In this kickoff episode of Project Medtech’s “Five Things You Need To Know” miniseries, Duane Mancini is joined by Sean Thompson to break down the essentials of sterile medical device packaging compliance. Sean shares a practical, startup-friendly roadmap anchored in ISO 11607, starting with defining device inputs that drive packaging design decisions (sensitivities, geometry, sterilization method, scalability). He then walks through the four pillars—Make, Ship, Store, and Usability—covering sealing process validation, distribution simulation testing and feasibility testing, shelf-life strategy via accelerated and real-time aging, and the newer focus on usability and aseptic presentation. The episode highlights how missed packaging steps can create costly timeline and commercialization setbacks.

• Sean Thompson LinkedIn

• Packaging Compliance Labs Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Alicia Wagner shares the deeply personal journey that led her to build Sunra Health after her daughter’s long and traumatic health challenges exposed major gaps in how pediatrics handles chronic conditions. She breaks down Sunra Health as an AI-powered pediatric health platform paired with an at-home cheek-swab genetic test, designed to help families and clinicians move from “guessing” to more personalized, data-informed early childhood wellness decisions. The conversation explores how Sunra aims to function as an FDA-aligned clinical decision support tool, why direct-to-consumer access is a key early strategy, and how AI can responsibly translate complex genetic insights into practical guidance, education, and care planning. Alicia also shares hard-earned founder lessons on resilience, pitching, and educating in a controversial space.

• Alicia Wagner LinkedIn

• Sunra Health Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Grant Kruger joins Duane Mancini to share his journey from growing up in South Africa to becoming a University of Michigan researcher and medtech entrepreneur. He discusses his roots in electrical engineering and AI-driven manufacturing, the leap to Michigan for a postdoc, and the pivotal shift from automotive-focused research into collaborating with physicians to solve real clinical problems. Grant explains how early pain-research tooling evolved into Veracron Wellness Systems, and how an NIH I-Corps-style customer discovery process reshaped their thesis, revealing clinicians didn’t need better pain intensity scores, but objective, workflow-friendly functional data. He outlines their single-use wearable “functional assessment test kit,” designed to remove clinic burden and support better chronic pain decisions, approvals, and patient satisfaction, plus lessons on team, ecosystem support, and why usability beats perfection.

• Grant Kruger LinkedIn

• Veracron Wellness Systems Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Tony Mango and Evan Gomez from Orlando Health’s Strategic Innovations team break down how a major nonprofit health system accelerates ideas from its 40,000+ team members into real solutions. They explain Orlando Health’s unique capability to develop medical devices in-house under FDA registration, how they triage innovation disclosures, and when they choose outside-in partnerships versus building internally based on speed, workflow fit, and adoption. The conversation explores the realities of commercialization—reimbursement, CFO-driven purchasing, long U.S. sales cycles, and why great technology can still fail without economic alignment. They also share how Orlando Health uses innovation as a recruitment and retention engine, expands regionally, and builds industry connections through curated clinical immersion sessions.

• Tony Mango LinkedIn

• Evan Gomez LinkedIn

• Orlando Health Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Ankit (founder of UGen) and Brent (a physical therapist at University Hospitals) about why rehab is primed for innovation, and how UGen is tackling the biggest breakdowns in physical therapy. Ankit shares how his grandfather’s Parkinson’s journey inspired him to apply his electrical engineering and sensor research background to build wearable motion sensors that deliver real-time, multi-sensory feedback at home, while capturing clinician-ready data to improve care decisions. Brent explains the clinical pain points UGen can solve: limited face-to-face time, poor home-exercise compliance, and the “honor system” that leaves therapists guessing, plus how UH’s sports medicine growth and the Haslam Sports Innovation Center create a pathway for tech adoption. They also discuss UGen's presence at the NFL Combine, expansion into neuro and assessment, and founder lessons on hardware difficulty, workflow fit, and building with patient safety in mind.

