Episodios

  • 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 h y 16 m
  • 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 m
  • How To Make Your Material Selection An Unfair Advantage

    How To Make Your Material Selection An Unfair Advantage
    Mar 12 2026
    I'm joined by Lucas Pianegonda, Founder at Gradical, as we explore sustainable plastics in medtech, from the four forces driving change across a $340 billion industry to practical strategies for choosing better materials without sacrificing patient outcomes.The Four Forces Driving Sustainable Medtech→ 49 of the top 100 medtech companies have committed to climate targets through SBTI, representing $340 billion in turnover and 60% of the industry→ Customer demand is accelerating as hospitals focus on waste reduction, while GPOs like Premier create dedicated sustainability-focused solicitation categories→ Competitive FOMO compounds the pressure. Once one competitor launches a sustainable product, every company in that space starts their own 2-3 year development cycle→ European regulations including PPWR and the Green Deal are introducing mandatory eco-design requirements for medical devicesDevice Categories Moving Fastest→ Ophthalmology leads. Cataract surgery is the most prevalent on the planet at 30 million procedures annually, expected to double next decade→ Endoscopy advancing with Ambu as the poster child, embedding eco-design into corporate strategy→ Auto-injectors seeing a push from the GLP-1 revolution, alongside lab consumables and complex single-use devices like powered staplersSingle-Use vs. Multi-Use: Not Black and White→ The spectrum runs from syringes (always single-use) to CT scanners (always reusable). The question is where your device falls on that continuum→ Ambu's LCA research found 4 out of 5 studies showed single-use endoscopes had a lower environmental footprint than multi-use→ The more complex the device and the more rare earths involved, the more multi-use makes sense economically and environmentallyThe Hilti Model: Subscription-Based Medical Devices→ Lucas advocates device-as-a-service models that decouple physical production from revenue, comparing surgical staplers to power tools→ Medtronic's hybrid stapler pairs a durable reusable part with a sterile single-use consumable. Already on marketRemanufacturing: The Controversial Third Path→ German company Vanguard remanufactures single-use devices by gathering from hospitals, cleaning, testing, re-sterilizing, and reselling as their own legal manufacturer→ Vanguard gets sued roughly three times a year. The EU is moving toward a unified market for reprocessing single-use devicesNavigating the Sustainable Plastics Landscape→ The plastic pyramid ranks materials from polypropylene at the bottom to PEEK at the top. Goal: downgrade wherever possible since higher means higher cost and CO2→ Alternatives include mechanically recycled, chemically recycled, and bio-based drop-ins. Biodegradable plastics cause shelf life problems in 99% of medtech cases→ Lucas's favorite: polypropylene. Cheap, reliable, manufacturable, already offered in bio-based and chemically recycled variantsBest Quotes:"Sustainability has degraded into meaning just ecology. Real sustainability means something that can be carried on into the future without detriment.""If you can make it work with polypropylene, it should be polypropylene.""My competition has something on the market - I need to do that too. And you know it's going to take two or three years."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 LUCAS PIANEGONDA ON SOCIALLucas's LinkedIn - https://www.linkedin.com/in/lucas-r-pianegonda-81142b110Gradical Website - https://www.gradical.chDiscovery Call - https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradicalEpisode Timestamps:0:00 - Introduction to Lucas Pianegonda and Gradical8:29 - The Four Forces Driving Sustainable Medtech16:16 - Device Categories Moving Fastest19:27 - Single-Use vs. Multi-Use: The Real Tradeoffs30:34 - Remanufacturing and Vanguard's Model34:04 - Hybrid Devices and the Subscription Model41:24 - Sustainable Plastic Alternatives50:12 - Why Polypropylene Is the Most Underrated Plastic
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    46 m
  • She replaced her entire sales team with AI agents (and how you can too)

