Summative Usability Evaluation Testing: prior or during Clinical Investigation?

[QARA93]

Hi,

Can the Summative Usability Evaluation be conducted during a Clinical Investigation for a Medical Device or should it always be completed prior?

Thank you very much!

 

[yodon]

I can see cases where that could work but I wouldn't make a blanket statement that it's either always a good idea or must be completed prior.

 

[Tobias_HF]

Hi,

Can the Summative Usability Evaluation be conducted during a Clinical Investigation for a Medical Device or should it always be completed prior?

Thank you very much!

I would also point out two questions
- do you plan a summative study included in a clinical study?
- if so, what are your measures to make sure that device use is realistic (as in the intended use)
It is possible, though you have to make sure that the summative study data is not "polluted" by the cinical study data, in terms of patient / user / environment. Those have to be "simulated", and typically a clinical study delivers much more patient / user support than you would do in a summative study.

Or, if the activities are parallel (and independent from each other), you just have to proove that your device is safe to use, for the clinical study. By providing enough data about (use) risk management, formative studies etc. And, if necessary, provide means to counter unsafe use. But this is really device specific.
And of course you should include possible use related risks in the informed consent for the clinical study.

 

[ChloeArmstrong]

The experience of my colleagues tells me that the Usability Evaluation should be scored in advance.

 

[QARA93]

Thank you all for your advice! I just saw that the FDA guidance on Human Factors recognises that usability validation may require actual use of the device, which may be part of a clinical investigation. However, in advance, you need to collect sufficient simulated-use testing evidence to demonstrate that the device is sufficiently well designed to be safe in actual use. Additionally, you need to factor in the differences in study set up.

 

[ChloeArmstrong]

Thank you all for your advice! I just saw that the FDA guidance on Human Factors recognises that usability validation may require actual use of the device, which may be part of a clinical investigation. However, in advance, you need to collect sufficient simulated-use testing evidence to demonstrate that the device is sufficiently well designed to be safe in actual use. Additionally, you need to factor in the differences in study set up.

I am glad that you were able to find an answer to your question.

 

[hvk159]

Usually the summative study be conducted in smaller "pilot" phase and be deemed safe. Though I have seen lower classed devices usually conduct summative studies in parallel with clinical investigation.