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

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A VC’s View of the Reimbursement Evolution: An Interview with Mike Carusi

Market PathwaysMar 27, 2024

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49:25

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 into the current hot topic: TCET.

Mar 27, 202449:25

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 help drive change in the current debate over TCET (transitional coverage for emerging technologies) to help speed this process.

Sep 19, 202356:26

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 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 innovative technologies. Two China medtech experts, Ari Silverman and Olivier d’Arros, talk about the changes taking place in the Chinese market and how they expect it to progress in the face of continuing geopolitical tensions.

Aug 10, 202335:56

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 implications for the market.

Jun 27, 202336:22

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 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, 202341:38

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 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://bit.ly/3vgFTlT

About 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

Feb 09, 202301:04:37

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 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, 202256:01

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 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 Congress (1:47)

a new medtech coverage pathway (21:54)

tribulations in the EU come up (36:04)

check-in on India and China (46:50)

Here’s some Market Pathways content referenced in this episode:

Market Pathways Podcast episodes:

Jeff Shuren on FDA-sponsor interactions: Where they’ve been and where they’re going https://apple.co/3QY3n89

Do We Need an Expedited Medtech Reimbursement Program? An Interview with Mark McClellan https://apple.co/3LqhRMK

Market Pathways’ articles:

House vs. Senate vs. Senate: FDA Bills Diverge https://bit.ly/3dxmlol CMS TCET Vision: Significant Change or Same Old Coverage Framework? https://bit.ly/3QQiYqp

Germany and France Push to Move MDR Deadlines to Avoid Crisis https://bit.ly/3xCC5NE

Sep 22, 202256:24

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, 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 reimbursement: https://bit.ly/3QRMa0C

View the latest issue of Market Pathways: https://bit.ly/3M4gsLc

View more podcast episodes: https://bit.ly/3vgFTlT

About Market Pathways

Aug 18, 202247:24

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 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://bit.ly/3vgFTlT

About 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

Jul 19, 202236:50

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, 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 latest issue of Market Pathways: https://bit.ly/3M4gsLc

View more podcast episodes: https://bit.ly/3vgFTlT

Jun 16, 202235:21

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. 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.

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 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/3vgFTlT

About Market Pathways

May 13, 202233:60

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 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 after two years in the pandemic.

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 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 European Device Regulation Is Closer Than You Think: What Comes After MDR? New Chinese Medtech Regs Offer New Opportunities

Mar 03, 202233:01

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, 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 Watch
https://bit.ly/3JNdRUS

Q&A: AdvaMed’s Scott Whitaker on Partnering, Advocacy, and the Medtech Policy Year Ahead
https://bit.ly/3LSDx3U

Device User Fee Talks Stalled as a Deadline Approaches
https://bit.ly/3p86G1A

Feb 22, 202235:26

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 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.

Makower talks here about the initial efforts Stanford Biodesign has launched to get the policy ball rolling, beginning with reimbursement, which has replaced regulatory as the biggest problem currently facing medtech companies. Kicking off this effort is a paper published recently in the Health Management Policy & Innovation Journal that makes the data-driven case for a need both on the part of patients and the innovation ecosystem for accelerated Medicare coverage of innovative technologies. (Keep an eye out for an article on this report in the February issue of Market Pathways.)

The over-arching theme of this discussion is that, even with the recent improved transparency and accountability at FDA, major regulatory, reimbursement and policy hurdles remain for device companies and entrepreneurs with reimbursement being the next major obstacle. Makower is committed to using a data-driven approach – at a time when data and science generally are under attack – to add policy expertise to Stanford Biodesign’s armamentarium of resources for next-generation entrepreneurs and industry to call upon in addressing these challenges.

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9

View more podcast episodes: https://bit.ly/3AvBFrm

About 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

Feb 05, 202201:01:30

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 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 a variety of public and private organizations, makes this a complex pathway for small and large companies alike, and that doesn’t even begin to address international coverage.

Our recent San Francisco Innovation Summit, held in November 2021, featured a reimbursement panel moderated by Stephen Levin, Market Pathways’ Editor-in-Chief, that, rather than talking in hypothetical terms, highlighted perspectives from two companies with innovative cardiovascular technologies that have successfully navigated the reimbursement process, and an experienced consultant who has worked with many device companies to achieve payment for their products.

The panelists were Christopher Brooks, Director of Healthcare Economics for Impulse Dynamics NV (implantable device for heart failure), Heather A. Brown, SVP of Market Access and Reimbursement for Heartflow Inc. (non-invasive coronary artery disease diagnosis), and Adi Renbaum, president of ANR Consulting. An excerpt from this discussion also appears in the January 2022 issue of Market Pathways. We hope you enjoy the podcast.

