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Project Medtech

The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.

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22 episodes
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Avg 44 min
English

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S1 · E275
Monday · 36 min
Episode 275 | Shannon Clark, Founder & President of HavenSafe | From Human Factors to Ending Homelessness
What happens when a medical device innovator applies human factors thinking to one of society’s biggest challenges? Shannon Clark, founder and president of HavenSafe, shares her journey from pioneering human factors engineering in medical technology to tackling homelessness through data and systems-level solutions. She discusses why human factors goes far beyond FDA compliance, what startups often get wrong, and how the same principles used to improve patient safety can help create better outcomes in social services. Shannon Clark LinkedIn HavenSafe LinkedIn Project Medtech Podcast Episode 121 "Homelessness is a Housing Problem" by Greg Colburn and Clayton Page Aldern "Positive Intelligence" by Shirzad Chamine Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E274
August 17 · 52 min
Episode 274 | Joe Tumolo, Founder & President at JTSC | Why Relationships Win in MedTech Commercialization
In this episode, Joe Tumolo shares why the best medtech companies don't just build innovative products; they build relationships that drive commercialization. Drawing on more than 25 years in healthcare and life sciences, Joe reveals how founders can strengthen fundraising, hire the right sales team, navigate healthcare adoption, and create commercialization strategies that lead to lasting success. Discover why aligning with customers, investors, and partners may be the most valuable competitive advantage a startup can have. Joe Tumolo LinkedIn JTSC, LLC LinkedIn JTSC, LLC Website “Thinking Fast and Slow” by Daniel Kahneman Revisionist History Podcast with Malcolm Gladwell “The Undoing Project” by Michael Lewis Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E273
August 10 · 36 min
Episode 273 | Caron Trumbo, Vice President of Operations at VirginiaBio | Building a Biotech Ecosystem That Actually Works
How do you build a thriving biotech ecosystem? In this episode, Caron Trumbo, VP of Operations at VirginiaBio, shares how collaboration, workforce development, commercialization support, and statewide partnerships are helping Virginia become a growing hub for life science innovation. Learn why connecting startups, universities, investors, and healthcare systems is key to turning breakthrough ideas into real-world impact. Caron Trumbo LinkedIn VirginiaBio Website VirginiaBio LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E272
August 3 · 50 min
Episode 272 | Mike Monovoukas, CEO & Co-founder at AcuityMD | The Future of Medtech Commercialization: AI, Data, and Smarter Growth
What does it take to successfully commercialize medical technology in today's rapidly evolving healthcare landscape? In this episode, Mike Monovoukas, CEO and Co-Founder of AcuityMD, shares how a failed startup inspired him to build one of medtech's leading commercialization platforms. From leveraging AI and data to helping companies launch products more effectively, to raising an $80M Series C and building a mission-driven business, Mike offers valuable insights for medtech founders, innovators, and commercial leaders. Tune in to learn why commercialization starts long before product launch and how AI is changing the future of medtech. Mike Monovoukas LinkedIn AcuityMD LinkedIn AcuityMD Website AcuityMD Press Release Biodesign Book Link Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E271
July 27 · 22 min
Episode 271 | Christopher Gates, Founder & CEO of arsMedSecurity | The First Five Things You Need to Know About Medical Device Cybersecurity
Cybersecurity has become one of the biggest challenges facing medical device innovators, and it's about much more than protecting data. In this episode of Project Medtech's mini series, cybersecurity expert Christopher Gates breaks down the first five essential principles every medtech company should understand, from designing secure devices from day one to navigating FDA expectations and staying ahead of evolving threats powered by AI and quantum computing. Whether you're building your first device or scaling an established company, this conversation is packed with practical insights to help you strengthen your cybersecurity strategy and bring safer technologies to market. Christopher Gates LinkedIn arsMedSecurity Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E270
July 20 · 36 min
Episode 270 | Franco Kraiselburd, Founder & CEO, Asclepii | Reimagining Wound Care Through Accessible Innovation
