Human Factors / Usability validation in the time of COVID

pziemlewicz

Involved In Discussions
#1
Last December, I had what I thought was a pretty solid Human Factors Validation Plan for Class 2 device seeking 510(k). Enter COVID-19: Interactions with clinicians have been forced virtual and said plan went out the window. Has anyone attempted a virtual summative study?

I'd hoped to see some guidance from the FDA, but no such luck. Once a plan is in place, it can be reviewed via Q-sub, but I'm struggling with how to start writing it. Shipping devices directly to participants just seems way too risky/uncontrolled.

I'd appreciate any feedback from others navigating the same. Thanks in advance.
 
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yodon

Staff member
Super Moderator
#2
Haven't yet been confronted with this but I understand your concern.

Is it not feasible to conduct it virtually? Is it a cost issue or a product type issue?

I don't think the data would be questioned if you could do it remotely and still accomplish the same objectives. You might even wrap a little risk assessment around it, acknowledging the deviation from the original plan, and asserting the data still supports your conclusion of a UI promoting safe and effective use.
 

pziemlewicz

Involved In Discussions
#4
Is it not feasible to conduct it virtually? Is it a cost issue or a product type issue?

I don't think the data would be questioned if you could do it remotely and still accomplish the same objectives. You might even wrap a little risk assessment around it, acknowledging the deviation from the original plan, and asserting the data still supports your conclusion of a UI promoting safe and effective use.
It is a product type issue: the device is used for open surgical procedures. Historically, testing has happened in an OR/lab setting using porcine organs. The user should be able to concentrate fully on device function in use case (i.e. not worry about whether the temperature of the organ, blood flow, etc are being controlled in accordance with body protocol).
 

levatorsuperioris

Starting to get Involved
#6
don't know how you would do training etc, then 1 hour cool down. this is something that I don't think anyone had to really answer before. Given how expensive Usability Testing can be its gonna be up to the firm if they are willing to take the risk.
 

yodon

Staff member
Super Moderator
#7
I take it training is intended to be hands-on? You may have to switch to a model of interactive virtual sessions / video. (Not ideal but if options are limited, may be the best you can do.) Maybe re-think the risks of the training approach and there may be things you can do to supplement.

I'm curious where you came up with the "1 hour cool down." If training is a risk control, then "an appropriate elapsed time to accommodate learning decay" should occur. I would expect that to be > 1 hour (but I guess if training isn't a risk control that's fine).

I think that being creative and doing the exercise will be better tolerated than not doing the exercise.
 

levatorsuperioris

Starting to get Involved
#8
I asked the question to the FDA and Taiwan FDA once in a joint presentation -> you are correct, but practicably the answer was well because its always been that way.
 
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