Entering The U.S. Medical Device Market Isn’t As Hard As Many International Teams Expect
- Beng Ee Lim
- 2 days ago
- 3 min read
For many international medical device manufacturers, entering the US market carries a particular kind of weight.
The FDA is seen as conservative.
Documentation is assumed to be heavier.
Reviews are thought to be unpredictable.
So the US often feels like a fundamentally harder market.
In practice, most of the difficulty teams encounter does not come from stricter rules or higher scientific standards.
It comes from confusion about where to start, what applies, and how to translate existing work into a system they have never operated inside before.
Where teams expect the difficulty to be
Most international teams prepare for US entry by bracing for “more.”
More documentation.
More testing.
More scrutiny.
The assumption is that US compliance is simply a higher bar.
Sometimes that’s true. But more often, teams discover they are not being asked to redo their work from scratch.
They are being asked to explain it in a way that fits a different regulatory logic.
That difference matters.
Where the difficulty actually shows up
The real challenge in US market entry is translation.
Most international manufacturers already have regulatory experience.
They have made design decisions, selected comparators, generated test data, and documented tradeoffs.
What often does not carry over cleanly is the context behind those decisions.
Why a specific requirement was interpreted the way it was.
Why one comparator was acceptable and another was not.
Why certain tests were chosen early and others deferred.
That reasoning often lives in internal spreadsheets, old email threads, slide decks, or in the heads of a few people who were involved early on.
When teams assume prior compliance will transfer directly, these gaps tend to surface late, usually during review.
Confusion is often the real blocker
For many international teams, the hardest part of US entry isn’t effort. It’s orientation.
Which FDA guidances actually apply to this device?
Which ones are optional, outdated, or only partially relevant?
Where does one guidance end and another begin?
Teams without large internal regulatory groups often struggle here.
The information is public, but it is fragmented.
Knowing what to read and what to ignore takes experience most teams don’t yet have.
Seeking external help can add another layer of uncertainty.
There is no single professional body that certifies FDA consultants. Credentials vary widely. Reputations are built through word of mouth. For teams entering the US for the first time, it can be difficult to know who to trust, or even what kind of help they need.
That uncertainty compounds early, before any submission work has truly begun.
The translation gap teams underestimate
From the inside, this confusion can feel like unnecessary friction.
Often, the issue is that the reasoning behind it isn’t visible to someone new to the file.
Teams are sometimes surprised when a reviewer asks why a particular predicate was chosen, not because the choice was flawed, but because the original rationale lives in an internal document no one expected to matter later.
US reviewers are not asking teams to redo their work. They are asking them to make it legible within the FDA’s framework.
When that framework isn’t accounted for early, delays feel unpredictable and frustrating.
Why this can feel harder than starting from scratch
Paradoxically, experienced teams often feel this friction more than first-time entrants.
Prior compliance creates confidence, and that confidence is usually deserved. But when decision context isn’t preserved, progress becomes fragile.
Instead of building forward, teams find themselves reconstructing reasoning they already worked through once.
The work moves but doesn’t compound.
This is why US entry can feel harder than it should, even for capable organizations with strong products.
What successful teams do differently
Teams that navigate US entry smoothly don’t treat it as a clean restart, or as a simple extension of prior approvals.
They treat it as a translation exercise.
They focus on preserving decision context, not just documents.
They make assumptions explicit early.
They align internal teams around shared rationale before submission pressure builds.
As a result, questions surface sooner, when they are easier to address, and timelines feel more predictable.
A calmer way to think about US entry
The US medical device market is demanding. But it is rarely chaotic in the way teams fear.
Most delays do not come from hidden rules or moving goalposts.
They come from context that gets lost between regulatory systems, especially when teams are navigating unfamiliar guidance and fragmented advice.
For international manufacturers, success in the US is less about doing more work and more about structuring existing work so it carries forward.
When that happens, US entry becomes manageable because the process stops resetting.
