Big tech is transforming every aspect of our world. But how, and at what cost? This season of Land of the Giants – The Disney Dilemma – focuses on Disney’s ability to weather the ups and downs of the business cycle and changing tastes and explores what has kept it successful for over 100 years. The entertainment giant has leveraged nostalgia and its intellectual property to build a beloved brand, but after an acquisition spree that included Marvel, Lucasfilm, and 20th Century Fox, can it sus ...
…
continue reading
Content provided by Greenlight Guru + Medical Device Entrepreneurs. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Greenlight Guru + Medical Device Entrepreneurs or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
Similar to Global Medical Device Podcast powered by Greenlight Guru
A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
…
continue reading
It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
…
continue reading
The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
…
continue reading
Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
…
continue reading
Best Business Podcast (Gold), British Podcast Awards 2023 How do you build a fully electric motorcycle with no compromises on performance? How can we truly experience what the virtual world feels like? What does it take to design the first commercially available flying car? And how do you build a lightsaber? These are some of the questions this podcast answers as we share the moments where digital transforms physical, and meet the brilliant minds behind some of the most innovative products a ...
…
continue reading
Hop aboard for an insightful ride with SE Ranking’s ‘Agency Rollercoaster’ podcast! We sit down with digital agency leaders to chat about their wild professional journeys. From dizzying highs to challenging lows, we cover it all—innovative strategies, client success stories, and insider tips straight from the experts. Whether you’re a seasoned pro or just starting out, our podcast plunges into the twists and turns of client management, team leadership, and business growth in the digital worl ...
…
continue reading
Concise summaries of everything published in the latest weekly issue of the New England Journal of Medicine (NEJM). NEJM publishes new medical research findings, review articles, and editorial opinion on topics of importance to biomedical science and clinical practice.
…
continue reading
Some Goodness is hosted by Richard Ellis, a seasoned sales leader passionate about inviting top business minds to share their wisdom. Each episode is only 15-20 minutes, perfect for your commute or workout.
…
continue reading
Pat Flynn from The Smart Passive Income Blog reveals all of his online business and blogging strategies, income sources and killer marketing tips and tricks so you can be ahead of the curve with your online business or blog. Discover how you can create multiple passive income streams that work for you so that you can have the time and freedom to do what you love, whether it's traveling the world, or just living comfortably at home. Since 2008, he's been supporting his family with his many on ...
…
continue reading
Player FM - Podcast App
Go offline with the Player FM app!
Go offline with the Player FM app!
))
#403: Global Perspective on Medical Device Reimbursement
Manage episode 479944147 series 1017311
Content provided by Greenlight Guru + Medical Device Entrepreneurs. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Greenlight Guru + Medical Device Entrepreneurs or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
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 show it!
Feedback:
We love hearing from you! Share your thoughts, feedback, or topic suggestions by emailing us at [email protected]. We personally respond and value your input to shape future episodes!
Sponsor:
Discover how Greenlight Guru Quality can unify your SOPs, documents, and product development process into a single living system — from idea to post-market. Learn more at greenlight.guru.
430 episodes
Share
Manage episode 479944147 series 1017311
Content provided by Greenlight Guru + Medical Device Entrepreneurs. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Greenlight Guru + Medical Device Entrepreneurs or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
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 show it!
Feedback:
We love hearing from you! Share your thoughts, feedback, or topic suggestions by emailing us at [email protected]. We personally respond and value your input to shape future episodes!
Sponsor:
Discover how Greenlight Guru Quality can unify your SOPs, documents, and product development process into a single living system — from idea to post-market. Learn more at greenlight.guru.
430 episodes
All episodes
×
Welcome to Player FM!
Player FM is scanning the web for high-quality podcasts for you to enjoy right now. It's the best podcast app and works on Android, iPhone, and the web. Signup to sync subscriptions across devices.
Similar to Global Medical Device Podcast powered by Greenlight Guru
Big tech is transforming every aspect of our world. But how, and at what cost? This season of Land of the Giants – The Disney Dilemma – focuses on Disney’s ability to weather the ups and downs of the business cycle and changing tastes and explores what has kept it successful for over 100 years. The entertainment giant has leveraged nostalgia and its intellectual property to build a beloved brand, but after an acquisition spree that included Marvel, Lucasfilm, and 20th Century Fox, can it sus ...
…
continue reading
A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
…
continue reading
It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
…
continue reading
The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
…
continue reading
Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
…
continue reading
Best Business Podcast (Gold), British Podcast Awards 2023 How do you build a fully electric motorcycle with no compromises on performance? How can we truly experience what the virtual world feels like? What does it take to design the first commercially available flying car? And how do you build a lightsaber? These are some of the questions this podcast answers as we share the moments where digital transforms physical, and meet the brilliant minds behind some of the most innovative products a ...
…
continue reading
Hop aboard for an insightful ride with SE Ranking’s ‘Agency Rollercoaster’ podcast! We sit down with digital agency leaders to chat about their wild professional journeys. From dizzying highs to challenging lows, we cover it all—innovative strategies, client success stories, and insider tips straight from the experts. Whether you’re a seasoned pro or just starting out, our podcast plunges into the twists and turns of client management, team leadership, and business growth in the digital worl ...
…
continue reading
Concise summaries of everything published in the latest weekly issue of the New England Journal of Medicine (NEJM). NEJM publishes new medical research findings, review articles, and editorial opinion on topics of importance to biomedical science and clinical practice.
…
continue reading
Some Goodness is hosted by Richard Ellis, a seasoned sales leader passionate about inviting top business minds to share their wisdom. Each episode is only 15-20 minutes, perfect for your commute or workout.
…
continue reading
Pat Flynn from The Smart Passive Income Blog reveals all of his online business and blogging strategies, income sources and killer marketing tips and tricks so you can be ahead of the curve with your online business or blog. Discover how you can create multiple passive income streams that work for you so that you can have the time and freedom to do what you love, whether it's traveling the world, or just living comfortably at home. Since 2008, he's been supporting his family with his many on ...
…
continue reading
Player FM - Podcast App
Go offline with the Player FM app!
Go offline with the Player FM app!
