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Applied Human Factors in Medical Device Design
1st Edition - June 15, 2019
Editor: Mary Beth Privitera
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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… Read more
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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) a. Hardware i. Fit: anthropometry ii. Physical Interactions: biomechanics b. Software Chapter 9. Applied Ergonomics in Instructions For Use Chapter 10. Formative Usability Testing Chapter 11. User focused Risk Analysis a. AFMEA 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: 368
Published: June 15, 2019
Imprint: Academic Press
Paperback ISBN: 9780128161630
eBook ISBN: 9780128161647
Mary Beth Privitera
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.
Affiliations and expertise
Director, Medical Device Engine, University of Cincinnati Medical Center, Cincinnatti, OH, USA