We unlock FDA pathways, reimbursement, and hospital adoption for medical devices, diagnostics, and digital health from Europe, Australia, and New Zealand.
Your device, diagnostic, or digital health platform is CE-marked and clinically adopted at home. You’ve established a US presence, perhaps cleared the FDA. And the revenue still isn’t following.
US life sciences has four gates, and clearing the first one — the only one most companies plan for — doesn’t open the other three:
This is the terrain we work in daily. The companies that win here treat regulatory clearance as the entry ticket, and reimbursement and adoption as the actual game.
510(k), De Novo, or PMA; predicate strategy; Pre-Submission planning; US Agent, establishment registration, and device listing — sequenced so the pathway decision drives everything else.
CPT/HCPCS coding, coverage with CMS and private payers, and the health-economic value story that turns clearance into revenue.
GPO and IDN channels, value-analysis committees, and the clinical champions and KOLs who actually move purchasing decisions.
US-relevant clinical evidence and real-world data, plus the HIPAA and Anti-Kickback/Sunshine guardrails your commercial model has to live within.
We map your FDA pathway, reimbursement route, buyer landscape, and evidence gaps as one plan — because a decision at any gate reshapes the other three. Most US life-science failures are sequencing failures.
Reimbursement and health-economic work starts alongside regulatory, not after it. Arriving at clearance with coding, coverage strategy, and clinical champions already in motion compresses time-to-revenue by quarters.
One health system adopting fully — through its value-analysis committee, with measured outcomes — becomes the reference that carries you across the GPO and IDN landscape.
It helps your internal readiness, but it doesn’t substitute. The FDA pathway for your product class — 510(k), De Novo, or PMA — sets its own evidence requirements, and European clinical data isn’t automatically accepted. Establishing the pathway and the predicate is the first real US decision.
Because clearance lets you sell legally, while reimbursement determines whether anyone can afford to buy. Without a coding, coverage, and payment path — through CMS and private payers — hospitals have no budget mechanism for your product, however good the clinical story.
Rarely one person. Value-analysis committees weigh clinical benefit against cost; GPOs and IDNs shape which products are even available to buy; clinicians champion but seldom sign. Selling to the committee is a different craft from selling to the physician.
The FDA requires foreign establishments to designate a US Agent — that’s the minimum. A US entity becomes important for liability, hospital contracting, hiring, and credibility, and most companies that get traction establish one. The right timing depends on your channel model.
If your device, diagnostic, or digital health platform is proven at home and underrealized here — we should have a conversation.
Traksjon assesses fit before committing. The conversation is the first step, not the commitment.
Begin a Conversation →