Project Medtech
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.
Episodes
Mentioned books
Jun 24, 2024 • 35min
Episode 185 | Simon Mason, President at National Evaluation System for Health Technology Coordinating Center (NEST) | Systematically Leveraging Real-World Evidence
In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.
Jun 17, 2024 • 39min
Episode 184 | Matt Iorio, Senior Manager Clinical Affairs and Data Analytics at Neuros Medical | The Importance of Clinical Data and How to Collect It
In this episode, Matt Iorio at Neuros Medical and Duane Mancini discuss his background in the Medtech space, the collection of clinical data, the importance of clinical data for regulatory and commercial purposes, and so much more.
Jun 10, 2024 • 38min
Episode 183 | Rick Geoffrion, President & CEO at Cyrano Therapeutics and Chip Hance, CEO at Regatta Medical | The History and Importance of the Early Feasibility Studies (EFS) Program at the FDA
In this episode, Rick Geoffrion at Cyrano Therapeutics and Chip Hance at Regatta Medical and Duane Mancini discuss history of the Early Feasibility Studies (EFS) Program at the @FDA, the importance of it, how @MDIC supported mission and so much more.
Jun 3, 2024 • 43min
Episode 182 | Andy Fish, CEO & President and Joe Sapiente, Senior Vice President at Medical Device Innovation Consortium (MDIC) | Facilitating Discussions between Government and Industry
In this episode, Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) and Duane Mancini discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more.
May 27, 2024 • 34min
Episode 181 | Brittani Ritchie, Consultant, Operations at Project Medtech | Making Quality a Part of Company Culture
In this episode, Brittani Ritchie at Project Medtech and Duane Mancini discuss her background in the Medtech industry, making quality a part of your culture, what to expect in an FDA audit and so much more.
Apr 29, 2024 • 37min
Episode 180 | Charles Allan, Chief Executive Officer at MY01 | Lessons Learned So Far from a Medtech Startup CEO
In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.
Apr 22, 2024 • 35min
Episode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR Updates
In this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.
Apr 15, 2024 • 43min
Episode 178 | Kevin Saem, Commercial Director at Zapyrus | 2023 Medtech Report
In this episode, Kevin Saem at Zapyrus and Duane Mancini discuss what Zapyrus does, their 2023 Medtech report on the industry and so much more.
Apr 8, 2024 • 34min
Episode 177 | Katrina Holland, Executive Director at MedTech Color | Increasing Diversity in Medtech
In this episode, Katrina Holland at MedTech Color and Duane Mancini discuss her new role at MedTech Color, closing the diversity gap in Medtech, her short, medium and long term vision of Medtech Color, and so much more.
Apr 1, 2024 • 51min
Episode 176 | Ken Callahan, Principal at The Hargan Group; Former HHS Chief of Staff to the Deputy Secretary | United States Department of Health and Human Services (HHS)
In this episode, Ken Callahan at The Hargan Group and Duane Mancini discuss his background with HHS, what startups need to know about the department, what are the biggest policy decisions being discussed right now, how the upcoming election could affect those policies, big issues coming up in 2025 and beyond, and so much more.
