Global expansion planning and management

Most small device and IVD companies do not have an expansion plan. They have a list of markets someone asked about, in the order the questions arrived. We help you turn that into a sequence you can defend, and then help you run it.

Expansion is usually run as a series of unrelated projects

It rarely starts as a strategy. A distributor approaches you at a trade show and asks about their country. A customer's parent company wants the product somewhere you do not sell. A board member asks why you are not in Brazil.

Each one becomes its own small project, resourced separately, tracked in its own spreadsheet by whoever picked it up. Individually they are all reasonable. Together they are not a plan, and three things tend to go wrong:

The order is accidental. Markets get done in the order they were asked about rather than the order that builds on itself. A reference base in one market often makes the next two easier and cheaper — but only if you enter them in that order.
Nobody holds the whole picture. The person who knows where the Thai submission stands is not the person managing the Colombian partner, and neither of them is looking at the renewal that lapses next quarter.
The timeline is optimistic in a specific way. Registration timelines get estimated. The things that actually consume the years — labelling, the local entity, appointing and replacing partners, the first tender cycle you miss by three weeks — do not get estimated at all.

What a plan has to answer

An expansion plan that is worth writing down answers four questions for every market you are considering, not just the ones you have already decided on:

Is it worth entering? Size, reimbursement, the competitors already there, and what it would take to be the third or fourth option rather than the first.
What does entry actually require? The regulatory route for your class of device or IVD, whether a local entity or a local holder is mandatory, and what that means for who controls the registration.
What will it cost, and when? Not just fees. Consultant time, testing, translation, the local partner's expectations, and the period where you are spending before anything is sold.
What has to happen first? Dependencies between markets — reference approvals, a manufacturing certificate, a clinical publication, a regional distributor who wants two countries or none.

Regional market assessment

Competitor analysis and regulatory pathways for a region you are considering, starting at $5,000. Ask us what it covers.

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Then someone has to run it

A plan that lives in a slide deck stops being true about four months in. The part clients tell us matters more is the management afterwards — one place where every market's status is current, and a standing rhythm for reviewing it.

In practice that means keeping track of:

Where each submission stands, and what it is waiting on
What expires when, far enough ahead that a renewal is a task rather than an emergency
Which partner is performing, which is quiet, and which agreement is up for review
What changed in a market that affects a plan you made last year

We run quarterly check-ins as part of the engagement rather than as an extra. Most of the value shows up in them — a launch that slipped, a partner who has gone quiet, a market that has become easier since you last looked.

Launches take longer than anyone plans for

This is the thing we most want clients to build around. A market entry that starts today may not produce meaningful revenue for years, and the companies that do well internationally are the ones that accepted that early and sequenced accordingly.

The practical consequence is that you need a system that survives staff turnover and a plan that is still legible in year three. Both are unglamorous. Both are what separates companies that are genuinely in eight markets from companies that have registrations in eight markets.

Devices and IVDs

We work across both. The two follow different regulatory routes in most markets, and IVDs are frequently the ones caught out — classification rules diverge from devices, the evidence expected differs, and a partner who is excellent at selling implants may have no route to a laboratory buyer at all. Where the plan differs by product type, we will say so rather than average it.