Uh, what does a good early stage device or combination product gap assessment actually look like?

Um, I think a good one provides a, a 10,000-foot view, high level on FDA's, um, expectations and requirements, but also, uh, probably more importantly, uh, shortcomings of the program that y- that you're looking at and what it's going to take to mitigate re-risk or, um, you know, mediate what- whatever is missing, uh, with the timeline that the client is working with.

And that's usually the trickiest part is being able to, um, manage, okay, here's what needs to be done, here's the amount of time that it's gonna take, but here's the timeline that the client is working with and that they're targeting, like s- let's say, for their marketing application or their next milestone.

So, um, a lot of creative thinking, a lot of thinking outside the box, uh, to help the client get to where they need to be and work, uh, help them work inside of their framework, uh, but, uh, also at the same time achieve the ultimate goal, which is a, a smooth review and approval process.

Um, and I appreciate we've covered this in different, you know, areas, but if you were to kind of put it together, what should companies be thinking about before phase three rather than leaving it late until NDA and BLA prep?

Uh, usability and human factors is one.

Um, you know, uh, having a robust, uh, which is becoming more and more important for FDA as a whole, um, devices, biologics, drugs, all, all of the regulated products, uh, that I work with.

Um, so you know, thinking about that early, many times clients will get to the phase three and say, "Okay, we can run our, our, uh, summative program and have that done.