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9

View more podcast episodes: https://bit.ly/3AvBFrm

About 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

Jan 20, 202253:43

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” 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 the pandemic narrative. But Whitaker has been heartened by industry’s ability to rally to the challenge. And he believes that his work, the work of government advocacy, has been strengthened by the experience. The need for industry to work with policymakers in new ways to achieve quicker action in response to the emergency has enhanced appreciation for productive partnerships on both sides, he says. He thinks that dynamic will be lasting, beyond pandemic policies.

More productive government-industry partnerships would certainly help over the next months, and year, as the device industry’s DC representatives face having to start from square one following CMS’ recent repeal of the Medicare Coverage of Innovative Technology program, bringing challenging user fee negotiations with FDA to a close, and engaging in what could be a very active congressional session for medtech in the mix of election-year politics. Whitaker talks about those issues and more with Market Pathways Executive Editor David Filmore.

Relevant articles: MCIT Rule May Be Toast, But There’s More on the Medicare Menu: https://bit.ly/3i1SiEj
Capitol Hill Staffers are Impatient for Device User Fee Deal: https://bit.ly/2ZDJdM9
Pathways’ Picks November 17: Big Week in Washington, Aussie Reclassifications, China Picks, and More: https://bit.ly/3xLOvSs

View the latest issue of Market Pathways: https://bit.ly/3uSbUzS

View more podcast episodes: https://bit.ly/3ai8nBy

Dec 02, 202139:38

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 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, discuss the agency’s special allowances for digital tools during the pandemic and how FDA may transition these policies as we eventually move beyond the public health emergency. The experts also offer insights on real-world evidence, the Precertification Program, AI/ML regulatory strategies, and the FDA experience seen through the eyes of start-ups versus big medtech. The discussion was moderated by David Filmore, Executive Editor of Market Pathways.

Digital Health Moves to the Center: Bakul Patel on Next Steps: https://bit.ly/3FrSlTd

FDA’s AI Evolution: Perspectives from an Innovator and a Regulator: https://bit.ly/3x0F2WX

FDA’s Software Efforts Shine Light on the Challenge of Harmonization: http://bit.ly/2TOTiQT

View the latest issue of Market Pathways: https://bit.ly/3uSbUzS

View more podcast episodes: https://bit.ly/3ai8nBy

Nov 18, 202133:13

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 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.

Panelists:

Andrew Glass, CEO, Vivasure Medical
Chip Hance, CEO, Regatta Medical
Jaime Walkowiak, General Counsel, Instil Bio
Aaron V. Kaplan, M.D., Chairman and CMO, Conformal Medical

Moderator: Stephen Levin, Editor-In-Chief, Market Pathways

Read the full article: https://bit.ly/305JF5H

View the latest issue of Market Pathways: https://bit.ly/3uSbUzS

View more podcast episodes: https://bit.ly/3ai8nBy

Oct 07, 202156:38

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 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-industry endeavors on the boards of AdvaMed, the Medical Device Innovation Consortium, and, most recently, the CRO NAMSA, where is currently the board chair. In this conversation, Yared talks about the evolution and what to look for next at FDA, CMS, and in the clinical research realm.

One update note: During the interview, Yared discusses the Medicare Coverage of Innovative Technology (MCIT) program at CMS. After the conversation took place, CMS issued a proposed rule to repeal MCIT before it takes effect in December and the agency stated plans to pursue new rulemaking. In a follow-up phone call with Market Pathways, Yared called this a “stunning reversal” from CMS.

View Market Pathways’ updated insights on MCIT and what’s to come at CMS: https://bit.ly/3i1SiEj

View our recent feature article on CVRx’s reimbursement strategy: https://bit.ly/3zCrhx8

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9

About 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

Sep 23, 202152:43

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 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 permanent approvals/clearances;
an inside look at the current status of the MDUFA/user fee negotiations, including whether we could see an FDA “concierge” program;
what we might expect from the CURES 2.0 legislation—is ARPA-Health in our future?;
reimbursement challenges, including parallel review, coverage of advanced technologies such as AI, and the debate on site of service payment rules;
is prior authorization dead?; and
will the drug pricing debate spill over into medical devices?

Sep 09, 202101:05:57

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 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

Aug 12, 202118:15

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 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 Pathways

Jul 28, 202120:12

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 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 (TAP), which Shuren says will be a game-changer, allowing companies unprecedented access to FDA, payors, providers, and others along the development route.

View the full article: https://bit.ly/2USj8Gi

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9

About Market Pathways

Jul 15, 202129:00

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 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 from the truth and that there actually are more questions than answers for both product companies and regulators concerning MDR.

The good news, according to Bernasconi, is that most medtech companies appear to have used the lead-up time wisely, preparing to operate under the new standards and thereby avoiding what could have been one major bottleneck. The flip side of that preparation is the myriad questions that remain unanswered.

View the full interview: https://bit.ly/2T9OLe3

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9

Jul 01, 202133:48