FDA efforts to prioritize medtech innovation pay dividends

From left to right: Kwame Ulmer, Jennifer McCaney and DeviceTalks West moderator Tom Salemi discuss medtech innovation. [Photo by Brian Buntz/Medical Design & Outsourcing]

A decade ago, medical device companies often turned to Europe to score initial regulatory approval for new products. Even though the U.S. is a larger market, many companies looked to Europe to win regulatory approval for their medtech innovation efforts. As a result, European patients received access to new therapies an average of two years earlier than U.S. patients, according to 2010 research from Dr. Josh Makower.

But now the tables have turned, and the FDA is more likely to approve or clear novel medical devices before their European counterparts.

“Where we were 10 years ago is not where we are today,” said Jennifer McCaney, the executive director of UCLA Biodesign at DeviceTalks West.

McCaney collaborated wi…

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