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 conductedwhen 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.

​Russell J. Branaghan, PhD, has worked as a human factors engineer, research scientist, consultant and educator for over 30 years. He is President of Research Collective, a Human Factors and User Experience (UX) consulting firm and laboratory in Tempe, AZ. His work centers on healthcare human factors and user experience for leading companies in robotic surgery, cardiac rhythm management, diagnostic imaging, chronic disease management (e.g., hemophilia, diabetes), artificial organs, in vitro diagnostics, reprocessing, healthcare apps, wearables home health, and many others. Russ also serves as Associate Professor of Human Systems Engineering, Co-Director of the Master of Science in User Experience Program, and Director of the User Experience Laboratory (XLab) in the Ira A. Fulton Schools of Engineering at Arizona State University (ASU). He holds additional affiliations with the Kern Center for the Science of Healthcare Delivery at Mayo Clinic, the ASU-Mayo Center for Innovative Imaging,  and the Master of Product Design and Development program at Northwestern University. His research has been funded by The National Science Foundation, Mayo Clinic, The Veterans Health Administration, Federal Aviation Administration, Air Force Research Laboratory, Office of Naval Research, Motorola and others. His teaching has been recognized with awards from ASU and Northwestern. Prior to returning to academics and consulting, Russ held leadership positions in human factors and user experience at Hewlett Packard, IBM, Fitch and Lextant Corporation. An active researcher, Russ has edited one book and published over 100 journal articles, book chapters, and conference proceedings. He frequently serves as a reviewer for scientific and medical journals, and has sat on many editorial and industry boards, including the Human Factors and Ergonomics Society (HFES) Product Design Technical Group, the Organizing Committee for the HFES Healthcare Symposium, the Editorial Board of the Journal of Human Factors, the Advisory Board for Mayo Clinic’s Center for Innovation.