Usability Testing of Medical Devices

Michael E. Wiklund, P.E., Jonathan Kendler, Allison Y. Strochlic

December 20, 2010 by CRC Press
Reference - 412 Pages - 126 B/W Illustrations
ISBN 9781439811832 - CAT# K10595

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  • Provides a singular source of guidance on conducting a usability test in an industry-specific manner, as opposed to a manner better suited to evaluating consumer and business products, for example, that pose different demands
  • Presents the information in a highly visual format, making it appealing to the audience comprised mostly of marketers, engineers, and regulatory affairs specialists
  • Draws on the experience of the author, a widely recognized authority in the medical industry on usability testing of medical devices
  • Includes an accompanying CD-ROM that contains videos of mock usability tests, demonstrating the techniques described in the book
  • Supplies sample test plans for practitioners who would prefer to "plug" content into an authoritative template


To paraphrase a popular saying, usability testing should be done early and often. However, it doesn’t have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death.

The book has been carefully designed to be concise and visually, easily read in one sitting or perused from one section to another as needed It begins with a review of human factors engineering and how usability testing fits in, and then discusses the government regulations and industry standards that have motivated many medical device manufacturers to conduct usability tests. It then covers the nitty-gritty of planning, conducting, and reporting the results of a usability test, making the process as smooth and painless as possible for the development team, and therefore making the medical devices they develop as safe, effective, and appealing as possible.

As you read the book, keep in mind that, like snowflakes, each usability test is unique. And while 100 usability specialists working independently might take 100 different approaches to testing, albeit with considerable methodological overlap, there would also be meaningful differences that the practitioners would energetically defend as the best given the circumstances. To make your testing process easier, the authors, seasoned human factors specialists who have conducted thousands of test sessions involving medical devices used by physicians, nurses, therapists, technicians, and patients, have painstakingly put together an informative, practical, and engaging handbook for conducting usability tests of medical devices.