PODCAST · business
Market Pathways
by Market Pathways
Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com
Episodes
-
Ep. 35: MDR: Is Real Change on the Horizon?
The need for important changes to MDR has been clear since its enactment in 2017. EU authorities have been reluctant to make substantive revisions, content to do nothing more than extend regulatory timelines. Now, however, there seems to be newfound resolve in Brussels to engage in fundamental...
-
Ep. 34: What I Learned From 25 Years at CMS: An Interview With Tamara Syrek Jensen
After a long career at CMS, including running the Coverage and Analysis Group for the past 10 years, Tamara Syrek Jensen can now candidly share her views on medical device reimbursement generally, particularly when it comes to Medicare. She provides a frank assessment on the systemic challenges,...
-
Ep. 33: What Does it Mean to be a Reimbursement Professional?
Veteran medtech reimbursement executive Keely Scamperle talks about her newly launched Reimbursement and Market Access Professional Society, or RAMPSociety. She discusses the growth of reimbursement and market access as a distinct profession over her career and how she hopes the new group will…
more -
Ep. 32: The Tariff Challenge, Policy Optimism, and The MedTech Conference With Scott Whitaker
Scott Whitaker, president and CEO of AdvaMed, sits down with Market Pathways’ David Filmore to talk about hot topics in medtech policy, including the current situation with tariffs, future optimism for policies coming out of FDA and CMS, a Breakthrough Device coverage bill moving in Congress,...
-
EP 31: Haven’t We Heard This Song Before? Major EU Regulatory Changes on the Horizon
A special panel from our Innovation Summit Dublin conference in April 2025 Pedro Eerdmans, MD, PhD, Director, Global Strategy Services at NAMSA Tom Melvin, Associate Professor in Medical Device Regulatory Science, Institute for Clinical Trials, University of Galway; Chair, Biomedical Alliance in...
-
BTIG Weighs In on Whether Trump Policies Can Dent MedTech’s Healthy Run
By Wendy DillerFollowing a robust 2024, the medical device sector continues to thrive in 2025 and remains somewhat insulated from dramatic shifts in healthcare policies, at least in the short term. Market Pathways and MedTech Strategist writer Wendy Diller spoke on March 3, 2025 with Ryan...
-
Pioneering the Use of Real-World Evidence in Medtech: A Discussion with J&J’s Paul Coplan
The use of real-world evidence is increasing rapidly throughout the device industry. Here we talk with Paul Coplan, who is leading that effort at J&J, which received the first FDA-approved label extension using real-world evidence. Our conversation embraces the breadth of real-world evidence…
more -
FDA Inspections Getting Prepped and Avoiding Pitfalls
FDA inspections are nobody’s idea of a good time. However, proper planning is crucial not only for ensuring baseline compliance, but also for establishing an effective corporate culture and building long-term company value. In this edition of Consultants Corner, we spotlight advice from Jamie...
-
A VC’s View of the Reimbursement Evolution: An Interview with Mike Carusi
Reimbursement has gone from being largely ignored to becoming top of mind for both product companies and investors. Mike Carusi was among the early proponents of understanding and improving the coding, coverage and payment processes. Here he takes us through the reimbursement evolution and delves...
-
Reimbursement for Breakthrough Devices Still Lags—Need for TCET: An Interview with Josh Makower
This discussion with Stanford Biodesign director and co-founder Josh Makower highlights a recent Stanford report that found the median time for initial coverage of breakthrough devices was nearly six years. Here we discuss how this data, much like information from previous Stanford reports, can...
-
Ep. 25: Medtech in China: An Island of Relative Calm in a Sea of Volatility
This edition of the Market Pathways highlights how the opportunities for Western medtech companies looking to enter China are increasing at a time when US-China economic, political and military affairs are becoming increasingly volatile. While US-China relations remain volatile, the Chinese…
more -
An Interview With Kevin Fu, The First Device Cyber Czar
In Episode 24 of Market Pathways, we sit down with Kevin Fu, a renowned cybersecurity expert and the former FDA/CDRH Acting Director of Cybersecurity, and is currently head of the Archimedes Center at Northeastern. Join us as we delve into the critical topic of healthcare cybersecurity and its...
