Market Pathways
Episodes
Ep. 34: What I Learned From 25 Years at CMS: An Interview With Tamara Syrek Jensen
05 Feb 2026
Contributed by Lukas
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 vi...
Ep. 33: What Does it Mean to be a Reimbursement Professional?
16 Oct 2025
Contributed by Lukas
Veteran medtech reimbursement executive Keely Scamperle talks about her newly launched Reimbursement and Market Access Professional Society, or RAMPSo...
Ep. 32: The Tariff Challenge, Policy Optimism, and The MedTech Conference With Scott Whitaker
22 Sep 2025
Contributed by Lukas
Scott Whitaker, president and CEO of AdvaMed, sits down with Market Pathways’ David Filmore to talk about hot topics in medtech policy, including th...
EP 31: Haven’t We Heard This Song Before? Major EU Regulatory Changes on the Horizon
24 Jul 2025
Contributed by Lukas
A special panel from our Innovation Summit Dublin conference in April 2025Pedro Eerdmans, MD, PhD, Director, Global Strategy Services at NAMSATom Melv...
BTIG Weighs In on Whether Trump Policies Can Dent MedTech’s Healthy Run
07 Mar 2025
Contributed by Lukas
By Wendy DillerFollowing a robust 2024, the medical device sector continues to thrive in 2025 and remains somewhat insulated from dramatic shifts in h...
Pioneering the Use of Real-World Evidence in Medtech: A Discussion with J&J’s Paul Coplan
01 Aug 2024
Contributed by Lukas
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&am...
FDA Inspections Getting Prepped and Avoiding Pitfalls
25 May 2024
Contributed by Lukas
FDA inspections are nobody’s idea of a good time. However, proper planning is crucial not only for ensuring baseline compliance, but also for establ...
A VC’s View of the Reimbursement Evolution: An Interview with Mike Carusi
27 Mar 2024
Contributed by Lukas
Reimbursement has gone from being largely ignored to becoming top of mind for both product companies and investors. Mike Carusi was among the early pr...
Reimbursement for Breakthrough Devices Still Lags—Need for TCET: An Interview with Josh Makower
19 Sep 2023
Contributed by Lukas
This discussion with Stanford Biodesign director and co-founder Josh Makower highlights a recent Stanford report that found the median time for initia...
Ep. 25: Medtech in China: An Island of Relative Calm in a Sea of Volatility
10 Aug 2023
Contributed by Lukas
This edition of the Market Pathways highlights how the opportunities for Western medtech companies looking to enter China are increasing at a time whe...
An Interview With Kevin Fu, The First Device Cyber Czar
27 Jun 2023
Contributed by Lukas
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,...
The Real World Impact of MDR: How CEOs and Investors are Adapting
19 May 2023
Contributed by Lukas
This special episode of the Market Pathways podcast features a panel discussion from our recent Medtech Strategist Dublin Innovation Summit. This sess...
Medtech Law & Policy - Clearing Up the Confusion on MDR: Where Do We Go From Here?
09 Feb 2023
Contributed by Lukas
The last few months have brought a flurry of MDR regulatory and legislative activity, causing a morass of confusion. In this interview, le...
What Do the US Midterms Mean for Medtech?
01 Dec 2022
Contributed by Lukas
Key retirements, important changes in leadership, and some surprising new faces. Now that the dust has almost settled, leaving just one Senate &...
What in the (Medtech) World is Happening?
22 Sep 2022
Contributed by Lukas
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 ta...
Tracking the Changing Reimbursement Landscape
18 Aug 2022
Contributed by Lukas
Reimbursement has replaced regulatory as the leading barrier facing device companies today. Here several leading CEOs and entrepreneurs sh...
Changes in China Present New Opportunities
19 Jul 2022
Contributed by Lukas
Experienced medtech China hands discuss the opportunities opening up for Western companies to more easily enter that potentially huge market. These CE...
MDR is Here - Now What Does That Mean?
16 Jun 2022
Contributed by Lukas
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 upd...
Sandra Siami on the Promise and Challenges of Real World Evidence
26 May 2022
Contributed by Lukas
The National Evaluation System for health Technology, or NEST, was set up to build a dependable real world evidence ecosystem to support &...
Do We Need an Expedited Medtech Reimbursement Program? An Interview with Mark McClellan
13 May 2022
Contributed by Lukas
One of the hottest issues in medtech reimbursement is whether there is a need for an expedited reimbursement program following the repeal of &nb...
The Medical Imaging Perspective with Patrick Hope
14 Apr 2022
Contributed by Lukas
Medical imaging equipment companies share some underlying policy goals with the broader medtech sector. But the realities of capital equipment &...
Looking Ahead in MedTech Policy: Part 2
03 Mar 2022
Contributed by Lukas
Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022. In th...
Looking Ahead in MedTech Policy: Part 1
22 Feb 2022
Contributed by Lukas
Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022....
Bringing the Value of Medtech Regulatory, Reimbursement and Policy Issues to Innovators Through Data: A Conversation with Stanford Biodesign’s Josh Makower
05 Feb 2022
Contributed by Lukas
In this episode of the Market Pathways Podcast, Stephen Levin talks with medtech entrepreneur/innovator/investor Josh Makower, MD. Makower recently re...
Bridging the Regulatory-Reimbursement Gap: Opportunities and Challenges
20 Jan 2022
Contributed by Lukas
This episode of the Market Pathways Podcast tackles the biggest problem facing device companies today: reimbursement. Ask medtech executives and inves...
AdvaMed’s Scott Whitaker on Partnering and Advocacy
02 Dec 2021
Contributed by Lukas
“We were forced to collaborate with such speed and collective work, and collective passion, and the results were very good. That’s going to ...
FDA and Digital Medtech
18 Nov 2021
Contributed by Lukas
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 ...
FDA's Revival of US Early Feasibility Studies; Can Industry Keep Up?
07 Oct 2021
Contributed by Lukas
In this panel discussion from our virtual Dublin Innovation Summit Conference 2021 experts dive deep on FDA’s recent revival of early fe...
Appraising the Medtech Innovation Ecosystem with Nadim Yared
23 Sep 2021
Contributed by Lukas
Nadim Yared is a medtech CEO who is not afraid of digging into the details—the regulatory details; the nooks and crannies of Medicare co...
A Look Ahead at the Coming Medtech “School Year”: A Conversation with MDMA’s Mark Leahey
09 Sep 2021
Contributed by Lukas
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 ...
New Chinese Medtech Regulations Offer New Opportunities
12 Aug 2021
Contributed by Lukas
China continues its recent trend of reforming its regulatory system to make it more attractive for Western companies to introduce innovative technolog...
The Role of Health Tech Assessments in EU/UK Reimbursement
28 Jul 2021
Contributed by Lukas
Device companies seeking global market access can no longer ignore health technology assessment bodies, but there are an expanding number ...
Jeff Shuren on FDA-sponsor interactions: Where they’ve been and where they’re going
15 Jul 2021
Contributed by Lukas
Opportunities for companies to engage with FDA during the development and review of new devices have grown over the years. And if Jeff Shuren, &...
MDR is Here – Now What?” featuring Serge Bernasconi, CEO of Medtech Europe
01 Jul 2021
Contributed by Lukas
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 regulato...