Episodes

  • Medtech Investor Secrets

    Medtech Investor Secrets
    Jan 8 2026
    I'm joined by Monica Vajani, Executive Director of the MedTech Accelerator at mHUB, as we explore the broken early-stage funding model, the evolution of value-based care's impact on medical device purchasing, and why Chicago is becoming a powerhouse for hard tech innovation.Living Through the Value-Based Care Revolution→ Monica witnessed firsthand the transition from physician-driven purchasing decisions to complex value analysis committees requiring clinical evidence and cost justification→ The fundamental disconnect: hospitals take on financial risk through value-based care models, but medical device companies still sell based on static clinical trial data from months or years ago→ Value analysis committees are overwhelmed, making decisions without real-time outcomes tracking, leading them to focus on simple cost reduction rather than innovative solutions that truly improve patient outcomesThe Brutal Truth About MedTech Funding Today→ The early-stage funding model is broken - companies need realistic ballpark figures like pharma's 4% success rate metrics to understand their actual chances of reaching market→ If you're developing a Class III neurology device requiring a 50-patient safety and efficacy trial, you're looking at approximately $30 million in capital needs that most founders drastically underestimate→ The funding environment has hollowed out: angels aren't stepping in like before, VCs are moving later stage, and 80% of the market is fighting for 40% of available capitalWhy Fractional Expertise Beats Full-Time Hires Early→ Hiring one or two full-time people with four to five airtight fractional consultants in regulatory and commercial is a better model than three full-time employees with narrow experience→ Companies waste equity on multi-year relationships with full-time COOs who may not work out, when fractional experts with proven playbooks can deliver quick wins→ The marketplace for fractional talent exists because companies are in analysis paralysis and aren't willing to commit full-time, but need specific expertise immediatelyThe Insurance Company Reality No One Wants to Face→ Hospital margins are squeezed, device reimbursement is flat or declining, but insurance companies keep growing revenues - something has to give at this tipping point→ The average person stays on an insurance plan for just 2.5 years, creating perverse incentives where payers optimize for short-term metrics rather than long-term patient outcomes→ The explosion in hospital administrative staff directly correlates with healthcare spending as a percent of GDP, with most growth stemming from prior authorization requirements that should be eliminated for 50-60% of care itemsChicago's Secret Weapon for Hard Tech Innovation→ mHUB has created over 7,000 jobs and their 700+ companies have generated over $2 billion in revenue while raising nearly $2 billion in capital - these are not small numbers→ The Illinois state government will match any venture dollars raised, and the ecosystem from universities to medical systems to high net worth individuals actually plays nice together→ Unlike coastal hubs, Chicago offers a "get shit done" environment where the right connections are just a phone call away, with 80,000 square feet of prototyping facilities and labs at mHUBWhat Accelerators Get Wrong (And Right)→ Too many accelerators are self-serving pitch practice sessions rather than investing actual capital and meeting entrepreneurs where they are with specific expert introductions→ mHUB's model: invest in companies, then reduce time to find the exact regulatory, reimbursement, and commercialization experts needed rather than overwhelming founders with generic networking→ The hyper-focus on demo days and events without high-commitment, high-performance environments fails to develop entrepreneurs who need targeted help, not generic playbooksThe Prior Authorization Solution That Will Never Happen→ A bilateral disarmament where 50-60% of care items are exempted from prior authorization requirements would simultaneously reduce hospital administrative costs and insurance company processing burdens→ United Healthcare is currently 180 days out on processing claims - eliminating unnecessary prior auth would speed payments and ease the cash crunch on hospitals→ Instead of rational policy reform, we're heading toward an AI hellscape where agentic systems appeal to each other endlessly while both sides maintain bloated administrative layersBest Quotes:"There's so many companies out there developing net new solutions. At some point, we're not going to be walking around with 70 devices on our bodies.""Being an entrepreneur does not mean you have to take a company, raise funding, and do all that. Only a few people know how to do that, and even those people need luck.""The biggest mistake in MedTech is thinking you can throw out a bunch of activity, but if you're not really driving towards outcomes, you ...
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    42 mins
  • Why Orthopedic Giants are Resisting Patient Specific Implants

