From Idea to Market: Ep 10 - What Breaks at Scale

Send us Fan MailWhat real-world use reveals about a medical device that no clinical trial ever could — and why the most dangerous moment in med tech innovation often comes after success, not before. A conversation about the fatigue failures, reimbursement gaps, and feedback breakdowns that surface only at scale.For ten episodes, the From Idea to Market series has followed medical innovation through every threshold an idea must survive — the first clinical insight, the years of iteration, the funding rounds, the regulatory climb, the investor's decision room. Episode 10 asks what happens after all of that succeeds. When a product is working, when demand is building, when expectations have risen, what new vulnerabilities does that very success create?Joe Schwab is joined by four voices who have lived this stage from different positions. Jared Foran is an orthopaedic surgeon in Denver and co-founder and chief scientific officer of Forcast Orthopedics. Doug Fairbanks is the president, CEO, and board member at VISIE Inc. Charlie DeCook is the president of Total Joint Specialists, a 17-surgeon group in Atlanta. Robert Cohen is the vice president of innovation and technology for Stryker's orthopaedic group, with four decades of watching the commercial environment for med tech innovation shift around him.The episode works through three questions: what does real-world use reveal that no development program ever can, which structural and commercial weaknesses surface only at scale, and how do teams build the organizational discipline to act on what the market tells them. The conversation moves from product iteration after launch, to the second valley of death between regulatory clearance and reimbursement, to the feedback loops inside an organization that determine whether real-world signals reach the people who can act on them. For surgeon-founders, for engineers in med tech, and for anyone trying to understand why so many clinically promising ideas stall after they reach the market, this episode is about what scale actually demands.⏱️ Chapters:00:00 What happens to medical devices after they reach the market02:53 Surgeons and industry leaders who scaled med tech innovations04:35 The fatigue failure principle applied to medical devices06:05 What real-world use reveals that clinical trials never can09:15 Why most med tech products require a major pivot post-launch11:33 How to sustain commercial momentum after launch14:32 The second valley of death between clearance and reimbursement16:13 Inside the new FDA-CMS RAPID coverage pathway17:36 How reimbursement uncertainty kills good clinical ideas22:35 Building feedback loops before scale exposes the gaps25:39 Why launch is the start of development, not the end30:55 Preview: built to last or built to sellListen to the AHF Podcast on your preferred platform:Buzzsprout: https://ahfpodcast.buzzsprout.comApple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHcLinkedIn: https://www.linkedin.com/showcase/ahf-podcastYouTube: https://www.youtube.com/@anteriorhipfoundationHomepage: https://anteriorhipfoundation.comThis podcast is intended for educational and informational purposes only.The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.#anteriorhipfoundation   #AHFPodcast #MedTech #MedTechInnovation #FromIdeaToMarket #PostMarketSurveillance #MedicalDevices #Reimbursement #FDA #ValleyOfDeath #Stryker #OrthopedicSurgery