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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Episode 185 | Simon Mason, President at National Evaluation System for Health Technology Coordinating Center (NEST) | Systematically Leveraging Real-World Evidence
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In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.
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Episode 184 | Matt Iorio, Senior Manager Clinical Affairs and Data Analytics at Neuros Medical | The Importance of Clinical Data and How to Collect It
39:03
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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.
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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
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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.
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Episode 182 | Andy Fish, CEO & President and Joe Sapiente, Senior Vice President at Medical Device Innovation Consortium (MDIC) | Facilitating Discussions between Government and Industry
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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.
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Episode 181 | Brittani Ritchie, Consultant, Operations at Project Medtech | Making Quality a Part of Company Culture
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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.
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Episode 180 | Charles Allan, Chief Executive Officer at MY01 | Lessons Learned So Far from a Medtech Startup CEO
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36:45
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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.…
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Episode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR Updates
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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.
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Episode 178 | Kevin Saem, Commercial Director at Zapyrus | 2023 Medtech Report
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42:59
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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.
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Episode 177 | Katrina Holland, Executive Director at MedTech Color | Increasing Diversity in Medtech
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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.
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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)
50:56
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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.…
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Episode 175 | Timothy Boire and Geoff Lucks at VenoStent | Achieving Milestone and Raising Capital as a Class III Medical Device Startup Company
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In this episode, Tim Boire and Geoff Lucks at VenoStent and Duane Mancini discuss their background in the Medtech space, how they founded VenoStent, their clinical trial, fundraising strategy, and its correlation to achieving milestones and so much more.
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Episode 174 | Ronan O'Hagan, President and CEO at Bectas Therapeutics | The Importance of Clinical Validation and Data
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In this episode, Ronan O'Hagan at Bectas Therapeutics and Duane Mancini discuss the overlap between pharma and medtech, what can a medtech company learn from a pharma startup, the importance of communicating science in a digestable manner, building your team, fundraising strategy and so much more.
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Episode 173 | Matt Eisendrath, President and Chief Commercial Officer at Full Spectrum Software | The Excitement Around the Future of Medtech
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In this episode, Matt Eisendrath at Full Spectrum Software and Duane Mancini discusses his background in the medtech space, software as a medical device vs. digital therapeutics, what excites him about the future of Medtech and so much more.
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Episode 172 | Angelica Maestas, Founder & CEO at HealthTech Rx | Building a Health Innovation Hub on a Mission to Eliminate Health Inequities
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In this episode, Angelica Maestas at Healthtech Rx and Duane Mancini discuss her time in the Medtech space, health economics and reimbursement, her obsession with data analytics, taking a company through an exit, her passion for ending health inequities and so much more.
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Episode 171 | Eric Horesnyi, CEO at Matrix Requirements | Instilling Quality Early at your Medtech Startup
36:55
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In this episode, Eric Horesnyi at Matrix Requirements and Duane Mancini discuss his background as an entrepreneur, quality management systems and the importance of quality as a key pillar for culture, and so much more.
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Episode 170 | Ryan Confer, CFO at Genprex | Understanding Finances in an Early Stage Medtech Company
46:57
46:57
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In this episode, Ryan Confer at Genprex and Duane Mancini discuss his background in startup companies, the importance of understanding finances in an early-stage company, why they took Genprex public, and so much more.
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Episode 169 | Mark Dybul, CEO at Renovaro Biosciences | Physician to Diplomat to Entrepreneur
54:21
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In this episode, Mark Dybul at Renovaro Biosciences and Duane Mancini discusses his background in the US government, what they are working on at Renovaro Biosciences, the importance of being able to communicate complex problems in an easy-to-understand way, and so much more.
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Episode 168 | Anish Kaushal, Associate at Amplitude Ventures | From Here To There: A Niche Guide to Navigating Career Transitions
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In this episode, Anish Kaushal at Amplitude Ventures and Duane Mancini discuss his background in the medtech space, his transition from being a medical doctor to venture capitalist, his new book and so much more.
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Episode 167 | Jeffrey Sirek, Chief Executive Officer, Board Member at PRIA Healthcare | The Importance of Health Economics and Reimbursement in Medtech
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In this episode, Jeffrey Sirek at PRIA Healthcare and Duane Mancini discuss the importance of health economics and reimbursement, scaling a medtech service company, the culture of a growing company, and so much more.
