Scientific article

The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach

Published inValue in Health
Publication date2021

For medical devices, a usability assessment is mandatory for market access; the objective is to detect potentially harmful use errors that stem from the device's design. The manufacturer assesses the final version of the device and determines the risk-benefit ratio for remaining errors. Nevertheless, the decision rule currently used to determine the sample size for this testing has statistical limitations and the lack of a clear decision-making perspective. As an alternative, we developed a value-of-information analysis from the medical device manufacturer's perspective. The consequences of use errors not detected during usability testing and the errors' probability of occurrence were embedded in a loss function. The value of further testing was assessed as a reduction in the expected loss for the manufacturer. The optimal sample size was determined using the expected net benefit of sampling (ENBS) (the difference between the value provided by new participants and the cost of their inclusion).

  • Decision theory
  • Early technology assessment
  • Medical device
  • Usability testing
  • Value of information
  • Swiss National Science Foundation - Useval-DM
  • Swiss National Science Foundation - 164279
Citation (ISO format)
CARON, Alexandre et al. The Optimal Sample Size for Usability Testing, From the Manufacturer’s Perspective: A Value-of-Information Approach. In: Value in Health, 2021. doi: 10.1016/j.jval.2021.07.010
Main files (1)
Article (Published version)
ISSN of the journal1098-3015

Technical informations

Creation09/17/2021 3:36:00 PM
First validation09/17/2021 3:36:00 PM
Update time03/16/2023 2:09:01 AM
Status update03/16/2023 2:09:01 AM
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