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 197 | Todd Ponsky, Chief Innovation Officer at Cincinnati Children's | The #1 Children's Hospital's Mission: Improving Global Pediatric Health
32:31
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In this episode, Todd Ponsky at Cincinnati Children's and Duane Mancini discuss his background as a pediatric surgeon, his startup company that he launched around education, the changes to the innovation and venture arm of Cincinnati Children's, the importance of having a supportive hospital leadership team for the innovation department, and so muc…
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Episode 200 | Aaron TenHuisen, Rich Mazzola, and Jamie Easterling | Celebrating Project Medtech's Growth and Future Vision
55:07
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In this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much Duane Mancini LinkedIn Aaron TenHuisen LinkedIn Rich Mazzola LinkedIn Jamie Easterl…
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Episode 199 | Rebecca McManus, Commercial Lead at Amethyst Care | Escape the Time Trap: Stop Obsessing Over How Long Everything Takes in Medtech
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In this episode, Rebecca McManus at Amethyst Care and Duane Mancini discusses the technology she is working on out of Trinity College of Dublin, their next 18 months, the innovation scene in Dublin, Ireland, her interest in Northeast Ohio, Adapt Research Center, lessons learned so far, how she overcame the anxiety of how long everything takes in Me…
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Episode 198 | Crystal Weber, Chief Executive Officer at Group 31 | The Importance of Effective Communication: From Pitch Deck to Selling Your Product
41:00
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In this episode, Crystal Weber at Group 31 and Duane Mancini discuss her second career as a marketing expert, how her first career as a nurse prepared her for this role, the importance of tailoring messaging to investors, how to position your product in the healthcare system, and so much more. Crystal Weber LinkedIn Group 31 Communications LinkedIn…
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Episode 196 | Dylan Horvath, Founder & CEO at Cortex Design | Innovations vs. Features: Tips for Designing your Product
50:16
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In this episode, Dylan Horvath at Cortex Design and Duane Mancini discusses how he founded his company, features vs. innovations, lessons learned, common mistakes, and so much more. Dylan Horvath LinkedIn Cortex Design LinkedIn Cortex Design Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Mittal Co…
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Episode 195 | Don Pohl and Sheri Krajewski at NAMSA | Tips to Successfully Navigate Biocompatibility Testing of Medical Devices
48:29
48:29
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In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the glob…
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Episode 194 | Omar Khateeb, Founder at Khateeb & Co. | Growth Marketing in Medtech
1:02:54
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In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more. Omar Khateeb LinkedIn Khateeb & Co. Website State of Medtech Podcast Duane Mancini LinkedIn …
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Episode 193 | Kristen Mittal and Mridul Mittal at Mittal Consulting | Regulatory Consultant vs. Regulatory Strategist
46:23
46:23
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In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneur…
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Episode 192 | Monica Vajani, Executive Director, Medtech Accelerator at mHUB | 80,000+ sq ft Innovation Center in Chicago, Illinois
46:11
46:11
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In this episode, Monica Vajani at mHUB and Duane Mancini discuss her background at Abbott and Medtronic, carrying the bag, early adopters vs. laggers, mHUB, the next cohort of companies for their medtech accelerator, and so much more. Monica Vajani LinkedIn mHub Medtech Accelerator Application mHub LinkedIn mHub Website Duane Mancini LinkedIn Proje…
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Episode 191 | Craig Misrach, President & Chief Executive Officer at UpLyft | Choosing the Right Contract Manufacturer based on Your Stage of Commercialization
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In this episode, Craig Misrach at UpLyft and Duane Mancini discuss what has changed since his last appearance on the podcast, choosing and changing your contract manufacturer based on the commercialization stage, the importance of quality, creative ways to finance your startup, and so much more. Craig Misrach LinkedIn UpLyft LinkedIn UpLyft Website…
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Episode 190 | Hilary Swan, Founder at Rebel Scout Consulting | Medical Device Sales: Keys to a Successful Sale and Implementation
30:20
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In this episode, Hilary Swan at Rebel Scout Consulting and Duane Mancini discuss her background in the medtech space, inside sales vs. outside sales, tips for selling into a hospital, the user journey, the importance of implementation and so much more. Hilary Swan LinkedIn Rebel Scout LinkedIn Rebel Scout Website Duane Mancini LinkedIn Project Medt…
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Episode 189 | Megan Doberstein, CEO at Ignite Medtech | Marketing and Brand Development: Being Persistent and Consistent
41:55
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In this episode, Megan Doberstein at Ignite Medtech and Duane Mancini discuss her background in the medical device space, marketing for a direct to consumer medical device, understanding all your customer profiles, strategically marketing to all of those customers and so much more. Megan Doberstein LinkedIn Ignite Medtech LinkedIn Ignite Medtech We…
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Episode 188 | Tim Lucas, CEO at NeuroTech Institute | A NeuroTech Focused Venture Studio
43:07
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In this episode, Tim Lucas at The NeuroTech Institute and Duane Mancini discuss why Universities have historically struggled to commercialize innovation, the Broad Institute, how he modeled the NeuroTech Institute after it, achieving clinical adoption, and so much more. Tim Lucas LinkedIn The NeuroTech Institute Website Duane Mancini LinkedIn Proje…
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Episode 187 | Kathryn Dougherty, Founder & Owner at KCD & Co | The Intersection of Finance and Marketing
48:26
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In this episode, Kathryn Dougherty at KCD and Duane Mancini discuss her background in the medtech space, the intersection of finance and marketing, upstream and downstream marketing, the difficulties of being an entrepreneur, her best advice for medtech startup companies and so much more. Kathryn Dougherty LinkedIn Project Medtech Podcast Duane Man…
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Episode 186 | Matthew Schonauer, Intellectual Property Lawyer and Anthony Tomusko, Intellectual Property Lawyer at UB Greensfelder | The Art of Protecting Your Product
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In this episode, Matthew Schonauer and Anthony Tomusko at UB Greensfelder and Duane Mancini discuss what led them into being life science-focused IP attornies, the process of engaging an IP attorney, the intangibles an IP attorney can bring to the team, freedom to operate and so much more.
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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
42:32
42:32
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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
34:00
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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
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
35:16
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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
42:59
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)
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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
55:00
55:00
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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
45:13
45:13
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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
54:56
54:56
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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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38:11
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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
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
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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
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
48:32
48:32
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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
38:05
38:05
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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
49:41
49:41
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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
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
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
36:40
36:40
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36:40
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
38:24
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
53:37
53:37
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53:37
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
40:28
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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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41:58
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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
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
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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
50:34
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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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