Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a difference?

In this episode, Michelle Lott joins Monir El Azzouzi on the Medical Device Made Easy podcast to unpack the truth behind the Breakthrough Devices Program — from eligibility and benefits to the myths, statistics, and reality checks every medtech company needs before applying.

They discuss how this program — and its sibling, the Safer Technologies Program (STEP) — fits into the FDA’s pre-submission framework, the most common reasons applications are rejected, and why only a fraction of “breakthrough” devices ever make it to market.

Here's what else you’ll learn:

• What the FDA Breakthrough Device Program is — and what it’s not

• Key differences between Breakthrough and Safer Technologies (STEP) programs

• How to prove your device treats a life-threatening or permanently debilitating condition

• Why early data, prototypes, and patient advocacy are essential for success

• What the real benefits (and limits) of designation are

• Hard stats: only ~12% of devices reach market authorization

• How to make your submission persuasive — and avoid the “rose-colored glasses” trap

Whether you’re an early-stage startup or an experienced RAQA professional, this conversation demystifies one of FDA’s most talked-about programs — and shows you how to navigate it strategically.

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