Humanizing Healthcare – Human Factors for Medical Device Design

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.