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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.
- Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU)
- Explains technology development and the application of human factors throughout the development process
- Covers FDA and MHRA regulations
- Includes case examples with each method
Medical device industry professionals in human factors, design, engineering, marketing and regulatory agencies. Students in human factors, experimental psychology, industrial design, design research, ergonomics, and biomedical engineering. Consultants and specialists of health technology assessment. Clinical engineers and health technology managers
Chapter 1. Background on the application of HF in medical device design
a. Applicable international standards
b. Incorporating HF in early product development and design control (TIR 59)
Chapter 2. Contents of a HF Toolbox
a. Brief description of each tool
b. Overview of when to use/when not to use tools
Chapter 3. Contextual Inquiry Methods (TIR 51)
Chapter 4. Heuristic Evaluation/Cognitive Walkthroughs
Chapter 5. Task Analysis
Chapter 6. Competitive Ergonomic Analysis
a. Subtle differences in design, manufacturing impact the “feel” of a device
Chapter 7. Known Use Error and Post Market Surveillance
a. Database searches
b. Internal quality reporting
Chapter 8. Applied Ergonomics for UI/UX Product Design (HE 75)
i. Fit: anthropometry
ii. Physical Interactions: biomechanics
Chapter 9. Applied Ergonomics in Instructions For Use
Chapter 10. Formative Usability Testing
Chapter 11. User focused Risk Analysis
b. Other tools
Chapter 12. Summative Usability Testing
a. Root Cause Analysis
Chapter 13. Preparing an HFE Report for agency submission
Chapter 14. Special cases:
a. Combination Products
b. At- Risk User Populations
- No. of pages:
- © Academic Press 2019
- 15th June 2019
- Academic Press
- Paperback ISBN:
- eBook ISBN:
Privitera’s research focus is in collaborative medical device design and the application of human factors in design. She is a member of the Association for the Advancement of Medical Instrumentation Human Factors Committee and has coauthored various sections in HE 75 and recently a TIR on Contextual Inquiry. To date, she has been associated with more than 40 product releases, holds several patents and provisional patents, and has published and lectured on a variety of topics including design research, transdisciplinary/collaborative design, innovation methodology, and surgical techniques.
Director, Medical Device Engine, University of Cincinnati Medical Center, Cincinnatti, OH, USA
"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
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