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Episode 166 | Scott Filer, CEO at ProMedix | Green Beret to Medtech Entrepreneur: Improving Sepsis Diagnosis
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In this episode, Scott Filer at ProMedix and Duane Mancini discuss his background as a green beret, the problem with diagnosing sepsis, what he has learned in his entrepreneurial journey, and so much more. Scott Filer LinkedIn ProMedix Website Project Medtech Website Duane Mancini LinkedIn
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Episode 165 | Tosan Ugbeye, Founder & CEO at Scope Med | The Journey: Clinician turned Entrepreneur
28:37
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In this episode, Tosan Ugbeye at ScopeMed and Duane Mancini discuss his background as a clinician, the evolution of Scope Med, what he has learned so far, and so much more. Tosan Ugbeye LinkedIn Scope Med Website Project Medtech Website Duane Mancini LinkedIn
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Episode 164 | Karen Zaderej, President, CEO and Chairman of the Board at AxoGen | Revolutionizing Nerve Repair
52:12
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In this episode, Karen Zaderej at Axogen and Duane Mancini discuss her background in the medtech space, the story of Axogen, how they are revolutionizing nerve repair and so much more. Karen Zaderej LinkedIn AxoGen Website Project Medtech Website Duane Mancini LinkedIn
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Episode 163 | Shawnnah Monterrey, Founder & CEO at BeanStock Ventures | FDA Accredited Third Party Review Organizations and Digital Health Regulations
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In this episode, Shawnnah Monterrey at BeanStock Ventures and Duane Mancini discuss Grassroots Dx, 3rd party review accreditation for FDA, software in Medtech, digital health and so much more. Shawnnah Monterrey LinkedIn BeanStock Ventures Website Project Medtech Website Duane Mancini LinkedIn
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Episode 162 | Howie Chan, Principal & Founder at Healthy Brand Consulting | The Importance of Brand Strategy to Ensure Commercial Success
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38:24
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In this episode, Howie Chan at Healthy Brand Consulting and Duane Mancini discuss brand development throughout the various stages of a Medtech startup company and so much more. Howie Chan LinkedIn Health Brand Consulting Website Project Medtech Website Duane Mancini LinkedIn
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Episode 161 | Randy Armstrong, CTO at Velentium | Innovations, Breakthroughs, and Challenges in IPG Development
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In this episode, Randy Armstrong at Velentium and Duane Mancini discuss innovations, breakthroughs, and challenges in IPG development and so much more. Randy Armstrong LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn
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Episode 160 | Dan Purvis, CEO & Founder at Velentium | The Importance of Mission, Vision, and Values
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In this episode, Dan Purvis at Velentium and Duane Mancini discuss his background in the Medtech industry, how and why he founded Velentium, the importance of why and who, culture and so much more. Dan Purvis LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn
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Episode 159 | Susan Xu, Principal at WyDus | Author of the Book: Healthcare's Reimbursement Maze
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In this episode, Susan Xu at WyDus and Duane Mancini discuss healthcare in the United States and its reimbursement maze, reimbursement of digital health products, what payers look for, and so much more. Susan Xu LinkedIn Link to Book by Susan Xu Project Medtech Website Duane Mancini LinkedIn
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Episode 158 | Christopher Gates, Director of Product Security at Velentium | Embedded Cybersecurity for Medical Devices
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In this episode, Christopher Gates at Velentium and Duane Mancini discuss embedded cybersecurity for medical devices, the importance of addressing cybersecurity early, hackers, and so much more. Christopher Gates LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn
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Episode 157 | Chris Hanna, CEO at Pacific Therapy Access, Kathleen O'Neill, Director, Health Policy and Reimbursement at Pacific Therapy Access | Reimbursement 101
53:27
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In this episode, Chris Hanna at Pacific Therapy Access, Kathleen O'Neill at Pacific Therapy Access and Duane Mancini discuss the reimbursement process of medical technologies in the United States, the coding system, why reimbursement pathway is so important and so much more. Chris Hanna LinkedIn Kathleen O'Neill LinkedIn Pacific Therapy Access Webs…
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Episode 156 | Brendan Boland, Co-Founder at Loci Orthopaedics, Fionn Lahart, Co-Founder and CEO at LUMA Vision, and Gerard Insley, Chief Science Officer at PBCbiomed | Spin the Globe: Ireland
50:47
50:47
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In this episode, Brendan Boland at Loci Orthopaedics, Fionn Lahart at LUMA Vision, Gerard Insley at PBCbiomed and Duane Mancini discuss what each one of them are working on, the Medtech ecosystem in Ireland, what makes the ecosystem so strong, their favorite Irish Whiskey and so much more. Brendan Boland LinkedIn Loci Orthopaedics Website Fionn Lah…
