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.

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.

Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail?

Bringing a medical device to market is hard — but most startups make it much harder than it has to be.

In this episode of Lean RAQA Today, Michelle Lott and Renae Franz reveal the most common mistakes medtech startups make from concept through commercialization — and how to avoid the “butterfly effect” that can turn a minor oversight into a million-dollar failure.

From creating a traceability matrix that actually prevents design disasters to aligning your regulatory, quality, and business strategy, Michelle and Renae share practical frameworks, real-world cautionary tales, and actionable advice to help startups save time, money, and credibility on the path to FDA clearance and market success.

In this episode, you’ll learn:

• Why most startups are only 20% done when they think they’re 80% ready for FDA

• How to use a trace matrix to prevent downstream compliance failures

• Real-world horror stories: cold-weather power cords, overdrawing donors, and untested adhesives

• How early regulatory strategy affects design, documentation, and market selection

• How to avoid the “Porsche vs. Ford Focus” problem in medical device design

• What to know about 510(k), de novo, and PMA pathways (and what each really costs)

• Why unsubstantiated marketing claims can derail your entire launch

• Commercialization strategy 101: distribution, sales models, and hospital adoption

• Protecting your IP and product cost structure before it’s too late

If you’ve ever thought “we’ll deal with regulatory later,” this episode will convince you otherwise — with humor, humility, and decades of hard-earned insight.

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/94gm5sP0EDUVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion.

In this episode, Michelle Lott joins Etienne Nichols (Greenlight Guru) and Karandeep Singh Badwal to debate the real-world impact of MDR on medtech innovation, market access, and patient safety.

From notified body bottlenecks to language barriers, inconsistent interpretations, and the myth of increased safety, the trio unpacks what MDR is really doing to the industry — and what manufacturers can do to survive (and thrive) under it.

Here's what you’ll learn:

• How MDR differs from MDD — and why it’s not a total overhaul

• Why software, AI, and post-market surveillance have become regulatory pain points

• The 12–18 month reality of CE marking under MDR

• How to select the right notified body (and why language matters)

• Why documentation ≠ device safety — and integrity still matters most

• The “significant change” rule: what triggers recertification

• Why smaller companies are struggling to stay in the EU market

• Practical steps to build a quality culture and navigate MDR effectively

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/Kgbmh0neJpE

Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.