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The West Coast's largest medical device tradeshow, MD&M West, is being held this week, and we will be keeping you up to date on all of the latest news through Thursday. Check back frequently for updated images and new stories from the Anaheim Convention Center.
MD&M West 2006 Show Daily

Building Business for Medical Device Testing

In 2002, Impact Analytical (Midland, MI) began making an effort to gain GPL and CGMP certification to build its customers in the medical devices arena, said Eric Hill, marketing development manager for Impact Analytical. The company presented its plans for the coming year at a press briefing at MD&M West trade show in Anaheim, CA. "Today about 5% of our customers are in the medical device business and we are hoping to build more," he said. The company is ISO 9001:2001 certified. It gained GLP compliance in 2003 and became GMP registered in 2004.
Filed Thursday, Feb 9, 2006, 09:24 PST

Company Expands Biomedical Material Testing Line

A supplier of testing equipment has introduced an addition to its line of biomedical material testing systems. BioPuls devices from Instron (Norwood, MA) are designed to measure load and strain in an environment that simulates the human body.
Filed Thursday, Feb 2, 2006, 09:52 PST

To Survive FDA Inspections, Organization and Preparation Are Key

For medical device manufacturers, an FDA inspection can be a source of considerable anxiety. Although the intricacies of regulatory statues can create confusion, good organization and a carefully constructed inspection plan can help companies safely navigate an FDA audit, Elizabeth Kempen, senior vice president at Alquest Inc. (Minneapolis), told a Wednesday morning audience at MD&M West.
Filed Thursday, Feb 2, 2006, 09:46 PST

Software Suite Facilitates GMP Compliance

A comprehensive software suite provides medical device manufacturers with a framework for regulatory-process management, helping prioritize compliance initiatives and mitigate risk. Introduced at MDM West 2006, the MEDIC suite from Brooks Software (Chelmsford, MA) can control critical data across operational and business systems, reportedly reducing lead times and improving visibility of the manufacturing process.
Filed Wednesday, Feb 1, 2006, 15:30 PST

Swiss Pavilion Debuts at MD&M West

Eight Swiss medical device technology manufacturers have joined forces for the MD&M West debut of the Swiss Medtech Pavilion, located in booth 2825. The pavilion, developed in partnership with Swiss Business Hub USA (Chicago), is designed to showcase Swiss high-precision medical manufacturing.
Filed Wednesday, Feb 1, 2006, 15:04 PST

Schurter Debuts New Medical Electronics

Schurter Electronic Components has launched two new filters specifically for medical applications. "We are excited to offer these new options to device manufacturers," said Nikila Kareesan, applications engineer for the company. She spoke at a press briefing at MD&M West. The filters are available with a leakage current rating of <5 µA (M5) and <80 µA (M80). “The M80 is designed for nonpatient contact and is a new option for medical equipment manufactures,” said Kareesan. Typical applications include medical imaging systems.
Filed Wednesday, Feb 1, 2006, 14:56 PST

Hypotube Vaults onto the Market

A study conducted by technology consulting firm Cambridge Consultants and Creganna Medical Devices (Galway, Ireland) revealed that more than 5 million diagnostic and therapeutic interventional cardiology procedures were performed in the United States in 2004. The prevalence of interventional cardiology procedures coupled with the rise of minimally invasive surgery results in a demand for improved tools and devices.
Filed Wednesday, Feb 1, 2006, 14:17 PST

DuPont Debuts Next-Generation Tyvek at MD&M West

At MD&M West 2006, DuPont Medical Packaging introduced U.S. medical device manufacturers to a new material in its Tyvek family of products, Tyvek Asuron. The new material is available for coated and uncoated applications, including bags, pouches, lidding, and rollstock. DuPont developed Tyvek Asuron after consulting medical device manufacturers, sterile packaging manufacturers, and other experts about how it could improve upon its widely used Tyvek 1073B with a next-generation product.
Filed Wednesday, Feb 1, 2006, 10:50 PST

Fiber Laser Offers Consistent, Stable Performance

SPI Lasers (Southampton, UK) launched its 200-W continuous wave/modulated fiber laser at the MD&M West trade show. Designed for micromachining metals, plastics, or ceramics, the laser offers a small footprint and high stability.
Filed Tuesday, Jan 31, 2006, 15:10 PST

Determining What Poor Quality Costs Can Bring Huge Savings

Strong management control is central in establishing an organized quality system. The manager with executive responsibility (MER) has the ultimate responsibility to set up and change a company’s procedures that comply with the Quality System Regulation (QSR). The QSR is the organizational structure, responsibilities, processes, and means for establishing quality management.
Filed Tuesday, Jan 31, 2006, 14:59 PST

Unclear Rules Aren’t Holding Up Transport Tests

Distribution testing requirements can often be unclear, but a majority of medical device professionals perform and validate such tests, a recent survey found. Marci-Ann Ando from Celera Diagnostics presented survey results on Monday during MD&M West 2006’s packaging validation conference. Ando conducted the survey as part of her master’s project for Michigan State University.
Filed Tuesday, Jan 31, 2006, 11:54 PST

Weigh Your Options When Testing Seal Strength

For evaluating package seal strength, testing professionals may employ burst or creep tests, tensile (peel) tests, or some combination. Each method has advantages and disadvantages that testers need to consider, attendees were told at the Medical Design & Manufacturing West 2006 conference on Monday.
Filed Tuesday, Jan 31, 2006, 11:38 PST

Delivering One Globally Harmonized Document

The newly revised ISO 11607: Packaging for Terminally Sterilized Medical Devices not only features reorganized guidelines that make the standards easier to understand, but also accomplishes what the original 1997 version of ISO 11607 failed to do. The new standard eliminates the need for and use of EN 868-1 by incorporating it into the new ISO 11607.
Filed Tuesday, Jan 31, 2006, 11:27 PST

Management Control Key Part of QSR Compliance

Strong management control is central in establishing an organized quality system. The manager with executive responsibility (MER) has the ultimate responsibility to set up and change a company’s procedures that comply with the Quality System Regulation (QSR). The QSR is the organizational structure, responsibilities, processes, and means for establishing quality management.
Filed Tuesday, Jan 31, 2006, 11:12 PST

Registering with FDA Requires Manufacturer Savvy

Registering a medical device firm with FDA and establishing a medical device listing are two crucial steps to marketing a medical device in the United States. The registration establishes an OEM as just that—a device maker that plans to introduce products to market. "It lets FDA know where you are, and that you’re doing something that requires GMP or QSR compliance," explained William Sutton, deputy director of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA). Sutton spoke at a conference at MD&M West in January 2006.
Filed Monday, Jan 30, 2006, 16:35 PST

FDA Official Promotes Third-Party Review Option

Medical device manufacturers preparing to file a 510(k) with the U.S. Food and Drug Administration (FDA) might want to consider the alternative of working through the agency’s third-party 510(k) review program, according to Marjorie Shulman with FDA’s Center for Devices and Radiological Health (CDRH).
Filed Monday, Jan 30, 2006, 16:10 PST