Lessons from the field: usability (engineering) in regulated healthcare

Abstract

Abstract Regulated healthcare settings continue to face gaps between established HCI methodology, user-centered design principles, and everyday clinical practice. Although standards and regulatory frameworks mandate usability engineering, their integration into regulated clinical settings often remains inconsistent, compliance-driven, and detached from real-world workflows. To better understand and address this disconnect, we report insights from applied work in clinical studies, hospital collaborations, and industry partnerships. Our aim is to identify methodological and organizational challenges in assessing digital health technologies and discuss potential strategies to mitigate them. While usability evaluations are typically conducted in accordance with international standards, our observations reveal systemic problems: hospital stakeholders are rarely involved in early design stages, procurement decisions are frequently made without structured user testing, and patients are often excluded from technology selection processes. We argue that usability engineering should be a formative, safety-critical discipline integrated throughout the product lifecycle, including aftermarket deployment, and not merely a compliance task. Drawing on case study reflections and practitioner experience, we articulate actionable lessons and practical strategies for integrating usability engineering more effectively into regulated healthcare environments. By bridging methodological, regulatory, and organizational divides, the paper contributes to guidance for aligning human-centered design with the needs of complex healthcare systems.