3 hurdles to bringing medical devices to the U.S. market

In theory, it's easier to bring medical devices to the market than drugs. But getting a device approved in the U.S. is often difficult.
Medical devices have historically been seen as having faster paths to market than their pharmacological counterparts. The growing requirement for cost-effectiveness trials may be slowing them down.

When a colleague and I started our medical device company in 2009, we were in our second year at Harvard Medical School. Some classmates joked that they would still be in residency by the time we had moved on to our next big idea. We knew better — we expected it to be a long haul. Eight years into our journey, thousands of individuals have used our product in countries where it has been approved. But we have yet to gain approval in the U.S. — a long and

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