The Medtech Innovation Podcast copertina

The Medtech Innovation Podcast

The Medtech Innovation Podcast

Di: Spencer Jones
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A proposito di questo titolo

 Medtech Innovation Podcast: Spencer Jones dives deep into winning medtech startup strategies. Each episode unpacks hot takes and insider tactics from the trenches of medtech innovation. Join physician inventors, founders, engineers, and healthcare market makers as they share actionable insights to navigate the FDA, secure medtech funding, and drive medtech breakthroughs. No-nonsense advice to be a change maker in medtech.©️ 2024 XO Medtech Economia Gestione e leadership Leadership Ricerca del lavoro Successo personale
Episodi
  • She scaled her engineering team from 2 to 150 (steal her secrets)

    She scaled her engineering team from 2 to 150 (steal her secrets)
    Apr 21 2026
    I'm joined by Lindsay Crescenzo, R&D Director at Heraeus, as we explore how contract manufacturers are powering the electrophysiology boom, the strategic logic behind selective automation investments, and what it actually takes to build a high-performing engineering team from scratch.In this episode, we dive deep into:The DNA of Heraeus: Contract Manufacturing for EP→ Heraeus focuses exclusively on contract manufacturing and design support without developing competing products — from process development through commercialization→ Heavy investment in their Costa Rica facility for scaled catheter production, with a customer mix spanning large OEMs and strategic startups→ How they evaluate which programs to take on and the capabilities that make them worth the conversationWhy Large OEMs Send Programs Outside→ The three core reasons OEMs go external: keeping their internal pipeline moving, cost optimization, and launching programs they can't otherwise resource→ Contract manufacturers must be faster, bring space the OEM doesn't have, and match technical depth — or they don't add real value→ How Heraeus approaches large OEM relationships by forward-investing in automation and team capacity before the askClinical Immersion: Engineers in the Cath Lab→ Heraeus sends engineers to observe live procedures and interact directly with physicians — most engineers designing EP devices have never seen one used→ Understanding real physician workflow and patient need produces better device designers, full stop→ Clinical immersion closes the gap between engineering specs and what actually works at the tableAutomating Bottlenecks, Not Full Lines→ Heraeus targets only the constraint steps in manufacturing for automation — not attempting to automate entire production lines→ Investment focus: robotics and laser systems that serve multiple products across multiple customers→ The decision framework weighs labor cost, operator ergonomics, and margin improvement — not just what's technically possibleThe PFA Race and EP Catheter Innovation→ Electrophysiology is growing double-digit with every major customer running hard on Pulse Field Ablation→ Key engineering challenges: optimizing flex circuits, microelectronics, and high-voltage delivery in increasingly compact form factors→ Companies are merging capabilities into single catheters — space optimization is the defining engineering constraintReimbursement as a Design Input→ Reimbursement has to be in the room during design — not something you revisit after submission→ The real value driver isn't a better mousetrap for existing procedures — it's expanding which patients physicians can treat→ 40 million AFib patients worldwide. Only 6% are getting treatment. That's the actual opportunity.Hiring Philosophy: Filter First, Then Find Good People→ Lindsay's three non-negotiables: no arrogance, no selfishness, no drama — screen those out before anything else→ Hire before you win the program, not after — having the right people in place when the contract lands changes everything→ Building from 2 to 150 engineers required asking the right questions early and narrowing quickly to candidates who fit both sidesBest Quotes:"There are 40 million people in the world that need treatment and only 6% of them are getting treatment.""I don't like arrogance or selfishness or drama. I sort those out. Then you just look for the good people.""If you're not sure what programs are going to hit, having the people in place is going to make a huge difference rather than waiting until you win the program.""AI is going to significantly help us with engineering - not by reinventing things, but by helping us move faster."Want more insights on medtech innovation?Subscribe to the channel so you don't miss hot takes and insider tactics from the trenches of medtech startups.🤝 Join the #1 network for medtech innovators on the internet. Become a member to accelerate your journey, collaborate and build valuable ventures. Join for free using this link - https://xo-medtech.circle.so/XO-medtech-pricing-pageFind the perfect vendors for your medtech project for free at MedtechVendors - https://www.medtechvendors.com/📈 My FREE 5-day course for Medtech Innovators to create successful ventures: https://xomedtech.com/free-courseFIND SPENCER JONES ON SOCIALSpencer's LinkedIn — https://www.linkedin.com/in/medtech-innovation/XO Medtech LinkedIn — https://www.linkedin.com/company/xo-medtech/FIND LINDSAY CRESCENZO ON SOCIALLindsay's LinkedIn — https://www.linkedin.com/in/lindsay-crescenzo-mba-mdi-07797945/Heraeus Website — https://www.heraeus.com/Episode Timestamps:0:00 - Introduction to Lindsay Crescenzo and Heraeus2:54 - The DNA of Heraeus: Contract Manufacturing and Design Support3:34 - Transitioning from Medtronic OEM to Contract Manufacturing5:06 - Career Advice: Diversifying Skills Across Clinical Verticals9:10 - Clinical Immersion: Sending Engineers ...
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    46 min
  • Use This Former CEO's Sales Framework That Doubles Profitability

