His Reg-Tech Tool Automates Market Expansion For Medical Devices

His Secret To Keep Tech Debt From Killing Your Team

I'm joined by Ryan Schoonmaker, Founder & CEO at Tight Line Solutions, as we explore why growth-stage medtech teams burn out fixing past shortcuts, the two-roadmap discipline almost nobody actually runs, and how to lead engineering through five-alarm fires without breaking your team. In this episode, we dive deep into: Why "Tight Line" Is the Right Mental Model for Product Development → Ryan named the company after fly fishing — keeping the right line tension is the instinct great engineering leaders have → Too much tension snaps the team, too little and the program gets away → That nascent expectation level inside a team is rarely written down but drives everything Cutting Your Teeth at Helbling and Dexcom → Weekly client work at Helbling forced Ryan to communicate engineering decisions, not just make them → Dexcom G6 and G7 taught him that wearable medtech lives or dies on integration points between hardware, firmware, software, and human factors → "Killer questions" like battery size or PCB footprint can flip your entire architecture if you don't surface them early The Two-Roadmap Playbook Most Growth-Stage Medtech Misses → Run an iterative roadmap on the product just launched AND a separate technology roadmap five years out → Biggest misstep: putting unproven technology into V1 instead of shipping fast and learning from users → V1 should generate revenue, expose failure modes, and feed Gen 2 — trying to make V1 perfect kills companies The Stairstep Regulatory Strategy Sophisticated Founders Use → Get something cleared, then use it as your own predicate via special 510(k) or letter to file → While FDA reviews your initial submission, your team iterates Gen 2 in parallel → Ryan's seen this used to dodge a de novo pathway when one feature would have triggered it Don't System-Architect Yourself Out of Cost Reductions → Most teams assume they'll automate their way to better COGS later — a $750K assembly cell and a year of capex → A smarter Gen 2 with fewer components and a cleaner architecture beats automation alone → Design Gen 1 so cost-down doesn't require a complete redesign — that's the trap that kills margin Where Growth-Stage Companies Actually Break → Moving from low-cavity to high-cavity molds introduces variability that wrecks downstream bonding and welding → A 5% process difference when switching suppliers is enough to detonate a launch → Identify what's "new, unique, and difficult" upfront and characterize those subsystems deeply before scaling Tech Debt Is Real in Hardware → Hardware debt costs more to fix later than to implement now — exactly like financial debt accruing interest → Pay it down on a "payment plan" via your Gen 2 roadmap, not by ignoring it Best Quotes: "You want to keep the line tight. Too much tension is going to break. Too little tension, you're going to lose the fish." "The misstep that a lot of companies make is they try to put new technology in their products too early." "The key is to not system-architect yourself out of cost reductions." "Where are the gremlins hiding? Because they're always there. Let's go out and find them." 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 RYAN SCHOONMAKER ON SOCIAL Ryan's LinkedIn - https://www.linkedin.com/in/ryan-schoonmaker-59048411/ Ryan's Substack - https://substack.com/@ryanschoonmaker Tight Line Solutions Free Technical Risk Launch Scan - https://stan.store/ryanschoonmaker/p/free60-minutes Episode Timestamps: 0:00 - Intro and the "Tight Line" mental model 5:00 - Career roots: Helbling, Dexcom, and wearable integration points 11:00 - When to start designing Gen 2 (when you submit Gen 1 to FDA) 17:00 - The COGS trap and cost-reduction architecture 22:00 - Stairstep regulatory strategy and using yourself as your own predicate 29:00 - Why Ryan started Tight Line 32:00 - Growth-stage pitfalls: scale, suppliers, and hidden cliffs 46:00 - Technical debt in hardware and how interest accrues 58:00 - Leadership in a crisis: pulling teams out and driving clarity 1:00:00 - The joy of engineering and authentic leadership

She scaled her engineering team from 2 to 150 (steal her secrets)

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 conversation Why 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 ask Clinical 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 table Automating 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 possible The 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 constraint Reimbursement 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 sides Best 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-page 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 LINDSAY CRESCENZO ON SOCIAL Lindsay'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 Heraeus 2:54 - The DNA of Heraeus: Contract Manufacturing and Design Support 3:34 - Transitioning from Medtronic OEM to Contract Manufacturing 5:06 - Career Advice: Diversifying Skills Across Clinical Verticals 9:10 - Clinical Immersion: Sending Engineers into the Cath Lab 10:11 - Why Large OEMs Outsource Engineering and Manufacturing 16:06 - Connecting R&D Engineering with Sales and Marketing Teams 22:42 - Automating Bottlenecks, Not Full Lines 30:20 - Design Changes Between Clinical Trial Phases 33:41 - EP Catheter Innovation: Flex Circuits and Microelectronics 37:52 - Reimbursement as a Device Design Constraint 41:59 - AI Integration in Development and Manufacturing 48:40 - Hiring Philosophy: No Arrogance, Selfishness, or Drama 52:07 - Career Advice for Young Engineers