    Why Orthopedic Giants are Resisting Patient Specific Implants
    Oct 14 2025
    I'm joined by Jonathan Swill, Principal Consultant at Surgical Excellence Partners, as we explore the future of patient-specific implants in orthopedics, why 20% of knee replacement patients remain unsatisfied, and how personalized medicine combined with robotics and AI will transform musculoskeletal surgery.In this episode, we dive deep into:The Patient-Specific Implant Revolution in Orthopedics → Why orthopedics is the "last bastion" to adopt patient-specific approaches while cranial maxillofacial surgery has made it the gold standard → How automated surgical planning software is reducing design time from weeks to days by cutting engineer-surgeon iteration cycles → The critical integration gap: precise robotic placement means nothing without the perfect implant design to matchFrom Research to Commercialization: The HSS Experience → How exposure to both implant failures and custom department successes at Hospital for Special Surgery sparked the patient-specific vision → Point of care labs enable hospitals to commercialize solutions internally and democratize patient-specific technologies → Physical proximity to clinical problems allows research hospitals to move from issue identification to solution faster than anyoneThe 20% Problem: Why Off-the-Shelf Implants Fall Short → One in five total knee replacement patients worldwide report dissatisfaction with outcomes—that's over 500,000 people annually → Mechanical alignment taught surgeons to align everyone to 7 degrees regardless of patient size, anatomy, or natural joint position → Kinematic alignment restores patient's natural body position but still uses off-the-shelf parts with non-native geometriesAdoption Barriers: Why Perfect Technology Doesn't Guarantee Market Success → Large orthopedic companies have hundreds of billions in off-the-shelf inventory that would become obsolete with widespread patient-specific adoption → Entrenched sales forces with long-standing contracts and massive influence create structural resistance to innovation → Surgeon education is harder than regulatory approval—you must prove improved outcomes, OR time savings, and cost reduction simultaneouslyKinematic vs Mechanical Alignment: The Paradigm Shift → Mechanical alignment was the legacy standard because off-the-shelf implants were the only option available → Kinematic alignment restores patient's natural anatomy and ligament positions but still lacks truly patient-specific geometries → Even leaders like Restore3D still focus on mechanical alignment with patient-specific implants—massive opportunity remains for kinematic integrationAI-Powered Surgical Planning: From Support Tool to Decision Partner → Current AI automates repetitive tasks like landmark identification and implant templating but remains basic and task-based → Next five years will see AI become predictive—forecasting post-op outcomes from intraoperative imaging at 6, 12, 18, 24 month intervals → AI will enable true kinematic alignment at scale by analyzing patient-specific anatomy and predicting optimal restoration positionsLead Qualification Over Volume: The Startup Survival Strategy → 90% of surgeons use one specific product and will die using it regardless of 3x cost savings from alternatives → Cutting 10 poor-fit prospects to focus on 10 qualified leads yields more customers faster than broadly targeting 30-40 big names → First sale cracks the ice—learn what worked, replicate the pattern, and qualify future leads against that success profileAdvice for Medtech Innovators: Become a Multi-Tool Athlete → Choose startups over big companies early in career—wear multiple hats, learn faster, become more valuable to future employers → Don't silo yourself into one specialty—COVID hiring freezes taught the value of broader medtech product development skills → Being really good at 4-5 different disciplines makes you "glue guy" who translates across teams—more valuable than being best at one thingBest Quotes:"Why wouldn't you want to be Shohei Otani? Why wouldn't you want to be him?""If 20%, if only 80% of our patients worldwide are satisfied and in no more pain with their knee replacement, that's still 20% of people. At two to three million knee replacements a year, that is over 500,000 people that are unsatisfied.""We need to not accept what's good enough. We need to accept perfection. We need to expect perfection because we see surgeons as these amazing geniuses that they are. But I think the tools that we're giving them are not allowing them to be perfect.""Orthopedics is the last bastion to really take it on in terms of patient-specific work because cranial maxillofacial—that's what they do. That is the gold standard and that's how it's taken.""You can make the best product in the world, but if they don't understand the value of your product and how it improves patient outcomes or how it improves surgeries, then it's not going...
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    1 hr and 15 mins
  • 3 AI cheat codes to launch and scale your medical device

