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How do medical device startups meet today's regulatory challenges?

Deanna Pogorelc

What’s the best strategy for developing and launching a new medical device? The uncertainty of the regulatory and reimbursement environment in the United States has made venture capitalists wary of investing in new medical device companies, but that doesn’t mean all is lost. Big companies like Boston Scientific and Johnson & Johnson still depend on small startup companies for many of their new product introductions, and studies have shown that people are still making series A investments.

Jonathan Fleming, the managing general partner of Boston venture capital firm Oxford Bioscience Partners, says there are billions of dollars eagerly awaiting investment in startup companies, but uncertainty with the U.S. Food and Drug Administration and the Center for Medicare & Medicaid Services is preventing them from going into healthcare companies. In this video (17:53 – 24:42) from a presentation at Princeton University, he gives a rundown of some of the biggest trends and issues that are impacting startups and investment in medical devices, and how the challenges can be overcome by formulating a marketing plan that starts with European approval.

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