ARTICLE SUMMARY:
This year, Market Pathways readers turned to us to make sense of changes in the global regulatory climate, particularly the EU’s MDR and IVDR as well as China’s regulatory reforms. Our case studies of reimbursement and approval strategies also resonated with readers, as did practical, pointed strategic advice from medtech industry experts. Here are the top 10 Market Pathways articles for 2021, chosen by readers and editors.
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#1: How the New Medical Device Regulation is Shaping Europe
After years of anticipation and delays, the new EU Medical Device Regulation has finally become effective, turning discussions of regulatory changes from hypothetical to reality. Yet, many questions and uncertainties still remain for product companies and regulators. Our discussion with Serge Bernasconi, CEO of MedTech Europe, highlights both the knowns and the still unknowns, with, not surprisingly, the latter far outnumbering the former.
#2: CVRx: A Pioneering Reimbursement Strategy Pays Off
Now nearly 20 years old, CVRx may have switched its clinical focus, but it has remained committed to the importance of developing a reimbursement strategy early on, including collecting health economics data as part of its clinical studies. This outlier approach has paid off with the company receiving NTAP approval for increased reimbursement.
#3: The COVID De Novo Path Blazed by BioFire
Executives at BioFire Diagnostics talk with Market Pathways about their route to the first de novo authorization of a SARS-CoV-2 test, a potential predicate for the hundreds of molecular COVID-19 assays with Emergency Use Authorizations.
#4: Remote Audit Readiness: Leaders Share Key Learnings
Virtual audits promise to become an established practice in the post-COVID world. Do you have the resources in place to do them right? Industry leaders at Abbott Rapid Diagnostics, Team NB, and TÜV SÜD provide best practices for conducting remote audits.
#5: Overcoming the Funding Challenges of Bringing Digital Health Technologies to Market
There has been an increased focus on use of digital health technologies in recent years, now accelerated by the COVID-19 pandemic, but several barriers remain to market access, mainly regarding reimbursement. The Life Sciences Practice team at CRA explores these challenges and how companies might overcome them to encourage faster access and reimbursement of DHT.
#6: MCIT Rule May Be Toast, But There’s More on the Medicare Menu
CMS’ proposed repeal of its planned automatic temporary coverage pathway for FDA Breakthrough Devices sends a bad signal to medtech investors and innovators. But it’s worth taking time to see what the agency does next on this issue, and other policy matters with an even more expansive impact on the device industry, before coming to any final conclusions about CMS’ plans for the sector.
#7: Jeff Shuren on FDA-Sponsor Engagement: Where It’s Been and Where It’s Going
The FDA device center director joined the Market Pathways Podcast to talk about how opportunities for device firms to interact with FDA during the development and review of new devices have evolved, and his vision for the future: CDRH’s TAP proposal. “We have been building to this moment for now basically a decade,” Shuren tells us.
#8: New Chinese Medtech Regs Offer New Opportunities
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.
#9: Seeking Reimbursement for AI Tech? Five Things to Remember
Devices driven by artificial intelligence algorithms are becoming more prevalent in healthcare, but reimbursement remains a challenge. Deborah Godes from McDermott+Consulting spoke to Market Pathways on the topic, offering insights for companies entering the coverage, coding, and payment trenches for AI tech in the latest "From the Experts" column.
#10: On to the IVDR: A Paradigm Shift in Diagnostics Regulation is Coming, Ready or Not
Set to take effect in May 2022, the EU IVD Regulation has played second fiddle to the Medical Device Regulation in terms of public focus. But no more. The transition challenge is in many ways steeper for IVDR than it is for MDR, and anxiety levels about system readiness are intensifying. IVDR represents a paradigm shift for diagnostics makers in terms of data and process expectations in Europe. Here’s a look at where things stand and what to expect.