July 19, 2014

Medical Device Industry Warily Eyes More FDA Reorganization Plans

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

That sound you heard last week was the device industry sighing and maybe even applauding lightly when the FDA announced  it was seeking the public’s input on a plan to identify and harness a web of outside experts who may help it speed device approval.

As Reuters reported, FDA formed a pilot committee of experts, which will run through December 30 and expand the pool of vetted sources the agency already has on tap. It’s all part of the FDA’s effort to reform the 510(k) medical device review process. Some say the agency isn’t tough enough in protecting the safety of device users; others say the agency is stifling innovation and sending more jobs overseas.

Device manufacturers we spoke to were guardedly optimistic about this and other recent FDA moves. “We support the creation of such a network, providing that the FDA ensures that the experts do not have any personal or professional ties or conflicts of interest with the products / manufacturers / specific device industries they oversee,” Kelly Roman, Vice President at Fisher Wallace Laboratories, told us.

“We are aware that current Panel members that the FDA works with on PMA and reclassification matters may have these types of ties and conflicts,” Kelly continues. “It is difficult to retain top experts who have no vested interest in the fate of the industries they oversee, but ensuring that the process is completely free of bias is essential to the FDA’s mission and to public health.”

She suggests that, as with Panel members, FDA should “provide the full professional biographies of network experts. “ She also called on the agency to provide a forum by which the public may raise concerns over potential conflicts of interest on a case by case basis, and provide some process by which these concerns are officially addressed.

“This will help provide transparency and resolution to conflicts of interest that will inevitably arise. As of now, there is no clear, prescribed way to address such issues.

But Charlie Chi, Ph.D., former CEO and co-founder of OtisMed (now part of Stryker Orthopaedics), is a medical device industry entrepreneur and inventor flat out thinks it’s a bad idea for the FDA to get involved in new medical technologies.

Chi doesn’t think any company would want the FDA to get involved in every step of the product development cycle. In addition, he thinks it would take longer and be more costly for companies to develop new medical devices even though the approval process might be faster.

Chi noted that most U.S. companies are now going to Europe/Asia first to launch their new products because the approval process is quicker and less stringent than in the U.S. Yet, the failure rate is actually less than here in the U.S. He thinks the FDA should follow a review and approval process similar to other countries around the world.

Doug Mowen

Doug Mowen, Accenture

Accenture’s Doug Mowen feels the pain of both sides and urged the medical device industry to take a “wait and watch” approach. “There has been so much noise around FDA and these issues, but I believe the FDA has now heard everyone loud and clear.” He and his team work with medical device firms to handle 483s and other FDA-related dealings.

Doug sees some reasons for optimism because the FDA does seem to finally understand the medical device industries concerns. “If the FDA is able to reform a few things in the 510(k) process and make it more transparent, that will be such a positive thing.”

With over 15 years of experience in the Life Sciences industry, Doug has worked broadly across the medical technology industry, assisting major MedTech companies with compliance in key areas including emerging markets, supply chain, and pricing and customer profitability. Most recently Doug developed a research paper “Achieving High Performance: Reinventing Medical Technology for a Dramatically Different Future,” addressing how global regulatory issues are changing the overall business landscape for MedTech.

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  1. [...] We’ve written about this back and forth he said/she said battle for many moons now and it boils down to this: The medical device industry says FDA is too cumbersome and slow and that it is thwarting innovation. FDA says it is doing better than it gets credit for and slams some device industry studies backing its position as flawed and misleading. [...]

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