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 notKey differences between Breakthrough and Safer Technologies (STEP) programsHow to prove your device treats a life-threatening or permanently debilitating conditionWhy early data, prototypes, and patient advocacy are essential for successWhat the real benefits (and limits) of designation areHard stats: only ~12% of devices reach market authorizationHow to make your submission persuasive — and avoid the “rose-colored glasses” trapWhether 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.Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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