Market Pathways

As the calendar turns from summer to fall, there is no shortage of issues important to the medical device industry emerging on all fronts, addressing legislative, regulatory and policy matters. No one is better aware of the state of play of these issues than Mark Leahey, CEO of MDMA. Here Mark touches all bases with Medtech Strategist/Market Pathways editor-in-chief Stephen Levin, including discussing:

China continues its recent trend of reforming its regulatory system to make it more attractive for Western companies to introduce innovative technologies to the Chinese market. This presents a window, particularly for small to mid-sized companies, to access what historically has been a difficult market to crack.

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Device companies seeking global market access can no longer ignore  health technology assessment bodies, but there are an expanding number  of HTA pathways that firms can utilize, particularly for truly  innovative, next-generation technology, experts said during a recent  panel discussion at MedTech Strategist’s Virtual Innovation Summit  Dublin 2021. Check out the full video.   

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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

Opportunities for companies to engage with FDA during the development  and review of new devices have grown over the years. And if Jeff Shuren,  Director of the agency’s Center for Devices and Radiological Health,  has his way, there will be even more fundamental change in the years to  come.   

In this conversation, Shuren talks about the evolution of FDA-sponsor  interactions that has occurred over his tenure, the “real-time”  engagements during COVID-19, and CDRH’s proposal for a TPLC Advisory  Program (TAP), which Shuren says will be a game-changer, allowing  companies unprecedented access to FDA, payors, providers, and others  along the development route.   

View the full article: https://bit.ly/2USj8Gi

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9  

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

After all the years leading up to the implementation of the new EU Medical Device Regulation (MDR) on May 26, 2021, it is fair to assume that regulators and industry would have worked out most of the basics of the new rules in advance of launching the new regimen, especially given the added year delay due to the pandemic. Yet, as you’ll see in this conversation with Serge Bernasconi, CEO of MedTech Europe, the medical device industry trade association, it appears that nothing could be further from the truth and that there actually are more questions than answers for both product companies and regulators concerning MDR.

The good news, according to Bernasconi, is that most medtech companies appear to have used the lead-up time wisely, preparing to operate under the new standards and thereby avoiding what could have been one major bottleneck. The flip side of that preparation is the myriad questions that remain unanswered.

View the full interview: https://bit.ly/2T9OLe3

View the latest issue of Market Pathways: https://bit.ly/2UEqmO9