The Medtech Innovation Podcast

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

I'm joined by Brent Lavin, Founder of Ironwood Medtech Partners, as we explore product commercialization mastery, the critical mistakes medtech companies make in development, and how to navigate M&A as both acquirer and startup.

The Product Development Trap Most Startups Fall Into
→ Companies commit to their solution too early without sufficient iteration - taking multiple prototypes to physicians saves months later when you discover fundamental flaws during verification testing
→ The biggest mistake is treating early-stage innovation like a regulated activity instead of moving fast with rapid prototyping and real-world physician feedback
→ Spend an extra month or quarter in the fuzzy front end of innovation to avoid costly pivots during the long documentation phase - go slow to go fast

How Overlooking Human Factors Kills Great Products
→ Physicians love products that fail in practice because it's the scrub techs at the back table who struggle to unbox, prep, or load devices onto wires
→ Human factors testing shouldn't be about "teaching to the test" for FDA submission - it should uncover genuine workflow gaps that lead to unintended consequences
→ Most companies recruit from one hospital doing one procedure type instead of getting a representative sample of physicians who only do your procedure one out of eight cases

The Segmentation, Targeting, Positioning Framework
→ Positioning isn't about being faster - it's about enabling physicians to treat new patient populations or do something fundamentally better for specific procedure types
→ Real example: Straub Medical's Rotorex succeeded against six competitors by targeting mixed morphology thrombotic and calcific lesions plus instant restenosis specifically
→ If you're marketing to everybody, you're marketing to nobody - geographic focus beats spreading thin across top-volume physicians nationwide in year one

M&A Reality Check: What Strategics Actually Want
→ Big companies aren't looking for expensive pivots - they evaluate whether acquired technology can easily generate the data needed for regulatory expansion
→ The -10M acquisition sweet spot is rarely just about revenue multiples - it's about strategic fit, IP strength, and regulatory pathway clarity
→ Most startups undervalue their clinical data and bench testing demographics - these become dealbreakers when strategics can't use existing work for global submissions

Best Quotes:

"We treat even concept development like a regulated activity and that's not what we should be doing. We should be working as quickly as possible to get prototypes in front of physicians."

"If you're truly looking at human factors like uncovering gaps and problems instead of teaching to the test, you would increase sample size and get people from around the country, not just your backyard."

"If you're marketing to everybody, you're essentially marketing to nobody. You have to know specifically who you're going after."

Want more insights on medtech innovation?

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Find the perfect vendors for your medtech project for free at MedtechVendors - https://www.medtechvendors.com/

🤝 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.

📈 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 BRENT LAVIN ON SOCIAL
Brent Lavin's LinkedIn - https://www.linkedin.com/in/brentlavin/
Ironwood MedTech Partners Website - https://www.ironwoodmedtechpartners.com/

Episode Timestamps:
0:00 - Introduction to Brent Lavin and his medtech journey through GE, CR Bard, and BD
3:35 - Why product development is more complex today than 15 years ago
8:09 - The biggest mistake: committing to solutions too early in development
13:01 - Human factors and clinical workflow - the underappreciated nuance
22:09 - Segmentation, targeting, and positioning for commercial success
32:15 - Geographic targeting strategies for early-stage companies
38:20 - Evaluating M&A opportunities from the strategic acquirer's perspective
45:30 - The $10M acquisition sweet spot and what makes deals happen
52:18 - Advisory boards vs consultants: when and how to use physician expertise

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 outcomes

The 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 capital

Why 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 immediately

The 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 items

Chicago'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 mHUB

What 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 playbooks

The 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 layers

Best 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 have to reevaluate what you're doing."

"We should be able to say, here's how much money it's going to take, here's the percentage of success for people in your type of role - so you can think about other opportunities like licensing deals or partnerships."

Want more insights on medtech innovation?

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🤝 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 MONICA VAJANI ON SOCIAL
Monica's LinkedIn - https://www.linkedin.com/in/monica-vajani/
mHUB Website - https://www.mhubchicago.com/

