MedCity News September 18, 2024
Mary Lou Jepsen

The current model of siloed, proprietary development is failing us. It’s slow, expensive, and often results in technologies that never see the light of day. What if, instead, we embraced an open-source approach to medical device innovation?

For years, I’ve watched promising medical technologies languish in labs, never reaching the patients who desperately need them. The culprit? Not overzealous regulators, but our antiquated approach to innovation. It’s time we stop pointing fingers at the FDA and take a hard look in the mirror.

The truth is, the FDA isn’t the enemy of medical innovation – it’s a crucial partner. But to unlock its full potential as an ally, we need to radically rethink how we develop medical devices. The current...

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