From Innovation to Adoption: The Realities of Medical Device Market Entry
Brilliant technology is not enough.
In this episode, Renae Franz unpacks the realities of medical device commercialization — including regulatory strategy, reimbursement, clinician adoption, usability, and market validation.
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.”
Topics include:
Market assessment and competitive positioning
The impact of Europe’s transition from MDD to MDR
Clinician usability failures
Unknown clinical problems and slow market education cycles
A practical discussion for MedTech founders, regulatory professionals, commercialization teams, and healthcare innovators navigating the gap between invention and adoption.
8 Dec 2025
Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams
Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance.
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.
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.
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.
2 Dec 2025
How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6
A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room.
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).
Watch the video on YouTube: https://youtu.be/s9oFmyFZGL0 (https://youtu.be/s9oFmyFZGL0)
Visit us at https://leanraqa.com/ (https://leanraqa.com/) for evenmore regulatory goodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!
Reach and audience
Public platform figures. Ratings count people who left a rating, not total listeners.
YouTube views
40,373
Score snapshot 15 Sept 2025
Apple Podcasts (US)
5.0 / 5
1 ratings
Podcast Authority Score: 38 / 100
A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.
Quality
23
Social presence
0
YouTube
85
Engagement
50
Contact RAQA Today
Guest appearances
Does not typically book guests
Based on episode analysis; this does not confirm that the show is currently accepting guests.
Host of RAQA Today?
Claim your podcast to manage its listing and keep your show details accurate.
Pod Engine is an independent podcast discovery and analytics service and is not affiliated with or endorsed by this podcast. Artwork and show content belong to their owners. Full legal notice.
Explore this show Podcast research with Pod Engine
