Regulatory pathway sequencing
510(k), De Novo or PMA strategy — with specialist regulatory counsel alongside — chosen for the commercial plan, not in isolation.
Sectors · Life sciences
The US rewards proven health technology. It just makes you prove it again — its way.
Medical devices, diagnostics and digital health navigating FDA, reimbursement and hospital adoption.
The challenge
MHRA approval and NHS adoption prove the product. They do not transfer. FDA pathway selection, reimbursement coding and coverage, and hospital value-analysis committees form a second gauntlet — different evidence, different buyers, different economics.
Companies that treat the US as a bigger UK spend two years discovering the differences one stalled deal at a time. The regulatory question is rarely the hard one; the reimbursement and adoption questions are.
What we unlock
Four channels. One firm.
Reimbursement strategy
Coding, coverage and payment mapped before US entry, because it determines whether hospitals can afford to say yes.
Hospital-system and GPO access
The health systems, group purchasing organisations and value-analysis processes that control adoption.
Clinical champion development
The physicians and department leaders whose advocacy moves your technology through committee.
The method, applied
Think slow: we map the pathway, the payment and the adoption route as one system before you commit.
Act fast: we open the clinical and commercial doors that match — health systems, distributors, KOLs.
Win big: flagship health-system references and a reimbursement position that makes national scaling arithmetic, not hope.
Asked often
Does our CE or UKCA marking help with FDA?
It helps your data package; it does not shortcut the pathway. FDA runs its own logic, and pathway choice shapes both timeline and claims.
When should reimbursement work start?
Before US entry. If there is no code, no coverage and no payment, regulatory clearance produces a product hospitals admire and cannot buy.
Do we need a US clinical study?
Sometimes — for FDA, for reimbursement, or simply for adoption. American clinicians weight American evidence. The need should be established before the budget is set.
Where will you play in this market?
If what you build is proven at home and under-realised here — we should have a conversation. AXEL assesses fit before committing. The conversation is the first step, not the commitment.
Begin a conversation →