Project Medtech

What if quality management could be the key to driving medtech innovation, not holding it back? In this episode, Ashkon Rasooli, Founder and Principal of EnGenius Solutions Consulting, breaks down how medtech companies can build quality systems that go beyond compliance to support innovation, efficiency, and long-term growth. The conversation dives into the challenges of keeping quality and regulatory strategies ahead of rapidly evolving technologies like software, cloud platforms, and AI, while exploring how companies can avoid costly mistakes, scale effectively, and prepare for the complexities of entering the U.S. market.

Ashkon Rasooli LinkedIn

EnGenius Solutions LLC LinkedIn 
⁠EnGenius Solutions Website

"Never Split The Difference" by Chris Voss 

"Million Dollar Consulting Toolkit" by Alan Weiss 

Duane Mancini LinkedIn
Project Medtech Website

Project Medtech LinkedIn

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

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.