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.

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

"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.

• 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.

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

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...

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kirk Petyo, Managing Partner at Talent Factory Recruiting, to explore the art and science of hiring in MedTech.

Kirk shares strategies for building magnetic employer brands, explains the difference between competencies and capabilities in candidates, and warns about the hidden costs of bad hires or delayed recruitment. They also discuss how to attract top talent from outside traditional MedTech backgrounds, and why companies must clearly define their values to thrive in today's competitive hiring landscape.

• [00:02:00] – Introduction to Kirk Petyo and Talent Factory Recruiting's unique approach
• [00:05:30] – What makes a company a "magnet" for top talent in MedTech
• [00:12:20] – How to recruit candidates from outside traditional MedTech backgrounds
• [00:20:00] – How to differentiate between a good worker and a good interviewer
• [00:30:10] – The ripple effects of a single bad hire in a MedTech company
• [00:35:50] – The cost of leaving key roles unfilled for too long
• [00:44:00] – Outdated hiring practices that repel top candidates
• [00:50:00] – Trends in hiring and workforce planning for 2025
• [01:02:00] – Final advice for MedTech hiring managers and company leaders

1. "If you treat hiring like a transaction, you'll get transactional results. But if you treat hiring as a critical strategy for growth, you’ll flourish." – Kirk Petyo
2. "Your candidate’s life must be better at your organization than it was at their last job—if you can't tell that story, you'll struggle to attract top talent." - Kirk Petyo

• Define your value drivers clearly: Understand what makes your company unique before trying to attract top talent.
• Focus on capability, not just competency: Prioritize what candidates can learn and contribute over time, not just what they know today.
• Structure your interview process: Build a consistent, benchmark-driven approach to avoid gut-feel hiring mistakes.
• Partner with strategic recruiters: Seek recruiters who genuinely understand your company culture and goals, not just resume matchers.
• Act early on critical hires: Don’t delay filling strategic roles; the opportunity cost and cultural risk multiply with time.

• Kirk Petyo’s LinkedIn Profile
• Talent Factory Medical Website
• Etienne Nichols' LinkedIn Profile

Competency vs. Capability (Simplified):

Think of competency like what’s already in a candidate’s toolbox—their current skills and experiences. Capability is their potential—the size of the projects they could build if you give them the right tools and environment.

Poll Question: What’s the biggest challenge you face when hiring MedTech talent?

• Defining clear job expectations
• Attracting candidates from outside the industry
• Avoiding bad hires
• Speeding up the hiring...

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development.

They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.

• [02:30] – Introduction to Sarah Moeller and her role in ISO 18969 updates.
• [07:00] – Overview of ISO standards update processes and FDA’s critical role.
• [15:20] – The impact of AI and digital evidence on clinical evaluations.
• [22:10] – Why FDA's temporary absence from standards writing matters.
• [31:45] – Resumed communications: FDA’s current engagement status.
• [41:00] – Implications of leadership changes at the FDA.
• [50:15] – Strategic advice for MedTech companies amidst regulatory uncertainty.
• [58:00] – Passionate case for FDA's continued involvement and defense of public service.
• [1:12:30] – Big updates in ISO 14155 and 18969 and what they mean for clinical trials.

• "Without FDA at the standards table, we risk global disharmony—and patients pay the price." – Sarah Moeller
• "Taking care of each other must be our number one goal in both hospitality and healthcare." – Sarah MoellerKey Takeaways:

1. Maintain proactive and open communications with your FDA reviewers.
2. Incorporate rigorous digital evidence management to future-proof clinical evaluations.
3. Advocate for clear regulatory processes by contacting your congressional representatives.

• ISO 14155: Good Clinical Practice for Medical Device Trials—Updated to reflect decentralized trials and enhanced CRO oversight.
• ISO 18969: Clinical Evaluation Standard aligning evaluations across the total product lifecycle.
• MDUFA and PDUFA: Critical funding mechanisms supporting timely FDA review processes.
• Etienne Nichols on LinkedIn

ISO Standards: International standards that ensure quality, safety, and efficacy in products across global markets.

MDUFA (Medical Device User Fee Agreement): Agreement where companies pay fees to FDA for timely device reviews.

Clinical Evaluation: Systematic process for assessing and analyzing clinical data to verify the safety and performance of a medical device.

Poll Question: "Do you believe the FDA should have a permanent seat at all ISO standards committees?"

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