Project Medtech

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.