FDA Building Effective Fast Track for US Medtechs While Other Countries Starting to Show Delays

Medtech Podcast Episode 049

EPISODE 049

Lisa Wipperman Heine, COO of Mitralign, says the FDA is making quicker work of review times. But the same might not be said for other countries where Medtechs once had a faster time to market. In this interview at the offices of Fox Rothschild in Minneapolis, the Medtech veteran lays out Mitralign’s success with the agency’s Early Feasibility program.

Read more about Mitralign here.

Podcast Guest

Lisa Wipperman Heine

Lisa Wipperman Heine

COO

Mitralign

Lisa Wipperman Heine is currently Chief Operating Officer at Mitralign, Inc., a venture-backed innovator of transcatheter heart valve technologies. Prior to joining Mitralign, she was the Founder and Principal at deArca Strategic Solutions, LLC, a consulting firm focused on helping medtech companies assess, develop and execute strategies related to market opportunities and technology adoption. Lisa has also served in multiple leadership roles at Covidien, Inc., including Global Vice President of Medical Affairs for Vascular Therapies. During her tenure at Covidien, she helped drive the strategy in support of a $1.7B business and was also responsible for leading the strategy and operations of Clinical Affairs, Healthcare Economics, Policy and Reimbursement and Medical Education functions. Lisa also currently serves as a member of the Board of Directors of Surmodics Inc. (NASDAQ: SRDX).

She received her BA from St. Olaf College and MSC from the University of Manitoba.

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Meet Our Host

Geoff Pardo

Geoff-Pardo

Geoff has been in medtech for over two decades in both operational and investment roles. He is passionate about the industry potential and sharing stories from the front lines of innovation.

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