Use This Former CEO's Sales Framework That Doubles Profitability

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 feel The 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 rep Sales 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 force From 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 check Capital 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 months Pitch 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 itself Best 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 SOCIAL Spencer's LinkedIn - https://www.linkedin.com/in/medtech-innovation/ XO Medtech LinkedIn - https://www.linkedin.com/company/xo-medtech/ FIND BRIAN CARLISLE ON SOCIAL Brian Carlisle's LinkedIn - https://www.linkedin.com/in/brian-carlisle Carlisle Strategic Partners Website - https://carlislestrategic.com Episode Timestamps: 0:00 - Introduction to Brian Carlisle and Carlisle Strategic Partners 1:24 - Brian's Career Journey: From Biomed Orthopedics to CEO 4:33 - The Evolution From Sales Leader to C-Suite Operator 8:32 - The Value of an MBA and Building a Mentor Network 14:18 - Building a Predictable Sales Process That Mirrors the Buyer 19:20 - How to Map Customer Buying Processes Across Different Call Points 22:00 - Managing Independent Reps and Distributor Groups Effectively 27:56 - Sales Communication Cadence: The Bi-Weekly Rhythm 30:30 - Avoiding Shiny Object Syndrome in Sales Strategy 35:35 - Arming Your Sales Team With the Right Collateral 39:29 - Targeting and Account Focus for Early-Stage Companies 42:40 - Carlisle Strategic Partners: The Operator-Investor Advisory Model 46:46 - The Current Capital Markets Landscape for Medtech 56:46 - Capital Raising Strategy: Don't Lead With Valuation 1:11:34 - The Ask Slide: How to Present Your Raise 1:14:00 - Using AI to Refine Investor Pitch Decks

His Reg-Tech Tool Automates Market Expansion For Medical Devices

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 collection Why 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 compliance Orchestrate: 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 documentation Building 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 team The 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 overlooked Team 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 first The 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 weeks Best 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 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 RHYS WILLIAMS ON SOCIAL Rhys Williams's LinkedIn - https://linkedin.com/in/rhysjwilliams Orchestrate Website - https://orchestrate.management Episode Timestamps: 0:00 - Introduction to Rhys Williams and Orchestrate 1:16 - Rhys's journey from medical physics to medtech entrepreneurship 3:57 - Running a Pan-Africa disability innovation accelerator 6:30 - The elevator pitch: what Orchestrate does 8:03 - The $20-50K regulatory clarity problem nobody questions 10:37 - Why paper-based systems persist and why some friction is good 14:12 - Live demo: Orchestrate's regulatory expansion tool 19:46 - The AI-native QMS reveal 24:45 - Meeting users where they are with deep tool integrations 29:48 - The RegTech founder mindset and greenfield opportunity 37:24 - Building teams in the AI agent era 42:07 - The eager intern problem with AI coding tools 47:10 - Regulatory future: AI notified bodies and the banking parallel 55:04 - Hiring for mindset not generation 59:36 - Orchestrate's roadmap: localization partnerships and value chain expansion

How To Make Your Material Selection An Unfair Advantage

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 devices Device 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 staplers Single-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 environmentally The 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 market Remanufacturing: 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 devices Navigating 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 variants Best 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-page 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 LUCAS PIANEGONDA ON SOCIAL Lucas's LinkedIn - https://www.linkedin.com/in/lucas-r-pianegonda-81142b110 Gradical Website - https://www.gradical.ch Discovery Call - https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical Episode Timestamps: 0:00 - Introduction to Lucas Pianegonda and Gradical 8:29 - The Four Forces Driving Sustainable Medtech 16:16 - Device Categories Moving Fastest 19:27 - Single-Use vs. Multi-Use: The Real Tradeoffs 30:34 - Remanufacturing and Vanguard's Model 34:04 - Hybrid Devices and the Subscription Model 41:24 - Sustainable Plastic Alternatives 50:12 - Why Polypropylene Is the Most Underrated Plastic