Dr Tom Fogarty presented a session on the changing face of innovation in medical device and the challenges faced within the US. He focused on the increased regulatory environment in the US compared to Europe and Asia. Noting that the cost of development for what ultimately became known as the fogarty catheter in 1962 was about $2000 while the 2000 R&D costs for development of drug eluting stent technology is over $250 million for the stent and $3 million for the drug. Clearly these costs far outstrip adjusted inflation.
His conclusion is that more and more medical device R&D will occur outside the US particularly in the EU
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