Design Criteria for Robotic Rehabilitation Medical Devices: The PICO-Driven Approach

The translation of knowledge and methodologies across disciplines represents a valuable source of innovation, particularly in user-centered design approaches that have become essential in medical device development. This study explores the use of the PICO (Population, Intervention, Comparison, and Outcome) framework, a cornerstone of evidence-based medicine for formulating clinical questions, as a conceptual structure to support the alignment between clinical needs and engineering design consideration in robotic rehabilitation devices, with a focus on hand exoskeletons. Through a conceptual reinterpretation and application-oriented exploration supported by illustrative case studies involving both rigid and soft robotic glove prototypes, this study shows how each PICO component can inform engineering parameters, from defining user impairments and intervention strategies to benchmarking and outcome measurements. The analysis highlights the potential of PICO in fostering a user-centered design perspective and bridging clinical and engineering domains while also identifying its structural limitations when applied to device design contexts. This study concludes that while the PICO framework offers a valuable foundational structure, it requires customization to fully address the multifactorial requirements of effective, patient-specific robotic rehabilitation device design.