In this episode, Duane Mancini chats with Holly Cotter, a seasoned regulatory quality and clinical consulting expert in MedTech and co-founder of indieMedTech. Holly discusses the inception of indieMedTech, a platform designed to support MedTech professionals, especially independent consultants and startups, with a robust community and marketplace. The conversation delves into Holly's background in biomedical engineering, her hands-on experiences with regulatory submissions, quality management, and clinical trials, and the significance of community and networking within the MedTech space.

• Holly Cotter LinkedIn

• indieMedTech Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

In this episode, Duane Mancini interviews Allison Komiyama, a former FDA reviewer turned successful entrepreneur, who shares her journey from her early passion for biology, through her academic achievements in molecular cell biology and neuroscience, to landing a role at the FDA. She recounts the challenges and lessons learned starting her own regulatory consulting business and scaling it to a successful acquisition. The conversation delves into her latest venture, Bluestocking Health, a medtech hype company aimed at educating the public and professionals about medical technology. They discuss the importance of understanding the FDA’s role, navigating the complexities of bringing new tech to market, and the significance of promoting and celebrating medtech innovations.

• Allison Komiyama LinkedIn

• Bluestocking Health LinkedIn

• Bluestocking Health Website

• “Your Life Depends on It” Book by Talya Miron-Shatz, PhD

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

In this episode, Duane Mancini, Tino Chow, and Lindsey Dinneen dive into the intricacies of pitching, focusing on both the technical and emotional aspects. The conversation highlights the importance of authenticity, building relationships, and the critical role a cohesive and credible team plays in attracting investors. They share strategies for maintaining consistency across your brand and various pitching scenarios, whether it's a pitch competition or casual networking.

• Tino Chow LinkedIn

• Giant Shoulders Website

• Lindsey Dinneen LinkedIn

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Amy Rinaldo LinkedIn

• Ward Law Office Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Leo Eisner LinkedIn

• Eisner Safety Consultants Website

• Impacts on IEC 60601-1 Webinar

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Logan McKnight LinkedIn

• GoodKnight Consulting Website

• “Mindset: The New Psychology of Success” by Carol Dweck 

• “The Culture Code: The Secrets of Highly Successful Groups” by Daniel Coyle

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Kevin Saem LinkedIn

• Zapyrus Website

• Zapyrus H1/Q2 2025 MedTech Financial Report

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Lisa Jacobs LinkedIn

• STRIPES Network Website 

• eCential Robotics Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Walter Haydock LinkedIn

• StackAware Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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.

• Eduardo Palma LinkedIn

• 415 Capital LinkedIn

• 415 Capital Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn