Market Pathways

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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

1 AUG

Pioneering the Use of Real-World Evidence in Medtech: A Discussion with J&J’s Paul Coplan

The use of real-world evidence is increasing rapidly throughout the device industry. Here we talk with Paul Coplan, who is leading that effort at J&J, which received the first FDA-approved label extension using real-world evidence. Our conversation embraces the breadth of real-world evidence uses, including the recent FDA guidance, as well as global applications of real-world evidence, and its use in emerging areas like health equity and AI.

1h 6m
25 MAY

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.

32 min
27 MAR

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.

49 min
19/09/2023

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.

56 min
10/08/2023

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.

36 min
27/06/2023

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.

36 min
19/05/2023

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.

42 min
09/02/2023

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

1h 5m

See All (29)

Creator

Market Pathways
Years Active

2021 - 2024
Episodes

29
Rating

Clean
Show Website

Market Pathways

Market Pathways

Episodes

Pioneering the Use of Real-World Evidence in Medtech: A Discussion with J&J’s Paul Coplan

FDA Inspections Getting Prepped and Avoiding Pitfalls

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

Reimbursement for Breakthrough Devices Still Lags—Need for TCET: An Interview with Josh Makower

Ep. 25: Medtech in China: An Island of Relative Calm in a Sea of Volatility

An Interview With Kevin Fu, The First Device Cyber Czar

The Real World Impact of MDR: How CEOs and Investors are Adapting

Medtech Law & Policy - Clearing Up the Confusion on MDR: Where Do We Go From Here?

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