    She replaced her entire sales team with AI agents (and how you can too)
    Mar 10 2026
    I'm joined by Brett Jansen, Founder & CEO at HealthTech House, as we explore how AI is transforming go-to-market strategy for medtech startups, why the one-person growth team is becoming reality, and lessons from taking Butterfly Network's handheld ultrasound to market.From Gym Receptionist to MedTech Growth Leader→ Brett started as a facilities coordinator at Cerner's gym before executives recruited her into sales, launching a 16-year career across healthcare sales, strategy, and consulting→ After VP roles at Butterfly Network and CGO at Heartbeat Health, she walked away from W-2 employment entirely. AI gave her the tools to build two successful solo businesses→ She now hits over $100K per month without sending a single outbound message in 18 months, building entirely through LinkedIn content and inbound demandAI Turned One Person Into an Entire Commercial Team→ Brett uses AI to replace what would require a full marketing, copywriting, and social media team, delivering go-to-market services at a fraction of traditional agency costs→ Her core stack: Claude for deep work and decks, Granola for meeting transcription, GenSpark for rapid content. She built 16 pitch decks on a single flight to JP Morgan Health→ Claude Opus eliminated her need for a deck designer after it perfectly recreated slides from screenshotsButterfly Network: Cracking Go-to-Market for Handheld Ultrasound→ Butterfly was selling $2,000 probes direct-to-consumer when Brett came in to build a B2B enterprise sales motion from scratch→ The biggest unlock: selling in bulk to medical residency programs with 500-600 students graduating at any given time→ They productized software alongside the probe, creating named use-case programs with education, wraparound software, and Epic integrationWhy Adoption Kills More Deals Than Product Quality→ Butterfly's biggest enterprise barrier wasn't the tech. It was adoption. Hundreds of probes sent to ED physicians went unused→ The fix: wrap education into deployment itself, building clinical use case playbooks like FAST protocols for emergency departments→ The strongest sales rep was a former ultrasound tech doing show-and-tell in hospitals. Clinical credibility beat software sales experience every timeAI Literacy Is the New Competitive Moat→ Brett teaches the CRTO formula (Context, Role, Task, Output) as the foundation for any AI prompt→ Most companies wanting AI transformation can't define what good work looks like, meaning any AI deployment is doomed from the start→ Start with "how do I transform what Monday morning looks like" and identify specific bottlenecks before scalingThe AI Arbitrage Window Is Closing→ Sales reps who learn AI now will secure their jobs for the next 10 years. Those who don't get left behind→ Brett used Claude to role-play her speaking panel after Barbara Corcoran. By the time she arrived, she didn't need her note cardsBest Quotes:"Do I need to outsource this, or can I build this with AI? I'm delegating it out to my army of agents.""I used Claude to role play with me in the car on the drive down. By the time I got there, I didn't need my note cards. I was cool as a cucumber.""Those that get curious about AI and start creating their own ecosystem of how to do what they're really good at with AI, you're going to secure your job for the next 10 years."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 BRETT JANSEN ON SOCIALBrett Jansen's LinkedIn - https://www.linkedin.com/in/thebrettjansen/HealthTech House Website - https://www.healthtechhouse.comEpisode Timestamps:0:00 - Introduction to Brett Jansen and HealthTech House3:16 - From Gym Receptionist to Healthcare Sales Leader5:06 - How AI Enabled Two Solo Businesses Without a W-210:22 - One-Size-Fits-All AI Is a Trap25:04 - Butterfly Network: Building B2B From D2C31:52 - Adoption Is the Real Enterprise Sales Barrier42:00 - Career Advice: Using AI to Plan Your Next Move51:15 - The CRTO Formula for Effective AI Prompting53:00 - Top 3 AI Tools: Claude, Granola, GenSpark1:00:37 - Go-to-Market Cohort: 6-Week AI Growth Operating System
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    1 h y 1 m
  • Your Medtech Reimbursement Plan Needs Work (Steal Her Playbook)

    Your Medtech Reimbursement Plan Needs Work (Steal Her Playbook)
    Mar 3 2026

    I'm joined by Courtney Turich, Global VP of Sales and Marketing at Cooler Heads, as we explore how scalp cooling technology is transforming chemotherapy for cancer patients and the go-to-market challenges of selling devices outside the traditional surgical setting.

    From Stryker Sales to Shark Tank
    → Built her career at Stryker as one of few women in her division, then launched Monkey Mat and landed a deal with Mark Cuban and Lori Greiner on Shark Tank
    → The biggest lesson from Shark Tank: the hardest part of entrepreneurship is simply getting started

    The Mission Behind Cooler Heads
    → Mechanical cold caps circulate cold fluid to protect hair follicles from chemotherapy, adding 2-3 hours to treatment sessions across pre-cooling, infusion, and post-cooling phases
    → Courtney joined pre-commercialization to build the commercial strategy, helping treat their very first patient after FDA clearance