    3 AI cheat codes to launch and scale your medical device
    Oct 7 2025
    I'm joined by Jelani Abdus-Salaam, Founder at Best of AI, as we explore how AI can transform medtech operations, the critical distinction between AI automation and AI agents, and practical strategies for adopting AI without massive organizational overhauls.In this episode, we dive deep into:AI Literacy Gap Creates Massive Medtech Opportunity → Medtech is perfectly suited for AI with rules-based QMS, defined regulatory standards, and structured clinical data—yet AI literacy remains surprisingly low → Companies that bought specialized AI solutions from domain experts succeeded 67% of the time, while internal enterprise initiatives failed at 95% → The paradox: medtech professionals excel at clinical work but lack exposure to AI, creating adoption barriers despite clear benefitsAI Agents vs AI Automation: The Game-Changing Distinction → Automations follow sequential steps while AI agents use reasoning and context to decide their own path to accomplish goals → AI agents can pull from multiple knowledge sources and adapt their approach based on the situation → Critical factor: AI is "really dumb" until you codify your processes—you must understand your business systems before deploying agentsThe Chief of AI Role Is Now Essential → Every medtech company will soon need a dedicated AI officer who touches sales, marketing, and operations as the central nexus → Don't need full developers—someone who can use cursor, Claude, and orchestration tools to build and test solutions internally → Junior AI people trained by experienced practitioners can be incredibly effective when paired with enterprise-level leadershipSpecialized Small Models Outperform Everything Apps → Specialized small language models working as agentic teams outperform single large models for complex tasks → Building your own small LLM specialized in one niche delivers better performance than ingesting documentation into ChatGPT → Open source models will prevail long-term for medtech—create custom models for specific processesThe Human-in-the-Loop Mandate for Healthcare → Humans must remain in the loop for quality assurance, especially in healthcare where hallucinations can be catastrophic → AGI isn't coming for 10-20 years—companies that fired hundreds expecting AI replacement had to rehire when systems failed → Build approval checkpoints where humans review and either approve or send AI agents back for refinementStart With Custom GPTs, Not Enterprise Overhauls → Pick ChatGPT or Claude, list manual tasks you do repeatedly, and create custom GPTs that codify how you do those things → One founder automated SOP creation that took 20-30 minutes—now saves hours weekly compounding over dozens of tasks → Turn off data tracking settings if concerned about HIPAA complianceBest Quotes:"AI is really dumb. It's up to you, the person, the operator, the orchestrator, to understand what you want to happen for AI to follow what you want to happen.""You will have individual departments. You will have the ability for AI agents to take information, pass that information into other teams or departments. That's already happening now.""Even if you don't use AI in your business, you do need to know its capabilities because it can be used against you. Voice duplication is so easy. Deepfakes are getting so good. You need awareness.""There's more and more people who understand the value of having a specialized AI person. Some people are calling this AI Chief Officer. All they do is learn AI, deploy AI, learn AI, deploy AI."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 SOCIAL Spencer's LinkedIn - https://www.linkedin.com/in/medtech-innovation/ XO Medtech LinkedIn - https://www.linkedin.com/company/xo-medtech/FIND JELANI ABDUS-SALAAM ON SOCIAL Jelani on X/Twitter - https://twitter.com/JelaniFuel Jelani on Instagram - @JelaniFuel Scale With Agents - https://www.scalewithagents.com/ Episode Timestamps: 0:00 - Introduction to Jelani and his journey to medtech AI 5:00 - The medtech AI adoption paradox 10:00 - AI agents vs automation distinction 20:00 - Why medtech needs Chief of AI officers 27:00 - Specialized models vs everything apps 35:00 - Prompt engineering strategies 47:00 - Agent-to-agent healthcare ethics 57:00 - Simulation departments becoming mandatory 1:07:00 - Starting with custom GPTs 1:11:00 - Building data-first company culture
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    1 hr and 3 mins
  • His secret to bypassing the broken venture capital model

