FDA readiness – the gap between ‘working’ and ‘ready’
Customers arrive at FMS believing they’re closer to market than they are. A concept that works in the lab “most of the time” feels like enough to move into validation and manufacturing. It’s an understandable place to be – you’ve built something, it works, and the finish line looks close.
It usually isn’t. The FDA doesn’t grade on “most of the time.” For a device to be considered safe and effective, it has to work every time, and meet every claim every time it’s used. That standard sounds obvious written down, but it is more difficult to achieve than most system architects realize.
Why the gap is hard to see
The distance between “working” and “market-ready” is usually bigger than anyone wants to admit. Not because people are careless, but because it’s nearly impossible to judge the size of a problem while you’re still standing inside it. When a device is working ninety percent of the time, it feels like you’re nearly there. Then the law of diminishing returns arrives, and that last ten percent turns out to hold most of the effort.
The teams that make it to market tend to be the ones who find this out early, from someone other than the FDA. That’s most of what the work is: not building certainty, but locating the uncertainty while there’s still time and budget to do something about it. Designing a device that overperforms during development should safely meet specification during validation across multiple lots.
What that looks like in practice
Finding it early isn’t a single test or a gate you pass. For the clients we work with, it comes out of regular technical meetings, typically once a fortnight, that are about more than reviewing the latest data. We track where the project is heading overall, and where there’s a need, we give a view on regulatory risk: what we’d expect regulators to be looking for in a submission, measured against the client’s own intended-use statement. In some cases that extends to the device validation plan, and what we see there feeds back into development activity.
A concrete example. Say a client plans to let non-skilled operators use the device on-label. That triggers a CLIA-waiver requirement, which in turn means additional robustness has to be designed into the device and designed in early, because it’s validated later through flex testing. There’s no point running that testing if the robustness was never built in at the development stage. Catching that in a fortnightly review, rather than after a failed validation, is the difference between an adjustment and a rebuild. In cases like this, it’s also usually worth running a pre-submission with the FDA to be sure.
None of this is about slowing a project down. It’s the opposite: the earlier a readiness gap surfaces, the cheaper and simpler it is to close.
Why we work this way
FMS’s role isn’t to tell a customer their concept isn’t good enough. It’s to understand what the product actually needs to clear, and to hold that standard up against where the project currently is, honestly, and early enough to matter. That means sometimes being the ones to say the gap is wider than it looks. It’s a more useful thing to hear from a development partner than from a regulator.
Most concepts are further from ready than the person holding them believes. The ones that get to market are the ones who learn that in a technical meeting, not a rejection letter, and who have the time, when they learn it, to do something about it.
That’s consistent with how we work more broadly: supporting customers from concept through to commercialisation, and reducing the risk in that journey rather than adding to it.