POPULARITY
Hosted by duane mancini
2 episodes with duane mancini
2 episodes with duane mancini
In this episode, Duane Mancini is joined by Harrison Lands, Director of Translational Sciences at UPMC Enterprises. Harrison brings a unique perspective, shaped by his background as a physician, MBA, consultant, and now investor. We delve into the workings of UPMC Enterprises, exploring their investment thesis – the who, what, how much, when, and how their fund operates. Harrison also sheds light on the powerful advantages of UPMC's payer/provider integrated medical system and its impact on fostering innovation. The conversation touches on the vibrant Pittsburgh life science community, Harrison's time at the University of Virginia, and insights from CvilleBioHub. Tune in to understand how a major integrated health system strategically invests and drives translational science forward.Harrison Lands LinkedInUPMC Enterprises WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
In this episode, Duane Mancini sits down with Isaiah Kaiser, Co-Founder and CEO of Auxilium Health, and Elyse Ball, Vice President of Programming at Bounce Innovation Hub. Fresh off Auxilium Health's exciting $1.5M oversubscribed pre-seed round and new office at Cleveland Clinic, Isaiah returns to share their journey since his first appearance in episode 147. Elyse discusses the vital role of Bounce Innovation Hub in supporting startups and how her journalism background aids in her work. Together, they delve into navigating the regional iCorp program and the JumpStart accelerator, offering invaluable advice for raising capital and maneuvering the startup landscape. Tune in to hear their insights and get a glimpse into Auxilium Health's next major milestones.Isaiah Kaiser LinkedInElyse Ball LinkedInDuane Mancini LinkedInAuxilium Health WebsiteBounce Innovation Hub WebsiteProject Medtech WebsiteProject Medtech LinkedIn
In this episode, Duane Mancini interviews Devon Campbell, Christie Johnson, and Dan Tipaldo to continue the theme from episodes 207, 208, and 209 about how startups can effectively 'do it yourself' when budgets are tight, this episode tackles the next frontier: Artificial Intelligence. We acknowledge that resource-strapped startups need to be resourceful, but how can AI help avoid costly mistakes and actually accelerate progress? Join us as we explore practical ways startups can leverage various types of AI – often at low or no cost – to improve internal processes, support essential tasks, and ultimately keep moving the needle forward without breaking the bank. Tune in to learn how AI can become a powerful tool in your startup's DIY toolkit.Devon Campbell LinkedInChristie Johnson LinkedInDan Tipaldo LinkedInDuane Mancini LinkedInProdct WebsiteProject Medtech WebsiteProject Medtech LinkedIn
In this episode, Duane Mancini interviews Joao Rezende-Neto on his remarkable journey through the global landscape of medicine and innovation. From medical training in Brazil to a trauma fellowship in the US, exposure to Boston's cutting-edge medical advancements, and experiences in Canada, this episode explores the unique insights gained from navigating diverse healthcare systems. Discover how these international experiences spurred the drive to bring innovative solutions across borders, adapting ideas from Boston for Brazil and vice versa. We delve into the critical considerations of clinically relevant research, fostering effective collaborations between clinicians and business leaders, and the balance of scientific rigor with economic impact. Hear firsthand about the challenges and rewards of being a physician entrepreneur dedicated to advancing healthcare on a global scale. Tune in for a unique perspective on the intersection of global medicine, innovation, and entrepreneurial spirit.Joao Rezende-Neto LinkedInInventoRR Md LinkedInAbClo WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website
In this episode, Duane Mancini interviews Kelly Collier at LifeX on the dynamic life science startup ecosystem thriving in Pittsburgh. We explore the unique synergy between major academic institutions like the University of Pittsburgh and Carnegie Mellon University, and healthcare giants such as UPMC and Allegheny Health Network. Discover Kelly's entrepreneurial journey and learn how LifeX provides crucial support and programming for emerging life science companies. We also discuss the common pitfalls startups face and the specific advantages Pittsburgh offers to innovators. Tune in to understand the key ingredients fueling Pittsburgh's rise as a life science hub.Kelly Collier LinkedInLifeX WebsiteDuane Mancini LinkedInProject Medech WebsiteProject Medtech LinkedIn