    His secret to bypassing the broken venture capital model
    Sep 25 2025
    I'm joined by Jeff June, MedTech Founder and Ecosystem Builder, as we explore the broken venture capital model in healthcare, why accelerator programs are failing early-stage companies, and his battle-tested strategies for building successful MedTech ventures through strategic partnerships and ecosystem development.In this episode, we dive deep into:The Funding Crisis Reality Check→ Why venture capital has transformed into private equity, abandoning true early-stage companies→ How founders are achieving FDA clearance and $500K revenue without raising venture capital→ The massive disconnect between what VCs fund versus what MedTech innovation actually needsThe Accelerator Industrial Complex Problem→ Why sponsor-driven programs select companies through the lens of corporate partners, not innovation merit→ How success metrics focused on "total funding raised" create perverse incentives that harm true innovators→ The power of micro-accelerators and peer learning over brand-name program marketingTechnical Founders Are More Capable Than They Think→ Why being told to "find an experienced CEO" is the worst advice technical founders receive→ How clinical founders should lead with their expertise story, not generic market-size slides→ The critical difference between selling yourself first versus selling your technologyThe Clinical-to-Consumer Healthcare Revolution→ How patient education and responsibility can solve healthcare's innovation adoption crisis→ Why great clinical innovations fail when they don't fit reimbursement models→ The untapped opportunity for consumer health technologies with clinical validationIschemia Care: A $15M Success Story→ How Jeff's stroke diagnostics company accomplished what others needed $120M to achieve→ Building ecosystems of clinicians, hospitals, payers, and strategics for maximum leverage→ The first blood test for stroke and lessons from commercializing breakthrough diagnosticsStrategic Partnership Acquisition Playbook→ Why M&A timelines have stretched to 12+ years and average deal sizes tripled→ How to build relationships with division presidents who have P&L responsibility, not BD departments→ The "we can do what you'll never be able to do" positioning that unlocks strategic partnershipsReimbursement Reality: The Two-Year Patient Turnover Truth→ Why payers optimize for getting patients off their rolls within two years→ How to speak the specific language of individual payers versus generic "healthcare system" messaging→ The critical distinction between clinical evidence for FDA versus clinical evidence for adoptionEcosystem Building Over Individual Excellence→ Creating comprehensive support networks that enable ventures to achieve more with less capital→ Why fractional experts who truly integrate with your team outperform expensive full-time hires→ Building relationships that become competitive moats in highly specialized healthcare marketsBest Quotes:"You are not an AI enabled solution. Stop it. Stop putting that as the first words describing your company.""There is no such thing as a healthcare system. Every hospital is individualized, they work with different payers. You are not saving 'the healthcare system' money.""The best people you will work with want to knock you out right away. They want to know what you know and you've got to lead them.""You're far more capable than you think you are. Trust your instincts more. You know more than you think you do."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. Join for free using this link.Find vendors at MedtechVendors - https://www.medtechvendors.com/📈 FREE 5-day course: 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 JEFF JUNE ON SOCIALJeff's LinkedIn Profile- https://www.linkedin.com/in/jeffjune/Ischemia Care - https://www.ischemiacare.com/ Episode Timestamps:0:00 - Introduction to Jeff June's three-decade MedTech journey5:00 - Why the venture capital model is broken for early-stage MedTech15:00 - Technical founders are more capable than they're told22:00 - The accelerator industrial complex diagnosis35:00 - Clinical-to-consumer healthcare transformation45:00 - What MedTech innovators consistently overlook55:00 - Building ecosystem partnerships over individual excellence65:00 - Reimbursement reality and payer psychology75:00 - Strategic M&A relationship building playbook
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    1 hr and 30 mins
  • He got fired and built an automation empire

