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

Article preview from IN VIVO - July 1, 2011

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.

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

Article preview from IN VIVO - July 1, 2011

By any measure, the medical device industry should be the pride of US commerce. Few other industries have been as creative or innovative in bringing new technology to the fore – technology that offers tremendous benefits to society in prolonging lives and improving quality of life. And unlike other industries, the medical device industry, globally considered, is largely a US phenomenon, with a disproportionate number of players, both large and small, US-based.

So why then is the industry in such a funk – particularly the medtech start-up community that is the source of so much innovation? Indeed, 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?

The anxiety and concern isn't about the value or viability of the technology per se, but rather about a series of external forces that individually and collectively have made the push of innovative devices out of the lab increasingly challenging. A regulatory process that has gone from simple and straightforward to unreceptive and unpredictable, a venture financing climate that has grown skittish about the viability of device investing, and an academic research community that, wrestling with its own demons, has become overly bureaucratic – all of which has many device entrepreneurs and innovators worried that bringing forth innovative devices is becoming increasingly difficult if not impossible.

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