Project Medtech

Staci Miller, founder of Gen UX Consulting, joins Duane Mancini for a rapid-fire rundown of the first five things you need to know about human factors validation testing, from the risk documents nobody prioritizes but everyone needs, to the razor-thin line between a task sheet and a leading question that could invalidate your study, to why a 300-page report might be doing you more harm than good. Packed with hard-won insight from nearly 15 years in the field, this episode gives you a practical playbook for getting your validation study and your FDA submission right.

Staci Miller LinkedIn

Gen UX LinkedIn

Gen UX 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 barrier to medtech innovation isn’t the technology, buti fear? In this episode, Merom Klein explores how entrepreneurs can recognize hesitation, build trust, and move investors, customers, and teams from “wait and see” to active champions of innovation. From raising capital to changing the standard of care, Merom shares practical insights on building courage, understanding incentives, and creating the conditions for meaningful adoption. Tune in for a conversation about the human side of medtech innovation and what it really takes to change the game.

Merom Klein LinkedIn

Courage Growth Partners LinkedIn 

Project Medtech Podcast Episode 249

"Biotech in the Balance: Saving a Strategic Industry in an Age of Distrust" by Jeremy M. Levin 

"Leadership the Hard Way" by Dov Frohman and Robert Howard 

"Start-Up Nation: The Story of Israel’s Economic Miracle" by Daniel Senor and Saul Singer 

Duane Mancini LinkedIn
Project Medtech Website

Project Medtech LinkedIn

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

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.