I help MedTech and healthtech leaders turn breakthrough ideas into funded, FDA cleared, globally adopted products. Founders, C-suites, hospitals, and investors come to me when the path is hard, the stakes are real, and generic advice won't cut it.
The FDA just changed the rules on AI-enabled devices. Most MedTech companies don't know it yet.
Under FDA's new Total Product Lifecycle expectations, the moment your device contains any AI — a smarter stethoscope, an EKG interpreter, clinical decision support, even a downloaded open-source model running locally — the old hall pass is gone. Clearance is no longer a stamp in time. You now have to prove, continuously, that the model isn't drifting on real-world data, learning things it shouldn't, or behaving differently from what you submitted. Your quality system almost certainly isn't built for that. Your labeling isn't either. And your hospital customers are about to subject your product to a procurement review that doesn't exist yet but is coming fast.
At the same time, your inventors are quietly putting your patent estate at risk every time they paste a novel mechanism, formulation, or algorithm into ChatGPT, Claude, or a copilot tool. USPTO guidance on AI-assisted inventorship is being rewritten in real time. Public disclosure via a prompt can nuke ex-U.S. patentability in Japan, Europe, and China — jurisdictions with no grace period. Training-data freedom-to-operate is the next big litigation wave and MedTech hasn't been hit yet, but it will be. This is what I help MedTech leaders get ahead of.
How I work with MedTech teams on AI
Careful invention — protect the IP before it leaks. I build AI-era invention hygiene into your R&D workflow so inventors know which tools are approved for which stages, what never gets pasted into a public model, how human contribution gets documented contemporaneously to survive a future inventorship challenge, and how the grace-period clock and global patentability stay intact. Sold as the Inventor Integrity Playbook — a written policy plus training for your engineering and product teams.
Careful design — build devices that can actually be cleared and insured. I work three to five years upstream of your submission, embedding AI considerations into design controls, DHF, and QMS before the mistakes get expensive. This includes the Total Product Lifecycle monitoring architecture FDA now expects, global regulatory sequencing across FDA, EU MDR, PMDA, and NMPA (the order is shifting — Europe is no longer first), and the freedom-to-operate and training-data due diligence that tells you whether the AI you're embedding is a liability you just inherited
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Careful commercialization — survive procurement and sales scrutiny. AI-enabled devices are triggering a new class of hospital procurement review that your sales force isn't trained for and your labeling doesn't address. I build the claims guardrails, sales training protocols, and procurement-ready documentation that let your reps answer the hard questions and close, rather than stall in IT security review for six months.
Careful partnerships and upgrades. Much of the MedTech installed base — ultrasound systems, infusion platforms, capital equipment one to four years old — can be upgraded with AI intelligence rather than amortized as obsolete. I help OEMs, health systems, and investors evaluate which assets can be retrofitted, which partnerships unlock that value, and how to structure the deal so the AI component doesn't create downstream liability for whoever bolts it on.
Who this is for
Device manufacturers with an AI feature on the roadmap. Founders of SaMD and SiMD startups. Diagnostics and drug-device combination companies. Capital equipment OEMs deciding whether to upgrade a legacy platform or sunset it. Multinational clients trying to sequence U.S., EU, Japan, and China entry in the new regulatory reality. Investors doing diligence on an AI-enabled MedTech target and needing someone to stress-test whether the company actually has its invention, regulatory, and deployment house in order.
Why me, specifically
Thirty years in MedTech. Twenty-plus patents, so I know what a defensible invention record looks like from the inside. Three-time healthtech CEO and two-time MedTech founder, so I've sat on both sides of the table — the one building the product and the one explaining it to the FDA, the payer, the hospital, and the board. Founder of EZassi, an "open innovation" SaaS platform, so I understand how AI and predictive analytics work under the hood, not just as a buzzword. And I work in partnership with a specialized AI governance legal and consulting network on the demand side — providers, ACOs, payers — so when your device reaches procurement, the language, the credentialing, and the trust framework your customers will apply are ones I've already helped shape.
AI in MedTech isn't a software question, an IT question, or a compliance checkbox. It's a product question, an invention question, and a commercialization question — which is exactly the lane I've spent my career in.
Contact me at p.vondyck@gmail.com or schedule a meeting.
About
Peter M. Von Dyck
If your innovation can possibly save lives, augment quality of life, save money and create new markets. I'll help you make it happen.
I know how hard this is. Whether you're a founder fighting entrenched clinical practices, a C-suite executive racing to implement AI strategy, a healthcare system evaluating emerging technologies, or a VC assessing whether a MedTech startup can scale, I've navigated these challenges and I'll help you through them.
I specialize in the hardest problems:
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Creating new markets where incumbents say "impossible"
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Changing physician behavior when clinical inertia is your biggest competitor
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Navigating FDA/CE Mark pathways without burning capital
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Securing strategic funding and partnerships that accelerate growth
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Building global distribution where relationships trump products
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Implementing AI that delivers clinical value, not just tech novelty
When clinical practice is entrenched, I'll help you create the paradigm shift
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I helped shift ICU nutrition from IV to early enteral feeding by developing seven novel feeding systems and leading protocol changes across thousands of facilities. I'll help you build the clinical evidence, KOL networks, and implementation frameworks that make new standards of care inevitable.