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Episode 155 | Rich Mazzola, CFO at Project Medtech | Introducing the New Host of the Funding Medtech Podcast powered by Project Medtech
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In this episode, Rich Mazzola and Duane Mancini discuss Rich's background in the Medtech space, what we can expect from him as host of the Medtech Money podcast series and so much more. Rich Mazzola LinkedIn Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn
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Episode 154 | Giovanni Lauricella, Co-Founder and Managing Partner at Lifeblood Capital | A Recap of Giovanni's Time as Host of the Medtech Money Podcast powered by Project Medtech
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In this episode, Giovanni Lauricella and Duane Mancini discuss Giovanni's time as the @medtech money podcast host, what he learned, the connections he made along the way and so much more. Giovanni Lauricella LinkedIn Lifeblood Capital Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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Episode 153 | Devon Campbell, Founder and Managing Director at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: Due Diligence
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In this episode, Devon Campbell and Duane Mancini discuss the due diligence process, what you need to be prepared to answer as a startup company, common errors, recommendations, and so much more. Devon Campbell LinkedIn Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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Episode 152 | Edward Steakley, Managing Partner at Cognition IP and Devon Campbell, Founder at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: IP and Trade Secrets
59:37
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In this episode, Edward Steakley, Devon Campbell and Duane Mancini discuss intellectual property, patents, trade secrets, overall strategy around these topics, why they are important, and so much more. Edward Steakley LinkedIn Devon Campbell LinkedIn Cognition IP Website Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini …
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Episode 151 | Nikki Batista, Vice President at MCRA and Devon Campbell, Founder and Managing Director at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: Regulatory
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In this episode, Nikki Batista, Devon Campbell and Duane Mancini discuss the merger of regulatory and business strategy, allowing business to lead decisions not regulatory, global regulatory strategy, how to communicate with the FDA, and so much more. Nikki Batista LinkedIn Devon Campbell LinkedIn MCRA Website Prodct Website Project Medtech Website…
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Episode 150 | Sean McKibben, Stefan Agamanolis, Rich Mazzola and Aaron TenHuisen at Project Medtech | The Expansion of Project Medtech Consulting & Advisory
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In this episode, Sean McKibben, Stefan Agamanolis, Rich Mazzola, Aaron TenHuisen and Duane Mancini discuss the problem they saw in the industry, the mission of Project Medtech, the growth and expansion of Project Medtech's consulting and advisory services and so much more. Sean McKibben LinkedIn Stefan Agamanolis LinkedIn Rich Mazzola LinkedIn Aaro…
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Episode 149 | Lissa Tallman, Executive Vice President at Flashfield | Market Research
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In this episode, Lissa Tallman and Duane Mancini discuss market research, when you should think about doing market research, the different kinds of market research, AI and Machine Learning in Market Research and so much more. Lissa Tallman LinkedIn Flashfield Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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Episode 148 | Salvatore Buscemi, CEO and Co-Founding Partner at HRN | Partnering with Family Offices to Take Your Product to Market
35:04
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In this episode, Salvatore Buscemi and Duane Mancini discuss his new book called “Investing Legacy: How the .001% invests”, family offices and how they evaluate opportunities and so much more. Salvatore Buscemi LinkedIn HRN Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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Episode 147 | Isaiah Kaiser, Co-Founder & CEO at Auxilium Health | PhD to Entrepreneur: Taking on Wound Care
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In this episode, Isaiah Kaiser and Duane Mancini discuss the technology they spun out of University of Akron, how his PhD helped him with his entrepreneurial skills, finding non-dilutive capital, their experience with the iCorp program, working with the University so that both parties win, what he has learned so far during his early journey of entr…
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Episode 146 | Neal Piper, Founder & CEO at Luminoah | Being Obsessed with a Problem...not a Solution
43:28
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In this episode, Neal Piper and Duane Mancini discuss his personal tie to the problem they are solving, the importance of culture, the focus on team and problem, advice for raising capital, not delaying hard conversations, and so much more. Neal Piper LinkedIn Luminoah Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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Episode 145 | Katrina Rogers, CEO at Evergreen Bioscience Innovation Cluster | Growing the Medtech Ecosystem in the Pacific Northwest
