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FDA walks line between innovation and safety

"We're scared. We don't know what to expect."

That's what one medical device company executive told me about the U.S. Food and Drug Administration's plans to revamp the way it approves new technologies for market, as we were milling about before the start of a roundtable event here yesterday. Her worries were shared by many in the medtech industry who made up the audience of some 500-plus.

It was the mission of the guest of honor, Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiologicial Health, to assuage their fears, and explain how he and his colleagues are trying to fix what virtually everyone agrees is a troubled system: Industry officials say the approval process for devices seems to be dragging on longer than ever; they complain that the CDRH is being swayed by complaints from consumer groups that devices are being rushed onto market before they are fully checked out as safe.

Shuren didn't candycoat the situation. He said that the medical device industry is caught in a "perfect storm," as a result of the weakened economy, changing health-care reimbursements, new emphasis on medical cost control, declining research and development effectivenesss - "and declining predictability, consistency and transparency in FDA pre-market decision making." That last one was the focus of his remarks, and he was optimistic. "The problems are many and the causes lie both with FDA and with industry, but I believe they are solvable," said Shuren.

Since officially taking the helm of the CDRH in January, Shuren has helped to oversee the production of two reports: one on the 510(K) program that the CDRH uses to review applications, the other on the use of scientific evidence. Together, they offer dozens of recommendations for improving CDRH's operations. They extend from making certain terms in the regulations less ambiguous to tapping outside scientific expertise when evaluating leading-edge innovations. Shuren said that such changes would lead to a more transparent, consistent and predictable system, making it easier for device companies to plan for the future.

And Shuren tried to dispel the notion - voiced by some at the event - that the CDRH was placing a greater emphasis on safety at the expense of innovation. "You're right that some folks have raised safety concerns about devices coming on the market, but actually one of the bigger drivers is industry [officials] who were telling us that they were not happy with the way things were going. " He added that he starts off his cover letter for the reports with the credo, "Foster innovation."

"That's one of the goals of the 510(K) program, and we take it very seriously," he said.

The devil is, of course, in the details, and a panel of industry leaders grilled Shuren about the proposals. It's not clear that they were satisfied with all that they heard, but Shuren's effort to communicate (this is one in a series of meetings he has held) was appreciated. One panelist, Josh Makower, MD, a successful medtech entrepreneur and a consulting associate professor at Stanford, remarked. "You have been the most open center director we've seen in the history of the device industry, which is great because we are in crisis now."

The event lasted more than two hours and a webcast is to be made available later this week on the home page of the Stanford Biodesign progam, which hosted the event with Stanford Health Policy and the Program in Health-Care Innovation at the School of Business.

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