Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design

1st Edition - June 15, 2019

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  • Editor: Mary Beth Privitera
  • Paperback ISBN: 9780128161630
  • eBook ISBN: 9780128161647

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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.

Key Features

  • 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

Table of Contents

  • 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

Product details

  • No. of pages: 368
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: June 15, 2019
  • Imprint: Academic Press
  • Paperback ISBN: 9780128161630
  • eBook ISBN: 9780128161647

About the Editor

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

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