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

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

Send us Fan Mail [https://www.buzzsprout.com/2369508/fan_mail/new] What 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 market 02:53 Surgeons and industry leaders who scaled med tech innovations 04:35 The fatigue failure principle applied to medical devices 06:05 What real-world use reveals that clinical trials never can 09:15 Why most med tech products require a major pivot post-launch 11:33 How to sustain commercial momentum after launch 14:32 The second valley of death between clearance and reimbursement 16:13 Inside the new FDA-CMS RAPID coverage pathway 17:36 How reimbursement uncertainty kills good clinical ideas 22:35 Building feedback loops before scale exposes the gaps 25:39 Why launch is the start of development, not the end 30:55 Preview: built to last or built to sell Listen to the AHF Podcast on your preferred platform: Buzzsprout: https://ahfpodcast.buzzsprout.com Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487 Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc LinkedIn: https://www.linkedin.com/showcase/ahf-podcast YouTube: https://www.youtube.com/@anteriorhipfoundation Homepage: https://anteriorhipfoundation.com This 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

FITM Extended Interview: Alexander Sah

Send us Fan Mail [https://www.buzzsprout.com/2369508/fan_mail/new] Alex Sah on what it actually takes for a practicing surgeon to develop new orthopaedic tools — from first idea to OR adoption. An honest conversation about mentors, mistakes, AI, and knowing when to walk away from a collaboration. Most surgeons spot problems in the OR daily and quietly adapt to the limits of existing tools. Alex Sah, a high-volume hip and knee surgeon in Silicon Valley and Chief Medical Officer at Think Surgical, has chosen instead to engage directly with industry — first as an evaluator, then as an advisor, and eventually as a design partner. In this conversation with Joe Schwab, he walks through how that progression actually works in practice, and why he thinks every surgeon with a good idea owes it to themselves to start the process now rather than later. The discussion gets practical fast. Alex breaks down how to vet an idea with a mentor and a patent search, why timing and portfolio fit can make or break a great concept, how to set milestones that let you walk away gracefully from a stalled collaboration, and why the technologies that succeed are usually the ones that speak for themselves the first time a surgeon uses them. He also shares a small habit with big implications — keeping his OR team blinded when testing new products to neutralize the placebo effect that quietly distorts informal evaluations. The conversation closes on AI's inevitable arrival in orthopaedics, the surgeon's role in shaping it before it gets shaped for us, and the AHF Shark Tank as a live laboratory for the From Idea to Market journey. If you've been sitting on an idea, or wondering whether to take that next call from a device rep with a prototype, this episode is a realistic map of the road ahead. ⏱️ Chapters: 00:00 Introduction and Silicon Valley innovation roots 01:02 Why surgeons should solve problems instead of adapting 03:25 Surgeon roles in product development 04:24 First steps for surgeons with no industry connections 05:41 Turning a clinical idea into a development concept 06:46 Setting milestones and knowing when to walk away 08:01 Lessons from working with Think Surgical 10:50 Evaluating new surgical technology objectively 12:14 Essential advice for first-time surgeon innovators 15:47 Why surgeons must help shape AI in orthopaedics 17:40 Inside the AHF Shark Tank for surgical innovation Listen to the AHF Podcast on your preferred platform: Buzzsprout: https://ahfpodcast.buzzsprout.com Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487 Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc LinkedIn: https://www.linkedin.com/showcase/ahf-podcast YouTube: https://www.youtube.com/@anteriorhipfoundation Homepage: https://anteriorhipfoundation.com This 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 #AlexanderSah #SurgeonInnovator #MedicalDeviceDevelopment #ThinkSurgical #Ospitek #OrthopaedicInnovation #JointReplacement #HipAndKneeSurgery #AIinSurgery #FromIdeaToMarket #MedTech #SurgicalRobotics

