Market Pathways

"Docs of the Month" is a recurring feature showcasing notable findings from Pathways’ Document Depot—a comprehensive database of global #medtech regulatory and policy documents. It includes key resources such as rules, guidance, memos, white papers, and more from national authorities, non-governmental organizations, and international bodies. Standards are foundational tools for making, testing, and using #medicaltechnology. Here are some noteworthy standards recently published, according to tracking by Document Depot, as well as recently recognized standards and new items in the works: https://bit.ly/4i9Syii

What can you get in the November 2024 Digital Edition of Market Pathways? Edwards Lifesciences execs discuss #regulatory and reimbursement strategies for their pioneering tricuspid valve, one of CMS' test cases for TCET; The challenge of meeting EU clinical data requirements; Guidance on preparing for the EU Artificial Intelligence Act; and Windham Capital Partners's Sarah Fox on mastering market access challenges for digital health technologies. Peak inside here: https://bit.ly/3V92PB4 #medtech #medtechinnovation #medicaldevices

After a productive networking break, we’re nearing the end of Day 2 of #InnovationSanDiego with “The Ajax Model: A Middle Path to Innovation” panel session. Luke Rohlen, Associate, Ajax Health Greg Schiffenhaus, Chief of Staff to CEO, Cordis Stephen Levin, Editor-in-Chief, Market Pathways (moderator) Successful innovation in #medtech remains a challenge as the process is becoming more polarized with large companies continuing to focus primarily on incremental advances, while venture capitalists are looking for transformational home runs. This panel will discuss a different approach that Ajax has developed, which it calls the growth driver model, explaining how this strategy has revived innovation in Cordis, a large medtech firm. Remain informed on new articles, conference updates and more with our helpful #medtech community newsletter. Subscribe here: https://bit.ly/42KHJKI

We kick off the third and final day of #InnovationSanDiego with Stephen Levin, Editor-in-Chief of Market Pathways, moderating the Getting Funding From New Sources panel session discussion between Greg Garfield, Senior Managing Director of KCK Group - Financial Services Investments, Bill Little, EVP, Corporate Development and Strategy of Orchestra BioMed, and Chris Neil, MedTech, Partner of Advantage Fund. Greg Garfield currently serves as Senior Managing Director, and the head of KCK's Medtech Group. KCK Medtech is an evergreen investment fund whose flexible capital and operationally experienced team brings significant value in building companies. The KCK Medtech Team is composed of operators and leaders from both start up and fortune 500 companies. Bill Little joined Orchestra BioMed as its Executive Vice President of Corporate Development and Strategy in June 2023, bringing an extraordinary depth of knowledge, expertise and relationships in the #cardiovascular device industry. Chris Neil is an experienced venture & angel investor, senior executive, and start-up advisor. He is Partner and Co-Founder of MedTech Advantage Fund, investing in a broad portfolio of medtech, biotools, and #digitalhealth start-ups that have graduated from the MedTech Innovator accelerator program. Remain informed on new articles, conference updates and more with our helpful #medtech community newsletter. Subscribe here: https://bit.ly/42KHJKI

We wrap up the final day of Innovation Summit San Diego 2024 with a panel on MedTech Policy in 2025: A Post-Election Outlook on Industry Priorities moderated by David Filmore, Executive Editor of Market Pathways with Mark Leahey, President & CEO of Medical Device Manufacturers Association (MDMA) and Scott Whitaker, President & CEO of AdvaMed. Remain informed on new articles, conference updates and more with our helpful #medtech community newsletter. Subscribe here: https://bit.ly/42KHJKI

"Market Pathways Scorecard: FDA Breakthrough Devices" is a graphic review of FDA Breakthrough Device program activity and NTAP coverage. Here are stats and facts on #FDA-designated Breakthrough Devices: https://bit.ly/40Zo8ZD

After an exciting first day of presenting innovative startup companies at #InnovationSanDiego, we move on to this enlightening discussion between Scott Huennekens, Principal of Front Foot Ventures, and Stephen Levin, Editor-in-Chief of Market Pathways. Scott is a successful Medtech CEO, Chairperson, board member, entrepreneur, and investor, having been involved in one of those roles in 20+ startup, growth and public companies with market valuations that have totaled over $20b and more importantly over 20 million patients that have benefited from the therapies & diagnostics of these companies, including 8 IPOs. Current affiliations include Principal Front Foot Ventures, Chair Hyperfine, Inc. (HYPR) IPO 2021, Chair Envista Holdings Corporation (NVST) IPO 2019, Exec Chair KARDION, Exec Chair Elucid, Executive Chair On Target Laboratories, Board member Q'Apel Medical, Board member Proximie, Board member Foldax Inc. Stephen served as Executive Editor & General Counsel at Windhover Information followed by Editor-in-Chief of Medical Devices for Elsevier Business Intelligence, where he directed the company’s editorial coverage of the medical device industry. Before that, Stephen was Senior Counsel to the US Senate Permanent Subcommittee on Investigations, where he directed Senate investigations into a wide variety of areas including health care fraud and abuse, international organized crime, and corruption in federal contracting programs, while also participating in other Senate investigations including the Whitewater inquiry.  Before joining the Subcommittee, he was with the Federal Election Commission and the Department of Justice. Remain informed on new articles, conference updates and more with our helpful #medtech community newsletter. Subscribe here: https://bit.ly/42KHJKI

Pathways' Picks: RFK Jr., Dr. Oz, UK Reforms, Generative AI, and More In this week’s Pathways Picks: President-elect Donald Trump says he will nominate RFK Jr. as HHS secretary and Mehmet Oz as CMS administrator; the UK government seeks more input on its pending medical device #regulatory framework; FDA’s new Digital Health Advisory Committee meets to discuss generative #AI; and FDA updates on emergency use authorization and ethylene oxide. Get your picks here: https://bit.ly/4fZ5mpQ

Great insights from industry leaders at #InnovationSanDiego! Panels like 'Cracking the Black Hole of Private Payer Reimbursement' highlight the crucial intersections of innovation and #marketaccess. We're proud to engage with such valuable conversations.

I really enjoyed this conversation with MCRA, an IQVIA business ‘s Tim Marjenin and Kenneth Rayl about oncoming (at some point) FDA requirements for Diversity Action Plans and practical considerations for making medtech trials more diverse via protocols, site selection, study monitoring, and technology. #medtech #fda #clinicaltrials #diversity