Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams
From RAQA Today by Michelle Lott
December 8, 2025 · 41 min
About this episode
This episode discusses the importance of aligning regulatory, reimbursement, and commercialization strategies in medtech to avoid common pitfalls and accelerate market entry.
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.
People in this episode
Host: Michelle Lott
Guests: Renae Franz, Fernanda Nusbaum
Topics covered
- regulatory strategy
- reimbursement
- commercialization
- medtech challenges
- FDA submission
- financial risks
Keywords
- FDA submission
- reimbursement timelines
- commercial strategy
- CPT codes
- financial risks
- medtech companies
- regulatory pathway
Mentioned in this episode
Organizations: FDA, CPT, medtech
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