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.