In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybersecurity throughout the product lifecycle, rather than treating it as an afterthought. They both discuss the significance of robust design controls, the pitfalls of inadequate planning, and the power of leveraging professional networks. The conversation highlights how regulatory considerations should inform decisions across all business functions, and the crucial role of thorough market research in achieving success. Tune in for valuable insights on building compliant, secure, and market-ready medical devices.Niki Caporali Spaniel LinkedIn Chad Gibson LinkedInCMD WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Duane Mancini delves into the life science ecosystem in Kentucky with Christin Godale, Executive Director at LifeSciKY, and Nicholas Lyktey, Chief of Laboratory Operations at Gravity Diagnostics. Christin discusses the collaborative, bipartisan efforts driving innovation in the Commonwealth, including the launch of strategic initiatives and the benefits available to participating companies. Nicholas shares the remarkable growth story of Gravity Diagnostics, from a startup with 30 employees to a powerhouse of 330, highlighting the challenges and successes of rapid scaling. We also explore the partnership between Project Medtech and LifeSciKY and how it is shaping the future of the industry in Kentucky. Tune in to discover how strategic investments and collaborative partnerships are fueling a life science revolution in the heart of the Bluegrass State. Christin Godale, PhD LinkedInNicholas Lyktey LinkedInDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Matt Sokany joins Duane Mancini at Project Medtech to share his extensive experience in the medtech industry, from his time at Ethicon Endosurgery (Johnson & Johnson) to his impactful journey in the startup world. Matt details his strategic approach to building successful companies, including his remarkable exit with New Wave Surgical, which raised less than $3M and sold for $115M. Matt also discusses his leadership at Standard Bariatrics, emphasizing the importance of setting quarterly and two-year goals, fractionalizing key departments like CFO and regulatory/quality, and securing strong legal and board support. He highlights the crucial role of company culture, clear communication, and the necessity of over-funding to navigate the unpredictable startup landscape. Tune in for invaluable insights on building a thriving medtech startup from a seasoned industry leader. Matt Sokany LinkedInDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Tim Grace, Managing Partner at Techstars Columbus, joins Duane Mancini to unpack the dynamic world of startup acceleration and venture funding. Tim shares his journey from a tech background to leading a pivotal Techstars program, and discusses the creation of the LongJump venture fund. We delve into the origins and growth of Techstars Columbus, exploring the successes of its various cohorts and the unique ecosystem it fosters. Tim provides invaluable insights into common startup pitfalls, particularly the critical mistake of neglecting customer validation. We also cover essential strategies for preparing for fundraising, and the key factors investors look for. Tune in to gain a behind-the-scenes look at how Techstars Columbus is shaping the future of innovation and entrepreneurship in the Midwest.Tim Grace LinkedInTechstars LinkedInTechstars WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Antony Watson, COO of Xenocor, joins Duane Mancini to share his journey from Medtronic sales rep to startup founder. Antony discusses his experience in the operating room, observing surgical cases firsthand, and how this unique perspective shaped his leadership approach and ultimately prepared him to launch and lead Xenocor. Discover how valuable lessons learned in the field can translate to success in the startup world. Tune in for insights on transitioning from a corporate environment to the challenges and rewards of entrepreneurship in the medtech industry.Antony Watson LinkedInXenocor LinkedInXenocor WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Yaky Yanay, CEO at Pluri, joins Duane Mancini to explore the captivating world of regenerative medicine and the unwavering resilience required to lead in the life sciences. We delve into the profound power of cells and how Yaky's deep scientific understanding fuels Pluri's entrepreneurial success. Yaky shares invaluable insights on work-life integration, the gradual discovery of one's authentic CEO voice, and the undeniable truth that a strong management team is a company's greatest asset. We also discuss the crucial role of cultivating long-term relationships and the enduring passion that drives innovation in this vital field. Tune in to learn how Yaky navigates the complexities of entrepreneurship while harnessing the incredible potential of cellular therapies at Pluri.Yaky Yanay LinkedInPluri WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Tino Chow, CEO and Founder of Giant Shoulders, joins Duane Mancini for a deep dive into the power of branding in the medtech industry. 1 Tino, a "three-headed monster" with experience in the military, industrial design, and business, shares his expertise on building a brand strategy that empowers "on-brand" decisions, even in the absence of leadership. 