Podcast by Michelle Lott
RAQA Today
Claim This Podcastby Michelle Lott
67 episodes
Updated Bi-weekly
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38
Podcast Authority
BetaPoorBased on show quality, social media presence, reviews, charts, and more
Quality23
Social0
YouTube85
Engagement50
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38
Podcast Authority
BetaPoorBased on show quality, social media presence, reviews, charts, and more
Quality23
Social0
YouTube85
Engagement50
6
Excellent Areas
2
Good Performance
11
Growth Opportunities
excellent
Episode Length
26 minutes
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good
Show Notes Quality
3.0/5
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poor
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Every 31 days
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Recent Episodes
May 26, 2026
From Innovation to Adoption: The Realities of Medical Device Market Entry
<p>Brilliant technology is not enough.</p><p>In this episode, Renae Franz unpacks the realities of medical device commercialization — including regulatory strategy, reimbursement, clinician adoption, usability, and market validation.</p><p>Through real-world medtech case studies, the conversation examines why technically strong products fail when they ignore workflow, reimbursement, or the “voice of the customer.” </p><p>Topics include:</p><ul><li>Market assessment and competitive positioning</li><li>The impact of Europe’s transition from MDD to MDR</li><li>Clinician usability failures</li><li>Unknown clinical problems and slow market education cycles</li></ul><p>A practical discussion for MedTech founders, regulatory professionals, commercialization teams, and healthcare innovators navigating the gap between invention and adoption.</p><p></p>
December 8, 2025
Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams
<p>Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance. </p><p><br></p><p>In this episode, regulatory expert Michelle Lott, commercialization strategist Renae Franz, and reimbursement specialist Fernanda Nusbaum unpack the leadership blind spots, strategic missteps, and easily avoidable financial risks that derail medtech companies every day.</p><p><br></p><p>You’ll learn why regulatory, reimbursement, and commercial strategy must be developed in parallel; how misaligned claims create expensive detours; what payers actually look for (hint: not FDA clearance); when coding fails; how reimbursement timelines stretch into years; and how to pick the right regulatory pathway without blowing your budget.</p><p><br></p><p>Packed with real examples—including companies that lost funding because they misunderstood CPT codes and companies that reached market faster by stair-stepping claims—this episode gives founders, CEOs, and RA/QA leaders a roadmap for reducing rework, avoiding FDA surprises, and accelerating revenue. </p><p><br></p>
December 2, 2025
How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6
<p>A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room.</p><p><br></p><p>Learn how regulatory and quality professionals can build trust, lower resistance, and communicate across cross-functional teams without becoming the “department of no.” This episode covers communication habits, emotional intelligence, conflict navigation, and how to say no without alienating coworkers.Be sure to like and subscribe for even more insights on medical device regulations, compliance, and quality systems (it will be fun and not painful, we promise). </p><p><br>Watch the video on YouTube: <a href="https://youtu.be/s9oFmyFZGL0" target="_blank" rel="noopener noreferer">https://youtu.be/s9oFmyFZGL0</a><br>Visit us at <a href="https://leanraqa.com/">https://leanraqa.com/</a> for evenmore regulatory goodness and to learn more about our services.<br>📩Got a question or a topic for a future session? Drop it in the comments below!<br><br></p><p><br></p>
67 total episodes available
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- What is RAQA Today?
- How often does this podcast release new episodes?
This podcast updates bi-weekly.
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This podcast is available on 6 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
No, this podcast does not typically feature guests.
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