Applied Human Factors in Medical Device Design

A ‘human factors toolbox’ that guides users through the process of integrating human factors into medical device design

Mary Beth Privitera (Edited by)

9780128161630, Elsevier Science

Paperback, published 18 June 2019

368 pages
23.4 x 19 x 2.4 cm, 0.77 kg

"Overall, this text is a very good contribution to the literature and is recommended for those persons entering medical device design. It gives a very good overview of the need for and use of human factors in medical device design, especially as experienced in the United States. All information is logically presented and is, as is necessary, very patient-centric." --IEEE

Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation.

1. Background on the application of HF in medical device design
2. Contents of a HF Toolbox
3. Contextual Inquiry Methods (TIR 51)
4. Heuristic Evaluation/Cognitive Walkthroughs
5. Task Analysis
6. Competitive Ergonomic Analysis
7. Known Use Error and Post Market Surveillance
8. Applied Ergonomics for UI/UX Product Design (HE 75)
9. Applied Ergonomics in Instructions for Use
10. Formative Usability Testing
11. User focused Risk Analysis
12. Summative Usability Testing
13. Preparing an HFE Report for agency submission
14. Special cases

Subject Areas: Biomedical engineering [MQW]