In this episode, Duane Mancini sits down with Amy Rinaldo, Partner at Ward Law Office, to discuss the strategic intricacies of intellectual property in the medtech industry. Amy shares her extensive experience in patent and trademark law, exploring the intersection of IP strategy with regulatory compliance and commercialization. The conversation covers the importance of comprehensive IP planning, the nuances of patents, trademarks, copyrights, and trade secrets, as well as global IP considerations for medtech startups.
In this episode, Duane Mancini sits downs with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IEC 60601 standards. With a career spanning over 40 years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricacies of compliance testing. Discover the complexities of the IEC 60601 updates, the importance of staying informed, and practical advice for medical device manufacturers.
In this episode, Duane Mancini chats with Logan McKnight, a seasoned professional with a vast background in medtech. Logan shares her journey from starting in medical services and neuromonitoring to leadership roles, culminating in the establishment of her consulting firm, GoodKnight Consulting. The conversation dives into the nuances of managing corporate and field leaders, the importance of transparency, communication, and trust in leadership, and the complexities of managing people. Logan also highlights the benefits of feedback mechanisms like 360 reviews and underscores the significance of self-awareness and mindset in effective leadership.
In this episode, Duane Mancini welcomes back Kevin Saem, Managing Director of Zapyrus, for an enlightening discussion on the future of the MedTech industry. The episode delves into the latest trends in medtech funding, highlighting a significant increase in investments outside the U.S., the pivotal role of diagnostic technologies, and the importance of clinical data over revenue for attracting investments. Kevin shares groundbreaking advancements in data analytics and predictive machine learning applications, helping medtech companies and service providers enhance their commercialization strategies and efficiency.
In this episode, Duane Mancini chats with Lisa Jacobs, US President of eCential Robotics and Founder of STRIPES. With over 20 years of experience in orthopedics, robotics, and spine, Lisa delves into her motivations, challenges, and significant career milestones, including her personal connection to orthopedics through her brother's medical condition. The conversation covers her leadership style, emphasizing hands-on mentorship and the importance of not rushing commercialization efforts in startups. Lisa also discusses her organization, STRIPES, a women-focused networking group in medtech offering mentorship and support to help break industry barriers.
In this episode, Duane Mancini sits down with Walter Haydock, founder of StackAware and former Marine Corps intelligence officer, to explore the intersection of AI, cybersecurity, and startup leadership in the healthcare and life sciences sectors. Walter shares how his military background informs his approach to risk, decision-making, and company building, and offers practical strategies for navigating regulatory challenges, implementing effective AI governance, and avoiding common pitfalls as a healthtech founder.
In this episode, Duane Mancini welcomes to the show Eduardo Palma, a senior analyst at 415 Capital, a VC firm specializing in cardiovascular medtech investments. Eduardo shares insights on his background, the emergence of Portugal as a VC hub, and the strategic advantages of their Munich base. The conversation explores 415 Capital’s origin, investment thesis, and their unique focus on clinical-stage PMA-track devices. Highlights include the critical role of clinical data, strategies for effective fundraising, and the importance of teamwork between VCs and startups. Eduardo also discusses the challenges and learning experiences of raising a second fund, offering invaluable advice for startups aiming to stand out in their pitches.
In this episode, Duane Mancini welcomes to the show Jessica Richter, a seasoned medtech executive and board member of MedtechWOMEN. With over 20 years in the industry, Jessica shares her extensive career journey from a medical device sales rep, through various leadership roles at companies like Medtronic, to her current independent consulting role. The discussion covers vital topics such as navigating the US healthcare market, effective sales strategies, the importance of stakeholder alignment, and tips for early-stage entrepreneurs transitioning into leadership roles. Jessica also highlights the critical role of diversity in medtech and shares insights on the mission and initiatives of MedtechWOMEN, a nonprofit organization dedicated to empowering female leaders in the field.
In this episode, Duane Mancini welcomes to the show Dasha Tyshlek, Founder & Chief Strategic Officer of StratCraft. An innovator who's bridging the gap between groundbreaking research and market-ready technologies, Dasha shares her fascinating journey from a science-loving student to a leader in the medtech, biotech, and defense industries. Learn how her experiences at Bridgewater Associates and Micro-Ant have shaped her approach to strategic planning and commercialization, discover the mission behind her consulting firm, StratCraft, and the impact of her Biomedical Frontiers podcast. Plus, get an inside look at the upcoming Disrupt Health conference in Jacksonville, where real-world case studies and innovative discussions promise to elevate the industry.
In this episode, Duane Mancini welcomes to the show Aaron DeGagne, Healthcare Senior Analyst at PitchBook. From quarterly reports to market dynamics, Aaron sheds light on significant healthcare investments, including the rise in surgical tools, devices, and the blurring lines between healthtech and medtech. They delve into the impact of global market uncertainties, interest rates, and the noteworthy deals like Neuralink’s $600 million raise. The conversation also explores themes like consumer health advancements, cancer diagnostics, and the potential shifts in IPO activities.
In this episode, Duane Mancini welcomes Bob Roda, President and CEO of HemoSonics, to discuss the essential components of building a successful and purpose-driven career in the medical device industry. The conversation explores Bob's formative experiences at Johnson & Johnson and Becton Dickson, the critical need for purpose as a guiding principle, and the continuous process of learning and absorbing information. They delve into practical strategies for building brand equity, the intricacies of the selling process, and the thinking behind acquisition strategy and innovation, including his commercial due diligence on CareFusion. The episode also introduces the value of context and being humbled, highlighting how vulnerability creates connection and why adapting your communication style like a "chameleon" is crucial for impactful leadership.
In this episode, Duane Mancini welcomes Brian Morley, CMO of Native Orthopaedics, and returning guest Tino Chow, CEO and Founder at Giant Shoulders, to discuss the critical aspects of building and growing a medtech brand. The conversation explores Brian's journey into Native Orthopaedics, the importance of a clear, operationalized vision for startups, and how to effectively balance creative ideation with execution. They delve into practical strategies for achieving brand alignment, identifying when a rebrand is necessary, and leveraging the digital age for reach. The episode also introduces the valuable concept of visionary and integrator roles, highlighting how a strong brand can serve as an integrator to connect a company's vision with its team and partners.
In this episode, Duane Mancini reconnects with Joseph Mocanu, Managing Partner at Verge HealthTec Fund, for a follow-up to their insightful conversation in episode 103. Joseph shares the significant milestones Verge HealthTec Fund has achieved since their last discussion and offers a glimpse into what we can anticipate in the coming years. The conversation takes a critical look at the venture capital landscape, exploring what needs to change and addressing the often-broken feedback loop between startups and investors. We delve into the importance of developing technologies with a global impact, the strategic advantages of a global approach to collecting clinical data, and navigating the complexities of various healthcare systems across the world. Tune in for a thought-provoking discussion on the future of healthtech investment and innovation.
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.
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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.
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