• Ankit Shah LinkedIn

• Brent Pekarski LinkedIn

• UGen Website

• Haslam Sports Innovation Center Website

• SportsLand Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

  Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Cory Criss joins Duane Mancini to share his path from pediatric surgeon to building innovation infrastructure at Nationwide Children’s and helping launch the Midwest Pediatric Device Consortium (MPDC), an FDA-funded Pediatric Device Consortium created to accelerate pediatric device development. The conversation breaks down why pediatrics is uniquely hard—small, fragmented markets and the need for multi-institutional clinical evidence—alongside the stark funding gap, with less than 1% of VC dollars going to pediatric-only companies despite children representing 25% of the population. Corey explains how Nationwide’s Innovation Center de-risks and educates through an innovation fellowship, and how MPDC unites Nationwide, Cincinnati Children’s, Ohio State, Cleveland Clinic Children’s, and others to support pediatric startups nationwide with expert evaluation, hospital access, and non-dilutive funding. They also discuss lessons learned managing multi-institution partnerships, sustainability beyond grant funding, and why clinician and hospital buy-in is critical for international startups entering the U.S. market.

• MPDC Website

• MPDC YouTube Channel

• Pediatric Device Consortium: Cardiovascular Focus Event Registration 

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Brent Lavin shares how two decades in product and portfolio management at GE Healthcare, C.R. Bard, and BD shaped his mission to help Series A and B medtech startups build commercial logic into every stage of innovation. Brent breaks down what surprised him most moving from strategics to early-stage teams and why large companies often operate like startups when resources must be earned through influence, not authority. The conversation dives into how his engineering training powers a structured, “marketing-as-a-science” approach to product management, the most-missed elements of customer discovery, and a concrete example of winning by simplifying a “Cadillac” product into a segmented solution. Brent also unpacks what strategics look for in acquisitions plus lessons from LSI, leadership, and the discipline of endurance running.

• Brent Lavin LinkedIn

• Ironwood Medtech Partners LinkedIn

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini speaks with vascular neurologist Anit Behera about what it takes to improve stroke care from the ER through long-term recovery. Anit shares his path through an MD-PhD in outcomes research, how consulting and clinical trials shaped his innovation mindset, and why stroke care advancement spans four phases: prevention, acute treatment, post-acute care, and rehabilitation. He explains where he sees major opportunity next, pointing to emerging devices and research in post-stroke rehab alongside stronger prevention strategies and better health literacy. The conversation also breaks down how clinicians evaluate new technologies, emphasizing rigorous data, patient safety, and real-world workflow fit, plus the role of key opinion leaders and conferences in driving adoption.

• Anit Behera LinkedIn

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Jake Ward joins Duane Mancini to break down how startups should think about intellectual property from day one and why smart IP decisions directly impact fundability. Jake shares how Ward Law grew from a three-person boutique to a 35-person, multi-state virtual firm, and why their Midwest roots help deliver high-quality IP services at accessible rates for entrepreneurs. The conversation dives into where to start with patents, then shifts to trademarks and brand strategy and why selecting the right mark early, staying consistent, and timing registration can prevent costly rebrands later. They also tackle AI in legal work, exploring confidentiality concerns, “don’t trust the robot” pitfalls, and how to use AI as a tool without letting it undermine strategy or enforceability.

• Jake Ward LinkedIn

• Ward Law Website 

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Jenny Lynn—founder of milkmade and a mom-turned-entrepreneur—shares how a frightening breastfeeding experience, including an undiagnosed tongue tie and the exhausting “weighted feed” routine, sparked the idea for a Smart Nipple Shield that can deliver continuous, actionable insight into infant milk intake. The conversation explores why breastfeeding—despite being the clinical “gold standard”—so often breaks down early, driven by perceived and actual low milk supply, fragmented care, and limited access to lactation support, especially in rural communities. Jenny Lynn also unpacks her path from marketing and health tech into regulated medtech, including patents, pursuing clinical validation, and navigating a Class II De Novo pathway with no predicate.

• Jenny Lynn Walding LinkedIn

• milkmade Website

• “Invisible Women” by Caroline Criado Perez

• “She Persisted” by Chelsea Clinton & Alexandra Boiger 

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.