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 Zimmerman, a managing director and senior equity analyst--medtech at BTIG, in the lead up to one of the sector’s most important medical meetings, the American Academy of Orthopedic Surgeons (AAOS) Annual Meetin...
Mar 07, 2025•30 min
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 uses, including the recent FDA guidance, as well as global applications of real-world evidence, and its use in emerging areas like health equity and AI.
Aug 01, 2024•1 hr 6 min
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 Harris and Nancy Lincé, who discussed the issue onstage last month at the MedTech Strategist Innovation Summit in Dublin.
May 25, 2024•32 min
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 into the current hot topic: TCET.
Mar 27, 2024•49 min
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 help drive change in the current debate over TCET (transitional coverage for emerging technologies) to help speed this process.
Sep 19, 2023•56 min
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 medtech market, although evolving both in terms of advancing product development and shifting investment patterns, is seeing lower barriers to entry emerging for western companies, particularly those with inn...
Aug 10, 2023•36 min
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 implications for the market.
Jun 27, 2023•36 min
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 decision-making in running their companies and deciding which start-ups they will invest in given the ever-changing regulatory climate in Europe.
May 19, 2023•42 min
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 these uncertain times, providing a look at what the future looks like for medtech regulation in Europe. View the latest issue of Market Pathways: https://bit.ly/3M4gsLc View more podcast episodes: https://b...
Feb 09, 2023•1 hr 5 min
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 the rest of this year and for the new Congress in 2023? MDMA’s Mark Leahey and Advamed’s Greg Crist offer their perspectives on this podcast with Market Pathways editors Stephen Levin and David Filmore....
Dec 01, 2022•56 min
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 then talk about what to expect from CMS on a new medtech coverage pathway. The ever-present tribulations in the EU come up, of course, and we finish with a quick check-in on India and China. nail-biter in ...
Sep 22, 2022•56 min
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, coverage, and payment in the US and Europe, with the hope that other companies can benefit from their experience, avoid similar mistakes, and achieve comparable success. Read more about the changes in reimbu...
Aug 18, 2022•47 min
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 how to avoid potential pitfalls along the way. #medicaldevices #medtech #mdr #medicaldeviceregulation View the latest issue of Market Pathways: https://bit.ly/3M4gsLc View more podcast episodes: https://b...
Jul 19, 2022•37 min
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, CEO, StasticaMedica Jeff Jump, CEO, Medalliance Marc-Pierre Möll, CEO, BVMed Stephen Levin, Editor-in-Chief, Market Pathways (moderator) #medicaldevices #medtech #mdr #medicaldeviceregulation View the l...
Jun 16, 2022•35 min
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. In this episode, we spoke to Siami about the role NEST plays in industry, the multi-stakeholder challenges to establishing a robust real world evidence framework, and next steps and milestones. Read more...
May 26, 2022•48 min
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 and regulatory concerns facing the device industry. #medtech #MedicalDevices #FDA #CMS #MCIT View the latest issue of Market Pathways: https://bit.ly/3M4gsLc View more podcast episodes: https://bit.ly/3v...
May 13, 2022•34 min
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 Imaging and Technology Alliance about the recently inked FDA user fee agreement, MITA’s legislative priorities for equipment servicing and cybersecurity, and the perspective of the imaging industry afte...
Apr 14, 2022•46 min
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 Dave also talk about the very active regulatory reform efforts in China and the rest of Asia. Read more about the topics discussed in this episode: MDR Is Here: Now What Does It Mean? The Future of Europ...
Mar 03, 2022•33 min•Ep. 13
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, where they discuss the environments in Europe and Asia, in the next episode. Read more about the topics discussed in these Market Pathways articles: Pathways’ Picks for 2022: 7 Medtech Policy Issues to Wat...
Feb 22, 2022•35 min•Ep. 12
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 enhance the pre-eminent Stanford program by adding a focus on medical device regulatory, reimbursement and policy issues, which today are critical for a successful medtech entrepreneur to understand. Mak...
Feb 05, 2022•1 hr 2 min•Ep. 11
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 response is that reimbursement has replaced regulatory as the biggest obstacle to successful commercialization. Dealing with the multiple elements of reimbursement - coding, coverage and payment - which involve...
Jan 20, 2022•54 min•Ep. 10
“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” on his five-year strategy plan when he took the helm of the powerful device industry trade association in 2016. The unexpected challenges have been steep, with the industry he represents at the center of...
Dec 02, 2021•40 min•Ep. 9
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 regulatory affairs experts talk about FDA’s efforts. Yarmela Pavlovic, VP of regulatory strategy at Medtronic, and Ankur Kaushal, VP of Regulatory Affairs and Quality at Big Health, digital therapeutics company...
Nov 18, 2021•33 min•Ep. 8
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 working to increase both the number and efficiency of these trials in the US, demonstrating that, at least on occasion, regulators can be ahead of industry. Now the burden is on device companies to follow suit...
Oct 07, 2021•57 min•Ep. 7
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 the helm of CVRx Inc., which as recently transitioned to a commercial phase, public company with its Barostim Neo heart failure device. And he has also done so as part of his very active role in cross-ind...
Sep 23, 2021•53 min
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 touches all bases with Medtech Strategist/Market Pathways editor-in-chief Stephen Levin, including discussing: the potential long-term impact of the pandemic on the industry and the transition from EUAs to...
Sep 09, 2021•1 hr 6 min•Ep. 5
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 market to crack. Read the full article: https://bit.ly/3AGxCc9 View the latest issue of Market Pathways: https://bit.ly/2UEqmO9 View more podcast episodes: https://bit.ly/3jMx65s About Market Pathways Yo...
Aug 12, 2021•18 min•Ep. 4
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 Strategist’s Virtual Innovation Summit Dublin 2021. Check out the full video. Read the full article: https://bit.ly/3BGuEFE View the latest issue of Market Pathways: https://bit.ly/3eZUBGw About Market ...
Jul 28, 2021•20 min•Ep. 3
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 conversation, Shuren talks about the evolution of FDA-sponsor interactions that has occurred over his tenure, the “real-time” engagements during COVID-19, and CDRH’s proposal for a TPLC Advisory Program...
Jul 15, 2021•29 min•Ep. 2
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 delay due to the pandemic. Yet, as you’ll see in this conversation with Serge Bernasconi, CEO of MedTech Europe, the medical device industry trade association, it appears that nothing could be further fr...
Jul 01, 2021•34 min•Ep. 1
