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by 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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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 LinkedInGen UX LinkedInGen UX WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInCourage 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 LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInEnGenius Solutions LLC LinkedIn "Never Split The Difference" by Chris Voss "Million Dollar Consulting Toolkit" by Alan Weiss Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInHavenSafe LinkedInProject Medtech Podcast Episode 121"Homelessness is a Housing Problem" by Greg Colburn and Clayton Page Aldern "Positive Intelligence" by Shirzad Chamine Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInJTSC, LLC LinkedInJTSC, LLC Website“Thinking Fast and Slow” by Daniel Kahneman Revisionist History Podcast with Malcolm Gladwell “The Undoing Project” by Michael Lewis Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInVirginiaBio WebsiteVirginiaBio LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInAcuityMD LinkedInAcuityMD WebsiteAcuityMD Press Release Biodesign Book Link Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInarsMedSecurity WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
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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