Should a device company launch in the US or the EU first?

It depends on device class and evidence. The US offers a single large payer landscape and a well-understood 510(k) route for devices with a predicate. The EU can be faster for some novel devices but EU MDR raised evidence expectations considerably. The answer should come from comparing both against your specific classification and data.

How long does medical device market access take?

Longer than the regulatory timeline alone suggests. A 510(k) review is measured in months, but reimbursement coding, coverage decisions, and hospital procurement cycles can each add a year or more before meaningful revenue. Planning for access means counting the full sequence, not just the clearance date.

What does market access work cost a startup?

The largest costs are usually not fees but time and evidence: clinical endpoints added late to satisfy payers, consultants hired per market, and duplicated regulatory submissions. A consistent market-comparison process early on is inexpensive relative to relaunching a study or entering a market that cannot pay for the device.

When should market access work start?

Before the clinical study design is locked. Reimbursement bodies and procurement committees ask for endpoints that regulators do not require, and adding them later usually means another study.

How many markets should be evaluated?

Enough to be sure the shortlist is not just the markets you already know. A wide, shallow scoring pass followed by depth on the top three or four is more reliable than deep research on two markets chosen by intuition.

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Guide

Medical device market access: choosing where to launch first

Market access is the work of getting a device approved, reimbursed, purchased, and used. Choosing the wrong first market rarely fails loudly — it just consumes a year of runway before the pattern becomes obvious.

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What is market access in medical devices?

Market access is the umbrella term for everything that has to be true before a device generates revenue in a country. Regulatory clearance is only the entry ticket: a payer must agree to cover the device, a hospital or health system must be able to buy it, and a clinician must have a reason to choose it over the incumbent standard of care.

This is why market access is a strategy question, not a regulatory afterthought. Teams that treat it as paperwork after clearance routinely discover — a year in — that the market they chose has no payment pathway for their device category, or that procurement rules require a local entity they do not have.

The dimensions that actually decide a launch market

Teams often rank markets by population or headline market size. Those numbers correlate poorly with how quickly a device generates revenue. The decision is better made across several dimensions weighted for your device and your capital position.

Regulatory route and expected time to clearance or certification for your device class
Reimbursement: whether a code and payment pathway exist, and who pays
Procurement: hospital, tender, or private purchasing dynamics
Clinical evidence expectations and whether your existing data satisfies them
Competitive density and the incumbent standard of care
Distribution and local representation requirements

A step-by-step market-entry workflow

Whatever the target country, the sequence of work is similar. The regulatory route detail differs — see the FDA regulatory pathways and EU MDR and UKCA compliance guides for the US, EU, and UK specifics — but the order of operations below holds.

1Classify the device in the target market and confirm the regulatory route and its evidence demands
2Map the reimbursement landscape: existing codes, coverage criteria, and who the payer actually is
3Assess whether your clinical evidence satisfies both the regulator and the payer, and plan any gaps into the study design
4Evaluate procurement dynamics — hospital purchasing, tenders, or private channels — and the local representation they require
5Compare candidate markets on one consistent rubric with explicit weights, and shortlist three or four
6Sequence the launch: pick a first market whose clearance, evidence, and reference customers carry into the second

Compare markets against one consistent rubric

The failure mode in most market-selection work is inconsistency: one market is researched in depth because someone had a contact there, another gets a paragraph. The comparison then reflects research effort rather than opportunity.

A consistent rubric — the same dimensions, the same weights, applied to every candidate market — makes the trade-offs visible and makes the decision defensible to a board six months later when conditions change.

Sequencing rather than picking one market

First market and second market are one decision, not two. A first market that produces clearance, clinical evidence, and reference customers usable in the next market is worth more than a larger market that produces none of those.

MedTech Compass brings medical device market intelligence to that decision: multi-dimensional market scoring across 25+ markets with custom weights and payment forecasting, paired with MedTech regulatory triage of global FDA pathways and EU MDR and UKCA routes, so sequencing accounts for both.

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Frequently asked questions

What is market access in medical devices?: Market access is everything required for a device to be approved, reimbursed, purchased, and actually used in a given country. It spans the regulatory route to clearance or certification, the coding and payment pathway that determines who pays, hospital or tender procurement, and the distribution and local-representation arrangements that put the product in front of clinicians. A device can be fully cleared by a regulator and still have no market access if no payer covers it and no hospital can buy it.
Should a device company launch in the US or the EU first?: It depends on device class and evidence. The US offers a single large payer landscape and a well-understood 510(k) route for devices with a predicate. The EU can be faster for some novel devices but EU MDR raised evidence expectations considerably. The answer should come from comparing both against your specific classification and data.
How long does medical device market access take?: Longer than the regulatory timeline alone suggests. A 510(k) review is measured in months, but reimbursement coding, coverage decisions, and hospital procurement cycles can each add a year or more before meaningful revenue. Planning for access means counting the full sequence, not just the clearance date.
What does market access work cost a startup?: The largest costs are usually not fees but time and evidence: clinical endpoints added late to satisfy payers, consultants hired per market, and duplicated regulatory submissions. A consistent market-comparison process early on is inexpensive relative to relaunching a study or entering a market that cannot pay for the device.
When should market access work start?: Before the clinical study design is locked. Reimbursement bodies and procurement committees ask for endpoints that regulators do not require, and adding them later usually means another study.
How many markets should be evaluated?: Enough to be sure the shortlist is not just the markets you already know. A wide, shallow scoring pass followed by depth on the top three or four is more reliable than deep research on two markets chosen by intuition.