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In this episode, Katrina Rogers and Duane Mancini discuss the ecosystem in the Pacific Northwest of the United States, the new innovation cluster she is leading, her experience in quality and so much more. Katrina Rogers LinkedIn Evergreen Bioscience Innovation Cluster Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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Episode 144 | Meg Powell and Travis Manasco at Bio54 | The Growing Startup Ecosystem in Research Triangle Park (RTP)
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In this episode, Meg Powell, Travis Manasco and Duane Mancini discuss 501 Ventures, Bio54, why don't we see more physicians take the lead at startup companies, the importance of talent for early stage Medtech companies, the growth in research triangle park (RTP) and what makes the ecosystem great, their best pieces of advice for startups, and so mu…
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Episode 143 | James Hamet, CEO at Vistim Labs | Building a Go-To-Market Strategy for an AI Diagnostic
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In this episode, James Hamet at Vistim Labs and Duane Mancini discuss licensing technology from a university, voice of customer, neurodegenerative diseases, the importance of your economic story, why they are focusing on clinical data, and so much more. James Hamet LinkedIn Vistim Labs Website Project Medtech Website Project Medtech LinkedIn Duane …
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Episode 142 | Shannon Hoste, President at Agilis Consulting Group | Human Factors for Digital Health and SaMD
41:09
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41:09
In this episode, Shannon Hoste at Agilis Consulting Group and Duane Mancini discuss her background in Medtech, human factors testing for software as medical device, cognitive systems engineering, IEC 62366 and the FDA guidance document on human factors, and so much more. Shannon Hoste LinkedIn Agilis Consulting Group Website Project Medtech Website…
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Episode 141 | Dennis McWiliams, Partner at Sante Ventures | Operator to Investor: The Apollo Endosurgery Story
53:43
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In this episode, Dennis McWilliams at Sante Ventures and Duane Mancini discuss starting in biotech, what he learned from his first company, being humble and building your team, the story of Apollo Endosurgery, the complicated process of licensing the Apollo IP portfolio, raising money during the great financial crisis, being replaced as CEO and tra…
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Episode 140 | Ben Holmes, CEO at Nanochon | Taking on the "P" (PMA Pathway) Word as a Medtech Startup
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43:59
In this episode, Ben Holmes at Nanochon and Duane Mancini discuss the University of Virginia biomedical engineering program, the importance of understanding the economics of the problem you are trying to solve, the iCorp program, taking on the PMA pathway as a startup, finding capital as a PMA product, what’s next for Nanochon and so much more. Ben…
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Episode 139 | Daniel Hawkins, Founder & CEO at Avail Medsystems | The Shockwave Medical Story: From Startup to a $10+ Billion Market Cap
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אהבתי
55:22
In this episode, Daniel Hawkins at Avail Medsystems and Duane Mancini discuss his background in the medical device industry, his time at Advanced Cardiovascular Systems (Abbot Vascular), Intuitive Surgical, his startup with the founder of Amgen, how he founded Shockwave Medical, his relationship with Antoine Papiernik at Sofinnova Partners, the pro…
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Episode 138 | Arpit Rao, Founder at Ankr Health | Generative AI Will Replace More than 25% of Jobs: Here's How to Save Yours
54:01
54:01
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נגן מאוחר יותר
רשימות
לייק
אהבתי
54:01
In this episode, Arpit Rao at Ankr Health and Duane Mancini discuss chatGPT, how it is going to change healthcare and business, generative AI and general AI, and so much more. Arpit Rao LinkedIn Ankr Health Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn
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Episode 137 | Lindsay Watson, Co-Founder & CEO at Augment Therapy | Physical Therapist to Entrepreneur: Daydreaming Just Enough
38:16
38:16
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אהבתי
38:16
In this episode, Lindsay Watson at Augment Therapy and Duane Mancini discuss gamifying therapy, remote patient monitoring and remote therapeutic monitoring, their partnership with CareSource, her relationship with Sesame Street, go-to-market strategy, culture, the relationship between co-founders and so much more. Lindsay Watson LinkedIn Augment Th…
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Episode 136 | David DeRam, CEO at Greenlight Guru | Company Culture: Mission, Vision, and Values
43:22
43:22
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43:22
In this episode, David DeRam at Greenlight Guru and Duane Mancini discuss what makes teams click, company culture, the Greenlight Guru story, the importance of mission, vision, and value, and so much more. David DeRam LinkedIn Greenlight Guru Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…
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