Is the Breakthrough Device Designation Truly a Breakthrough?

In June, MedTech Impact Partners’ Kwame Ulmer joined industry colleagues to tackle the controversial topic of deciding which regulatory path to take when getting a medical device through the FDA’s rigorous approval process. In their enlightening session, medtech innovators, investors, and former regulators provided guidance on whether the Breakthrough Device Program will bring value to your device or portfolio investment based on their experience in the program, industry research, and novel insights from the 95 devices that have obtained FDA market authorization to date.

In this blog, we share key takeaways from their discussion–insights that we hope will help you in your journey to market.