    Use This Former CEO's Sales Framework That Doubles Profitability
    Apr 7 2026
    I'm joined by Brian Carlisle, Managing Partner and Founder of Carlisle Strategic Partners, as we explore how to build predictable sales engines in medtech, manage distributor relationships like direct reps, and navigate the capital raising landscape without leaving money on the table.Building a Predictable Sales Engine: The Buying Process Mirror→ Brian deployed a customized sales methodology at Integra across a $500M+ division, doubling profitability at Permapure within two years using the same framework→ The core concept: map your customer's buying process first, then build your sales process to mirror each step with corresponding seller and customer action commitments→ Interview eight types of buying influences - from surgeons to supply chain heads - to understand how decisions actually get made→ The middle 60% of your sales team becomes dramatically more effective when they have a repeatable roadmap instead of relying on gut feelThe Independent Rep Playbook: Treating 1099s Like W-2s→ Most companies just send a contract and commission check to distributors - Brian calls this "extremely ineffective" after 18+ years as an operator→ Ride shotgun with your independent reps in their territory and ask "how can we help you win?" instead of beating them down on quotas→ Give distributors quotas, incentive plans, and recognition just like direct reps - most companies give indirects zero targets and get passive results→ Include independent reps on team calls and strategic planning - managed right, there's no reason they can't perform like a direct repSales Leadership: The Bi-Weekly Rhythm That Drives Results→ Brian held bi-weekly one-on-ones with every team member, spending an hour per person walking through their territory through a lens of "how can I help you?"→ The payoff: when it's the last day of the quarter and your rep is 20% over quota with a tee time, they'll still make that extra call because you built the relationship→ Avoid "shiny object syndrome" - make evolutionary changes annually and stop changing messaging every six weeks, which creates whiplash across the sales forceFrom Operator to Advisor: The Carlisle Strategic Partners Model→ Brian's combined buy-side M&A experience at Integra and Halma plus deep operator experience is what differentiates his advisory approach→ Built a proprietary commercial scoring tool for companies under $50M that would otherwise need McKinsey to assess their commercial readiness→ Firm rule: if someone doesn't add strategic value to the board, they shouldn't be on it - every cap table addition should bring more than a checkCapital Raising: Don't Lead With Your Valuation→ Never put a valuation on your ask slide - stating "we're raising $30M at a $50M pre" creates questions that cause investors to tune out the rest of the story→ Be crystal clear on three things: how much you need, the value creation plan, and the timeline to execution→ The capital environment is improving (2025 better than 2024, 2026 trending better) but expect longer timelines - diligence alone can take three monthsPitch Deck Mastery: Using AI to Refine Your Raise→ Brian's team uploads investor call recordings to AI tools that audit what went well and what needs improvement→ The pitch deck will never be "done" - accept that and constantly refine based on real investor feedback, not internal assumptions→ Most decks are 40 slides with too many words - get to the point and let the data speak for itselfBest Quotes:"If somebody doesn't add strategic value on the board, they shouldn't be on the board.""Your sales process should mirror your customer's buying process. When you institutionalize this, your middle 60% becomes as effective as your top 20%.""These aren't people that you just contract and send them a commission check and they're going to do what you need them to do. That's extremely ineffective.""The pitch deck will never be done. Just accept that. But if you can get the messaging right and let the data speak for itself, you can typically be successful."Want more insights on medtech innovation?Subscribe to the channel so you don't miss hot takes and insider tactics from the trenches of medtech startups.Find the perfect vendors for your medtech project for free at MedtechVendors - https://www.medtechvendors.com/FIND SPENCER JONES ON SOCIALSpencer's LinkedIn - https://www.linkedin.com/in/medtech-innovation/XO Medtech LinkedIn - https://www.linkedin.com/company/xo-medtech/FIND BRIAN CARLISLE ON SOCIALBrian Carlisle's LinkedIn - https://www.linkedin.com/in/brian-carlisleCarlisle Strategic Partners Website - https://carlislestrategic.comEpisode Timestamps:0:00 - Introduction to Brian Carlisle and Carlisle Strategic Partners1:24 - Brian's Career Journey: From Biomed Orthopedics to CEO4:33 - The Evolution From Sales Leader to C-Suite Operator8:32 - The Value of an MBA and Building a Mentor Network14:18 - Building a Predictable Sales Process That Mirrors the Buyer19:20 ...
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    1 ora e 16 min
  • His Reg-Tech Tool Automates Market Expansion For Medical Devices

