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.

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.

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.

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.…

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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

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

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

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

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

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

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

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…

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…

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

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…

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…

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 …

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…

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…

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…

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…

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…

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…

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…

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…

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 …

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…

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…

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…

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…

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

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…

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…

In this episode, Arlen Meyers and Duane Mancini discuss Sick Care vs. Healthcare, digital therapeutics, value based care vs. fee for service care, clinical advisor boards, and so much more. Arlen Meyers LinkedIn SOPE Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, David Narrow and Duane Mancini discuss the stagnant innovation in dialysis, reimbursement strategy, the strategy behind a limited market release, identifying various stakeholders and how they are incentivized, the importance of building your team, licensing from an University, and so much more. David Narrow LinkedIn Sonavex Website…

In this episode, Bryan Stewart and Duane Mancini discuss how he found non-dilutive capital, HMO Labs, what pieces of information he took from his diverse background to use in his startups, how do you take advantage of accelerators and incubators, his military background and how it prepared him to be an entrepreneur, the importance of your founding …

In this episode, Ty Hagler and Duane Mancini discuss industrial design, Trig, their current program called med+design by Trig, how to approach innovation for healthcare, and so much more. Ty Hagler LinkedIn Trig Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Martin Muller and Duane Mancini discuss what makes Philips Ventures unique, his background and the differences between private equity and venture capital, evaluating a company, what spaces he is most excited about, and so much more. Martin Muller LinkedIn Philips Ventures Website Project Medtech Website Project Medtech LinkedIn Dua…

In this episode, Leah Brownlee and Duane Mancini discuss their strategy to getting through the FDA in 90 days from submission, who they have raised money so far and how they are different, her background in legal and how it prepared her for a leadership role, the biggest mistakes a startup can make, why they are a LLC over a Delaware C-Corp, how to…