LTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices

Summary“Talk to the people you are building the device for. Assumptions may speed development, but they often miss the human realities that determine whether a product succeeds or fails.”In this Let’s Talk Risk! conversation, host Dr. Naveen Agarwal sits down with Hannah Walter to explore the human side of medical technology. From robotic surgery consoles to AR/VR-assisted procedures, Hannah explains why human-machine interaction has become a critical design priority, and why early conversations about inclusivity can make or break product safety and adoption.They discuss how differences in motion sickness between male and female users, or colorblindness among technicians, can introduce hidden usability risks if overlooked. Hannah emphasizes the value of partnering with universities, learning from real users, and fostering open feedback loops between engineers and healthcare professionals.Her message is clear: by recognizing human variability, building empathy into design, and communicating early, teams can create safer, more effective medical devices, and avoid costly human factors failures that derail regulatory approval.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:30 Introducing Hannah Walter02:39 Human Factors in Emerging Technologies05:25 Behavioral Adaptation in Virtual Environments07:50 Motion Sickness and Gender Differences10:45 Inclusive Design and Colorblindness13:32 Design Evolution and Adaptation17:18 Early Human Factors Conversations19:54 Practical Strategies for Inclusivity20:59 Standards, Guidance, and Research24:31 Key Takeaways and Closing ReflectionsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Think of human factors for AI as levels of automation.LTR: Understanding human factors aspect of AR applications in MedTech.LTR: Medical device recalls deep dive series - Part 1.Key Takeaways* Human factors must be integrated early, not treated as a final test.* Inclusivity isn’t optional - gender, color perception, and physical comfort all affect usability and safety.* Failure examples (e.g., color-blind-unfriendly devices) can be powerful motivators for change.* Academic partnerships can extend research beyond product-development constraints.* AR/VR environments highlight motion-sickness differences that designers must account for.* The FDA cites human-factors issues as a leading reason for product-clearance delays.* Iconography, feedback cues, and adaptive interfaces reduce user error.* Open dialogue with nurses, lab techs, and other users drives innovation.* Human-centered design is also business-centered - better usability means fewer recalls and more adoption.* “Don’t forget the human in human factors.”KeywordsHuman factors, inclusive design, usability engineering, AR/VR, motion sickness, robotic surgery, colorblindness, medical devices, human-machine interface, user experience, ergonomics, product development, safety, innovation, FDA guidanceAbout Hannah Walter, Ph.D.Hannah Walter is a Senior Human Factors Engineer specializing in usability engineering, cognitive and physical ergonomics, and accessibility in medical devices. She has extensive experience supporting the full product development lifecycle - from early user research and formative usability testing to validation, risk analysis, and regulatory submissions.Hannah earned her Ph.D. in Kinesiology (Human Movement Science) from the University of Minnesota, where her research explored motion sickness, postural adaptation, and human interaction in virtual environments. Before transitioning to industry, she served as an adjunct professor at the University of Minnesota, teaching courses on motor development and human perception.Her passion lies in advancing inclusive, human-centered design practices that bridge research, engineering, and user experience to make technology safer and more intuitive for everyone. Let’s Talk Risk! with Dr. Naveen Agarwal is a 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 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