This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented.

This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs.

• Teaches readers to design medical devices that are safer, more effective, and less error prone;
• Explains the role and responsibilities of regulatory agencies in medical device design;
• Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.