Highlights
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2024-02-25 20:48 And I think that is something that has been evolving and changing over the years, and I think that the medical device industry will benefit from that once that is embraced a little bit more, because the driver currently, of the bulk of human factors work that is done in the medical device space are the regulations. The FDA started regulating human factors more stringently in about 2011, and since then, the amount of human factors work that we do in the medical device space has increased exponentially.
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2024-02-25 20:49 FDA looks for are the human Factors engineering report, which is a report that summarizes the entirety of the human factors effort throughout the whole product development process. A component of that is the human factors validation report. So this is the thing, the main thing that is a requirement for certain types of medical devices and medical software being commercialized.
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2024-02-25 20:49 And there’s different tiers of it. I won’t dive into too much detail in terms of how that’s set up, but it’s risk based. Not surprisingly, if you have a medical software that provides information only and there’s no impact, ultimately, to how a treatment is delivered, then that’s going to be fairly low risk in most cases. But if you have something that is a software that is actually controlling or having a significant input to how care is delivered for a condition or a circumstance that has the ability to end someone’s life, obviously that’s going to be a higher risk. And there are different levels of investigation into those.
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2024-02-25 20:49 You previously said that AI to software is like software to hardware. So, I mean, think back to all the WebMD doctorates that we had when WebMD came out, and then again, multiply that by an exponential factor when you have AI doing the next step of that thing. So, yeah, it’s timing. It’s how the information is presented. There’s huge potential to leverage AI to reduce burden on care teams. No doubt. But to your point, you have to be careful with how you do that. You need to do it in such a way that the information that is being received by the patient is appropriate, timely, understandable, all of those things. So, corey, we’ve gone about half an hour, 40 minutes. I don’t want to keep you here much longer.