Humanizing Healthcare Human Factors for Medical Device Design

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This book presents human factors engineering (HFE) principles, guidelines, and design methods specifically for medical device design. It begins with an overview of human physical, perceptual, and cognitive abilities and limitations, exploring their implications for design. This analysis leads to a set of human factors principles applicable across various design challenges, which are then utilized to create guidelines for input controls, visual and auditory displays (alerts, alarms, warnings), and human-computer interaction. The text addresses specific challenges and solutions in diverse medical device domains, including robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors, insulin pumps, and reprocessing. It integrates human factors research and design methods into a comprehensive design lifecycle and discusses regulatory requirements and procedures, offering guidance on necessary human factors activities and documentation. This practical reference serves as an essential resource for students and professionals in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. It equips readers to design safer, more effective, and less error-prone medical devices while explaining the roles of regulatory agencies in the design process. Key analysis and research methods such as UFMEA, task analysis,