Usability Engineering for AI-Based Medical Devices

25 Years of Use-Lab. The Next 25 Years Start Now.

As part of our anniversary year 2026, Use-Lab is focusing on the questions that will shape the future of user-centered product development. One of these topics is the growing role of Artificial Intelligence in medical technology.

On September 17, 2026, our colleague Thore Reitz will speak at Treffpunkt Medizintechnik in Frankfurt on the topic: “Usability Engineering for AI-Based Medical Devices – Between Standards, Risk, and Real-World Use”

Usability Engineering has become an established part of developing safe medical devices through regulatory frameworks such as MDR and IEC 62366-1 and is closely linked to risk management according to ISO 14971 as well as design processes. However, the introduction of AI- and ML-based systems creates new challenges that push established methods to their limits.
Current guidance documents, including the DKE position paper, the MDCG documents AIB 2025-1 / MDCG 2025-6, and FDA guidances, provide initial direction, but only partially address real-world use in clinical practice.

The presentation will review the current state of the field, discuss key challenges from the users’ perspective, and present practical approaches. Drawing on Use-Lab projects, particularly the INTERREG project DAME, it will demonstrate how Usability Engineering can evolve in the context of AI-based systems to improve safety, comprehensibility, and user acceptance.

Further information and registration: https://www.treffpunkt-medizintechnik.de/