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.
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Table of Contents
1. Background on the application of HF in medical device design2. 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
