Medtech super-entrepreneur Amar Sawhney has not been shy about sharing his success story.
In the last few years Sawhney has managed to turn a single breakthrough technology into a slew of successful products. His hydrogel technology has formed the foundation for no less than 6 businesses, including one snapped up by Genzyme early in the decade and another that Covidien predecessor Tyco Healthcare acquired in 2006.
MassDevice caught up with Sawhney at our annual Big 100 East in Waltham, Mass., to pick his brain about a few subjects that are near and dear to the medical device industry:
MassDevice: What’s the best thing about working in the medical device industry?
Amar Sawhney: That we get to solve significant problems that affect real people.
MassDevice: What’s the hardest thing about working in the medical device industry?
AS: The FDA. Getting paid is getting harder, the reimbursement environment is challenging and the regulatory environment has gone from approvals to enforcement; a lot of inspections and stuff like that, so it just makes product development that much harder.
MassDevice: How can the FDA help keep medtech industry superiority here in the U.S.?
AS: Focus some of its resources on getting more reviewers, for example. Be able to adhere to time lines and not just keep kicking the can down and making the review cycles longer.
MassDevice: What can medical device companies do to keep industry superiority in the U.S.?
AS: Invest in innovation and not shy away from PMAs. Come up with non-traditional types of financing structures so innovation can still move forward.
MassDevice: What’s one of the biggest mistakes young companies make?
AS: Only getting enamored with product and technology and not understanding reimbursement and adoption and market sizes.