Which Nation Takes the Longest to Approve Devices?

What country takes the longest to review and approve new medical devices? The nation’s medical technology lobby, AdvaMed, wants to know (or at least wants to make a point) and is bankrolling a study to find out.

Photo courtesy of Flickr Creative Commons user Photo Monkey

One would suspect that the laggard might be the United States, given that the American medical device industry is looking into the possibility.  But in a briefing with reporters on Feb. 24, AdvaMed Chairman Michael Mussallem said that Japan — the second largest market for devices — has one of the slowest records for getting new medical technology into consumers’ hands.

Ironic, considering that the Land of the Rising Sun is a leader when it comes to adopting most new technologies, said Mr. Mussallem, who is the CEO of Edwards Lifesciences.

AdvaMed has hired the mega-consultant PriceWaterhouseCoopers to look at nine nations — a mix of developed and developing countries — to determine how each does on regulatory review. And, of course, most importantly, how quickly devices are available for physicians, hospitals, and ultimately, consumers.

Stephen Ubl, the president and CEO of AdvaMed, said the goal was to get a “valid objective measurement.”

Both he and Mr. Mussallem used the term “device lag” several times.  That kind of terminology has been used before as a weapon against the Food and Drug Administration.  Many times before, in fact.

Do American physicians feel like they’re the last ones to get their hands on cutting-edge devices? Drop me a line and let me know.

— Alicia Ault (on Twitter @aliciaault)

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Filed under Cardiovascular Medicine, Drug And Device Safety, Health Policy, IMNG, Practice Trends

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