Human Factors Engineering in Medical Devices in the Age of Intelligence: Evolution and Future Trends
1 Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058
2 Hangzhou Ruiqi Technology Service Co., Ltd., Hangzhou 310058
3 Zhejiang Institute for Medical Device Control, Hangzhou 310006
Abstract：Medical device human factors engineering focuses on optimizing the interactions among humans, devices, and their environments and is essential for ensuring the safety, effectiveness, and usability of medical devices. With the rapid development of artificial intelligence, telemedicine, and intelligent systems, the contexts of device use and forms of human–machine interaction have become increasingly complex, making human factors issues ever more critical to medical safety. This paper systematically reviews the development of medical device human factors engineering since the 1980s and delineates four major stages: early exploration, establishment as an independent field, system integration, and intelligent applications, summarizing the research focus and evolutionary characteristics of each stage. Building on this review, we examine key human factors challenges in intelligent medical devices, including trust and explainability in AI-assisted medicine, individualized design, interaction in telemedicine, and cognitive and safety challenges introduced by emerging technologies such as virtual and augmented reality. We further summarize major controversies and limitations in current research from theoretical, methodological, and translational perspectives, and discuss future directions in research focus, methodological innovation, and application models. This review aims to provide a systematic reference for the human factors design and evaluation of medical devices in the intelligent era, facilitating the translation of research findings into safe, user-centered clinical practice.
余喻,徐珂,沈模卫. 医疗器械人因工程的智能化演进与未来趋势[J]. 应用心理学, 2026, 32(1): 3-17.
Yu Yu,Ke Xu,Mowei Shen. Human Factors Engineering in Medical Devices in the Age of Intelligence: Evolution and Future Trends. 应用心理学, 2026, 32(1): 3-17.
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