Regulatory Isn’t Slow Because It’s Complex. It’s Slow Because It’s Fragmented.
- Beng Ee Lim
- 6 days ago
- 3 min read
Updated: 4 days ago
Most people assume regulatory work is slow because the rules are hard.
The requirements are strict, the stakes are high, and mistakes are costly.
Long timelines feel unavoidable.
In practice, that’s not what actually slows teams down.
Regulatory work isn’t slow because it’s complex.
It’s slow because of how information is handled.
Key takeaways
Regulatory teams lose time searching instead of making decisions
Scattered information makes work harder to defend and repeat
Small gaps often surface late and cause lengthy rework
Adding people increases cost without fixing scattered workflows
Complexity does not automatically create inefficiency
Many high-stakes, regulated fields have changed how they work over time.
Engineering teams build systems that are far more complex than they were a decade ago.
Finance teams manage audits, reporting, and compliance at scale.
These fields did not become simpler. They became better organized.
Regulatory work largely didn’t.
The rules evolved, but the workflows around them stayed mostly the same.
What actually eats time in regulatory work
From the outside, delays look like a documentation problem.
From the inside, much of the time goes to something more basic and more draining: rebuilding context.
A simple question like, “Does this requirement apply to our device?” often means checking:
one guidance document
two predicate summaries
an internal spreadsheet
an old email thread
and someone’s personal notes or memory
None of that moves the submission forward.
It only finds the information needed to do the real work.
When this happens once, it feels normal.
When it happens every day, it becomes the job.
Fragmentation is the real bottleneck
Most regulatory teams do not work inside a single system.
Information is spread across:
public guidance documents
regulatory databases
shared drives and folders
spreadsheets and trackers
email threads and meeting notes
consultant knowledge that exists only in conversations
Each source makes sense on its own. Together, they create fragmentation.
For international teams working across multiple regulators, this fragmentation compounds.
Fragmentation shows up in a few ways, and the cost is always the same:
Constant context switching.
Work becomes a loop of search, copy, reconcile, repeat.
Decisions that are hard to defend later.
Not because they are wrong, but because the reasoning is scattered.
Repeated work.
The same research and justification are recreated again and again.
This is why teams can be busy all day and still feel like nothing meaningful moved forward.
Why delays feel unpredictable
Founders and operators often describe regulatory work as unpredictable.
This is what fragmentation looks like from the outside.
Most delays do not start with a major issue.
They start with small gaps, a missing detail, an assumption that goes unchecked, or context that lives in the wrong place.
Because information is scattered, these gaps stay hidden until late in the process.
When they finally surface, they trigger rework, revisiting decisions that felt settled, and changes that ripple across timelines.
Nothing looks broken early on.
By the time it does, schedules have already slipped.
This is why regulatory timelines can move slowly for weeks, then suddenly stall.
Why adding people does not fix it
When regulatory timelines slip, the first reaction is to add resources.
Hire another consultant. Add headcount. Bring in more reviewers.
It makes sense but fragmented workflows do not scale cleanly with additional hands.
More coordination. More interpretations. More places for knowledge to live and get lost.
Instead of moving faster, teams spend more time aligning. Decisions take longer to explain. Context has to be rebuilt again and again.
The result is familiar. Costs go up. Timelines do not improve.
The uncomfortable conclusion
Regulatory work feels harder than it should because the way it is done has not kept up with the complexity it supports.
Whether it is the FDA or another regulator, they are rarely the real bottleneck. The science usually is not either.
The bottleneck is fragmented information stitched together by human memory and manual effort.
If this feels uncomfortably accurate, it is probably because you have lived it.
Regulatory work does not have to feel this way. It only feels normal because many teams inherited the same workflow.
Systems can be redesigned.
Mini FAQ
Why does regulatory work take so long?
Because teams spend too much time reconstructing information instead of executing decisions.
What causes most 510(k) delays?
Not usually scientific gaps, but missing context, late discovery of requirements, and rework.
Why doesn’t hiring more people fix delays?
Because fragmentation increases coordination overhead faster than it increases output.
Is this inefficiency inevitable?
No. It’s a systems problem, not a regulatory one.