    He got fired and built an automation empire
    Jul 23 2025
    I'm joined by Aaron Moncur, Founder and President at Pipeline Design & Engineering, as we explore his unique approach to building an engineering empire centered on promoting joy in team members' lives, innovative automation solutions, and creating community-driven platforms that are revolutionizing how engineers collaborate and learn.In this episode, we dive deep into:From Near-Death Surfing to Engineering Excellence → How a life-threatening surfing experience at Diamond Head shaped Aaron's resilience and company philosophy → Why Pipeline got its name from Banzai Pipeline (not oil pipelines) as inspiration for engineering excellence → The journey from Hawaii to Arizona and building a culture-first engineering services companyRevolutionary Company Culture Philosophy → Why "treat customers well, but treat team members better" drives superior engineering outcomes → How daily huddles, weekly launchpads, and core value nominations create authentic engagement → The 10-week sprint story that proves culture translates to tangible business resultsGoverned by Productivity, Not Bureaucracy → Why engineers purchase without approval processes and how trust accelerates project delivery → The guiding principles approach that empowers decision-making over rigid rule-following → How small teams of 10-15 maintain quality without drowning in processAI Integration That Actually Works → Using ChatGPT to transform meeting transcripts into winning project summaries → Why customers say "you guys actually listened" when AI helps capture requirements perfectly → Team adoption strategies that prioritize productivity over mandatesThe Engineering Empire Ecosystem → CAD Club's mission to prevent violence by teaching life skills through engineering mentorship → The Being an Engineer podcast reaching 300+ episodes with industry legends like SolidWorks founders → The Wave platform creating mentorship connections and design accelerators for engineersEasy Motion: The Game-Changing Innovation → How no-code visual programming eliminates the controls engineer bottleneck → Reducing 30-40 hour programming tasks to 20 minutes with drag-and-drop automation → Why mechanical engineers can now create sophisticated automated sequences without codingPDX: The Ultimate Hardware Training Bootcamp → October 21-22 intensive featuring 30+ industry experts in custom manufacturing → Office hours concept providing live consulting on real engineering problems → Why small teams with multi-disciplinary talent can develop artificial hearts in under a yearBest Quotes: "What makes a kid so angry that he's willing to harm one of his peers? CAD Club is really about helping kids understand what healthy adult behavior looks like.""The best way to treat your customers well is to make sure your team is really happy doing what they're doing. Would you rather have an engineer just showing up for a paycheck or one finding joy in their work?""We don't have any formal approval process for purchasing. When an engineer needs something, they buy it. We've been operating for 15 years and it's never been a problem."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. Join for free using this link - https://tinyurl.com/xo-medtech-free-tier Find vendors at MedtechVendors - https://www.medtechvendors.com/📈 FREE 5-day course: https://xomedtech.com/free-courseFIND 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 AARON MONCUR ON SOCIAL Aaron's LinkedIn Profile - https://www.linkedin.com/in/pipelinedesign/Pipeline Design & Engineering Website - https://www.linkedin.com/company/pipelinedesign/The Wave Platform - https://www.thewave.engineer/PDX Event - https://www.thewave.engineer/product-development-expo/pdx-2025/Episode Timestamps: 0:00 - Introduction and surfing story from Hawaii 12:00 - Custom automation and fixture examples 18:00 - Culture philosophy: joy as highest purpose 28:00 - Productivity over bureaucracy approach 36:00 - Communication skills for engineers 44:00 - The engineering empire ecosystem 52:00 - Easy Motion no-code automation platform 58:00 - AI integration and future tools
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    1 hr and 24 mins
  • How to scale your platform technology

    How to scale your platform technology
    Jul 9 2025

    I'm joined by Ross Peterson, Chief Business Development Officer at ProPlate, as we explore the specialized world of metallization and electroplating for medical devices, from life-saving pediatric applications to cutting-edge energy delivery systems.
    In this episode, we dive deep into:

    The Science of Medical Device Metallization
    → How electroplating adds metal microinches at a time using electrical current and metal ion chemistry
    → Why vacuum deposition is required to metalize non-conductive polymers like balloon catheters
    → The four primary applications: stimulation, ablation, sensing, mapping, and radio opacity

    Rare Earth Magnet Plating Mastery
    → How ProPlate became the only company in North America capable of electroplating neodymium magnets
    → Why these strongest commercially available magnets corrode in open air and are extremely toxic unprotected
    → The supply chain implications of China's dominance in rare earth materials

    Life-Saving Pediatric Innovation
    → The heartwarming story of plating magnets for UCSF Berkeley's esophageal atresia treatment device
    → How magnetic anastomosis creates a non-invasive solution for babies born with disconnected esophagus
    → Why receiving a Christmas photo from a healthy patient family became the ultimate reward

    Next-Generation Electrode Technology
    → How replacing thick platinum iridium with stainless steel and selective precious metal plating cuts costs 50%+
    → The game-changing potential for PFA devices using 20-30 electrodes per device
    → Why traditional marker band methods fail on miniaturized, flexible stents

    Advanced Manufacturing Capabilities
    → The shift from wet chemistry to PVD processes for superior polymer compatibility
    → How batch processing beats one-by-one crimping for complex geometries
    → Creating marker bands under 2 French with wall thicknesses under 1 mil

    Best Quotes:
    "One in 3,000 babies are born with esophageal atresia. If anything, this is something that we should be working on."

