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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 worked in senior MedTech and Digital Heath roles in industry for 5 years, before returning to academia in 2022.

His research goals are to advance the regulatory science of software as a medical device and AI-enabled medical devices. Innovative digital approaches to healthcare must be accompanied by innovative approaches in regulation to ensure speed to market, to maximum access of patients to life saving treatments whilst ensuring safety on market. His main research interests are in: (i) data sharing and the European Health Data Space; (ii) approaches to market approval of adaptive AI enabled medical devices; (iii) drugdigital/AI-enabled medical device product realisation; (iv) digital/virtual twins: as an organising concept of the future of healthcare.”

Further Reading

Derraz B, Breda G, Kaempf C, Baenke F, Cotte F, Reiche K, Köhl U, Kather JN, Eskenazy D, Gilbert S. New regulatory thinking is needed for AI-based personalised drug and cell therapies in precision oncology. NPJ Precis Oncol [Internet]. Nature Publishing Group; 2024 Jan 30 [cited 2024 Jan 30];8(1):1–11. Available from: https://www.nature.com/articles/s41698-024-00517-w
Gilbert S, Harvey H, Melvin T, Vollebregt E, Wicks P. Large language model AI chatbots require approval as medical devices. Nat Med [Internet]. Nature Publishing Group; 2023 Jun 30 [cited 2023 Jun 30];1–3. Available from: https://www.nature.com/articles/s41591-023-02412-6

Gilbert S and Kather JN. Guardrails for the use of generalist AI in cancer care. Nature Reviews Cancer [Internet]. Nature Publishing Group; 2024 Apr 16 [cited 2024 Apr 16]. Available from: https://www.nature.com/articles/s41568-024-00685-8

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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 company. Prior to that, he was for 2 years an AI R&D division manager at DeNa and for 10 years prior he was a software engineering division manager at General Electric, Japan. Before that, he spent two years as a research software engineer at Yale. The interview was recorded on Dec 6, 2023.

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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 Shorten Timelines, Reduce Risk and Improve Quality [Internet]. Orthogonal; 2020. Available from: https://orthogonal.io/insights/agile/ebook-agile-in-an-fda-regulated-environment/
Association for the Advancement of Medical Instrumentation (AAMI). AAMI TIR45: 2023; Guidance on the use of agile practices in the development of medical device software. Arlington VA: Association for the Advancement of Medical Instrumentation; 2023. Report No.: TIR45. https://webstore.ansi.org/standards/aami/aamitir452012r2018?gad_source=1

Agile Lego Game:
https://www.youtube.com/watch?v=0lA00lDs_R4
https://www.youtube.com/watch?v=7BKPDScVb5U

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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 been in IoT and, notably, he built a telematics platform that was sold to Verizon and now operates as Verizon Networkfleet. Recently he moved into MedTech. He states that there is a lot of overlap between these areas given how medical devices, sensors increasingly make heavy use of cloud analytics platforms. This interview was recorded on Dec
7, 2023.

Further Reading/watching:
Webinar: Crossing the Chasm: Growing Tech Professionals into MedTech Professionals | Orthogonal: https://www.youtube.com/watch?v=nB645qIuLFA
Code Generation AI:
• Github Copilot: https://github.com/features/copilot
Image Generation AI:
• Midjourney https://www.midjourney.com/
• DALL·E https://openai.com/research/dall-e

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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 intersection of insurance and emerging technologies. The interview was recorded on Dec 5, 2023.

Further Reading:
EU AI Act: https://artificialintelligenceact.eu/the-act/
Biden AI Executive Order: https://www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence/
Lior A. Insuring Ai: The role of insurance in artificial intelligence regulation. Harv J Law Technol. 2002;35(2):467–530. Available from: https://jolt.law.harvard.edu/assets/articlePDFs/v35/2.-Lior-Insuring-AI.pdf

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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. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cybersecurity in Medical Devices: Quality Systems and Premarket Submissions. Sep 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions

Healthcare Vulnerability Scoring System (HVSS) Version 1.0 Calculator: https://hvss.online/

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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. January 31, 2024
https://www.linkedin.com/pulse/ai-model-product-elad-walach-abemf

AIDoc. Understanding Recent AI Regulations and Guidelines. January 29, 2024. https://www.aidoc.com/blog/ai-regulations-guidelines/

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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).

Further Reading:

EU AI Act: https://artificialintelligenceact.eu/the-act/
Gilbert S, Harvey H, Melvin T, Vollebregt E, Wicks P. Large language model AI chatbots require
approval as medical devices. Nat Med [Internet]. Nature Publishing Group; 2023 Jun 30.
Available from: https://www.nature.com/articles/s41591-023-02412-6

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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

U.S. Food and Drug Administration. FDA; 2023[Office of the Commissioner. Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/application-human-factors-engineering-principles-combination-products-questions-and-answers

American National Standards Institute. ANSI/AAMI HE 75:2009 (r2018). 2018. Report No.: 75. Available from: https://webstore.ansi.org/standards/aami/ansiaamihe752009r2018?gad_source=1

Lew G, Schumacher RM Jr. AI and UX: Why Artificial Intelligence Needs User Experience. 1st ed. Apress; 2020. Available from: https://www.amazon.com/AI-UX-Artificial-Intelligence-Experience/dp/148425774X/

U.S. Food and Drug Administration (FDA) Center for Devices, Radiological Health. Digital Health Software Precertification (Pre-Cert) Pilot Program. 2023 May. Available from: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program

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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