A resource-limited MedTech startup cannot enter every international market at once, and should not try. The way to prioritize international markets is to score each candidate jurisdiction against five criteria — market size multiplied by real accessibility, regulatory cost versus realistic revenue potential, availability of a commercial or distribution partner, regulatory calendar time, and strategic importance to funding and partnerships — then pick the single highest-scoring next market and enter it fully before opening the second. Prioritisation is a subtraction exercise. The markets that do not make the shortlist are not "later" — they are explicitly cut from the current plan until a revenue signal from the markets on the list earns them a seat.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • Prioritising international markets is the decision of which single next jurisdiction to enter — not a list of five to open in parallel.
  • The five scoring criteria that actually matter are market size times accessibility, regulatory cost versus realistic revenue potential, partnership and channel availability, calendar time through the regulatory gate, and strategic importance to funding or partnerships.
  • The European Economic Area, entered through CE marking under the Medical Device Regulation (Regulation (EU) 2017/745), is the anchor market for most EU-based startups. Every other jurisdiction is scored against the cost of leaving the anchor.
  • The first five markets for most Class IIa software-driven devices cluster around a predictable shortlist: EU, then either the US or an MDSAP-anchored bundle, then the UK, Switzerland, and one strategic Asia-Pacific market — in that order, one at a time.
  • Opportunistic expansion — entering a market because a lead appeared in the inbox — is the most expensive prioritisation mistake a resource-limited startup can make.

Why prioritisation is the hard part

Every MedTech founder we talk to has the same international expansion problem, and almost none of them describe it as a prioritisation problem. They describe it as a bandwidth problem, a budget problem, a regulatory timeline problem, a partner problem. All of those are real. The underlying shape, though, is that the number of markets on the wishlist is larger than the number of markets the company can actually enter this year, and no one has been forced to say out loud which markets are on the list and which are off it.

That is what prioritisation does. It forces the uncomfortable conversation. Not "which five markets are interesting," but "which one market is next, and which four that sounded interesting have been deliberately cut from the plan for the next twelve months." The honest answer is almost always painful because it means telling an investor, a board member, or a founder themselves that a market they have been describing in the deck is not going to happen on the original timeline.

Resource-limited startups that cannot have this conversation end up running parallel half-plans in four jurisdictions, each underfunded, each under-supported by the commercial channel, each producing a regulatory submission that arrives without a customer ready to buy. The submissions count as wins on an internal dashboard. The revenue does not arrive. The runway compresses. The next round is harder to raise because the company has five markets "in progress" and none producing real signal.

Prioritisation is not a step that happens after the strategy is written. It is the strategy.

The prioritisation criteria

The five criteria below are the ones that, in our experience across many startup expansions, actually separate the markets that pay back from the markets that drain the runway. Score every candidate jurisdiction against all five. Do it honestly. Then rank.

Market size and accessibility

The first criterion is market size, but with a strict qualification: it is addressable market size, not macro market size. The US MedTech market is the largest in the world in absolute terms. The addressable market for your specific Class IIa device, in your specific indication, sold through the specific commercial channel you can realistically build, is a different and usually much smaller number.

The right market size figure for prioritisation is: how many specific hospitals, clinics, or end users in this jurisdiction would plausibly buy this device in the first three years, multiplied by an honest per-unit price, minus the cost of reaching them. That is the number that matters. Run the calculation per candidate jurisdiction. Some jurisdictions that look small on a macro map — Switzerland, the Nordics, Australia — have concentrated hospital networks or specific procurement dynamics that make them unusually efficient first steps for certain device categories. Some jurisdictions that look enormous are functionally closed without a local partner, a reimbursement pathway, and years of clinical evidence.

Market size and accessibility multiply. Neither number is meaningful alone. A giant market you cannot reach is zero. A small market you can reach cleanly is revenue. The product is what goes on the scorecard.

Regulatory cost versus revenue potential

The second criterion is the ratio between what it costs to get through a jurisdiction's regulatory gate and what that jurisdiction can realistically return in revenue within three years.

Regulatory cost is the full stack, not the headline submission fee. It includes classification analysis for the new jurisdiction's framework, gap work on the technical documentation, labelling and instructions for use in the required languages, any jurisdiction-specific testing or evidence the authority expects beyond what the shared core already contains, local representation (US agent, EU authorised representative, UK Responsible Person, Swiss Authorised Representative, Australian Sponsor, and so on), submission fees, QMS overlay work, and audit costs where applicable. For a startup that already holds a CE certificate under the MDR and runs a QMS under EN ISO 13485:2016+A11:2021, some jurisdictions add a thin overlay and some demand substantial additional work. The variance is an order of magnitude across the common candidates.