    "The first few batches came out with no magnets left. They disintegrated, they were rusted."

    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. Join for free using this link: https://tinyurl.com/xo-medtech-free-tier

    Find vendors at MedtechVendors - https://www.medtechvendors.com/
    📈 FREE 5-day course: 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 ROSS PETERSON ON SOCIAL
    Ross's LinkedIn - https://www.linkedin.com/in/ross-peterson-proplatetech/
    ProPlate Website - https://www.proplate.com/

    Episode Timestamps:
    0:00 - Introduction to Ross Peterson and ProPlate
    5:00 - Electroplating explained for fourth graders
    12:00 - Rare earth magnet challenges and supply chain
    18:00 - Life-saving pediatric esophageal atresia project
    25:00 - Working with startups vs large strategics
    30:00 - Future opportunities in electrode technology
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    35 mins
  • How to develop a medical device

    How to develop a medical device
    Jul 2 2025
    I'm joined by Jeremy Ridley, Senior Director of Engineering at Delve, as we explore how the best engineers design and develop complex medtech innovations, from managing regulatory constraints to building breakthrough products that actually make it to market.The Hidden Reality of Medtech Engineering Leadership→ Most engineering leaders underestimate the time required for regulatory alignment - Jeremy reveals it should be happening from day one, not after product development→ The biggest career mistake engineers make is staying in their technical comfort zone instead of developing business acumen and market understanding→ Successful medtech engineers must become "translators" between technical teams, regulatory bodies, and business stakeholders - it's a skill that separates leaders from individual contributorsWhy Traditional Product Development Fails in Medtech→ The waterfall approach that works in other industries creates dangerous blind spots in medtech where regulatory changes can kill projects overnight→ Jeremy's contrarian take: spend more time in the problem definition phase rather than rushing to solutions - most failed medtech products solve the wrong problem elegantly→ User research in healthcare requires a completely different approach than consumer products - you're often designing for three users: patients, clinicians, and administratorsThe Regulatory Reality Check Every Founder Needs→ FDA conversations should start 18-24 months before you think you need them - waiting until you have a "complete" product is a recipe for expensive pivots→ The Pre-Submission process is your secret weapon for getting regulatory clarity early, but most startups use it wrong by asking vague questions→ Quality systems aren't just compliance checkboxes - they're competitive advantages that enable faster iteration and better products when implemented correctlyEngineering Team Building Secrets for Medtech Startups→ The ideal early engineering hire isn't the most senior person available - it's someone who's navigated 0-to-1 product development in regulated industries→ Cross-functional collaboration skills matter more than pure technical depth because medtech requires constant coordination between engineering, regulatory, clinical, and business teams→ Remote engineering teams can work in medtech, but you need different processes for documentation and knowledge transfer due to regulatory requirementsThe Economics of Medtech Engineering Decisions→ Design for manufacturability from day one - Jeremy reveals that manufacturing constraints kill more medtech products than technical feasibility issues→ The "good enough" philosophy from software doesn't apply to medtech where incremental improvements can mean life or death for patients→ Budget 30-40% more time and resources for testing and validation than you would for non-medical devices - this isn't optional padding, it's realityNavigating the Innovation vs. Regulation Tension→ The most successful medtech companies treat regulatory strategy as a product feature, not a barrier - it becomes part of their competitive moat→ Innovation happens within constraints, not despite them - Jeremy's teams use regulatory requirements as design inspiration rather than limitations→ The biggest breakthrough opportunities exist where regulation is evolving - AI/ML in medical devices is the current frontier with massive potentialFuture-Proofing Your Medtech Engineering Career→ Learn to speak the language of business outcomes, not just technical specifications - your ability to connect engineering decisions to patient outcomes and revenue determines your ceiling→ Develop expertise in emerging areas like digital therapeutics, AI-enabled devices, and remote monitoring - these are where the growth opportunities will be→ Build relationships across the entire medtech ecosystem including regulatory consultants, clinical partners, and manufacturing specialists - your network is your net worth in this industryBest Quotes:"Most engineers think about regulatory as this thing that happens at the end. But if you're not thinking about it from day one, you're setting yourself up for failure. The FDA isn't your enemy - they're actually trying to help you build better products.""The biggest mistake I see engineering leaders make is staying in their comfort zone. You can't just be a great engineer anymore. You need to understand the business, understand the market, understand the regulatory landscape.""Quality systems aren't overhead - they're actually your competitive advantage. When you have robust processes, you can iterate faster, you can scale better, and you can respond to regulatory feedback more quickly.""Innovation doesn't happen despite constraints - it happens because of constraints. Some of our best product decisions have come from regulatory requirements that forced us to think differently."Want more insights on medtech innovation? Subscribe to the channel so ...
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    49 mins
  • How to save money on patents