2 Discover how to leverage your brand as a tool, navigate the different phases of brand development, and connect with your audience on a personal and emotional level. Tune in for valuable insights on scaling your brand internally and externally and creating a company culture where everyone embodies the brand's values.Tino Chow LinkedInGiant Shoulders WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Susan Xu, Principal at WyDus, joins Duane Mancini to unravel the complexities of reimbursement in the digital health landscape. Susan explains how Medtech startups can navigate the system to get paid for their innovations, covering everything from Health IT and wearables to telehealth and AI. Learn about the crucial role of diagnosis and treatment, key codes like RPM, and the importance of clinical data in securing reimbursement. Tune in for expert insights and ensure your digital health venture gets the financial support it deserves.Susan Xu LinkedInDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Tino Chow, Founder, and CEO at Giant Shoulders, join Duane Mancini to discuss building a strong Medtech brand without big budgets. Learn how to develop a compelling brand strategy, create a professional website on a shoestring budget, design impactful pitch decks, and maximize your brand's reach with limited resources. Tune in for actionable insights and create a powerful brand identity that sets your Medtech startup apart.Devon Campbell LinkedInTino Chow LinkedInDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website Midwest Showcase Registration
In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Eric O'Dell, Consultant at Project Medtech, join Duane Mancini in a must-listen for bootstrapped Medtech founders! This episode provides a DIY guide to managing your startup's finances without hiring expensive professionals. Learn how to set up bank accounts, choose the right corporate structure, master basic accounting with QuickBooks and spreadsheets, manage your cap table, and navigate taxes. Tune in for actionable advice and build a strong financial foundation for your Medtech venture, even on a limited budget. Devon Campbell LinkedIn Eric O'Dell LinkedIn Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Midwest Showcase Registration
In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Tom Morgan, Chief Scientific Officer at myBiometry, join Duane Mancini for a practical discussion on optimizing early development for Medtech startups.Devon and Tom highlight the crucial role of organization, process, and software in driving efficiency and success, even before a startup officially launches. They delve into the importance of defining direction, utilizing tools like Lucid, Coggle, Monday, and Notion, and implementing robust ELNs.Learn how to foster a culture of quality and compliance from the outset, while remaining scrappy and resourceful. Gain valuable insights into maximizing productivity and laying a strong foundation for Medtech innovation. Tune in for actionable strategies to streamline your lab practices and accelerate your development journey. Devon Campbell LinkedIn Tom Morgan LinkedIn Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Midwest Showcase Registration
In this episode, Simon Malpas, CEO of Kitea Health, joins Duane Mancini to share his incredible journey from blood pressure researcher to Medtech CEO. Simon details Kitea Health's innovative brain pressure implant, revealing the challenges and triumphs of navigating clinical trials and the FDA's PMA process as a startup.Hear firsthand accounts of Kitea's dedication – from attending every surgery during their pilot study to building a strong company culture. Simon discusses the critical role of fundraising, strategic planning, and execution in achieving success in the Medtech industry. Tune in for invaluable insights into leadership, perseverance, and the future of medical technology. Simon Malpas LinkedIn Kitea Health LinkedIn Kitea Health Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Midwest Showcase Registration
In this episode, Kirk Petyo at Talent Factory Recruiting and Duane Mancini discusses his background in recruiting, how startups attract talent, the biggest mistakes companies make in hiring, managing company culture, implementing a successful onboarding process, and so much more. Kirk Petyo LinkedIn Talent Factory Recruiting LinkedIn Talent Factory Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Midwest Showcase Registration
In this episode, Shalabh Gupta at Unicycive Therapeutics and Duane Mancini discuss going from a practicing physician to a biotech entrepreneur, why he made the switch, lessons learned in his career, how to think about your career long term and not short term, how he took his company public, measuring success, his best advice and so much more. Shalabh Gupta LinkedIn Unicycive Therapeutics LinkedIn Unicycive Therapeutics Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Midwest Showcase Registration
In this episode, Eric Eskey at Dark Horse Works and Duane Mancini discuss his background as an engineer, understanding what your customer wants, recommended books about innovation, behavioral economics, early adopters vs. laggers, common mistakes, his best advice to entrepreneurs, and so much more. Eric Eskey LinkedIn Dark Horse Works LinkedIn Dark Horse Works Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Beginski Wegner & CO Rook Quality Systems