From Idea to Market: Ep 9 - Inside the Decision Room

Send us Fan Mail [https://www.buzzsprout.com/2369508/fan_mail/new] What med tech investors and strategic acquirers actually evaluate when a founder walks into the room — and what separates the pitches that earn capital from those that don't. A conversation drawn from people who've sat on both sides of the table. For nine episodes, the From Idea to Market series has followed innovation from the founder's perspective — the problem noticed in a clinic, the iteration through years of prototypes, the regulatory climb, the manufacturing scale-up. Episode nine flips the lens. For the first time, the conversation moves into the room where decisions about that founder get made: by investors, by strategic acquirers, by the people whose capital and reputation come along with a yes. Joe Schwab is joined by voices who've lived this evaluation from every side. Charles Lawrie is a co-founder and chief medical officer at FIOS Health and the current president of the Anterior Hip Foundation. Charlie DeCook is the president of Total Joint Specialists and has watched dozens of Shark Tank pitches at AHF annual meetings. Alex Sah is past AHF president, chief medical officer at Think! Surgical, and chief innovation officer at Ospitek. Robert Cohen, vice president of innovation and technology for Stryker's orthopaedic group, has spent four decades evaluating med tech ideas from inside startups and from inside one of the largest companies in the field. The episode unpacks three questions: what truly drives the decisions made behind closed doors, how clinical value and financial logic and strategic interest actually intersect in real time, and which kinds of narrative survive due diligence — and which collapse the moment scrutiny begins. For surgeon-founders preparing to pitch, for clinicians thinking about their first innovation, and for anyone curious about how med tech capital actually gets allocated, this episode lays out what the decision room is really testing. ⏱️ Chapters: 00:00 Why this episode flips perspective from founder to investor 02:42 Surgeons and industry leaders inside the med tech decision room 04:46 What investors actually look for in a med tech pitch 08:23 How to structure a 15-minute med tech pitch 13:30 Where clinical value, profit, and strategy intersect 15:30 Why a great med tech idea can fail to scale 18:36 Why founders should pitch with a CEO at their side 22:02 How honest narrative wins under due diligence scrutiny 26:40 Stick to your competency: advice from a Stryker VP 29:12 What the decision room is really testing 31:43 Preview: when scaling success threatens to break the company Listen to the AHF Podcast on your preferred platform: Buzzsprout: https://ahfpodcast.buzzsprout.com [https://ahfpodcast.buzzsprout.com] Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487 [https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487] Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc [https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc] LinkedIn: https://www.linkedin.com/showcase/ahf-podcast [https://www.linkedin.com/showcase/ahf-podcast] YouTube: https://www.youtube.com/@anteriorhipfoundation [https://www.youtube.com/@anteriorhipfoundation] Homepage: https://anteriorhipfoundation.com [https://anteriorhipfoundation.com] This 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 #MedicalDevices #MedTechInvesting #OrthopedicSurgery #StartupPitch #VentureCapital #Stryker #SharkTank

FITM Extended Interview: Charles Lawrie (FIOS Health)

Send us Fan Mail [https://www.buzzsprout.com/2369508/fan_mail/new] Charles Lawrie, MD — president of the Anterior Hip Foundation and a high-volume anterior approach hip and robotic knee surgeon in Miami — walks us through how a frustration in his own clinic became FIOS Health, an AI-powered patient communication platform now used in orthopaedic practices across the United States. This is an extended From Idea to Market conversation about the often lonely process of turning a clinical observation into a commercialized med-tech product, and what surgeons should know before they try. Most surgeons see the same pattern every week: a flood of routine post-op questions about swelling, walking, showering, and driving that consumes clinic staff and amplifies patient anxiety. Lawrie's argument is that the bottleneck isn't surgical expertise — it's access to timely, trusted information, and that scaling that information is a fundamentally different problem than scaling clinical capacity. We get into why he chose an AI-first product layered on familiar SMS and WhatsApp instead of yet another app, how he found a complementary co-founder in engineer and serial entrepreneur Andrew McDaid, what he had to unlearn to translate clinical expertise into product-market fit, and where FIOS Health is heading next — from answering patient questions to acting as an intelligence layer for the entire clinic. If you're a surgeon thinking about innovation, this is a candid look at what it actually involves: starting with a problem you live every day, resisting the urge to build alone, defining a minimum viable product, and sitting with the daily self-doubt that comes with taking an idea to market. https://fioshealth.com/ ⏱️ Chapters: 00:00 Introducing Charles Lawrie and FIOS Health 01:14 Why patients struggle with information access after surgery 03:26 Solving staff scarcity and patient anxiety at the same time 05:43 Why AI plus SMS beats yet another patient app 08:53 Turning a clinical observation into a startup 13:07 The mahogany desk vision for patient care 18:21 Finding product market fit in a busy clinic 22:41 How FIOS becomes a surgeon's digital twin 26:50 Advice for surgeons who want to build a company 29:43 The intelligence layer for the entire clinic Listen to the AHF Podcast on your preferred platform: Buzzsprout: https://ahfpodcast.buzzsprout.com Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487 Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc LinkedIn: https://www.linkedin.com/showcase/ahf-podcast YouTube: https://www.youtube.com/@anteriorhipfoundation Homepage: https://anteriorhipfoundation.com This 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 #FIOSHealth #CharlesLawrie #FromIdeaToMarket #MedTechStartup #OrthopaedicInnovation #AIinHealthcare #PatientEngagement #HipArthroplasty #SurgeonEntrepreneur #DigitalHealth #ClinicalWorkflow

