Market Pathways

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

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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

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. 

Read more about the topics discussed:  

• 7 User Fee Riders to Watch: From Cybersecurity to Remanufacturing to  Payor Comms

• FDA Tries to Draw a Line on What Constitutes Regulated Remanufacturing

• FDA Targets Medtech Cybersecurity: An Interview with Kevin Fu, the First Device Cyber Czar

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

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:

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

Q&A: AdvaMed’s Scott Whitaker on Partnering, Advocacy, and the  Medtech Policy Year Ahead

Device User Fee Talks Stalled as a Deadline Approaches

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

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

“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

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

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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.

More Articles:

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

About Market Pathways

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

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

About Market Pathways

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