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Applied human factors in medical device design /

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 experie...

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Bibliographic Details
Corporate Authors: Elsevier Science & Technology.
Group Author: Privitera, Mary Beth
Published: Academic Press, an imprint of Elsevier,
Publisher Address: London ; San Diego, CA :
Publication Dates: [2019]
©2019
Literature type: eBook
Language: English
Subjects:
Medical instruments and apparatus > Design and construction.
Design > Human factors.
Human engineering.
Biomedical engineering.
MEDICAL > Instruments & Supplies.
DESIGN > Product.
TECHNOLOGY & ENGINEERING > Product. > Product.
Electronic books.
Online Access: https://www.sciencedirect.com/science/book/9780128161630
Summary: 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 regulationsIncludes case examples with each method.
Carrier Form: 1 online resource (xxv, 342 pages) : illustrations, portraits
Bibliography: Includes bibliographical references and index.
ISBN: 9780128161647
0128161647
Index Number: R856
CLC: R197.39
Contents: Introduction & background / Mary Beth Privitera, Ashley French and Melissa R. Lemke -- Overview of a human factors toolbox / Mary Beth Privitera -- Strategy, planning, documentation & traceability for human factors / Mary Beth Privitera -- How to use this book / Mary Beth Privitera -- Contextual inquiry methods / Mary Beth Privitera and Ian Culverhouse -- Task analysis / Ashley French, Leah K. Taylor and Melissa R. Lemke -- Applied human factors in design / Mary Beth Privitera, M. Robert Garfield and Daryle Gardner-Bonneau -- Combination devices / Jeffrey Morang and Mary Beth Privitera -- Applying design principles to instructional materials / Ren ee Bailey -- Heuristic analysis, cognitive walkthroughs & expert reviews / Mary Beth Privitera -- Simulated use formatives / Deborah Billings Broky, Tressa J. Daniels and Melissa R. Lemke -- Use-focused risk analysis / Sophia Kalita and Melissa R. Lemke -- Root cause analysis / Tim Reeves, Christina Mendat and Eric Shaver -- Known use error analysis & post market surveillance / Mary Beth Privitera -- Human factors validation (summative usability) testing including residual risk analysis / Mary Beth Privitera, Merrick Kossack and Kate Cox -- Human factors validation testing of combination products / Tim Reeves, Christina Mendat and Liz Mauer -- Preparing an HFE report for agency submission / Merrick Kossack -- Special cases : introduction / Mary Beth Privitera -- The Human Factors of Reprocessing Reusable Medical Equipment / Emily A. Hildebrand, L. Bryant Foster and Russell J. Branaghan -- Considerations for users with limitations / Melissa R. Lemke and Jessie Huisinga -- Augmented reality in medical devices / Kate Cox [and four others].

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