U.S. medical device makers have been flocking to Europe in recent years. The general industry perception is that the European regulatory process is quicker, more efficient and more predictable than the U.S. Food and Drug Administration’s process for clearing medical devices. A study earlier this year sponsored by the top device industry trade group in the U.S. found that the European process is just as safe as — and quicker than — its American counterpart. Start-ups, then, which must constantly focus on capital efficiency, may find that Europe holds lots of appeal for early commercialization.
