Episode 238 | Allison Komiyama, Founder of Bluestocking Health | From the FDA to Regulatory Consultant to Medtech Entreprenuer
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 LinkedInBluestocking Health LinkedInBluestocking Health Website“Your Life Depends on It” Book by Talya Miron-Shatz, PhDDuane Mancini LinkedInProject Medtech WebsiteProject 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 LinkedInGiant Shoulders WebsiteLindsey Dinneen LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
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Episode 236 | Amy Rinaldo, Partner at Ward Law Office | Bridging IP, Branding, and Compliance for Medtech Innovators
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 LinkedInWard Law Office WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
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Episode 235 | Leo Eisner, Founder and Principal Compliance & Regulatory Consultant of Eisner Safety Consultants | Navigating IEC 60601 Compliance for Medtech Innovation
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 LinkedInEisner Safety Consultants WebsiteImpacts on IEC 60601-1 WebinarDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
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Episode 234 | Logan McKnight, Founder of GoodKnight Consulting | Developing Effective Leadership in the Medtech Field
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 LinkedInGoodKnight Consulting Website“Mindset: The New Psychology of Success” by Carol Dweck “The Culture Code: The Secrets of Highly Successful Groups” by Daniel CoyleDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.
Ireland