications that require long-term seal life, the thin-walled diaphragms can be used in such applications as dispensing, fluid-filtration, and purification systems. Because these applications demand parts that can withstand temperature variation, resist aging, and operate for extended periods, the LSR diaphragms have heat resistance to 180ºC and good flexibility down to –45ºC.
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Flame-retardant and free of Halogen, Phthalate, Bromine and PVC…Technical Cable Engineered to Exceed
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 Northwire Technical Cable—innovative solutions provider—designs and manufactures medical and retractile cables and assemblies. Quotes in 24 hours or less. RoHS and REACH compliant, UL-rated, CSA-recognized and FDA-approved options available in 5 days or fewer. No minimums. Over-mold assembly compatible, stocking programs, custom colors, private labeling, lot traceability and more. Finite element analysis and rapid prototyping available. Northwire's experts help navigate domestic and international standards, agency compliance, environmental regulations, electrical, ergonomic and aesthetic requirements. + 1 715.294.2121
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A manufacturer of plastic tubing connectors has expanded its press-in plug (PIP) line, which can be used to seal off tubing during the sterilization process. The line, from Value Plastics, Fort Collins, CO, has been expanded to meet industry demand for increased production volumes of larger tubing sizes that, in turn, require larger PIP sizes, particularly 3/8 and 1/2in. fittings. To accommodate these needs, the company offers parts in USP Class VI, animal-free polypropylene, which also helps reduce potential contamination. For industry applications that use silicone and C-Flex tubing, the company’s 600-Series barbs have been enhanced with a strategic design that helps to create a tighter seal with soft and flexible tubing.
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Quick Couplings & Fittings
Make your medical device connections cleaner, faster, safer and smarter. Custom design, multiple material options, innovative hybrid connector solutions and RFID-enabled IdentiQuik Smart Couplings™ make it easy to solve your fluid handling challenges.
www.colder.com
Boker's 2011 Washer Catalog
Boker's 2011 Washer Catalog features over 25,000 non-standard flat washer sizes, available with no tooling charges, outside diameters of 0.080" to 5.140" and over 2,000 material options for endless possibilities.
www.bokers.com/mee
Design Tips Compilation, volume 7 now available
Protomold's monthly Design Tips are a popular and useful resource for designers and design engineers. We've compiled more than 80 tips for designing injection molded parts into seven handy, downloadable volumes. You'll find useful information on everything from selecting materials to designing parts cost-effectively. Download today!
Bishop-Wisecarver Corporation
ALR Aluminum Rings for light load medical applications are anodized for corrosion resistance – sizes available from 148mm to 300mm in diameter. DualVee® guide wheel compatible.
www.bwc.com
Phillips Plastics Corporation®
Medical OEM projects often require more that a custom part or a vendor with limited services. Learn more about the engineering services, materials support, clean rooms, quality control, packaging, sterilization, manufacturing technologies available from Phillips Plastics.
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