Episode 218 | Niki Caporali Spaniel and Chad Gibson at CMD Medtech | Navigating Medtech Regulations: Post Market Clinical Follow-up to Cybersecurity

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

⁠Jana Montgomery LinkedInActiVie LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠Duane 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