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Protecting Device Innovation: An Interview With Tom Fogarty

This article was originally published in The Gray Sheet

Executive Summary

Noted physician-entrepreneur Tom Fogarty has long been known for inventing breakthrough products. Here he discusses his recent efforts to protect the medical device innovation model, and corrects what he sees as serious flaws in its long-term viability, especially in the U.S.

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In an interview with “The Gray Sheet,” renowned inventor and entrepreneur Thomas Fogarty says he is encouraged, based on his recent experience with FDA, that regulatory trends slowing U.S. device innovation can be reversed.

The Fogarty Institute For Innovation: A Device Incubator For Difficult Times

Go to any gathering of medical device start-up CEOs and their investors, and beneath a veneer of passionate intensity about individual technology lie concern, anxiety, and in some cases, real pessimism. Central to the debate: is the device innovation model broken? Six years ago, one of the most celebrated device entrepreneurs, Tom Fogarty, MD, working with officials at El Camino Hospital in Mountain View, CA, an independent community hospital located in the heart of the San Francisco device community, launched the Fogarty Institute for Innovation, an initiative designed to help the earliest-stage companies ramp up technology development quickly and efficiently in an effort to minimize, if not eliminate the external challenges. To date, the Institute has started or nurtured five companies.

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