IT, logistics, construction, pharma, medtech, digital health — “entering Germany” means something different in each. For most sectors it's a commercial problem. For regulated healthcare, it's a different discipline entirely: not market entry, but market access.
In most industries, entering Germany is a commercial problem: localise, find partners, qualify for tenders, sign the first client. In regulated healthcare — pharma, medtech, diagnostics, digital health — the barrier isn't commercial, it's structural: a product can be fully legal to sell and still have no way to be paid for. That is the difference between market entry and market access — and it changes the whole plan.
Germany is the largest market in the EU and, for most companies, the first serious step into it. But the shape of “getting in” depends entirely on what you sell.
A software vendor and a device maker both need a German plan — but they are solving different problems. One needs a signed pilot and a reference customer; the other needs a reimbursement code before any hospital can use the product at all. Applying the first playbook to the second is the most expensive mistake foreign entrants make.
Everyone talks about market entry. In life sciences, the word that matters is access.
Nearly every sector falls into one of two modes of “getting in.” Knowing which one you're in is the first strategic decision — because it decides who you hire, what you fund, and how long it takes.
The barrier is commercial and relational: localisation, partners, qualification, a pilot, references. Real work — but the product is legal and sellable from day one.
The barrier is structural: authorization or a CE mark lets you sell, but reimbursement, coding and payer decisions decide whether anyone can actually use and pay for the product.
What actually stands between you and revenue — and who decides — differs sharply across sectors. The life-sciences rows (highlighted) run on a different logic from the rest.
Here the barrier moves from “can we sell it” to “will it be paid for” — a structural gate that the commercial playbook simply doesn't address.
A drug can be approved, a device CE-marked, an app listed — and still generate no revenue, because the reimbursement decision, the code, or the payer negotiation hasn't gone your way. Each track runs on its own mechanism:
Pretending one entry playbook covers pharma, devices and digital health is exactly what a generalist would do.
In a focused session we place your product on the entry-vs-access spectrum, map the actual barrier and timeline, and outline the first moves — whether that's partners and channels, or reimbursement and authorization.