-
The Real World Impact of MDR: How CEOs and Investors are Adapting
This special episode of the Market Pathways podcast features a panel discussion from our recent Medtech Strategist Dublin Innovation Summit. This session brings together an experienced group of CEOs and investors discussing how the new Medical Device Regulation is impacting day-to-day...
-
Medtech Law & Policy - Clearing Up the Confusion on MDR: Where Do We Go From Here?
The last few months have brought a flurry of MDR regulatory and legislative activity, causing a morass of confusion. In this interview, leading EU medtech lawyer Erik Vollebregt clarifies what the recent spate of proposals and guidances mean for product companies and how they should manage in…
more -
What Do the US Midterms Mean for Medtech?
Key retirements, important changes in leadership, and some surprising new faces. Now that the dust has almost settled, leaving just one Senate run-off and several House seats still to be settled, what does the election’s outcome mean for the medical device industry, both in terms of prospects for...
-
What in the (Medtech) World is Happening?
Summer’s over. A new school year is in session, and it’s time to get back to business. Market Pathways’ editors Steve Levin and David Filmore talk about global medtech policy issues they’ll be paying attention to this fall. We start with the FDA user reauthorization nail-biter in Congress, and…
more -
Tracking the Changing Reimbursement Landscape
Reimbursement has replaced regulatory as the leading barrier facing device companies today. Here several leading CEOs and entrepreneurs share the details of how they have successfully battled through the morass of acronyms and complexities to overcome the ever-changing intricacies of coding,...
-
Changes in China Present New Opportunities
Experienced medtech China hands discuss the opportunities opening up for Western companies to more easily enter that potentially huge market. These CEOs and advisers share how improvements in the regulatory and IP landscape make finding a reliable Chinese partner easier, while also highlighting…
more -
MDR is Here - Now What Does That Mean?
With the European Medical Device Regulation (MDR) now in effect in Europe we check back in with the experts in the space to provide an update on how MDR has been implemented and the issues that are arising. MDR is Here: Now What Does It Mean? Serge Bernasconi, CEO, MedTech Europe Gloria Crispino,...
-
Sandra Siami on the Promise and Challenges of Real World Evidence
The National Evaluation System for health Technology, or NEST, was set up to build a dependable real world evidence ecosystem to support development of devices and surveillance of device data. Sandra Siami leads NEST Coordinating Center from her perch at the Medical Device Innovation Consortium.…
more -
Do We Need an Expedited Medtech Reimbursement Program? An Interview with Mark McClellan
One of the hottest issues in medtech reimbursement is whether there is a need for an expedited reimbursement program following the repeal of MCIT. In this episode of the Market Pathways podcast, former CMS Administrator and FDA Commissioner Mark McLellan weighs in on this and other reimbursement...
-
The Medical Imaging Perspective with Patrick Hope
Medical imaging equipment companies share some underlying policy goals with the broader medtech sector. But the realities of capital equipment intended primarily for diagnostic or screening applications also raise special considerations. We spoke to Patrick Hope, executive director of the Medical...
-
Looking Ahead in MedTech Policy: Part 2
Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022. In this second of a two-part conversation, they delve into the EU picture, including the MDR, IVDR, and other oncoming regulatory challenges. Steve and...
-
Looking Ahead in MedTech Policy: Part 1
Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022. In this episode, they delve into the US picture, including what to expect from Congress, FDA, and CMS. Check out the second part of the conversation,...
-
Bringing the Value of Medtech Regulatory, Reimbursement and Policy Issues to Innovators Through Data: A Conversation with Stanford Biodesign’s Josh Makower
In this episode of the Market Pathways Podcast, Stephen Levin talks with medtech entrepreneur/innovator/investor Josh Makower, MD. Makower recently returned to run the Stanford Biodesign program following the retirement of Paul Yock, MD, with whom he co-founded the program. Makower is looking to...
