DTx Distributor for emerging markets.

The split between Scale and Go Beyond is structural, not geographical. The deciding factor is the reimbursement structure of the target market:

• Scale – wherever DiGA-adjacent, statutory DTx reimbursement exists (DE, FR PECAN, BE mHealthBelgium, UK NICE ESF, others in preparation). DUX operates your DTx as your DTx Operations Partner, with predictable monthly cost as in Build.
• Go Beyond – in emerging markets without statutory DTx reimbursement (LATAM, SEA, MENA, Sub-Saharan Africa). DUX takes over re-implementation, national approval and operations as your DTx Distributor – analogous to a pharma distributor. You receive revenue via revenue share, with no upfront cost.

The pharma distributor is the conceivable analogy: they licence a product from the manufacturer, bring it through local approval, build national distribution structures, and settle with the brand owner via revenue share. That’s exactly what we do for digital therapeutics – except that “distribution” here also includes re-implementation, national medical device registration and ongoing operations.

For most DTx manufacturers, expansion ends at the EU border for a non-technical reason: The investment risk for a non-validated emerging market isn’t sustainable out of their own cash flow. Every target market requires its own national medical device registration, its own localisation, its own operational infrastructure, its own distribution. At the same time, emerging markets lack the statutory reimbursement structure that carries ongoing revenue in Scale countries – without it, these markets lack the paying side for a classical subscription into the healthcare system.

That’s the reason for Go Beyond – and for the distributor model. In pharma this path has been established for a long time: a manufacturer licences their product to a local distributor, who brings it through national approval, builds a buyer structure, and settles with the brand owner via revenue share. The manufacturer carries no market-entry risk; the distributor carries operational risk and profits from revenue.

The buyer structure in emerging markets is different from Europe. Where EU countries have fragmented health-insurance systems or healthcare services controlling access, in many target markets a small number of large national institutions are the appropriate counterparties: health ministries with supply mandates, national health insurance systems with budget responsibility, public care networks. For certain target countries this is the decisive structural lever – and it’s less obvious than it sounds: many DTx manufacturers intuitively think of emerging-market expansion as a retail problem and miss that national buyers may be looking for scalably deployable solutions.

We carry this over to digital therapeutics. You own the clinical mechanism of action, the clinical validation and CE conformity under MDR. Together with selected local partners we take over re-implementation, national medical device registration, buyer relationships and operational running. You get revenue from markets you would otherwise not have invested in – with no flat licence, no setup invoice.

At the same time the care situation in many of these target markets tells a different story from Europe: lower specialist density, unevenly distributed clinical infrastructure, digital therapy often a primary route to care – not an additional channel. The market is large, the need is real, the regulatory landscape in several countries is receptive. But “receptive” doesn’t mean “approval-free”.

For target markets outside the EU and EEA: each market is regulatorily self-contained; the mHealth Suite is built so that the substance of the file is reusable, not the file itself. Selected emerging markets with their own medical-device authorities include for example ANVISA (Brazil), BPOM (Indonesia), SFDA (Saudi Arabia) and SAHPRA (South Africa). Digital-health-specific regulation in some of these countries doesn’t yet exist or is under development; medical-device approval runs through general device frameworks. Many authorities align with the SaMD guidelines of the IMDRF (International Medical Device Regulators Forum · Software as a Medical Device) – a voluntary international consensus framework, not a binding rule. Data residency, localisation and post-market requirements nevertheless remain country-specific.

The regulatory maturity of these markets varies considerably. That is why we carry out every project with an explicit market-readiness assessment before we sign licences – no one wins if we open a market that two years later has to recalibrate regulatorily.

For clarity: Structured regulated markets – whether EU (DiGA, PECAN, mHealthBelgium), UK (NICE ESF + DTAC), US (FDA SaMD + Commercial/Medicare/VA/Employer) or Switzerland (MepV + KVG/private) – belong to Scale. There, DUX continues to operate your DTx as your DTx Operations Partner (predictable monthly cost as in Build). Go Beyond is exclusively for emerging markets without statutory DTx reimbursement.

Go Beyond is a strategic direction, not a running distributor business. We are actively building the model – with the mHealth Suite as the regulatory and technical basis, with selected exploratory conversations in target regions, with robust criteria for local partners.

DTx manufacturers who are listing in Europe today and need an answer to the “and after that?” question should know this direction exists. Anyone who wants to go into a target market with us is welcome earlier rather than later – the first Go Beyond engagements will shape how the model develops.

Go Beyond is not a consulting offering in which we explain to you how an emerging market works. It is an operational model in build-up: we will take over re-implementation, national market entry, hosting, support and ongoing compliance – with our team in Karlsruhe and local partners on the ground that we are currently actively exploring. Your contribution after contract signing stays clinical leadership: ensuring that the medical mechanism of action remains unchanged.

This path only works because the mHealth Suite is designed for exactly this: one platform, many markets, one compliance base – with market configuration as a feature, not as new development. The technical and regulatory prerequisite is there; the next step is the first concrete target markets.