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.

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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