Revenue potential is the honest three-year addressable number from the accessibility analysis above, not a macro TAM figure. Divide cost by potential. Markets where the ratio is unfavourable drop down the list. Markets where the ratio is favourable — usually because the cost is low and the channel is warm — rise.

This criterion is where founders most often lie to themselves on the spreadsheet. The corrective is to write down the revenue assumption as a number of specific customers, not as a percentage of a macro TAM.

Partnership availability

The third criterion is whether a real commercial or distribution partner exists in the jurisdiction today, or whether finding one is still a hypothesis.

Regulatory approval is necessary and not sufficient. A device cleared by the FDA with no US sales team, no US hospital contracts, no clinical champion, and no reimbursement story is a device that consumed submission budget without generating revenue. The same is true of any jurisdiction. The sales channel either exists as a real asset — a named distributor with references, a direct hire in the country, a clinical champion who will use and advocate for the device — or it is a line in a business plan.

The prioritisation rule that works: prefer jurisdictions where the commercial channel is already warm over jurisdictions where the market is theoretically larger. A smaller market you can actually sell into produces revenue. A larger market you cannot sell into produces burn. For a resource-limited startup, this rule is close to absolute.

A useful test: for each candidate jurisdiction, can you name the first customer? Not the first hospital you hope to approach — the first one that has already said, in writing, "if you were cleared here, we would evaluate." If the answer is no for a jurisdiction, the partnership score drops.

Regulatory calendar time

The fourth criterion is calendar time from decision to market access in the jurisdiction.

Calendar time matters most when runway, commercial commitments, or investor milestones have hard dates. If your next round requires US revenue traction by a specific quarter, a two-year approval path is disqualifying regardless of how attractive the market looks on other criteria. If your runway is long and your commercial plan is flexible, slower jurisdictions become more attractive because the cost can often be lower.

Some jurisdictions collapse calendar time through bundling. A Medical Device Single Audit Program audit, performed by a recognised Auditing Organisation, can satisfy the QMS inspection layer for several jurisdictions at once — covering Canada, Australia, Japan, and Brazil in one coordinated visit rather than four separate national inspections. MDSAP does not grant premarket approval in any of those jurisdictions, but it collapses the QMS layer meaningfully. For the mechanics, see post 635. When calendar time is the binding constraint and several MDSAP jurisdictions are in the plan, bundling them is often the right prioritisation move.

Strategic importance

The fifth criterion is whether the jurisdiction supports the rest of the company's plan independently of direct revenue. Some markets matter for investor signalling — US clearance is often a prerequisite for Series B conversations with certain investor profiles, regardless of how quickly US revenue actually arrives. Some markets matter for partnership conversations — Japanese market access is often discussed as a prerequisite for wider Asia-Pacific distribution agreements. Some markets matter because the anchor customer or anchor clinical site happens to be there.

Strategic importance is a legitimate input when it is named and honest. It is dangerous when it is used to justify a decision the other four criteria would otherwise reject, with no one forcing the team to say out loud that the jurisdiction is being pursued for signalling rather than economics. The rule we use: strategic importance can promote a market one rank up the list. It cannot promote a market from the bottom to the top.

The typical first-five sequence

For most Class IIa software-driven devices from EU-based startups, the scoring exercise ends up producing a first-five shortlist that looks broadly similar across companies, even though the underlying calculations differ. That is not because there is one right answer. It is because the cost, channel, and calendar realities cluster.

  1. European Economic Area — CE marking under the MDR. The anchor. CE certificate, EUDAMED registration, PRRC in place, a running QMS, post-market surveillance rhythm established. Consolidate for at least one full PMS cycle before opening a second market. See post 636 for the full sequencing logic and post 637 for the scalable framework the shortlist fits into.
  2. The United States — FDA 510(k) or De Novo, or an MDSAP-anchored bundle. The shortlist forks here. If the commercial plan and investor expectations point at the US, the second market is an FDA submission. If the plan points at multiple smaller jurisdictions where a single audit extension covers the QMS layer, the second market is MDSAP-bundled Canada plus one other participating authority. Rarely both at once. See post 049 and post 050 for the US-versus-EU framing, and post 601 for the FDA primer.
  3. The United Kingdom — MHRA registration. Frequently underweighted by EU founders because it feels close to the EU. The UK operates an independent regulatory framework under the MHRA, the market is commercially reachable for most EU-based teams, and the overlay on top of the shared core is thin relative to the revenue potential. See post 624.
  4. Switzerland — Swissmedic. Also frequently underweighted. Switzerland decoupled from the EU regulatory route and now requires a Swiss Authorised Representative and specific registration, but the additional regulatory cost is modest relative to the market's procurement concentration and price levels. See post 625.
  5. One strategic Asia-Pacific or Latin America market. Usually driven by a specific partnership opportunity or an anchor customer, chosen deliberately rather than opportunistically. Canada sometimes sits here when it did not already arrive through MDSAP in step 2; see post 629. The fifth slot is where strategic importance has the most legitimate weight.

