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December 2010

Proposed Changes to the 510(k) Process: 10 Recommendations for Strengthening the 510(k) Program

by Claudette Kile
Principal Consultant, BMP Group

Recently released recommendations for changes to the Food and Drug Administration's (FDA) 510(k) clearance program for class II medical devices has been a hot topic within the medical device industry. The 510(k) notification process uses predicate devices that the Center for Devices and Radiological Health (CDRH) at FDA has previously cleared for market release through the 510(k) notification process. New devices submitted for clearance must show substantial equivalence to predicate (cleared) devices. Unlike the more restrictive premarket approval (PMA) process where the manufacturer must demonstrate reasonable safety and effectiveness (most often in combination with human clinical research trials) CDRH reviews documentation submitted as a 510(k) and determines if the device is substantially equivalent to a predicate device—and thus—cleared for market release. Of the roughly 4,000 510(k) submissions CDRH receives each year, it clears about 3,000 devices from some 1,500 firms.

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Med-tech Firms Face a Changing Economic, Regulatory Landscape

by Janet Moore
Minneapolis Star Tribune

The good news for medical technology companies is that they fared pretty well in the past year, despite harsh economic pressures.

The bad news? The long-standing business model for developing new medical devices is under siege, according to an industry study released this week by Ernst & Young.

First, the data: Revenue of U.S. publicly traded med-tech companies was essentially flat last year at $198 billion -- compared with $200 billion in 2008. The "slight year-over-year contraction" comes on the heels of 11 percent growth in 2008 and is the first time the U.S. industry has experienced a revenue decline since 2004, according to the report.

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MD&M West
February 7-10, 2011, Anaheim, CA

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Did you know that according to a recent ASQ survey, companies are expressing concern that BPO (Business Process Outsourcing) providers are falling short? Many companies seek the expertise of BPOs. Business Process Outsourcers have, in many cases, shown that the BPO model can save companies significant expense. However, a recent survey conducted by ASQ shows that those company representative respondents aren't expressing the satisfaction they'd like to express in their respective BPOs.
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