The question comes up in every first conversation with a Nordic medtech CEO who has US ambitions. Direct sales force or distributor? It gets discussed for eighteen months, postponed three times, and finally decided under deadline pressure when a board meeting demands an answer.
The decision is rarely as binary as the framing suggests. It is also not a matter of preference — there is a right answer for any given product, segment, and stage, and that answer is built from five concrete factors. Get the factors clear and the decision becomes obvious. Skip them and the choice becomes politics.
This is what those five factors look like in practice.
Factor 1: capital horizon and time-to-revenue
A direct sales motion in the US carries a sharp cost curve in the first eighteen to thirty-six months. You hire a country lead, then a small team of clinical-savvy reps, then sales operations and support. The build runs $1.5–$3M before the first repeatable revenue cycle, longer if the product needs IDN-level access or hospital tender capability.
A distributor model flattens that curve. The distributor carries the field cost, the relationship infrastructure, and often the regulatory navigation. You trade gross margin (typically 30–50% to the distributor) for capital efficiency.
The honest question to ask: what is the cost of not having revenue for the first 24 months? For some companies — well-funded, post-Series B, building defensible moats — direct is right because the cost of slow growth exceeds the cost of margin sacrifice. For most early-stage Nordic medtech, distributor is the only realistic answer, even if the long-term plan is to go direct later.
[DH: Insert concrete case here — anonymized, e.g. "A diagnostics company we worked with, post-Series A, chose direct because…" or "A medtech we advised…"]
Factor 2: regulatory complexity per segment
Some medtech segments require deep US regulatory navigation — 510(k) pathway management, ongoing FDA correspondence, post-market surveillance, MDR/IVDR alignment for products that also sell in Europe. If your product lives here, the regulatory function is non-negotiable, and it has to sit close to the customer.
That favors direct, or more precisely it favors a hybrid where the regulatory and clinical-affairs function is in-house but field commercial activity goes through a partner.
Other segments — established categories with clear predicate devices, mature reimbursement, well-understood clinical positioning — are far less regulatory-intensive at the point of sale. The distributor's existing FDA-experienced sales reps can carry the weight without daily back-and-forth with your team.
The test: how often does the customer ask a regulatory question in the sales conversation? If the answer is "every meeting," you are not in a distributor-friendly segment. If the answer is "rarely, mostly during procurement," distribution is viable.
For more on the regulatory-commercial intersection, see our guide to go-to-market strategy for medical devices.
Factor 3: customer density and buying behavior
Direct sales reps are economical in segments with concentrated, high-value buyers. A rep can carry a quota of $1.5–$3M ARR by managing twenty to forty accounts intensively. That works in academic medical centers, integrated delivery networks, large reference labs, and hospital systems with formal evaluation processes.
Distribution is economical in segments with fragmented, lower-value buyers — community hospitals, regional clinics, ambulatory centers, smaller research labs. Distributors carry hundreds of small accounts efficiently because their cost-per-account is far lower than yours can ever be.
The tell is the average deal size. Below roughly $50K initial PO, distribution is almost always more economical. Above $250K with multi-year service or consumable streams, direct usually wins. The middle is where the hybrid models live, and where most Nordic medtech actually operates.
[DH: Add specific deal-size benchmarks from your portfolio if comfortable — readers love specifics here.]
Factor 4: sales-force build cost vs. commission economics
This is the spreadsheet exercise people skip until late.
Direct field rep, fully loaded (salary + benefits + commission target + travel + tools): $250K–$400K per year per head in the US, depending on segment seniority. To cover even six metro markets meaningfully you need 6–10 heads. That is a $2–$4M annual run rate before the first dollar of revenue accrues to you net of margin.
Distributor commission: typically 30–50% of net price, sometimes negotiable down to 25% if you carry parts of the work (regulatory, clinical training, marketing) and the distributor only handles field activity.
The crossover point depends on volume. A useful rule of thumb: at sustained revenue above $15M ARR with healthy gross margins, direct usually pays for itself. Below that, distributor economics are almost always better. Most Nordic medtech entering the US is targeting $3–$10M in year three — squarely in distributor territory.
This is also where the Commercialization Sprint tends to land — a six-to-eight-week scoped engagement that builds the actual model with your numbers, not industry averages.
Factor 5: strategic optionality — what next?
The often-missed factor: which model preserves the future moves you might want.
A strong direct presence is harder to unwind but creates strategic value if the company is later positioning for acquisition. Acquirers — strategic ones especially — pay premiums for installed direct sales infrastructure in the US because it accelerates their own integration.
A distributor relationship is faster to set up and cheaper to run, but harder to take back. Distributors who built your business become a barrier to going direct later — they have the customer relationships, the contracts, sometimes exclusive territory rights you negotiated under duress when you needed them.
If the strategic intent is to build and exit within five years, distributor-first is usually right because the goal is capital-efficient revenue growth. If the intent is to build and operate as a long-term US presence, direct-first or aggressive direct-conversion clauses in distributor contracts are the move.
This is a board-level conversation, not a sales-strategy conversation. It deserves to be made explicit before the model is locked.
The hybrid trap
A common pattern among Nordic medtech: pick a hybrid because the team cannot agree on direct or distributor. One internal commercial lead, two distributors, a couple of "strategic accounts" the founder sells to personally.
Hybrids work when they are deliberate — for example, direct in the top ten target accounts, distributor everywhere else, with explicit territory and account boundaries written into both contracts. They fail when they are accidental — when "we will figure it out as we go" produces overlapping coverage, channel conflict, and customer confusion.
The diagnostic: can you draw a line on a map (or a list of named accounts) that separates direct from distributor coverage? If yes, hybrid is fine. If no, you are not running a hybrid — you are running two half-models that will collide.
How to actually decide
Stop debating the model in the abstract. Run this exercise instead.
List the first ten US accounts you will approach. Write them by name. Are they academic medical centers, IDNs, community hospitals, reference labs? What is the average expected deal size? Who buys, who decides, who blocks?
Map the regulatory-clinical content of the sale. How often does a regulatory or clinical question come up in the pitch? Who answers it credibly?
Calculate the 24-month cost of each model with your real assumptions. Not industry averages — your team, your margin structure, your travel costs.
State the strategic intent. Build to scale, build to sell, or build to operate? The honest answer changes the math.
Pick the model that wins on three of the four above. If no model wins three, you are not ready to enter the US — you are ready to do more market work first.
Most Nordic medtech we work with skips steps 1 and 4. They debate models in the abstract, settle on a hybrid by inertia, and discover the gaps eighteen months in. The exercise above takes a week of focused work and prevents most of those mistakes.
A closing observation
The teams who get this right share a habit: they treat the direct-vs-distributor decision as a commercial design problem, not a strategy problem. Strategy is the why. Commercial design is the how — the actual structure of how a customer goes from awareness to repeat purchase, who carries which step, and what economics make the system sustainable.
Strategy decks make this look like a binary choice. The work makes it look like an architecture decision with five inputs and a clear winner once the inputs are honest.
If you are mid-way through this question right now — whether the postponement is two months or fifteen — the AI Readiness Interview is a useful starting point. It is free, it forces the strategic intent question into the open, and the same diagnostic surfaces whether the rest of the model is ready to support either path.
The wrong choice you make under pressure costs eighteen months. The right choice made deliberately costs a week. Pick the cheaper option.
Written by Daniel Hesse, Founder of 4Front 2 Market. Daniel has led commercialization for Nordic life science companies for fifteen years, including the US expansion path covered above. If you have a specific case, start a conversation or book the free AI Readiness Interview.