Yale Certificate in Medical Software and Medical AI: Guest Experts

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Donna-Bea Tillman, a principal consultant at Biologics Consulting Group. She has 30 years of medical device regulatory experience. Prior to joining Biologics Consulting she held numerou...

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program . Our guest is Eric Henry. Mr. Henry is the Senior Quality Systems & Compliance Advisor at the Law Firm King & Spalding and works from his home in the Cleveland area. He joined King &...

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Ian Sutcliffe, who is Principal Solutions Architect at AWS. Prior to that he has many years in the health sciences and tech industry in various software roles as both a developer and ar...

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program . Our guest is Prof Frangi is the Bicentennial Turing Chair in Computational Medicine at the University of Manchester, Manchester, UK, with joint appointments at the Schools of Computer Science and H...

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Dr. Vishisht Mehta who is the Director of Interventional Pulmonology at the Lung Center of Nevada, a division of Comprehensive Cancer Centers and also the Department Chair of Pulmonolog...

Our guest is Riccardo Lampariello, who is a statistician by training and brings almost 25 years of experience in health. He initially spent 10 years in the pharmaceutical industry and then moved into the not-for-profit sector: GAVI, UICC and Terre des hommes. In 2022 he joined D-tree as their CEO. D-tree’s mission is to expand access to high-quality, essential healthcare by enabling better decisio...

Our guest is Prof. Stephen Gilbert ( https://www.linkedin.com/in/stephen-gilbert-31ba2587/ ) who is a Professor of Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden where he teaches and conducts research on regulatory science with a team of colleagues. He is also News and Views Editor, Nature Portfolio – Digital Health. H...

Our guest is Mr. Hirohito Okuda. Mr Okuda has close to 30 years of working experience in the medical device industry. Currently he is a principal AI engineer at Konica Minolta, Japan where he directs AI engineering across the company, leads generative AI adaptation, helps to establish AI guidelines and is also a member of the AI ethics review committee that reviews all AI products across the compa...

Our guest is Mr. Bernhard Kappe ( https://www.linkedin.com/in/bernhardkappe/ ) who is the founder and CEO of Orthogonal ( https://orthogonal.io/ ), a medical device consulting company. He is also a member of the AAMI working group AAMI SW WG-10 Cloud Computing. This interview was recorded on Nov 16, 2023. Further Reading: Kappe B. Accelerating Medical Product Development: Applying Agile Methods to...

Our guest is Mr Larkin Lowrey ( https://www.linkedin.com/in/larkinlowrey/ ). Mr Lowrey has spent the past 30 years in the Software Engineering Product Development space building new product development organizations but also turning around organizations which had fallen into traps resulting in poor quality, execution and products which did not resonate in the marketplace. Most of his career has be...

Our guest is Prof. Anat Lior ( https://drexel.edu/law/faculty/fulltime_fac/Anat%20Lior/ ) who is an assistant professor at Drexel University’s Thomas R. Kline School of Law, an AI Schmidt affiliated Scholar with the Jackson School at Yale and an affiliated fellow at the Yale Information Society Project. Her research interests include AI governance and liability, quantum computing policy, and the i...

Our guest is Mr. Oleg Yusim ( https://www.linkedin.com/in/olegyusim/ ) who is a currently vice-president and Chief Product Security Officer at Illumna. At the time we recorded this video, he was Senior Director of Information Security at Edwards Lifesciences. He has many years of experience in the area cybersecurity in medical devices. This video was recorded Dec 11, 2023. Further Reading: U.S. Fo...

Our guest is Elad Walach ( https://www.linkedin.com/in/elad-walach/ ) who is a founder and CE of AIDoc ( https://www.aidoc.com/ ) Based in Tel Aviv, Aidoc is a leading provider of medical AI solutions. It has 13 algorithms cleared by the U.S. Food and Drug Administration, with over 1,000 hospitals using its products across the globe. Further Reading: Elad Walach. An AI model is NOT An AI Product....

Our guest is Dr. Andrea Biasiucci ( https://www.linkedin.com/in/andreabiasiucci/ ) who is the CEO of confinis ( https://www.confinis.com/ ), a worldwide medical device regulatory consulting company based in Switzerland. Dr. Biasiucci received his Ph. D. in Brain-Computer Interfaces from EPFL in Lausanne, and has been an AI-based neurotech innovator for over a decade. The video was recorded on Nov...

Our guest is Mr. Korey Johnson ( https://www.linkedin.com/in/koreyrjohnson/ ), Managing Partner at Bold Insight ( https://boldinsight.com/ ), which is a consulting company focusing on User Experience and Human Factors research. The interview was recorded on Dec 15, 2023. Further Reading/watching: International Electrotechnical Commission (IEC). IEC 62366-1 Medical devices – Part 1: Application of...

Our guest is Mr. Randy Horton, who is the Chief Solutions Officer of Orthogonal ( https://orthogonal.io/ ), a medical device consulting company. He also co-chairs the AAMI working group AAMI SW WG-10 Cloud Computing. The video was recorded on Dec 7, 2023 Further Reading/watching: Association for the Advancement of Medical Instrumentation (AAMI). AAMI/CR510:2021; Appropriate use of public cloud com...

Our guest is Ms. Megan Graham who is an experienced medical software quality and regulatory consultant, focusing on digital health. Ms. Graham also serves on a number of international standards committees including most recently AAMI SW WG-10 Cloud Computing. She is also an adjunct faculty member at the University of Minnesota where she teaches in the Master of Science Software Engineering Program...

Our guest is Attorney Bradley Merrill Thompson RAC ( https://www.linkedin.com/in/bradleymerrillthompson/ ) who is a partner at Epstein Becker and Green P.C. At the firm, he leads the AI practice and serves in the medical device, digital health, and combination product practices. This video was recorded on Nov 28, 2023. Further Reading: Thompson BM, Snyder LS. FDA Oversight of AI Software Developed...

Our guest is Dr. Kicky van Leeuwen, who is the founder of AIforRadiology.com, a webpage providing objective insights into what AI products for healthcare professionals are on the market. She is also a cofounder and consultant at Romion Health, a company that aids AI procurement and implementation. This video is part of a series of guest expert interviews that we recorded for the new Yale Certifica...