Human factors engineering in intelligent medical devices: paradigm evolution, core issues and frontier prospects

Against the ongoing intelligent transformation of global healthcare, human factors engineering (HFE) is essential to the safe deployment of intelligent medical devices. Yet existing reviews largely offer chronological summaries and fragmented, scenario-specific analyses, leaving the field’s paradigm evolution and cross-scenario human–AI challenges under-synthesized. Following the PRISMA-ScR guideline, this scoping review synthesizes the literature to construct a four-stage developmental framework for medical HFE, delineate four interconnected core human–machine collaboration challenges, and clarify the prevailing theoretical, methodological, and translational constraints. It further identifies future directions—human–AI collaborative reliability evaluation, data-driven usability testing, and digital-twin-supported full-lifecycle validation. By integrating paradigm evolution, core challenges, and regulatory translation into a single analytical framework, this work provides a structured foundation for subsequent research, human-centered design, and regulatory evaluation of intelligent medical devices.