Simone Borsci
How many testers are needed to assure the usability of medical devices?
Borsci, Simone; Macredie, Robert D.; Martin, Jennifer L.; Young, Terry
Authors
Robert D. Macredie
Jennifer L. Martin
Terry Young
Abstract
Before releasing a product, manufacturers have to follow a regulatory framework and meet standards, producing reliable evidence that the device presents low levels of risk in use. There is, though, a gap between the needs of the manufacturers to conduct usability testing while managing their costs, and the requirements of authorities for representative evaluation data. A key issue here is the number of users that should complete this evaluation to provide confidence in a product's safety. This paper reviews the US FDA's indication that a sample composed of 15 participants per major group (or a minimum of 25 users) should be enough to identify 90-97% of the usability problems and argues that a more nuanced approach to determining sample size (which would also fit well with the FDA's own concerns) would be beneficial. The paper will show that there is no a priori cohort size that can guarantee a reliable assessment, a point stressed by the FDA in the appendices to its guidance, but that manufacturers can terminate the assessment when appropriate by using a specific approach - illustrated in this paper through a case study - called the 'Grounded Procedure'.
Citation
Borsci, S., Macredie, R. D., Martin, J. L., & Young, T. (2014). How many testers are needed to assure the usability of medical devices?. Expert Review of Medical Devices, 11(5), https://doi.org/10.1586/17434440.2014.940312
Journal Article Type | Article |
---|---|
Publication Date | Sep 1, 2014 |
Deposit Date | Jul 30, 2015 |
Publicly Available Date | Jul 30, 2015 |
Journal | Expert Review of Medical Devices |
Print ISSN | 1743-4440 |
Electronic ISSN | 1743-4440 |
Publisher | Taylor & Francis Open |
Peer Reviewed | Peer Reviewed |
Volume | 11 |
Issue | 5 |
DOI | https://doi.org/10.1586/17434440.2014.940312 |
Keywords | Evaluation cohort, Five-user assumption, Medical devices, product safety, Usability testing |
Public URL | https://nottingham-repository.worktribe.com/output/994436 |
Publisher URL | http://informahealthcare.com/doi/abs/10.1586/17434440.2014.940312 |
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