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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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FDA Inspections Getting Prepped and Avoiding Pitfalls
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. -
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.
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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.
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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.
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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.
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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.