    His Reg-Tech Tool Automates Market Expansion For Medical Devices
    Mar 17 2026
    I'm joined by Rhys Williams, CEO at Orchestrate, as we explore how AI-powered regulatory technology is breaking down the barriers to medtech commercialization and why the infrastructure gap — not the science — is what's really holding the industry back.The $50K Barrier Nobody Questions→ Medtech companies are told to budget $20,000-$50,000 minimum just for regulatory clarity — Rhys challenges this accepted cost as a solvable infrastructure problem, not a necessary expense→ The real cost isn't government fees — it's labor hours, quarterly billing cycles, and documentation overhead that compound into six-figure regulatory bills before a single submission is filed→ Companies that delay regulatory work until post-development discover expensive gaps in clinical data demographics that force costly retreats to data collectionWhy Paper-Based Systems Aren't Actually the Problem→ Regulatory affairs professionals don't love paper-based processes — they use them because they're robust, auditable, and proven to maintain safety standards across decades of use→ Intentional friction in the product development process serves a purpose — the goal isn't zero friction, it's eliminating the friction that doesn't serve safety or quality→ The real breakdown happens when formal processes force people out of their natural workflow, creating workarounds and local version deviations that actually undermine complianceOrchestrate: RegTech That Lives in Your Existing Tools→ Deep integration with Microsoft Office and Google Workspace means regulatory workflows live inside Word, Teams, and Google Docs — not another dedicated platform that requires a learning curve→ The platform analyzes existing certifications and documentation to show exactly what can be reused for new market expansion, generating 16+ page submission documents in clicks→ What would have taken hours of manual document prep can now be done in seconds by parsing, chunking, and reusing your existing regulatory documentationBuilding an AI-Native QMS from Scratch→ Rather than layering features onto legacy QMS platforms, Orchestrate reimagined quality management starting from document storage with change management and building up→ Automated workflows trigger change management, review, and approval processes the moment a document is modified — configurable per product, region, or company→ Dedicated auditor accounts with full immutable action logs solve the "what happens when the auditor arrives" anxiety that plagues every medtech teamThe RegTech Founder's "If Not Me, Then Who" Mindset→ Rhys's career thread from medical physics at UCL to prosthetics research to Meta advertising automation created a rare Venn diagram of health, computer science, and commercialization expertise→ Running a Pan-Africa disability innovation accelerator forced him to formalize what companies actually need to know to commercialize — building the philosophical foundation for Orchestrate→ While clinical trials and CROs receive heavy VC attention, regulatory infrastructure remains a greenfield opportunity that most builders have overlookedTeam Building When AI Changes the Rules→ The bottleneck has shifted from "can you build it" to "should you build it" — domain expertise and knowing what to build is now more valuable than raw engineering capacity→ AI coding assistants are like the most eager intern you've ever had — they'll move your button AND redesign your entire nav bar unless you maintain specificity and discipline→ Orchestrate is hiring regulatory affairs professionals before additional engineers, building the domain expertise feedback loop firstThe Banking Parallel That Predicts MedTech's Future→ UK banking went from three-to-five day paper-based money transfers to 30-second automated transactions — the same transformation is possible in medtech regulatory processes→ Legal frameworks around AI-augmented human judgment need to evolve first — once they do, Rhys predicts a "penny falls" cascade of rapid change across the industry→ AI-first notified bodies like Scarlett and semi-automated testing labs could compress biocompatibility report timelines from months to weeksBest Quotes:"I can build an innovative med product or I can accelerate all med products.""If not me, then who? Because someone's going to do it. Why not me?""Human judgment shouldn't be outsourced. We are a long way off that. But all of the steps in between — I think that's fair game.""Things like Claude Code, Lovable — they are amazing tools, but they are sometimes like the most eager intern that you've ever had on your team."Want more insights on medtech innovation?Subscribe to the channel so you don't miss hot takes and insider tactics from the trenches of medtech startups.🤝 Join the #1 network for medtech innovators on the internet. Become a member to accelerate your journey, collaborate and build valuable ventures. Join for free using this link.Find the ...
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    56 min
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