Category: 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. .
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.
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.
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.
This is a follow up interview to a previous discussion recorded with Dr. Biasiucci for the Yale Medical Software Coursera Class: https://www.youtube.com/watch?v=OhK6AQ3Qyfk (June
2021).
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, CH; 2015. Available from: https://www.iso.org/standard/63179.html
International Electrotechnical Commission (IEC). IEC 62366-2 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices. Geneva, CH; 2016. Available from: https://www.iso.org/standard/69126.html
U.S. Food and Drug Administration (FDA): Center for Devices and Radiological Health. Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff. 2016. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
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 computing for quality systems and medical devices. 2021. Report No.: CR510. Available from: https://array.aami.org/doi/book/10.2345/9781570208225
Securing SaMD & Medical Device Safety on the Ever Changing Cloud: A Conversation With AAMI. Robert Burroughs and Joseph Lewelling of AAMI interviewed Orthogonal’s Randy Horton and Philips’ Pat Baird on their work drafting and standardizing guidance on integrating the #cloud with SaMD. Nov 11, 2022 https://www.youtube.com/watch?v=wJqmuxiOrAo.
Randy Horton. How AI is turning your smartphone into the Swiss Army knife of clinical diagnostics. Bioimaging Sciences Seminar, Yale School of Medicine, April 2023. https://www.youtube.com/watch?v=YXDp4Kf0n8E
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 the Master of Science Software Engineering Program. This interview was recorded Dec 14, 2023.
ISO 13485:2016, Medical devices – Quality management systems – requirements for regulatory purposes. March 2016, International Organization for Standardization. Available from : https://www.iso.org/standard/59752.html
ISO 14971:2019, Medical devices – Application of risk management to medical devices. December 2019, International Organization for Standardization. Available from: https://www.iso.org/standard/72704.html
AAMI TIR 34971:2023, Application Of ISO 14971 To Machine Learning In Artificial IntelligenceÑGuide. March 2023, Association for the Advancement of Medical Instrumentation. Available from: https://doi.org/10.2345/9781570208669.ch1
NIST Secure Product Development Framework. National Institute of Standards and Technology. Available from: https://csrc.nist.gov/projects/ssdf
Overgaard SM, Graham MG, Brereton T, Pencina MJ, Halamka JD, Vidal DE, Economou-Zavlanos NJ. Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions. NPJ Digit Med. Nov 25;6(1):218. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10676432/
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.
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 Certificate Program on Medical Software and Medical AI. The interview was conducted on Nov 30, 2023.