-
Bridging the Regulatory-Reimbursement Gap: Opportunities and Challenges
This episode of the Market Pathways Podcast tackles the biggest problem facing device companies today: reimbursement. Ask medtech executives and investors the biggest change in the challenges currently confronting product companies compared with a decade ago and the overwhelming consensus…
more -
AdvaMed’s Scott Whitaker on Partnering and Advocacy
“We were forced to collaborate with such speed and collective work, and collective passion, and the results were very good. That’s going to shape how we think about public policy I think from this point on.” Scott Whitaker, president and CEO of AdvaMed, didn’t have “respond to a global pandemic”…
more -
FDA and Digital Medtech
Digital health is increasingly central to the overall medtech story, and FDA has placed a major emphasis on refining its approaches to meet the needs of this evolving space. In this panel discussion from the MedTech Strategist Innovation Summit San Francisco 2021 that took November 3, two...
-
FDA's Revival of US Early Feasibility Studies; Can Industry Keep Up?
In this panel discussion from our virtual Dublin Innovation Summit Conference 2021 experts dive deep on FDA’s recent revival of early feasibility studies in the US. The initial findings from an MDIC working group indicate that FDA’s efforts to promote early feasibility studies appear to be…
more -
Appraising the Medtech Innovation Ecosystem with Nadim Yared
Nadim Yared is a medtech CEO who is not afraid of digging into the details—the regulatory details; the nooks and crannies of Medicare coverage, coding, and payment; the finer-points of p-values and novel clinical trial designs. He has dug in deep on these matters and more during his 15 years at…
more -
A Look Ahead at the Coming Medtech “School Year”: A Conversation with MDMA’s Mark Leahey
As the calendar turns from summer to fall, there is no shortage of issues important to the medical device industry emerging on all fronts, addressing legislative, regulatory and policy matters. No one is better aware of the state of play of these issues than Mark Leahey, CEO of MDMA. Here Mark...
-
New Chinese Medtech Regulations Offer New Opportunities
China continues its recent trend of reforming its regulatory system to make it more attractive for Western companies to introduce innovative technologies to the Chinese market. This presents a window, particularly for small to mid-sized companies, to access what historically has been a difficult...
-
The Role of Health Tech Assessments in EU/UK Reimbursement
Device companies seeking global market access can no longer ignore health technology assessment bodies, but there are an expanding number of HTA pathways that firms can utilize, particularly for truly innovative, next-generation technology, experts said during a recent panel discussion at MedTech...
-
Jeff Shuren on FDA-sponsor interactions: Where they’ve been and where they’re going
Opportunities for companies to engage with FDA during the development and review of new devices have grown over the years. And if Jeff Shuren, Director of the agency’s Center for Devices and Radiological Health, has his way, there will be even more fundamental change in the years to come. In this...
-
MDR is Here – Now What?” featuring Serge Bernasconi, CEO of Medtech Europe
After all the years leading up to the implementation of the new EU Medical Device Regulation (MDR) on May 26, 2021, it is fair to assume that regulators and industry would have worked out most of the basics of the new rules in advance of launching the new regimen, especially given the added year...
We're indexing this podcast's transcripts for the first time — this can take a minute or two. We'll show results as soon as they're ready.
No matches for "" in this podcast's transcripts.
No topics indexed yet for this podcast.
Loading reviews...
ABOUT THIS SHOW
Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com
HOSTED BY
Market Pathways
CATEGORIES
Loading similar podcasts...
Frequently Asked Questions
How many episodes does Market Pathways have?
Market Pathways currently has 35 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is Market Pathways about?
Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on...
How often does Market Pathways release new episodes?
Market Pathways has 35 episodes. Check the episode list to see recent publication dates and frequency.
Where can I listen to Market Pathways?
You can listen to Market Pathways on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
Who hosts Market Pathways?
Market Pathways is created and hosted by Market Pathways.
URL copied to clipboard!