Market Pathways

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.

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 ever-changing regulatory climate in Europe.

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.

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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?  MDMA’s Mark Leahey and Advamed’s Greg Crist offer their perspectives on  this podcast with Market Pathways editors Stephen Levin and David  Filmore.

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 ever-present tribulations in the EU come up, of course, and we finish with a quick check-in on India and China. 

nail-biter in Congress (1:47)

a new medtech coverage pathway (21:54)

tribulations in the EU come up (36:04)

check-in on India and China (46:50)

Here’s some Market Pathways content referenced in this episode:

Market Pathways Podcast episodes:

Jeff Shuren on FDA-sponsor interactions: Where they’ve been and where they’re going https://apple.co/3QY3n89

Do We Need an Expedited Medtech Reimbursement Program? An Interview with Mark McClellan https://apple.co/3LqhRMK

Market Pathways’ articles:

Germany and France Push to Move MDR Deadlines to Avoid Crisis https://bit.ly/3xCC5NE

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 that other companies can benefit from their experience, avoid  similar mistakes, and achieve comparable success.

Read more about the changes in reimbursement: https://bit.ly/3QRMa0C

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

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 #medicaldeviceregulation

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

With the European Medical Device Regulation (MDR) now in effect in  Europe we check back in with the experts in the space to provide an  update on how MDR has been implemented and the issues that are arising.   

MDR is Here: Now What Does It Mean? 

Serge Bernasconi, CEO, MedTech Europe  

View the latest issue of Market Pathways: https://bit.ly/3M4gsLc    

View more podcast episodes: https://bit.ly/3vgFTlT  

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The National Evaluation System for health Technology, or NEST, was set  up to build a dependable  real world evidence ecosystem to support  development of devices and surveillance of device data. Sandra Siami leads NEST Coordinating Center from her perch at the Medical Device  Innovation Consortium. In this episode, we spoke to Siami about the role NEST plays in industry, the multi-stakeholder challenges to  establishing a robust real world evidence framework, and next steps and  milestones.   

Read more about the topics discussed:   

Keeping Medtech Real-World Evidence Real

MDIC: Breaking Down Silos Across Medtech to Spur Innovation

Data Debate: Paclitaxel Device Meeting Shows Rift in Regard for Real-World Evidence