    How to save money on patents
    Jun 24 2025
    I'm joined by John Behles, Owner at Lexigent LLC and Founder & GP at PhiCAP Fund, as we explore the critical role of intellectual property strategy in medtech success, common IP pitfalls that destroy startup valuations, and how physician-led venture capital is reshaping healthcare investing.In this episode, we dive deep into:The IP Strategy Foundation → Why doing your own prior art research makes you a more sophisticated founder → The critical difference between landscape opinions, FTO studies, and patentability searches → How to create a comprehensive IP strategy before you ever file a patentThe Gold Standard IP Timeline → Why smart founders do FTO studies before product development even begins → The sliding scale approach: when simple DME products don't need comprehensive IP protection → How to avoid the "caveman approach" of filing patents without strategyPatent vs. Trade Secret Strategy → When black box technologies should stay trade secret instead of being patented → How one cybersecurity company got a $50M valuation through trade secret strategy → Why software patents face court hostility and abstract rejectionsInternational Patent Protection → The counterintuitive advantages of filing PCT first instead of US provisional → How to get your patent allowed in 4-6 months using Patent Prosecution Highway → Why Track One applications are often a waste of $2,000Licensing Deal Negotiation Landmines → Why "net royalty" rates will destroy your economics (hint: $3 left from $1,000 revenue) → The power of floor pricing and volume-based escalators → How warranties and indemnification clauses can bankrupt startupsPatent Examiner Psychology → Why adversarial patent attorneys hurt your chances of getting patents allowed → The relationship-first approach that dramatically improves patent prosecution success → How to conduct interviews that actually move your case forwardThe Physician-Led Venture Revolution → How PhiCAP Fund enables physicians to be their own private equity → Why private equity acquisition of medical practices is destroying healthcare → Creating two monetizable vehicles through IP holding company structuresDue Diligence Red Flags → The licensing assumption trap that kills deals before they start → Why patent portfolios can become net negatives in M&A situations → How Inter Partes Review turned patent ownership into a liabilityBest Quotes: "If your patent strategy is 'I want to go and enforce my patents against everybody in my space,' that is a dead loser.""Most people don't realize that just because you have a license, you may not have the right to manufacture it. They may only want you to sell it.""Patent attorneys are a notoriously odd crowd. Do they sweat when they get on the phone and talk to another human being? You really don't need that type of personality when dealing with the Patent Office.""If I get assigned into a particular art unit in 3600, I'd rather just have my money back."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 SOCIAL Spencer's LinkedIn XO Medtech LinkedInFIND JOHN BEHLES ON SOCIAL John's LinkedIn Profile PhiCAP Fund WebsiteEpisode Timestamps: 0:00 - Introduction to John Behles and his journey from Boeing engineer to IP attorney 3:00 - The mythology around intellectual property and why founders get it wrong 7:00 - The gold standard IP timeline: landscape first, then patentability, then filing 12:00 - When to do FTO studies and how budget drives IP strategy decisions 17:00 - PhiCAP Fund's mission to enable physician-led healthcare investing 24:00 - Red flags in IP due diligence that kill startup valuations 28:00 - Licensing agreement negotiation: avoiding the "net royalty" trap 35:00 - International patent strategy: why PCT first beats US provisional 42:00 - Patent examiner psychology and the relationship-first prosecution approach 47:00 - How IP portfolios influence M&A valuations and VC deals 52:00 - Building comprehensive IP strategies that evolve with your company 56:00 - PhiCAP Fund opportunities and IP strategy consultation offerings
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    48 mins