In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets.

From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.

Key Timestamps:

00:00 – Intro and Sponsor Message (Greenlight Guru Quality)

02:30 – Why Reimbursement Must Be Considered Early

07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers

13:10 – EU Reimbursement: Challenges with Fragmented National Systems

17:45 – Asian Market Differences: Japan, China, and South Korea

23:20 – The Importance of a Reimbursement Expert

28:05 – Navigating Political Changes in Global MedTech Markets

33:30 – Special Challenges for AI and Software as a Medical Device

40:00 – Direct-to-Consumer vs. Prescription Strategies

46:20 – Integrating Real-World Evidence and Post-Market Surveillance

52:00 – How Management Reviews Can Align Business and Quality Goals

01:03:10 – Pros and Cons: US vs. EU Reimbursement Models

01:18:20 – Final Takeaways and Closing Thoughts

Standout Quotes:

"Reimbursement isn’t just the final step after regulatory approval — it is a core business strategy."

Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions.

"You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."

Why it matters: Innovation alone isn’t enough; financial strategy is crucial to survival and growth.

Top Takeaways:

• Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.
• Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.
• Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.
• Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.
• Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.

References:

• Etienne Nichols on LinkedIn
• Greenlight Guru Quality Management System
• Medtech Podcast hosted by Karandeep Singh Badwal

MedTech 101 Section:

What is "Reimbursement" in MedTech?

Reimbursement refers to how a company gets paid for a medical device after it’s cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.

Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...