Applied Human Factors in Medical Device Design

by Mary Beth Privitera (Editor)

Overview

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

Product Details

ISBN-13:	9780128161647
Publisher:	Elsevier Science
Publication date:	06/15/2019
Sold by:	Barnes & Noble
Format:	eBook
Pages:	368
File size:	70 MB
Note:	This product may take a few minutes to download.

About the Author

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.

Table of Contents

1. Background on the application of HF in medical device design
2. 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

What People are Saying About This

From the Publisher

A ‘human factors toolbox’ that guides users through the process of integrating human factors into medical device design

Editorial Reviews

"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

From the Publisher