    The Reimbursement Journey: Category 3 to Category 1
    → Transitioned to Category 1 CPT codes in January 2026, shifting from patient-purchased caps to facility-dispensed disposables
    → Hired a VP of Market Access and engaged a third-party agency to push commercial payers to follow Medicare's lead

    Selling to Infusion Centers: A Different Playbook
    → The decision maker isn't the oncologist, it's often the cancer center director or lead infusion nurse, with 6-9 month sales cycles even at lower price points
    → Every facility has a different adoption process, making early identification of key decision makers critical

    Go-to-Market: Relationships First, Then Scale
    → Leveraged existing relationships to land UPMC, then expanded across their infusion centers while using private centers for faster early traction
    → Patient advocacy became a powerful growth driver, with patients switching facilities to access scalp cooling

    Best Quotes:

    "Titles mean nothing in the startup world. I really like that cowboy, cowgirl feel of a startup."

    "There's no perfect time. You've gotta just jump in and start selling. You could delay your launch over and over again, but you just gotta get that first sell."

    "Crawl, walk, run. It is imperative. Get out of the mindset of paralysis by analysis and just get going."

    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 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-course

    FIND SPENCER JONES ON SOCIAL
    Spencer's LinkedIn - https://www.linkedin.com/in/medtech-innovation/
    XO Medtech LinkedIn - https://www.linkedin.com/company/xo-medtech/

    FIND COURTNEY TURICH ON SOCIAL
    Courtney's LinkedIn - https://www.linkedin.com/in/courtneyturich1/
    Bold Moves, Confident Choices Podcast - YouTube
    Cooler Heads - https://www.coolerheads.com/

    Episode Timestamps:
    0:00 - Introduction to Courtney Turich and Cooler Heads
    1:12 - Career Journey from Stryker to Shark Tank
    3:05 - Startup Mentality and Wearing Multiple Hats
    3:24 - Skills That Transfer from Big Corp to Startups
    6:25 - How the Medtech Selling Environment Has Evolved
    10:11 - What Is Cooler Heads and How Scalp Cooling Works
    14:38 - Reimbursement Journey: Category 3 to Category 1
    18:47 - Market Access Strategy and Working with Payers
    30:52 - The Shark Tank Experience with Monkey Mat
    35:32 - Go-to-Market Strategy for Infusion Centers
    48:57 - What's Next: Series B and Scaling for Acquisition
    49:51 - Biggest Advice for Medtech Founders
    55:24 - Leadership, Empathy, and Being Bold
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    50 m
  • Surviving Near Death Experiences In Medtech

    Surviving Near Death Experiences In Medtech
    Feb 20 2026
    I'm joined by Dan Mazzucco, CEO & Founder of ZSX Medical and Principal at Third Eye Associates, as we explore how he's survived two decades of pivots, FDA battles, and near-death startup experiences building a better way to close surgical wounds - plus an unfiltered look at why women's health innovation is decades behind the rest of medtech.From ACL Tear to Medical Device Entrepreneur→ Dan's entire career trajectory changed after tearing his ACL playing ultimate frisbee in college - the idea that you could put a screw in someone's body became the spark for a two-decade medtech career→ Despite earning a doctorate in biomedical engineering, Dan doesn't draw energy from pure research - he's driven by getting things done and seeing real-world impact on manufacturing costs and patient care→ Working as a consultant at Exponent, he realized that knocking 3% off manufacturing costs excited him more than novel photon therapy researchFounding ZSX Medical During the Economic Meltdown→ Dan started ZSX Medical in late 2008 when his previous startup laid everyone off due to the financial crisis, giving him six months notice to figure out what's next→ He partnered with Eric Ruggart after meeting at networking events, recognizing they had a good team and a good problem even before having a viable technology→ The company has survived multiple near-death experiences that would have killed most startups - Dan will be sharing those lessons at a conference later this yearThe FDA Pivot That Changed Everything→ FDA told ZSX they'd need to follow 300 women through subsequent pregnancies to validate their C-section closure device - a clinical study costing tens of millions of dollars→ Rather than building half a bridge, they pivoted to hysterectomy closure after gynecologists consistently said it was a bigger unmet need→ Their product is an absorbable clothespin-like clip that approximates tissue without piercing it - letting the body heal naturally instead of causing suture-related ischemia and necrosisWhen Your Product Fails in the Lab (And What It Actually Means)→ During cadaver testing, tissue kept pulling out of their clips - a result that felt company-ending until they realized the cadaver tissue was degrading after repeated use, not a product failure→ Dan shares the story of Active Protective's CEO testing hip airbags that never deployed - a reminder that frustration and failure are the constant companions of device development→ The key mindset: unexpected results mean you learned something new - now apply that knowledge and move forwardManaging Small Teams When You Can't Pick Your All-Stars→ On small teams you can't just pick whoever you want - you figure out what each person does really well, what's a stretch, and what's completely out of their range→ Dan teaches biomedical engineering at Rowan University and uses extended trial periods through teaching and internships to evaluate talent before committing to a full-time hire→ His best hire came when his CTO overheard a junior student confidently holding her own with three PhDs on a conference call - she now runs their clinical studyThe Women's Health Innovation Gap Nobody Talks About→ The women's health ecosystem is almost diametrically opposed to orthopedics - no track record of successful products, no surgeon profitability, no investor appetite, and a history of disastrous products creating massive headwinds→ Hospitals treat obstetrics as a loss leader with fancy TVs in delivery rooms - not because they make money, but because mothers choose where the whole family goes for future care→ From the Dalcon Shield to pelvic meshes, women's health has a legacy of disasters that poisoned the well for every new innovator trying to raise capital or gain FDA trustBest Quotes:"Medical device development is all about frustration and failure. If you can't handle frustration and failure, you just need to do something else.""We're not trying to pierce the tissue. We're just trying to hold it next to the other tissue for two to three weeks. Let the body do the healing.""Don't chase the largest paycheck. Chase the most learning. The more knowledgeable you are, the more valuable you can be down the road.""My responsibility behind improving patient lives is caring for the employees entrusted to me."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 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 ...
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    48 m
  • How to get your device acquired before FDA clearance

