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Mark Freitas

Aug 19, 2026

17:04
Mm-hmm.
17:04
And what, what organizations are, are really thinking of it when they treat it as a compliance checkbox, you know, it, it just is something that just isn't appreciated, isn't valued, and, and doesn't really provide the kind of competitive weight that it deserves.
17:21
But it does create this, like, moat that you can navigate around.
17:25
So it's not just having the certifications, it's the organizational muscle, right? Knowing how to run a 510[k] pathway efficiently, knowing how to manage post-market surveillance at scale, maintaining design history files that can kinda hold up under scrutiny.
17:42
And, and those just seem like, okay, yeah, that's just table stakes, but it's not, right? Because it becomes super complex when we talk about taking agency, moving quick, like, finding kind of where, where advantages exist, running those, those pathways efficiently, figuring out how to get Through the regulatory hurdles, figuring out ways to build resiliency into your, your portfolio, leveraging kind of the regulatory frameworks are, are opportunities.
18:11
So for a buyer acquiring a platform, um, that has an infrastructure that's already functioning, it could save two to three years versus building it, right? And so when you kinda look at that saying, "Okay, that savings has a real value," so, you know, why, why wouldn't you, you necessarily explore that? And for a seller, you might say, well, you know, it separates top-of-the-range kind of deal value, um, from middle-of-the-range, right? Because you, you kinda have like an off-the-shelf, like, you know, ready-to-go, uh, opportunity that's audit ready, uh, and, and it allows a premium, you know, to, to the sale, right? If you're trying to kinda do that.
18:48
So trying to kinda make sure those competitive advantages are clear.

7 MINS LATER

25:42
Should buyers and sponsors act now before competition intensifies, or should they keep their powder dry for a little while longer? What are your, what are your thoughts?

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