Human Factors / Usability validation in the time of COVID

[pziemlewicz]

In recent weeks I've seen physician training for OR device administered via virtual reality (Google Cardboard). For context, the manufacturer doing this is in the top five: I can only imagine the cost and FDA oversight involved.

 

[gogreen]

In recent weeks I've seen physician training for OR device administered via virtual reality (Google Cardboard). For context, the manufacturer doing this is in the top five: I can only imagine the cost and FDA oversight involved.

Looks like it's time to invest in Oculus.

 

[ChloeArmstrong]

Looks like it's time to invest in Oculus.

Virtual operations?

 

[gogreen]

Virtual operations?

Sure, but I was talking about virtual studies and usability testing.

 

[sravanvangari]

I think it's possible for me.

 

[powersthatbe]

I have heard FDA staff in multiple online conventions saying that the expectation for HF work is the same. So one way to frame the question is this: can you get the same level of data doing a remote study that you could for an in-person study? If not, you're unlikely to have much success with the FDA going down that route. There are somewhat safe evaluations depending on your exact situation (for example, the moderator behind the glass in a market research facility talking with a mic to the participant in the main room).

If the device is used for open surgical procedures, I would think most of the end users would be vaccinated by now as well, no?

 

[pziemlewicz]

If the device is used for open surgical procedures, I would think most of the end users would be vaccinated by now as well, no?

While HCO staff is likely vaccinated, most organizatons are still limiting people allowed in (visitors, vendors, etc).

 

[powersthatbe]

Do you think that you need to do the evaluation in the hospital as opposed to a usability lab (like a Fieldworks site) or a simple hotel conference room?