This is a template, not a formula. Class III implants, high-complexity imaging devices, and niche diagnostics produce different shortlists. The frame — one anchor, one deliberately chosen second, then a sequence of third-through-fifth additions one at a time — survives across device categories.

The trap of opportunistic expansion

The single most expensive prioritisation mistake a resource-limited startup can make is opportunistic expansion: entering a market because a distributor lead appeared in the inbox, an investor mentioned the country in a meeting, a conference produced a promising conversation, or a competitor announced a launch there. None of these are prioritisation inputs. All of them feel like them.

The pattern we see most often: a startup with a shortlist of three deliberate markets receives an unsolicited distributor enquiry from a fourth. The fourth market was not on the shortlist for good reasons — small addressable market, unfavourable regulatory cost ratio, no anchor customer, no strategic importance. The distributor enquiry bypasses the prioritisation exercise entirely because it feels free. It is not free. It costs regulatory affairs bandwidth, QMS audit scope, translation work, local representation, and commercial attention — all pulled off the three deliberate markets to serve the opportunistic fourth.

Six months later, the fourth market has not produced revenue because the distributor was optimistic rather than committed, and the three deliberate markets have slipped because the team has been distracted. That is the opportunistic expansion pattern, and it is more common than any single category of prioritisation error we see.

The corrective is a rule: unsolicited opportunities do not jump the queue. They enter the prioritisation scoring like any other candidate. If they score high enough to displace something on the current shortlist, the displacement is named explicitly and the market they replace is cut from the plan. If they do not score high enough, they are parked politely. No opportunistic jumps.

Common mistakes

The prioritisation mistakes we see most often are all variants of refusing to subtract.

  • Treating the shortlist as "plus also these." A shortlist of three markets that quietly grows to five during the year is not a shortlist — it is a wishlist with a different name. The cut is the whole point.
  • Scoring against macro TAM instead of addressable market. The US is the largest MedTech market in the world. Your addressable slice of it may not be. Write the number down as specific customers, not as a percentage of a macro figure.
  • Ignoring the partnership question until after the regulatory work starts. If the channel does not exist today, it has to be built during the regulatory timeline — which means it was never a zero-cost addition and should have scored lower from the start.
  • Letting strategic importance rescue every weak market. Every market sounds strategic if you pitch it hard enough. Strategic importance is one input of five, and it cannot carry a market that scored poorly on the other four.
  • Mistaking a warm conference conversation for a partnership. Business cards are not distribution agreements. Until a partner has signed something binding or a customer has committed to evaluate, the channel is a hypothesis.
  • Running three markets at half strength rather than one at full strength. Half-funded parallel projects produce half-finished regulatory work and no revenue. One fully funded market produces a submission, a launch, and a revenue signal — which is what earns the next market its seat on the list.
  • Not documenting which markets were deliberately cut. A shortlist without a cut-list is not a prioritisation. Write down which markets were considered and rejected, and why. The document protects the decision from being silently reopened by the next distributor enquiry.

The Subtract to Ship angle on prioritisation

Subtract to Ship applied to international prioritisation is not about entering fewer markets in the long run. It is about entering the markets on the shortlist one at a time, fully, and explicitly cutting the markets that did not make the list so they cannot drain attention from the ones that did.

The subtractions that matter are the opportunistic leads that bypass the scoring, the parallel half-plans that share bandwidth with the anchor market, the strategic-importance justifications that cover weak scoring on the other four criteria, and the wishlist markets that live quietly in the deck but not on the operational plan. Every cut frees capital, regulatory affairs bandwidth, and commercial attention for the markets that remain. That is the whole point of prioritisation.

