Bloggers at the Millennium Research Group's blog compared the FDA and the European CE mark and the effects on innovation in both markets.
According to industry experts the MRG authors interviewed, the FDA's approval process hinders innovation in the U.S. market while driving innovation in the European market — some companies even debut their device abroad to fund FDA trials.
"One prominent example is transcatheter heart valves—the first of these devices became available in Europe in 2007, while approval in the US had not been granted as of Sept. 2011," the authors wrote.
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According to industry experts the MRG authors interviewed, the FDA's approval process hinders innovation in the U.S. market while driving innovation in the European market — some companies even debut their device abroad to fund FDA trials.
"One prominent example is transcatheter heart valves—the first of these devices became available in Europe in 2007, while approval in the US had not been granted as of Sept. 2011," the authors wrote.
Related Articles about the Medical Device Industry:
Robotic Surgery Equipment Manufacturing Industry Expected to Reach $4.2B by 2016
Sen. Scott Brown Calls for Repeal of Medical Device Tax
Losses Put Pressure on Medical Device Industry to Lower Prices