    How to get your device acquired before FDA clearance
    Feb 12 2026
    I'm joined by Brad Shirley, Founder at DCMS Solutions, as we explore how he helped a physician-inventor's sports med device get acquired by Arthrex, the playbook for navigating strategic partnerships and IP deals, and why most early-stage medtech companies stall before they ever reach a strategic's radar.From Startup to Arthrex: The HolmesMed Acquisition Playbook→ How Brad helped Dr. Wendell Holmes take a sports med soft tissue repair device from stalled prototype to a completed deal with Arthrex in roughly two years→ Dr. Holmes had been getting the dreaded "this is really interesting Dr. Holmes, keep us posted, come back to us in three months" from strategics for years before Brad came on board→ The missing ingredient wasn't the technology - it was a development roadmap, a clear risk reduction strategy, and someone thinking about the project every single dayKnow Your Target: The Research That Closes Deals→ Before approaching any strategic, study their product portfolio gaps, expiring IP, recent acquisitions, balance sheet strength, and competitive positioning→ Brad specifically identified mid-market strategics (#4-6 players in the space) as ideal acquirers because they're hungry for differentiated products to move up the rankings→ Understanding where your technology fills a gap in their portfolio turns a cold pitch into a warm conversation about solving their problemR vs D: Why Strategics Want Development, Not Research→ The biggest mistake physician-inventors make is approaching strategics with a research project instead of a development-ready product with clear regulatory and manufacturing pathways→ Getting to "design freeze" is the critical inflection point that signals to acquirers your technology is real and de-risked enough to evaluate seriously→ Strategics aren't buying your idea - they're buying a shortened timeline to market with reduced technical and regulatory riskSlow Down to Speed Up: Iterating With Purpose→ Brad's philosophy of "slow down to speed up" means every design iteration has a specific purpose and defined outcome rather than open-ended tinkering→ Rushing prototypes without clear objectives wastes months and burns credibility with potential strategic partners watching your progress→ The HolmesMed team ran focused iteration cycles that each answered a specific question, dramatically accelerating their path to design freezeThe Fractional Talent Advantage in Early-Stage Medtech→ Post-COVID medtech layoffs created an incredible pool of experienced quality, regulatory, and R&D professionals available for fractional work→ Early-stage companies can now access senior talent for quality systems, regulatory strategy, and manufacturing engineering without full-time overhead→ Brad assembled a fractional team around Dr. Holmes that brought Fortune 500 medtech experience at a startup budgetPhysician Founders Need a Quarterback→ The single biggest gap for physician-inventors is having someone thinking about their project every day - a quarterback coordinating development, regulatory, IP, and deal strategy→ Most surgeon-inventors have full-time clinical practices and can't dedicate the sustained focus needed to drive a medtech product toward acquisition→ Brad's role at DCMS Solutions is exactly this: embedding with early-stage medtech teams as a fractional leader who drives the project forward dailyBest Quotes:"He was getting the dreaded, 'this is really interesting Dr. Holmes, keep us posted, come back to us in three months.' We all know those reactions and what they mean.""Know your target. If you're going to approach a strategic, you better understand their portfolio, their IP, their balance sheet, and where your technology fills a gap they can't fill themselves.""I think what most physician founders are missing is someone thinking about this project every single day. That's the quarterback role - someone coordinating all the pieces and driving it forward."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 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 BRAD SHIRLEY ON SOCIALBrad Shirley's LinkedIn - https://www.linkedin.com/in/bradshirley/DCMS Solutions Website - https://dcmsolutions.comEpisode Timestamps:0:00 - Introduction to Brad Shirley and DCMS Solutions2:02 - The HolmesMed Story: Dr. Wendell Holmes and His Sports Med Device3:40 - The ...
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    1 h
  • Use His Hardware Cheat Code

