The conversation we have most often with health companies arriving in the region is always the same: they have a device, a piece of clinical software, or a therapy with solid evidence back home, and they assume product quality will open the market on its own. It won't. In health, the product is barely 20% of the access work.
Between your technology and the patient sits a chain of decisions that almost no one maps in full before investing. When it fails, it isn't the product that fails: it's the link that got ignored.
1. Map the access chain before you spend
Every health technology travels the same sequence to reach a patient. Seeing it whole changes where you start:
| Link | Question it answers | Who decides |
|---|---|---|
| Regulatory | Can it legally be sold? | The health authority (COFEPRIS in Mexico) |
| Evidence | Does it work and is it safe here? | The clinician and the technology assessor |
| Economic value | What does the outcome cost? | The payer — public or insurer |
| Procurement | How does it enter the budget? | Institutional purchasing or the hospital |
| Adoption | Does the clinician actually use it? | The clinician at the point of care |
The classic mistake is working these links in series: registration first, evidence next, the payer later. By the time you reach the payer, you discover the evidence you generated doesn't answer their question — and you go back to the start.
2. Regulatory first, but with strategy
Without regulatory clearance there's nothing to discuss. In Mexico, COFEPRIS regulates medical devices and software with a medical function, and real timelines run from several months to more than a year depending on the risk class. The good news: there are equivalence routes that recognize prior approvals from agencies like the FDA or European authorities, and using them well shortens the path substantially.
Rule of thumbRegistration defines when you can sell, not whether you will. Start the regulatory file in parallel with your evidence and payer strategy — not before them.
3. The evidence your country generated isn't the evidence the system asks for
A clinical trial published in an international journal proves efficacy. It does not prove — to a Latin American payer — that the technology solves a problem they prioritize, at a cost their budget can sustain, in their population. That second question is economic, not clinical, and it needs local data or, at minimum, data adapted to the local context.
4. Understand who pays before you set the price
The health market is not one market. In most countries in the region, two worlds with opposite logics coexist:
- Public sector. The volume lives here (IMSS, ISSSTE and IMSS-Bienestar in Mexico cover most of the population). You enter through formularies, technology assessment and consolidated purchasing. It's large and slow, and price is negotiated by volume.
- Private sector. Insurers, private hospitals and out-of-pocket spending. It decides faster, tolerates higher prices, and is where you build local evidence and use cases before touching the public sector.
The sequence that tends to work is private first — to build traction and evidence — and public later to scale volume, not the other way around.
5. Access is multidisciplinary or it doesn't happen
None of these links resolves on its own. Regulatory, medical and scientific affairs, health economics (HEOR), local partnerships and technology transfer have to work as an ecosystem — not as departments passing the file down a line. That's exactly how we approach the health vertical at Linkr: aligning every link from day one so innovation reaches the people and systems that need it.