Michelle: So, you recently wrote an article for Quality called “The Evolving Role of the Quality Engineer in an AI-Enabled Medical Device Industry,” which, I think, is such a big topic lately in quality. Can you tell us a little bit more about the article and how you decided to write about this topic?

Sai: I would start with the buzzword called AI, right? That's the current buzzword across the globe that people have been saying, artificial intelligence. And people, as soon as they think about artificial intelligence as more of robots, kind of like in movies and stuff, but AI is something that gets embedded into our day-to-day activities as well, right, like from our emails to any kind of activity that we do, like our photo recognitions on our phones and other things.

So, when it's been evolving on a basic level, people exorbitantly see it as AI is more often robots or big activity work but actually helps a lot for people to do it on day-to-day jobs.

That is the one thing that piqued my in the interest in AI itself. And second thing is all about since I've been associated with medical devices, the involvement of AI, how it could improve the patient's health and safety and patient's health outcome. How it can improvise their lifestyle is what piqued my interest.

And as far as the industry norms currently go, a lot of companies have started to adopt AI into their regulated industry’s development. I didn't want to deep-dive much into it, but a quick example I can say is, there are a lot of devices out there like your glucose monitoring or the simplest one people can correlate is your ECG monitoring and your Apple watch. How do you know that is good enough? How do you know that is correct? The ratings or the readings that shows how good it is.

And those are the kind of artificial intelligence or software that is getting involved in monitoring you more than a traditional approach, more than an advanced approach at this point in time. And AI also is divided into product development, where we can use for design developments or prototyping, and as well as for document management when it comes to regulated industry. Unless you document it, it never happened.