When no market exists, I'll help you build the category
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I Invented the world's first bowel / fecal management system, helping spawn a now massive market from zero. Pioneered new FDA pathways, clinical protocols, and GPO categories. I'll help you navigate first-of-kind barriers and establish reimbursement where none existed.
When hospital costs block adoption, I'll help you prove the economics
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I developed new home-managed enteral feeding systems that eliminated unnecessary and prolonged hospitalizations in both children and adults. I'll help you build health economics cases and value-based contracting strategies that make your innovation change paradigns.
When innovation is too slow, I'll help you unlock external ecosystems to speed things up.
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I founded a leading “Open Innovation” SaaS company and platform called EZassi, solving IP protection with powerful automated predictive analytics, tech scouting and achieving widespread enterprise innovation acceleration. I'll help you build systems and partnerships that accelerate R&D velocity and create “sticky” SaaS customers.
When data is too siloed, I'll help you unlock AI's full potential
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The AI race in healthcare isn't just about better algorithms, it's about accessing more data. So much data is still disparate, EHRs don't connect with wearables, labs, or remote monitoring, limiting the longitudinal patient data AI needs to deliver breakthrough insights.
As medical devices increasingly integrate AI capabilities, data interoperability becomes critical.
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I have helped lead new analytics platforms that normalize heterogeneous data sources (EHRs, IoMT devices, point-of-care diagnostics) into unified real-time patient profiles. This comprehensive data integration can help enable AI to try and detect complex, time-sensitive conditions such as hospital-acquired infections (HAI), SEPSIS, and other mysterious deterioration patterns that fragmented systems miss.
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I'll help you integrate and commercialize robotics and AI-powered clinical decision support platforms that solve data fragmentation, power next-generation medical technologies, achieve physician adoption through transparent models, and demonstrate measurable outcomes: earlier detection, reduced mortality, lower readmissions, proven ROI.
Some kids grew up on baseball fields — I grew up in MedTech labs, production facilities and boardrooms
Raised in the world of MedTech, I secured my first medical invention at just 24, launching a career now spanning more than two decades of transforming clinical insight into breakthrough innovations that have improved patient care worldwide. From advanced inventions and products for Intensive care patients like advanced feeding systems and the world's' first Bowel Management System to pioneering predictive AI-powered analytics, I’ve secured over $20M in funding, built global partnerships, and guided multiple products to market leadership through strategic commercialization, regulatory expertise, and market-making initiatives across the globe. My work has driven changes in global clinical practice and opened entirely new markets through missionary product sales. As a 3× healthtech CEO, 2× MedTech founder, proud inventor of 20+ patents, and founder and CEO of several transformative companies including an "open innovation" pioneer, Ezassi.com in Ponte Vedra, FL. I’ve united cross-disciplinary teams, taken ideas from concept to reality, and delivered solutions that make a lasting impact. Along the way, I’ve been honored as an Ernst and Young Entrepreneur of the Year™ and received the Medical Design Excellence Gold Award for medical products design along with being named Fastest Growing Company in NE FL. More importantly, I believe innovation and entrepreneurship can come from anywhere and I'm here to help make it happen with your idea, technology or enterprise. Let's not only change lives but break new ground in award-winning new ways.
Peter M. Von Dyck
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20+
Patents Awarded, Issued and Making Money
3x
CEO, Founder & Board Member
20+
$20M+ Capital raised &
20 years of New Product Revenue Generation
Executive Advisory & Leadership
Core Expertise & Services
MedTech Commercialization & Global Market Entry
Accelerate product launches and achieve global adoption. With a track record of taking products from concept through regulatory clearance and international scaling, Peter M. Von Dyck will build you market-ready strategies that minimize risk and maximize growth. Services include commercialization planning, partner identification, and U.S. & EU market entry strategies and business plans
FDA Regulatory Strategy & QMS/DHF Setup
Regulatory compliance can make or break innovation. Peter M. Von Dyck helps teams build FDA-ready pathways, from De Novo and 510(k) submissions to robust QMS/DHF systems that meet global standards, ensuring devices reach patients safely and efficiently. Additional support in preparing for entry into the European Union and acquiring CE mark from top Notified Bodies and compliance with MDR is also a key area Peter can assist as he has an intensive network of Partners in Europe.
Reimbursement & Investor Strategy
Without reimbursement and capital, even the best innovations stall. Peter M. Von Dyck advises on payer engagement, coding strategies, and health economics while also supporting investment narratives with polished pitch decks, proforma models, and funding strategies that attract capital.
Strategic Partnerships & Distributor Networks
Success in MedTech depends on partnerships. Peter M. Von Dyck leverages global networks of distributors, hospitals, investors, and technology partners to create high-value alliances, build sales channels, and establish trusted relationships across markets.
Immersive VR/XR HealthTech Ventures
The future of care is immersive. Virtual, augmented, and extended reality (VR/AR/XR) enable new models of personalized care, remote monitoring, and patient engagement. Peter M. Von Dyck helps organizations evaluate, validate, and scale immersive technologies, guiding investment strategy, pilot design, and commercialization pathways.
Sample Achievements & Awards
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First Place Winner, Fastest Growing Company - NE FL
Issued by Jacksonville Business Journal
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Ernst & Young Entrepreneur of the Year Winner for Life Sciences - Florida
Issued by Ernst & Young
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100 Most Notable Executives in Medtech
Issued by MDDI
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Florida Governor's Award for Entrepreneurship and Diversity
Issued by Enterprise Florida is a public/private entity in Orlando