Episode Timestamps:
0:00 - Introduction to Monica Vajani and mHUB's MedTech Accelerator
2:00 - Monica's decade in clinical cardiac sales at Abbott and Medtronic
5:11 - The evolution from physician-driven to value-based care purchasing
8:24 - Why value analysis committees are overwhelmed and defaulting to cost
12:43 - The broken early-stage MedTech funding model
14:54 - Consolidation cycles and when innovation breaks off from big companies
17:52 - Why not everyone should be running a company
21:20 - The $30M reality check for Class III device development
24:44 - Fractional experts vs full-time hires for early stage companies
29:37 - Hospital margins, insurance growth, and the coming tipping point
32:29 - The average 2.5 year insurance plan tenure problem
33:54 - The explosion in hospital administrative staff since the 1990s
37:19 - What makes Chicago special for hard tech innovation
40:40 - mHUB's economic impact: 7,000 jobs and $2B in revenue
42:01 - What accelerators should do: invest and reduce time to experts
44:53 - How to get involved with mHUB's next accelerator cohort

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 match

From 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 anyone

The 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 geometries

Adoption 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 simultaneously

Kinematic 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 integration

AI-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 positions

Lead 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 profile

Advice 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 thing

Best 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 to be a successful adoption."

"Do it right the first time and you won't have to do it again. We are okay, at least in an industry level, we're okay with doing it again. Because we're saying, 'oh, it survived for 18, 20 years, it's fine.'"

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 JONATHAN SWILL ON SOCIAL 
Jonathan's LinkedIn - https://www.linkedin.com/in/jonathan-swill/
Surgical Excellence Partners - https://surgicalexcellencepartners.com/

Episode Timestamps: 
0:00 - Introduction to Jonathan Swill and Surgical Excellence Partners 
5:00 - The HSS experience: where patient-specific passion began 
12:00 - Patient-specific implants explained: from imaging to surgery 
18:00 - Biomimicry and the future of implant design 
22:00 - Surgical guides and cutting tools: precision at the planning stage 
28:00 - Kinematic vs mechanical alignment: the paradigm shift 
34:00 - Why patient-specific implants haven't achieved widespread adoption 
40:00 - The reimbursement problem and 2-3 year patient turnover 
45:00 - Building the value proposition for hospital VACs 
50:00 - Pre-replacement interventions: tissue engineering and PRP 
55:00 - Entering the US market: surgeon education and innovation partnerships 
62:00 - Lead qualification over volume: the startup survival str...

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 benefits

AI 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 agents

The 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 leadership

Specialized 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 processes

The 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 refinement

Start 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 compliance

Best 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-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 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

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 needs

The 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 marketing

Technical 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 technology

The 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 validation

Ischemia 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 diagnostics

Strategic 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 partnerships

Reimbursement 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 adoption

Ecosystem 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 markets

Best 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-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 JEFF JUNE ON SOCIAL
Jeff'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 journey
5:00 - Why the venture capital model is broken for early-stage MedTech
15:00 - Technical founders are more capable than they're told
22:00 - The accelerator industrial complex diagnosis
35:00 - Clinical-to-consumer healthcare transformation
45:00 - What MedTech innovators consistently overlook
55:00 - Building ecosystem partnerships over individual excellence
65:00 - Reimbursement reality and payer psychology
75:00 - Strategic M&A relationship building playbook

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 company

Revolutionary 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 results

Governed 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 process

AI 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 mandates

The 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 engineers

Easy 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 coding

PDX: 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 year

Best 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?

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🤝 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 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

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."

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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

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 contributors

Why 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 administrators

The 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 correctly

Engineering 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 requirements

The 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 reality

Navigating 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 potential

Future-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 industry

Best 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 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://tinyurl.com/xo-medtech-free-tier 

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 JEREMY RIDLEY ON SOCIAL
Jeremy's LinkedIn - https://www.linkedin.com/in/jeremy-ridley-delve/
Delve Website - https://www.delve.com/

Episode Timestamps:
0:00 - Introduction and Jeremy's background at Delve
3:15 - The evolution from engineer to engineering leader
7:42 - Why most medtech products fail before reaching market
12:28 - Regulatory strategy as competitive advantage
18:35 - Building engineering teams for medtech startups
24:12 - The hidden costs of poor design decisions
29:47 - Quality systems and process optimization
35:23 - Innovation within regulatory constraints
41:18 - Future trends in medtech engineering
46:52 - Career advice for aspiring medtech leaders
52:30 - The importance of cross-functional collaboration
57:15 - Final thoughts and key takeaways

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 patent

The 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 strategy

Patent 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 rejections

International 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 $2,000

Licensing 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 startups

Patent 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 forward

The 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 structures

Due 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 liability

Best 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-course

FIND SPENCER JONES ON SOCIAL
Spencer's LinkedIn
XO Medtech LinkedIn

FIND JOHN BEHLES ON SOCIAL
John's LinkedIn Profile
PhiCAP Fund Website

Episode 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