LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices

Summary“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned medical device human factors and UI design consultant, about how artificial intelligence is changing the practice of usability engineering in MedTech. Jonathan brings a rare perspective to the discussion, blending decades of experience in user interface design, human factors, and medical device development.The conversation explores a central tension facing the industry today: while AI introduces new interaction patterns, trust challenges, and potential safety risks, the core responsibility remains unchanged - understand the user, understand the context of use, and design for safe, effective human interaction. Jonathan also shares where he sees real promise, including AI-supported training, surgical planning, and stronger cross-functional collaboration across risk, quality, regulatory, engineering, and human factors teams.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Introduction02:53 Why AI changes the environment, but not the fundamentals of human factors05:46 Transparency, over-reliance, and helping clinicians stay vigilant09:36 AI-strengthened training and the shift from training to competence13:19 Promising AI use cases, especially in surgical planning and clinician support15:38 The future of human factors: creativity, collaboration, and new evaluation methods23:30 Jonathan’s upcoming workshop on advanced human factors and use-related risk26:45 Final takeaways: stay grounded in the user, fundamentals, and teamworkIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Start Treating Human Factors as Science, Not Art.LTR: Understanding Human Factors for AR/VR Applications in MedTech.LTR: LTR Risk Coach - AI-Powered Decision Support Tool.Key Takeaways* AI-enabled devices do not eliminate the need for strong human factors fundamentals; they make them more important.* One of the biggest emerging risks is lack of transparency around what the AI is doing and how users should interpret its output.* Accuracy alone is not enough; teams must design for the reality that AI can fail and users must remain appropriately vigilant.* AI may create meaningful opportunities to improve training, making it more interactive, adaptive, and competence-focused.* Some of the most promising applications of AI are those that strengthen clinician judgment rather than replace it.* Human factors professionals will need more creativity to anticipate novel use errors, misuse, and complex real-world interactions.* Conventional usability testing may not be enough for AI-enabled systems, especially when risks like habituation emerge over time.* The best outcomes will come from closer collaboration across human factors, engineering, risk management, quality, regulatory, and safety teams.KeywordsHuman factors, usability engineering, AI in medical devices, machine learning, transparency, clinician vigilance, use-related risk, AI training, competence, surgical planning, usability testing, cross-functional collaborationAbout Jonathan KendlerJonathan Kendler is a medical device human factors and UI design consultant with more than 20 years of experience supporting the development of healthcare products, including dialysis machines, infusion pumps, glucose monitors, and patient monitoring systems. He is Principal Consultant at Curiolis and previously co-founded Wiklund Research & Design, which was later acquired by UL.Jonathan has authored numerous articles on usability engineering and co-authored Usability Testing of Medical Devices and Designing for Safe Use. He has also taught graduate-level courses in user interface design at Tufts University and delivered workshops and lectures on usability engineering across North America, Europe, and Asia.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe