Medtronic’s new CEO –> US should “absolutely” adopt the EU Regulatory System |

Medtronic’s new CEO –> US should “absolutely” adopt the EU Regulatory System


MDT’s Ishrak: U.S. Should “Absolutely” Adopt EU Regulatory System (written by Lauren Uzdienski @ HealthPointCapital)

In comments to the Financial Times, Medtronic CEO Omar Ishrak criticized the FDA for a slow regulatory process that limits patient access to care. In the EU, “the response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers are less stringent,” Mr Ishrak told the FT. He also spoke in favor of adopting a regulatory process more like the Europe’s, adding, “It will certainly put products on the market more quickly, so from a very selfish device manufacturer perspective, absolutely.”

Medtronic is not the only devicemaker looking to Europe to accelerate time-to-market. The FT cites data from Arcoda Capital Management stating that between 2004 and 2010, more than half of all novel devices were first approved in Europe. Conducting clinical studies in Europe is becoming more prevalent, with just 45% of medical device studies being carried out in the U.S. in 2009, compared to 87% in 2004.

The FDA countered that “lowering the U.S. approval standard” by adopting more European regulatory process was a disservice to patients, payers and manufacturers. Mr. Ishrak said he has not seen a greater number of safety issues surrounding devices approved in Europe; similarly, AdvaMed reported earlier this year that device recalls occur in the U.S. and the EU at about the same rate.

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