Medical Device Product Development: From Concept to Commercialization | leanRAQA Today | S5:E2

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.