GMA is the global / international marketing agency treating this city as a buyer-evaluation problem inside market-entry marketing. The work is the local-market website, proof order, offer language, SEO/AI visibility, paid path, and follow-up a foreign or outbound company needs before serious buyers move.
The clinical literature is strong. EU adoption is real. The US value-analysis committee scores the device as untested in the US market. The reason is not the device. The US procurement evaluation function is calibrated to a different evidence stack than the one GMA sent.
If a US pilot ran successfully and did not expand, the device is fine. The procurement file above the pilot is not.
EU medtech evaluation is structured around clinical literature, CE-mark history, named-site adoption across EU centres, and reimbursement at the national-payer level. A device that performs well across these lands as best-in-class. Procurement and clinical evaluation are tightly coupled. A strong clinical story usually translates into adoption.
US medtech evaluation is structured differently. The value-analysis committee inside an integrated delivery network is a procurement function, not a clinical-evaluation function. It scores on six US-market signals: FDA pathway and clearance status, availability under an existing GPO contract, CMS coding and reimbursement clarity for the procedures the device sits inside, US clinical evidence with US sites and US authors, US KOL adoption, and total cost of care impact stated in US accounting language. The clinical literature lands as supportive only.
Per Deloitte life sciences outlook, US IDN procurement has consolidated around GPO and value-analysis frameworks, raising the evidence threshold for any device not already routed through those structures. Roland Berger medtech outlook documents the rising weight of US-site clinical data over EU-only data in first-evaluate scoring. Reuters US hospital procurement coverage 2024-2026 notes the tightening of total cost of care framing across major IDNs.
The Swiss medtech file built for EU evaluation leads with clinical depth. The US procurement file requires the same content but rebuilt for the six signals on the first evaluation. 6 signals, in that order, with one US clinical site visible, with a TCO model the value-analysis committee can evaluate, with a named US KOL strategy. The substance underneath is unchanged.
If you handed your file to a US IDN value-analysis committee tomorrow, would they find all six signals on the first evaluation, or would they file it under untested and move on?
"Best-in-class in Europe is real and not enough. US procurement judges a different evidence stack. Build that one too."House view on Swiss medtech US entry
Stage one: evaluate the file against the six signals. Pull the existing US-facing materials and score them against FDA pathway and status, GPO contract availability, CMS coding and reimbursement clarity, US clinical evidence with US sites and US authors, US KOL adoption, and total cost of care impact in US accounting language. Name every signal that is absent. House view is most Swiss medtech files arriving in US procurement carry three to five of the six absent.
Stage two: rebuild the file and anchor one US clinical site. Restructure the US website, deck, and sales material and the value-analysis dossier to lead with the six signals. Anchor one US clinical site with named US investigators producing US-published outcome data. The site does not have to be a flagship. It has to be visible, named, and in the US. Build a TCO model in US accounting language that translates the EU outcome data into IDN-relevant savings.
Stage three: brief the US channel and the value-analysis committee. The US sales team is briefed on the six signals and on how to present them in the VAC meeting. The IDN value-analysis committee is approached with a dossier built around their evaluation order. The GPO outreach is restarted with a contract-fit package. The structural channel is now set up for US procurement scoring rather than against it.
This work fits inside a Market-Entry Marketing Sprint (six to ten weeks, one IDN segment, one device line), a Cross-Border Marketing Build (three to six months, full US procurement and channel rebuild), or a Global Marketing Partnership (monthly retainer, twelve-month minimum, for groups with multiple US-facing medtech lines). Pricing is discussed privately after GMA knows the work needed.
| Before rebuild (EU register) | After rebuild (US procurement register) |
|---|---|
| Lead signal: EU clinical literature and CE-mark | Lead signal: FDA status, GPO contract, CMS coding visible |
| Clinical evidence: EU sites and EU authors | Clinical evidence: one named US site, US authors, US-published |
| Cost narrative: device price comparison | Cost narrative: TCO model in US accounting language |
| KOL strategy: EU-led | KOL strategy: US-named, US-society-aligned |
| Pilot expansion: zero | Pilot expansion: IDN-wide on the strength of the rebuilt file |
| VAC outcome: filed untested | VAC outcome: scored in the evaluation set, contract path open |
File first, site second, channel third. The clinical substance is real. The file and channel are the rebuild.
US hospital procurement does not import EU clinical evidence at face value. The procurement scoring function inside a US integrated delivery network judges for FDA clearance pathway and status, GPO contract availability, CMS coding and reimbursement, US clinical evidence and KOL adoption, and total cost of care in US accounting language. A medtech device with strong EU clinical penetration may have none of these visible. The device is excellent. The file is missing the US-market signals.
Six things: FDA status with the specific clearance pathway, GPO contract availability, CMS coding and reimbursement clarity, US clinical evidence with US sites and US authors, US KOL adoption, and total cost of care impact in US accounting language. The EU CE-mark and EU clinical literature land as supportive only, not load-bearing. A Swiss medtech file led by EU clinical depth without these six items lands as untested.
Materials and channel. The US hospital sales motion is structured around GPO contracts, IDN value-analysis committees, and US clinical evidence packs. A US rep selling a Swiss device without those three structures in place is asked the same questions every meeting and cannot move the process. The fix is upstream of the rep. The file has to be rebuilt for US procurement evaluation and the channel has to be set up for US scoring.
Less than firms expect, more than firms typically provide. A targeted US clinical site presence with named US investigators, US-published outcome data even in modest patient numbers, and a structured KOL adoption strategy moves GMA out of untested. Per Deloitte life sciences outlook, US procurement buyers explicitly weight one well-presented US clinical site above five strong EU sites for first-evaluate scoring.
Inquiry through the contact form and a first fit screening. Share the current US-facing materials, the FDA status and pathway document, the EU clinical pack, the last three IDN evaluations, and the GPO outreach record. Response within one business day. Pricing is discussed privately after GMA knows the work needed.
No legal services. No FDA submissions, no 510(k), De Novo, or PMA filings. No CE-mark or notified-body work. No clinical trial design, IRB submissions, or regulatory medical writing. No GPO contract negotiation. No CMS coding or reimbursement filings. No HIPAA, SaMD, or device cybersecurity certification. No US entity formation. No US tax structuring. No US banking introductions. No fiduciary services. No IP filing. No M&A transaction work. The clinical and regulatory substance sits with regulatory counsel, clinical research organisations, and reimbursement consultants on both sides of the corridor. GMA rebuilds the commercial and procurement-facing surface that runs alongside the regulatory and clinical file. When a marketing decision touches clinical, regulatory, or reimbursement implications, GMA flags it and defers before execution.
If the market is not responding, the first question is simple: what is the buyer not seeing, trusting, or doing yet?
| Action that should happen | The buyer should request a quote, ask for a call, send an RFQ, move a proposal forward, or hand the work to the right internal person. |
| What may be unclear | If that is not happening, the market may not understand the category, proof, offer, price, channel, service answer, or follow-up. |
| What to inspect | Check the page, sales deck, product proof, offer language, contact path, and follow-up before adding more traffic or more distributors. |
| Next step | If the break is commercial, continue to /engagements/ or /contact/#inquiry. |