Market Pathways

German industry groups and lawmakers are the primary drivers behind pending reforms to the EU MDR and #IVDR intended to support innovation. Steady growth in #software products that are gaining #reimbursement via the fast-track Digital Health Application (DiGA) program is likely to continue following recent reforms allowing higher-risk apps to qualify: https://bit.ly/486nif7

Thank you The MedTech Conference for a great event! We're looking forward to the next one. #MedTechCon

Have you been wondering what #TCET’s ultimate goal is? TCET's ultimate goal is to enable products selected for the pathway to complete their NCDs, based on requirements to collect the necessary clinical evidence, within six months. That is fairly aggressive compared with current standards. While industry leaders generally acknowledge that TCET represents a step in the right direction, based on the public comments, they also see the final version of the pathway as a bit of a missed opportunity or a step not far enough, particularly when viewed in comparison to MCIT, which, for all its shortcomings, provided nearly automatic coverage. Few #regulatory or #reimbursement programs have traveled the winding path that the Transitional Coverage for Emerging Technologies (#TCET) has followed in various incarnations before CMS launched the program with the final notice issued in August. At the recent Medical Device Innovation Consortium (MDIC) Annual Public Forum (APF) in Washington, DC, Steven Farmer, MD, PhD, chief strategy officer of CMS’ Coverage and Analysis Group (CAG) and a driving force behind TCET, was interviewed by Lindsay Bockstedt, PhD, Medtronic's VP of health economics, policy, and reimbursement, and a member of Medical Device Innovation Consortium (MDIC)’s health economics/patient value working group, to address some of industry’s concerns about TCET and explain how the pathway is being rolled out. #medicaldevices #medtech #marketpathways #marketaccess #healtheconomics

Looking forward to attending The MedTech Conference this year!

Did you know that most DiGA users are women, reflecting a broader trend where more women take part in DTx trials and engage with health digitalization (see Figure 2)? To date, almost all DiGA-listed products (87%) are low-risk, Class I medical devices, whereas some (13%) are moderate-risk Class IIa devices (classified under the MDR, as the original law required). Primary indications are for patient education, some cognitive behavioral therapies, and physiotherapy training. Germany’s high-profile DiGA legislation has successfully encouraged digital therapeutics innovation, according to two new studies, although critics say it still leaves room for improvement. The US company Enovis, which embraces digital therapeutics as a promising business, and its German start-up partner Orthopy Health GmbH are testing the DiGA waters in what Enovis considers to be an important ex-US market opportunity: https://bit.ly/4eWlwj6 #medtechinnovation #medicaldevices #medtech #DiGA #healthdigitization #digitalheath

Each month in Global Spotlight we provide market access facts and figures from the country featured on the cover of Market Pathways' print issue. In October, we featured the headquarters of Germany's Federal Institute for Drugs and Medical Devices in Bonn. Click here to get the resources you need from Germany: https://bit.ly/486nif7 #marketaccess #regulatoryaffairs #Germany #medtech #medicaldevices #resources

Germany's Pioneering DIGA Act Spurs Digital Health Innovation, With Limits While the RCTs required to meet DiGA’s standards are not as onerous as traditional pharmaceutical pivotal trials, they are still time-consuming, and the statue allows manufacturers to get an extendable one-year listing based on preliminary evidence, which enables them to generate revenue while they complete the more rigorous studies required for a permanent listing (see Figure 1 below). Germany’s high-profile DiGA legislation has successfully encouraged digital therapeutics innovation, according to two new studies, although critics say it still leaves room for improvement. The US company Enovis, which embraces digital therapeutics as a promising business, and its German start-up partner Orthopy Health GmbH are testing the DiGA waters in what Enovis considers to be an important ex-US market opportunity: https://bit.ly/4eWlwj6 #digitaltherapeutics #digitalhealth #medtechinnovation #digitalhealthinnovation #Germany #medtech

CMS’ recently launched Transitional Coverage for Emerging Technologies (TCET) pathway appears to be getting its first tryouts with new transcatheter tricuspid valve devices. Most recently, on October 3, the agency opened a national coverage analysis for the transcatheter edge-to-edge repair for tricuspid valve regurgitation (T-TEER) procedure performed with Abbott Laboratories’ recently FDA-approved TriClip device. In the tracking sheet launching the process, CMS states the analysis, opened in response to an Abbott request, is a TCET pilot, and that “the manufacturer of this device tested the processes and concepts of TCET.” Novel transcatheter tricuspid valve devices from Abbott Laboratories and Edwards Lifesciences have been enrolled as pilot cases in CMS’ new Transitional Coverage for Emerging Technologies (TCET) pathway: https://bit.ly/3TXA2yP Source of image: Edwards Lifesciences #devices #medtechdevices #medicaldevices #medtech #TCET

Pathways Picks: TCET Tricuspid Valve Tryout, EtO Actions, IMDRF Updates, and More   In this week’s Pathways Picks: Transcatheter tricuspid valve devices are among the first to pilot CMS’ Transitional Coverage for Emerging Technologies pathway; FDA plans new policies for ethylene oxide sterilization changes; the International Medical Device Regulators Forum accepts new members and approves new guides; the EU Parliament meets; a new IVDR guidance document is released; the Netherlands scrutinizes postmarket surveillance efforts; and more from Brazil, India, and the US. Get your picks here: https://bit.ly/3Y1ftCR #medtechregulations #regulatoryaffairs #medtech #IMDRF #MarketPathways #CMS #FDA

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