Project Medtech

In this episode, Duane Mancini sits down with Katie Brinkman to discuss the nuances of biocompatibility, the critical role of biological evaluation plans, and the evolving regulatory landscape, including the importance of risk assessment. Katie also shares her experience with biocompatibility evaluation during significant regulatory changes such as EU MDR remediation and the 10993 standard updates.

• Katie Brinkman LinkedIn

• Hohenstein Website

• Hohenstein Group LinkedIn

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini speaks with Matt Wunzin, a biomedical engineer from Ohio with nearly 20 years of experience in the medtech industry. Matt shares his career journey from earning his degree at the University of Akron to working at various medical device companies, both large and small, and also discusses his transition to consulting with his firm, Five Design and Development. He shares the importance of quality management and documentation in the medtech field, and highlights the opportunities available in Ohio's medtech ecosystem.

• Matt Wunzin LinkedIn

• Five Design & Development Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Duane Mancini chats with Michael Challenor to discuss his entrepreneurial journey in the medtech industry, starting from his early passion for invention through his pivotal experiences in the Stanford Biodesign program in Perth, to co-founding Vital Trace. He highlights his current venture, Innovate Medtech, which supports medtech startups with grants, fundraising, and product development. Michael shares valuable insights into the Australian medtech ecosystem, the significance of team and culture, and offers crucial advice for aspiring medtech entrepreneurs.

• Michael Challenor LinkedIn

• Innovate Medtech

• AusMedtech 2026

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Duane Mancini interviews Spencer Jones, a registered nurse turned medtech entrepreneur. Spencer recounts his journey from bedside nursing to founding two medtech companies, sharing valuable advice on navigating the often complex medtech landscape, including the critical role of thorough customer discovery and strategic vendor relationships in mitigating commercial risks. He also introduces XO MedTech, a training and community platform for medtech innovators, and MedTech Vendors, an AI-driven platform designed to connect medtech teams with ideal service providers.

• Spencer Jones LinkedIn

• XO Medtech

• Medtech Vendors

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Duane Mancini welcomes Emily Adams, Co-Founder of Leading with Human Design, who shares her remarkable journey from growing up in the Amish culture to becoming a leader in the tech and consulting world. Emily details her escape at 17, her transition into the corporate world, her rapid rise in the automotive manufacturing industry, and her healing journey through therapy and powerlifting, which led her to discover human design. Now, with her tech platform, she helps teams understand their unique working and decision-making styles to improve leadership and team dynamics.

• Emily Adams LinkedIn

• Leading with Human Design Website

• “From Choice to Change” Book

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

Duane Mancini welcomes Ben Fogarty, a design generalist and strategist and founder partner at Council. Ben shares his journey from an art student to leading an independent design practice working with startups and Fortune 500 companies. The conversation delves into the vital role of design thinking in problem-solving, the importance of internal and external brand alignment, and crafting clear, compelling narratives crucial for success in the MedTech industry.

• Ben Fogarty LinkedIn

• Council Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

This special episode of the podcast is a recording of a panel discussion that took place at the 2025 Ohio VC Fest powered by @JumpStart Inc. entitled "AI-Driven Healthcare: The Heartland Advantage." Panelists include Michael Dalton (CEO & Founder at @Ovatient), Kaleigh Gallagher (VP of Tech Services & Network Management at @JumpStart), Matthew Zenker (Director of Tech Partnerships & Investments at @University Hospitals Ventures), Jennifer Owens (Senior AI Program Administrator at @Cleveland Clinic), and moderated by Duane Mancini. The conversation dives into the rapidly-growing AI-driven healthcare innovation in the Midwest, exploring the unique advantages the region faces. The discussion covers various topics including talent acquisition, clinical validation, partnerships with healthcare systems, and the role of data in accelerating growth.

• Michael Dalton LinkedIn

• Kaleigh Gallagher LinkedIn

• Matthew Zenker LinkedIn

• Jennifer Owens LinkedIn

• JumpStart Inc. Website

• Duane Mancini LinkedIn

• Project Medtech Website

• Project Medtech LinkedIn

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