In this episode, Staci Miller at Gen UX Consulting and Duane Mancini discusses her background as a fashion designer, cognitive psychology, how she got into human factors testing, what she learned from her time with Medtronic and Abbott, and so much more. Staci Miller LinkedIn Gen UX Consulting LinkedIn Gen UX Consulting Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Beginski Wegner & CO Rook Quality Systems Kymanox
In this episode, Emma Scharfenberger Off at CincyTech and Duane Mancini discuss her background as an M&A lawyer, who is CincyTech and what they are focused on, how to leverage your board, decision-making within startup companies, bridge rounds, how to create value and so much more. Emma Scharfenberger Off LinkedIn CincyTech LinkedIn CincyTech Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Beginski Wegner & CO Rook Quality Systems
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 Easterling LinkedIn Project Medtech LinkedIn Project Medtech Website Rook Quality Systems Beginski Wegner & CO Kymanox LinkedIn
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 Medtech, and so much more. Rebecca McManus LinkedIn Amethyst Care Start Up Project LinkedIn Amethyst Care Start Up Project Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Mittal Consulting Rook Quality Systems Beginski Wegner & CO
In this episode, Crystal Weber at Grouup 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 Group 31 Communications Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Mittal Consulting Rook Quality Systems Beginski Wegner & CO
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 much more. Todd Ponsky LinkedIn Cincinnati Children's LinkedIn Cincinnati Children's Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Mittal Consulting Rook Quality Systems Beginski Wegner & CO
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 Consulting Rook Quality Systems Beginski Wegner & CO
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 globe, common mistakes and so much more. Don Pohl LinkedIn Sheri Krajewski LinkedIn NAMSA LinkedIn NAMSA Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Mittal Consulting Rook Quality Systems Kymanox
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 Project Medtech LinkedIn Project Medtech Website
In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO of Project MedTech, to discuss the importance of agility, strategic planning, and value creation for life science startups. Duane shares his insights on effective fundraising, the vital role of treating consultants as team members, and the need for startups to optimize marketing and value proposition in the healthcare ecosystem. He also delves into the significance of building a unique company culture and the phased approach to implementing quality management systems. This conversation is essential for MedTech professionals ready to take their idea from concept to commercialization, offering practical advice and real-world examples to navigate the complex landscape of medical technology innovation.About the Factor:The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry. About Kymanox:Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product's life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.The Factor is edited and produced by Earfluence.
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 entrepreneurs, and so much more. Kristen Mittal LinkedIn Mridul Mittal LinkedIn Mittal Consulting LinkedIn Mittal Consulting Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website
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 entrepreneurs, and so much more. Kristen Mittal LinkedIn Mridul Mittal LinkedIn Mittal Consulting LinkedIn Mittal Consulting Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website
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 Project Medtech LinkedIn Project Medtech Website
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 Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website
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 Medtech LinkedIn Project Medtech Website
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 Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website
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 Project Medtech LinkedIn Project Medtech Website
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 Mancini LinkedIn Project Medtech LinkedIn
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.
In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.
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.
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.
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.
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.
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.
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.
© 2020-2025 Ivy Podcast Discovery LLC
