# #403: Global Perspective on Medical Device Reimbursement

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-04-24
- Length: 37m
- Episode: 403
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-04-24-403-global-perspective-on-medical-device-reimbursement
- Listen: https://podcast.greenlight.guru/episode/403-global-perspective-on-medical-device-reimbursement

## Summary

Etienne Nichols interviews Karandeep Singh Badwal, a regulatory and reimbursement expert, about integrating reimbursement strategy into medical device development across the US, EU, and Asian markets. They discuss specific systems like US Medicare and CPT codes, EU fragmentation with national programs like Germany's NUB, and Asian pricing models, emphasizing that reimbursement must be a core business strategy from day one. Badwal highlights the importance of hiring jurisdiction-specific experts, leveraging post-market surveillance for real-world evidence, and using management reviews to align quality and business goals. The conversation concludes with a comparison of US and EU reimbursement pros and cons, stressing the need for strategic flexibility in a changing political landscape.

## Outline

1. Introduction: Etienne Nichols and Karandeep Singh Badwal
2. Why Reimbursement Must Be Considered Early in Development
3. US Reimbursement: Medicare, CPT Codes, and AI Challenges
4. EU Reimbursement: Fragmentation, NUB, and HTA Regulation
5. Asian Market Differences: Japan, China, and Korea Pricing Models
6. Hiring Jurisdiction-Specific Reimbursement Experts
7. Navigating Political Changes and Regulatory Uncertainty
8. Special Challenges for AI and Software as a Medical Device
9. Direct-to-Consumer vs. Prescription Strategies
10. Integrating Real-World Evidence and Post-Market Surveillance
11. Management Reviews: Aligning Business and Quality Goals
12. Pros and Cons: US vs. EU Reimbursement Models
13. Final Takeaways: Reimbursement as Core Business Strategy

## Topics

- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Medicare (other)
- CPT (other)
- HCPCS (other)
- EU MDR (other)
- FDA (other)
- NHS (other)
- DEGA (other)
- NUB (other)

## Related episodes from other shows

- [062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-07-062-reimbursement-in-europe-access-rebates-and-negotiation-with-stefan-walzer) (Let's Combinate)
- [058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban) (Let's Combinate)
- [044 -“Market Access” with Kasem Akhras](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-03-044-market-access-with-kasem-akhras) (Let's Combinate)
- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)
- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-04-24-403-global-perspective-on-medical-device-reimbursement. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.