What if the biggest breakthrough in wound care is making advanced treatments simpler? In this episode, Franco Kraiselburd, founder of Asclepii, shares how mentorship from stem cell pioneer Arnold Kaplan inspired a mission to transform wound care through accessible innovation. He discusses the launch of Poseidon, an innovative silver nanoparticle hydrogel designed to improve healing while simplifying treatment, previews the future of Artemis, a next-generation collagen dressing, and reflects on the lessons he's learned building a medtech startup. From raising capital to bringing new technologies to market, Franco offers an inside look at what it takes to challenge the standard of care and deliver innovations that have the potential to improve outcomes for patients and providers alike. Franco Kraiselburd LinkedIn Asclepii LinkedIn Innovators Dilemma by Clay Christensen The Hard Thing About Hard Things by Ben Horowitz Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E269
July 13 · 43 min
Episode 269 | Edwin Lindsay, Principal Consultant at CS Life Sciences | Unlocking Innovation with Strategic Roadmaps
What does it take to move a medical device from an idea to a solution that reaches patients? In this episode, Edwin Lindsay (Medtech's Guinness Guy) shares how 20+ years in medical devices shaped his hands-on approach to helping startups overcome regulatory, quality, and clinical challenges. He discusses why innovators need more than advice—they need experienced partners who help make decisions, execute strategies, and accelerate progress. Edwin also explores the hurdles facing pediatric device innovation and how his personal connection to the field inspired his mission to support founders and build stronger networks for life-changing technologies. Edwin Lindsay LinkedIn CS Life Sciences Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E268
July 6 · 38 min
Episode 268 | Ethan Drower, Co-Founder & CEO of CiteMed | Breaking Down Barriers with Clinical Evidence
In this episode, Ethan Drower, co-founder and CEO of CiteMed, shares the story behind Evidence Cloud, an AI-enabled platform transforming how medtech teams approach clinical evidence. Built to simplify complex literature reviews, strengthen regulatory submissions, and create a clear, traceable foundation for clinical claims, Evidence Cloud helps companies navigate one of the most critical steps in bringing innovation to patients. What began as a kitchen-table conversation evolved into a mission to reshape evidence generation and regulatory strategy. In this conversation, Ethan discusses how smarter evidence workflows can improve transparency, accelerate decision-making, and turn clinical evidence from a compliance requirement into a powerful strategic advantage. Ethan Drower LinkedIn CiteMed Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E267
June 29 · 49 min
Episode 267 | Michelle Ottey, President of CIC Campuses & Labs | Strategic Growth & Community Building in Innovation Spaces
In this episode, Michelle Ottey, President of CIC Campuses and Labs, unpacks what it really takes to build thriving innovation ecosystems and why flexible lab space is only the beginning. Michelle shares her personal journey from genetics and cell biology research into enabling entrepreneurship, and explains how CIC’s “invisible infrastructure” helps life science and medtech founders move faster by reducing operational, regulatory, and capital burdens through plug-and-play wet labs, shared equipment, safety and compliance support, and a deeply staffed community model. The conversation highlights how CIC strategically launches campuses through years of local ecosystem buy-in, why programming and connection points matter as much as square footage, and how CIC’s global footprint helps companies navigate international expansion and business culture. Michelle Ottey LinkedIn CIC Philadelphia Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E266
June 22 · 48 min
Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss
In this powerful episode, Laura Corcoran, CEO and Founder of Dignity Care, shares the deeply personal experience that drove her to invent the Miscarriage Collection Cradle, a patented Class I medical device designed to bring practical support and dignity to women managing miscarriage or pregnancy loss. Laura walks through the realities of home miscarriage management, the need for reliable collection for cytogenetic testing, and how gaps in standard care can compound trauma. The conversation explores how she translated an unmet need into a scalable product—rapid NHS adoption, health-economic evidence showing major system savings, and the stakeholder strategy required to drive change from hospitals to Parliament. Laura also discusses FDA clearance and plans for U.S. launch, and closes with advice for innovators: obsess over understanding the problem, and the right solution will follow. Laura Corcoran LinkedIn Dignity Care Network Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E265
June 15 · 45 min
Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund
In this episode, Dr. Malcolm Townes breaks down how WashU is building a more execution-focused commercialization engine through its Gap Fund, designed to advance non-drug, non-therapeutic technologies by funding the technology (not startups) to avoid conflicts and drive sharper development decisions. He shares why hands-on, milestone-based funding and rigorous customer discovery are essential to uncovering “unknown unknowns,” preventing expert blindness, and aligning products with real clinical workflows. The conversation also explores how WashU leverages EIRs and Venture Fellows to add commercialization horsepower, why “coachability” is the strongest predictor of success, and what innovators most often miss: FDA clearance isn’t enough—market access and reimbursement require different proof, data, and strategy. Dr. Malcolm Townes LinkedIn Washington University in St. Louis Gap Fund Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E264