    Use His Hardware Cheat Code
    Jan 27 2026

    I'm joined by Serge Kadjo, Founder & CEO at Wearer Lab dba Productflo.io, as we explore how AI-powered design tools are revolutionizing hardware development and compressing the medtech innovation cycle.

    From African Robotics Dreams to Global Hardware Innovation
    → Serge's journey spans West Africa, military service, and multiple continents (Poland, China, Morocco, France) with exits in smart agriculture and deep tech, culminating in Product Flow's mission to democratize hardware development
    → His multidisciplinary background across IoT systems, BCI neurotechnology (partnered with CERN), and medtech sleep devices informs Product Flow's systems-thinking approach

    Haitch: The AI Design Engine Transforming Ideas Into CAD
    → Haitch converts text prompts or engineering drawings into parametric 3D CAD models in minutes, generating complete design briefs with DFM analysis, dimensions, and manufacturing constraints automatically
    → Real application: Serge took a client's screenshot, prompted Haitch to design sliding mechanisms, generated three options with exploded views, and produced manufacturable CAD files conversationally

    Product Flow: Breaking Down Engineering Silos
    → Consolidates mechanical files, PCBs, code repositories, and drawings into one version-controlled workspace, enabling 75-80% faster development through unified visibility
    → Generates dependency trees showing how functions, components, and tasks interconnect—critical for complex systems like drug delivery devices with mechanical, electrical, and software components

    The AI-Academia Application Gap
    → NVIDIA's ML simulation engines perform FEA 10x faster, yet medtech domain experts remain unaware these tools exist because researchers and practitioners occupy separate worlds
    → Transit/ship testing and EO residuals involve known variables that computational models could simulate, potentially compressing 3-month, $40K validation cycles into days

    Security and the Zero-Trust Framework
    → Never trust AI providers even when they claim not to train on your data—design systems assuming they might, especially since legal obligations require permanent data storage
    → Product Flow decoupled the AI engine from collaboration—teams use file sharing without AI, then selectively enable Haitch for generation tasks

    Why Hardware Takes 4 Years and $4M
    → Companies spend equal time on every phase instead of using AI to compress the middle 70% of grunt work, preserving human expertise for critical first 10% and final 20%
    → Tools like Haitch for rapid prototyping and computational validation could cut development timelines and costs by 50-60%

    Best Quotes:

    "Building hardware is more about design system thinking. Break products into functions, tools, and solutions—you're way more able to communicate and collaborate."

    "There's a barrier between AI research and real-world application. Folks with domain knowledge don't know how to apply ML. They're not even aware those models exist."

    "We're in a wonderful era. The limits are on your imagination. Lower expectations at first, but try it—you'll be surprised."

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    Connect:
    Serge: https://www.linkedin.com/in/swkkadjo/
    Product Flow: https://www.productflo.io
    Spencer: https://www.linkedin.com/in/spencer-jones-xo/

    Timestamps:
    0:00 - Serge's global innovation journey
    5:45 - Smart agriculture, BCI/TDCS ventures
    14:15 - Product Flow and Haitch introduction
    22:05 - Security and zero-trust framework
    28:45 - Haitch demo: engineering drawings to CAD
    36:20 - Product Flow: version control demo
    42:10 - AI-academia gap in medtech
    49:00 - Compressing timelines: 4 years to 18 months
    54:15 - Computational validation models
    1:00:25 - Final thoughts on imagination
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