Post by Market Pathways

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 Byers Center for Biodesign program following the retirement of Paul Yock, MD, with who 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 Standford 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 Centers for Medicare & Medicaid Services coverage of innovative technologies. The over-arching theme of this discussion is that, even with the most 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. 👂LISTEN: bit.ly/3f4VjlR Our Market Pathways email newsletter keeps you up-to-date on new issues, articles, and podcast episodes. Market Pathways is the premium guide your #medtech company needs on global #medicaldevice regulation, reimbursement, and policy. Click here to stay informed. 👉 bit.ly/3orlw2F #reimbursement #policy #policyanalysis #regulations #regulatoryaffairs