Market Pathways

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.

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 te

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 shiftin

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.

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 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 l

Key retirements, important changes in leadership, and some surprising  new faces. Now that the dust has almost settled, leaving just one Senate  run-off and several House seats still to be settled, what does the  election’s outcome mean for the medical device industry, both in terms  of prospects for the rest of this year and for the new Congress in 2023? &nbs

Summer’s over. A new school year is in session, and it’s time to get back to business. Market Pathways’ editors Steve Levin and David Filmore talk about global medtech policy issues they’ll be paying attention to this fall. We start with the FDA user reauthorization nail-biter in Congress, and then talk about what to expect from CMS on a new medtech coverage pathway. The ev

Reimbursement has replaced regulatory as the leading barrier facing  device companies today. Here several leading CEOs and entrepreneurs  share the details of how they have successfully battled through the  morass of acronyms and complexities to overcome the ever-changing  intricacies of coding, coverage, and payment in the US and Europe, with  the hope tha

Experienced medtech China hands discuss the opportunities opening up for Western companies to more easily enter that potentially huge market. These CEOs and advisers share how improvements in the regulatory and IP landscape make finding a reliable Chinese partner easier, while also highlighting how to avoid potential pitfalls along the way. #medicaldevices #medtech #mdr #medicaldev