June 8 · 48 min
Episode 264 | Will Kaigler & Megan Shaw | From Innovation to Impact: Crafting Medtech Culture and Success in Pittsburgh
In this episode, Megan Shaw, CEO of the Pittsburgh Life Sciences Alliance, and Will Kaigler, co-founder and CEO of SovaSage, join the Project Medtech podcast to unpack what it really takes to build, scale, and ultimately create optionality in health tech startups. Megan shares her journey from being the first employee at HemoSonics to launching PLSA in 2024 to accelerate Pittsburgh’s life sciences ecosystem. Will reflects on his experience with multiple startups, and explains how sovaSage is reimagining sleep apnea management to improve outcomes and lower costs. Together, they discuss why customer value—not fixation on an exit—drives success, how to hire the right early team without over-hiring, and why systems and rigorous user discovery can make or break a company. They close with a deep dive into Pittsburgh’s unique strengths and upcoming opportunities to plug into the region’s innovation community. Will Kaigler LinkedIn Megan Shaw LinkedIn sovaSage Website Pittsburgh Life Science Alliance Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E263
June 1 · 55 min
Episode 263 | Mark Domyahn, Partner at JD Lymon Group | Strategic Reimbursement Planning for Medtech Innovators
In this episode, Mark Domayhn, Partner at JD Lymon Group, joins Duane Mancini to unpack what medtech innovators often miss most: reimbursement isn’t a box to check after FDA—it’s the commercial foundation that determines whether hospitals and physicians can adopt your technology. Drawing on experience across Medtronic, Zimmer, and St. Jude/Abbott, Mark breaks down the “three-legged stool” of coverage, coding, and payment, why clinical evidence must satisfy payer standards (not just FDA), and how to “follow the money” across fragmented U.S. systems. The conversation then dives into the New Technology Add-On Payment (NTAP) program, why it matters for inpatient launches, how breakthrough designation has increased NTAP success, and the major implications of CMS proposing to repeal the alternative pathway—plus what companies can do before the June 9 comment deadline. Mark Domyahn LinkedIn JD Lymon Group Website RAPID Coverage Pathway Information Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E262
May 25 · 44 min
Episode 262 | Huzaifah Salat, MD, Physician Executive | Pioneering Lung Cancer Diagnosis & Driving Clinical Insight in Healthcare Innovation
In this episode, pulmonologist, intensivist, and advanced bronchoscopist Huzaifah Salat joins Duane Manicini to unpack what’s changing in lung cancer care, and why the biggest constraint in MedTech isn’t the FDA, funding, or clinician adoption, but founders building for clinicians instead of with them. Huzaifah shares how robotic bronchoscopy, advanced imaging, and better CT quality are enabling diagnosis of tiny, moving lung nodules, and why the next wave may be non-invasive diagnostics like blood-based, saliva, or bronchial secretion testing. He offers an inside look at serving as a regional medical director and physician voice to the C-suite, where “no margin, no mission” meets patient-first priorities, and explains how diverse frontline perspectives, beyond physicians alone, shape products that truly fit real clinical workflows. Huzaifah Salat LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E261
May 18 · 23 min
Episode 261 | Sean Thompson, Senior Sales Engineer at Packaging Compliance Labs | The First Five Things You Need to Know About Medical Device Packaging
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.
S1 · E260
May 11 · 46 min
Episode 260 | Alicia Wagner, Founder & CEO of Sunra Health | Personalized Pediatric Care through Genetic Insights
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.
S1 · E259
May 4 · 49 min
Episode 259 | Grant Kruger, CEO/Founder at Veracron Wellness Systems | Bridging Engineering and Medical Needs to Revolutionize Chronic Pain Care
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.
S1 · E258
April 27 · 54 min
Episode 258 | Tony Mango & Evan Gomez, Orlando Health | Inside-Out and Outside-In: Navigating Healthcare Innovation
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.
S1 · E257
April 20 · 55 min
Episode 257 | Ankit Shah & Brent Pekarski of UGen | Transforming Rehabilitation Through Cutting-Edge Sensor Technology
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.
S1 · E256
April 13 · 44 min
Episode 256 | Cory Criss, Pediatric Surgeon, Nationwide Children's | Leading Pediatric Innovation & Industry Collaboration
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. Cory Criss LinkedIn Nationwide Children’s Hospital Website 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.

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