From Idea to Market: Ep 8 - Built to Run

Send us Fan Mail [https://www.buzzsprout.com/2369508/fan_mail/new] What does it actually take to move a medical device from a working prototype to a product that can be built reliably at volume? In this episode of From Idea to Market, surgeons, founders, and attorneys describe the discipline that separates an approved device from a scalable company. Most medical device teams underestimate what happens after a prototype works. Manufacturing at scale is a different problem from manufacturing at all, and the assumption that the hard work is done once the device is validated tends to be the most expensive miscalculation in med tech. This episode unpacks the transition from a hand-tuned engineering project to a controlled, reproducible production system, and why the process itself, not the device, becomes the real product. Jared Foran of Forcast Orthopedics, Leo Whiteside, Marie-Isabelle Batthyány of XRSynergies, Charles Lawrie of FIOS Health, Charlie DeCook of Total Joint Specialists, attorney Emily Ast, and Simon Mifsud of Garland Surgical share what they have learned from inside this transition. The conversation covers ISO 13485, design for manufacturability, supplier qualification, the economics of hardware versus software, supply chain design as part of the device itself, the kinds of problems that only surface at volume, and the contract clauses that quietly determine whether a successful product remains a fair deal once it scales globally. If you build, fund, regulate, or use medical devices, this episode is for you. It is the part of innovation that gets the least attention and decides the most outcomes — the daily, unglamorous work of building systems reliable enough that the product performs the same way every time, no matter who is in the room. ⏱️ Chapters: 00:00 Why scaling production breaks medical devices 02:57 Meet the founders, surgeons, and attorneys 05:30 What design freeze means in medical devices 06:46 Why the process becomes the product, not the device 09:32 Bringing manufacturing partners in before design freeze 12:18 The three-times rule of medical device development 15:59 Quality, cost, and scalability at production scale 18:02 Why hardware med tech is harder than software 20:18 Designing surgical kits for real-world supply chains 25:22 Problems that only emerge at production volume 28:11 Why founders should titrate the speed of scale 30:45 IP clauses and royalty timing for global products 34:58 What scale really proves about a medical device company Listen to the AHF Podcast on your preferred platform: Buzzsprout: https://ahfpodcast.buzzsprout.com Apple Podcasts: https://podcasts.apple.com/us/podcast/ahf-podcast/id1749521487 Spotify: https://open.spotify.com/show/5CrGJyvRiQFTCU3FFFVvHc LinkedIn: https://www.linkedin.com/showcase/ahf-podcast YouTube: https://www.youtube.com/@anteriorhipfoundation Homepage: https://anteriorhipfoundation.com This 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 #FromIdeaToMarket #MedTech #MedicalDeviceDevelopment #ISO13485 #DesignForManufacturability #DFM #QualityManagementSystem #MedTechScaling #OrthopedicInnovation #SurgicalInnovation #MedicalDeviceManufacturing #MedTechFounders