LatAm Market Access for Global Medtech.
The bridge to Latin American healthcare.
Istmo Health takes FDA- and CE-cleared medical technologies through regulatory approval, clinical launch, and distribution across Latin America — backed by a live network of operating clinics and the capital relationships to scale.
Latin America is the hardest market to enter — and the easiest to get wrong.
Every country in Latin America has its own regulator, its own registration timeline, its own distribution logic — and none of them align. Medtechs with strong FDA or CE clearance routinely spend 18–24 months and six figures trying to get a single product registered in a single country, often without ever reaching a clinician's hands.
The path is littered with consultants who delivered a strategy deck and disappeared. Regulatory filings stall. Local distributors overpromise and underdeliver. Clinical champions are hard to find without an existing operator network on the ground.
Most medtechs give up before they ever generate a dollar of LatAm revenue — not because the market wasn't there, but because they had no one to actually execute the entry.
The Cost of Going It Alone
18–24 months
Average timeline for a single-country registration attempt without established pathways
6 regulators
INVIMA, ANVISA, COFEPRIS, ANMAT, and equivalents — each with distinct documentation requirements
0 revenue
The outcome for most medtechs who attempt LatAm entry without an operator partner
One partner, four steps, one continent.
Istmo Health is not a consultancy. We are an execution partner — combining regulatory expertise, live clinical infrastructure, and a standing distribution network to move your product from cleared to commercial across Latin America.
Regulatory Approval
We register your product with national health authorities — INVIMA, ANVISA, COFEPRIS, ANMAT, and equivalents — using established relationships, proven dossier templates, and country-by-country pathway expertise that cuts years off a solo attempt.
Clinical Launch
Your product launches first inside PanAm Clinics' live network of diagnostic imaging and specialty clinics — real patients, real clinical validation, real reference data. Not a pilot proposal. An actual launch.
Distribution
From the initial launch, we scale into a broader network of partner clinics and hospital systems across Latin America. These are relationships we have already built — not cold outreach you are waiting on.
Capital
For medtechs that need funding to support their Latin American market entry, we make direct introductions into our investor network — accelerating the capital side of the equation alongside the commercial side.
We don't advise. We execute.
Most market-access consultants stop at a regulatory strategy deck. Istmo Health operates a live clinical network, meaning your product launches inside real clinics from day one — not a pilot proposal sitting in someone's inbox.
Our team combines Latin American healthcare operators, UK and Israel medtech market-access specialists, and a standing distribution relationship with one of Colombia's fastest-growing clinic platforms. When we say we can register, launch, and distribute — we mean the infrastructure to do it already exists.
Operating Clinics
Live launch sites already active in Colombia, ready for your product from day one
Medtechs in Pipeline
Active pipeline spanning imaging, diagnostics, and specialty devices across the region
Origin Markets
US, UK, and Israel — the network already spans the world's leading medtech innovation hubs
From clearance to commercial, in five steps.
A structured, repeatable process — built on years of operator experience across Latin American healthcare markets. Every engagement follows the same arc, from initial fit review to ongoing commercial support.
1. Fit Assessment
We review your regulatory clearance, clinical data, and target indications to confirm the right entry strategy and country sequence.
2. Regulatory Pathway
We map and execute your country-by-country registration plan — handling INVIMA, ANVISA, COFEPRIS, ANMAT, and additional authorities as needed.
3. Pilot Launch
Your product goes live inside a PanAm Clinics site — generating real clinical utilization, reference cases, and early commercial data.
4. Scaled Distribution
We expand into our broader partner clinic and hospital system network, growing commercial volume across multiple countries simultaneously.
5. Ongoing Market Access
Continuous commercial and regulatory support as your footprint grows — renewals, new indications, new country entries, and investor introductions as needed.
Three ways to work with us.
Whether you are testing LatAm fit for the first time or ready to commit capital and equity to a full-region rollout, we have a structured engagement model to match your stage. Pricing details are available on request — contact us for a custom quote.
Launch
For medtechs testing Latin American fit.
- Regulatory registration in 1 priority country
- Pilot launch inside one PanAm Clinics site
- Clinical reference data and utilization reporting
- Flat engagement fee — contact us for details
Scale
For medtechs ready to commit to the region.
- Regulatory registration across 3+ priority countries
- Distribution across the full partner clinic network
- Commercial expansion support and reporting
- Retainer + success commission — contact us for structure
Full Access
For medtechs that need capital as well as market access.
- Everything in Scale, plus
- Direct introductions to our investor network
- Capital strategy and fundraising support
- Retainer + commission + optional equity component
Built by operators, not intermediaries.
Istmo Health was founded by people who have built, scaled, and invested in healthcare businesses across Latin America, the UK, and Israel. We bring executable infrastructure — not just introductions.
Dennis Korthouwer
Founder & CEO
Founder and CEO of PanAm Clinics — the Colombian diagnostic and specialty clinic platform that serves as Istmo Health's primary launch network. Brings deep operator experience scaling clinic infrastructure across Latin America.
MarÃa José Carvajal
Head of Growth & Partnerships
Leads clinic and medtech partnership structuring across the Istmo Health network. Manages inbound medtech relationships and outbound clinic expansion across Colombia and beyond.
Gadi Arnon
Co-Founder, UK & Israel Market Access
Co-founder of Havilland Health, a UK healthtech market-entry firm. Brings the originating pipeline of Israeli and UK medtechs into the Istmo Health network and deep experience navigating CE-marked products into new markets.
Ready to bring your product to Latin America?
Tell us about your product, your clearance status, and your target markets. We will come back to you within 48 hours with an initial view on fit and next steps — no obligation, no generic brochure.
For direct inquiries: hello@istmohealth.com
For Medtech Companies
FDA- or CE-cleared products seeking LatAm registration, clinical launch, or distribution partnerships.
For Investors
Looking to deploy capital into LatAm medtech distribution or clinic-network growth opportunities.
For Clinic Operators
LatAm clinic networks interested in accessing a curated pipeline of cleared medical technologies.
Book a Market Access Assessment
Share a few details and we will set up a focused 30-minute call to assess your LatAm fit.
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Istmo Health — LatAm Market Access
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