The Medical Device Regulation (Regulation (EU) 2017/745) anchors the EU slot because the MDR is where most EU-based startups begin, and the MDR Annex II technical file is the most reusable core for every subsequent market. For the methodology in full, see post 065. For the true cost view that makes the second criterion concrete, see post 638.

Reality Check — Is your prioritisation honest?

  1. Can you name, in one paragraph, the single next market you are entering, and the specific reason it beat every other candidate?
  2. Do you have a written cut-list of markets that were considered and deliberately rejected for the current plan, with the reason for each rejection?
  3. For each market on your shortlist, have you scored all five criteria honestly — not just the two that make the case you already wanted to make?
  4. Have you written down your addressable market for each candidate as specific customers, or only as a percentage of a macro TAM figure?
  5. Do you have a rule for what happens when an opportunistic lead arrives for a market that is not on the shortlist, and has the rule ever actually been applied?
  6. Is every market on your shortlist fully funded, or are you running parallel half-plans that share the same budget and bandwidth?
  7. If your board asked tomorrow which markets are off the plan and why, could you answer without hedging?

If more than three of these produced a "not yet," the prioritisation exercise has not actually happened yet. It is waiting to.

Frequently Asked Questions

What does "prioritising international markets" actually mean for a resource-limited MedTech startup? It means picking the single next jurisdiction to enter, fully funding the regulatory and commercial work for that jurisdiction, and explicitly cutting the other candidate markets from the current plan until a revenue signal earns them a seat. Prioritisation is a subtraction exercise, not an ordering exercise.

How many international markets should a MedTech startup target in year one after CE marking? For most resource-limited startups, exactly one. The EU anchor has to stabilise first, and the second market is chosen deliberately and entered fully rather than being one of three parallel half-plans. A second market in year one is common; a third market in year one is rare and usually a sign the plan is overextended.

Which criteria matter most when choosing the next market? Five criteria in combination: addressable market size multiplied by real accessibility, the ratio of regulatory cost to realistic three-year revenue, the availability of a committed commercial partner or channel, calendar time through the regulatory gate, and strategic importance to the funding or partnership plan. No single criterion wins alone. All five go on the scorecard.

What about opportunistic leads from distributors in unexpected markets? They enter the scoring process like any other candidate. They do not jump the queue. If they score high enough to displace a market currently on the shortlist, the displacement is named explicitly and the replaced market is cut from the plan. Opportunistic jumps are the most expensive prioritisation error we see.

Does the Medical Device Regulation apply to international prioritisation at all? Directly, only for the EU slot. The MDR (Regulation (EU) 2017/745) governs conformity for the European Economic Area and nothing beyond it. Indirectly, the MDR matters across the whole prioritisation exercise because it is usually the anchor market for EU-based startups and the MDR Annex II technical file is the most reusable evidence core for subsequent jurisdictions. See post 637 for the scalable framework.

What is the single biggest prioritisation mistake to avoid? Running three or four markets in parallel at half strength rather than running one market at full strength. Half-funded expansion produces half-finished regulatory work in every jurisdiction and no revenue in any of them, which makes the next funding round harder and the next prioritisation decision even more crowded.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), Articles 1 and 2 (scope and definitions). Official Journal L 117, 5.5.2017. Cited here to establish that the MDR governs European Economic Area market access and to anchor the EU slot in the prioritisation shortlist.
  2. EN ISO 13485:2016 + A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes. Cited as the shared QMS baseline that keeps the regulatory cost of subsequent jurisdictions manageable for a startup already operating under the MDR.
  3. US Food and Drug Administration, Medicines and Healthcare products Regulatory Agency (United Kingdom), Swissmedic (Switzerland), Health Canada, Therapeutic Goods Administration (Australia), Pharmaceuticals and Medical Devices Agency (Japan), and Agência Nacional de Vigilância Sanitária (Brazil) — the non-EU regulatory authorities referenced in this post. Each operates its own framework cited at the general framing level; for current submission parameters in any specific jurisdiction, consult that authority's current guidance.
  4. Medical Device Single Audit Program (MDSAP) — programme documentation maintained by the International Medical Device Regulators Forum (IMDRF) and the five participating regulatory authorities. Referenced at the general framing level as the mechanism behind bundled prioritisation scoring.

This post is part of the FDA & International Market Access series in the Subtract to Ship: MDR blog. Authored by Tibor Zechmeister and Felix Lenhard. Prioritisation is where international expansion strategies succeed or fail, long before the first regulatory submission is drafted. The shortlist is the strategy. The cut-list is the discipline. The markets that do not make either list are the ones that were never going to pay back the work they would have cost.