About Yale Certificate in Medical Software and Medical AI: Guest Experts
This is a set of interviews that were recorded as supplementary teaching material for both our new online Yale Certificate Program in Medical Software and Medical AI, and the original Yale/Coursera Class Introduction to Medical Software. The topics cover issues important to medical software and medical artificial intelligence, ranging from regulatory issues, to algorithm development and software engineering, to clinical implementation, and other related areas. We try to keep most of the material at the introductory to intermediate level. We hope that you feel them useful and educational.
These interviews are also available in video form on YouTube. (https://www.youtube.com/watch?v=aeyYc9hCFLE&list=PLF8QgN7ybSHzDGDIPYbQwwdcK9Tqa3Lh7).
For more information on the certificate program see: online.yale.edu/medical-software-ai-program (https://online.yale.edu/medical-software-ai-program)
The audio theme is excerpted from the song “Opening” by Magiksolo. (https://artlist.io/royalty-free-music/song/opening/63838)
The FDA and Software: A Historical Overview with Dr. Donna-Bea Tillman
Dr. Donna-Bea Tillman, a 30-year medical device regulatory expert, provides a historical overview of the FDA's relationship with software, shedding light on the evolving landscape of medical technology regulation.
14 Nov 2024
The Current State of Medical Device AI Regulation with Eric Henry
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 … Read More Read More
23 Oct 2024
Medical Devices, Cloud Services and Regulatory Compliance with Ian Sutcliffe
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 … Read More Read More
26 Sept 2024
In Silico Trials of Medical Devices with Professor Alejandro Frangi FREng
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 … Read More Read More
17 Sept 2024
Integrating AI into a Healthcare Practice with Dr. Vishishit Mehta
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 … Read More Read More
18 Jun 2024
Global Health, Digital Health and AI
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/06/18/global-health-digital-health-and-ai/)
16 Apr 2024
Large Language Model-based Chatbots and Medical Regulation
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. He …
Read More Read More (https://yalepodcasts.blubrry.net/2024/04/16/large-language-model-based-chatbots-and-medical-regulation/)
26 Mar 2024
AI and Medical Software Engineering with Hirohito Okuda
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/03/26/ai-and-medical-software-engineering-with-hirohito-okuda/)
19 Mar 2024
Agile in a Regulated Environment with Bernhard Kappe
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/03/19/agile-in-a-regulated-environment-with-bernhard-kappe/)
12 Mar 2024
Software Development with/and AI with Larkin Lowrey
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/03/12/software-development-with-and-ai-with-larkin-lowrey/)
5 Mar 2024
Emerging Global AI Regulations with Anat Lior
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/03/05/emerging-global-ai-regulations-with-anat-lior/)
27 Feb 2024
Medical Device Cybersecurity with Oleg Yusim
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, …
Read More Read More (https://yalepodcasts.blubrry.net/2024/02/27/medical-device-cybersecurity-with-oleg-yusim/)
20 Feb 2024
Medical AI: From Algorithms to Solutions with Elad Walach
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/02/20/3332/)
13 Feb 2024
The EU AI Act and Medical Device Regulation with Andrea Biasiucci
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 22, 2023. …
Read More Read More (https://yalepodcasts.blubrry.net/2024/02/13/the-eu-ai-act-and-medical-device-regulation-with-andrea-biasiucci/)
6 Feb 2024
Human Factors and Medical Software with Korey Johnson
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 usability engineering to medical devices. Geneva, …
Read More Read More (https://yalepodcasts.blubrry.net/2024/02/06/human-factors-and-medical-software-with-korey-johnson/)
30 Jan 2024
Cloud Computing and Medical Devices with Randy Horton
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/01/30/cloud-computing-and-medical-devices-with-randy-horton/)
23 Jan 2024
Quality Systems and Risk Management with Megan Graham
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/01/23/episode-3-title-quality-systems-and-risk-management-with-megan-graham/)
16 Jan 2024
Regulatory Issues, Clinical Decision Support and AI with Bradley Merrill Thompson
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/01/16/regulatory-issues-clinical-decision-support-and-ai-with-bradley-merril-thompson/)
10 Jan 2024
Healthcare and AI with Dr. Kicky Van Leeuwen
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 …
Read More Read More (https://yalepodcasts.blubrry.net/2024/01/10/healthcare-and-ai-with-dr-kicky-van-leeuwen/)
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