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Medtech Winners of 2014: FDA

FDA FDA commissioner Margaret Hamburg


FDA commissioner Margaret Hamburg

The traditionally cool relationship between U.S. regulators and the medical device industry seemed to warm somewhat this year.

Nowhere was the shift more apparent than at AdvaMed 2014, the annual conference held by the industry’s biggest trade group. In session after session, panelists praised FDA for making progress in terms of transparency, predictability, and cooperation with industry.

Even Edwards Lifesciences CEO Mike Mussallem admitted the “FDA climate has dramatically improved.”

A town hall meeting with CDRH representatives including director Jeffrey Shuren was positively congenial, with Shuren cracking jokes and members of the audience actually laughing.

So what’s behind the industry’s change of heart? Perhaps the realization that regulations aren’t the only—or, in some cases, even the highest—hurdle medtech companies have to jump. Obtaining reimbursement is also a challenge. 

Scott Josephs, vice president and national medical officer for health insurer Cigna, captured the sentiment precisely when he said, “The enemy used to be the FDA, and now I hear it’s us.”


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