P
Hi all,
I have a question about the amount and selection of participants for the usability validation.
The IEC 62366 leaves this topic open it just says: "The appropriate number of subjects depends on the objectives of the research as well as the diversity of the USER population". This puts the responsibility to the manufacturer to make a pragmatic decision.
However if we look to the "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" of the FDA they are much more specific. They speak about a sample size of min 15 participants (also in informal discussion with FDA members they really state this as a reason for rejection). Additionally they state in the report: "To adequately represent users in the United States population, the participants in the validation test should reside in the United States."
I wonder how the industry looks upon these rules the FDA states. For a European based company who is also on the US market this brings some headaches. Because you are forced to organize a usability test with 15 US customers which more or less takes your entire budget leaving out European customers in your test. I also find it hard to understand the rationale why all test participants must be US citizens. Does anyone have practical experience about this topic?
Greetings,
Pieter
I have a question about the amount and selection of participants for the usability validation.
The IEC 62366 leaves this topic open it just says: "The appropriate number of subjects depends on the objectives of the research as well as the diversity of the USER population". This puts the responsibility to the manufacturer to make a pragmatic decision.
However if we look to the "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" of the FDA they are much more specific. They speak about a sample size of min 15 participants (also in informal discussion with FDA members they really state this as a reason for rejection). Additionally they state in the report: "To adequately represent users in the United States population, the participants in the validation test should reside in the United States."
I wonder how the industry looks upon these rules the FDA states. For a European based company who is also on the US market this brings some headaches. Because you are forced to organize a usability test with 15 US customers which more or less takes your entire budget leaving out European customers in your test. I also find it hard to understand the rationale why all test participants must be US citizens. Does anyone have practical experience about this topic?
Greetings,
Pieter
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