For investors
DUX Healthcare builds the regulatory infrastructure on which digital therapeutics scale faster, with more audit evidence, and across markets. We are looking for partners to fund the platform phase.
The thesis
The German DiGA market has a structural gap: regulatory requirements grow faster than classic DTx manufacturers can meet them individually. BSI TR-03161 per DiGA (without conditions for ours), TR-03185 on the process level, updated BfArM Data Protection Criteria, ongoing DiGAV amendment regulations – each regulatory round makes in-house development more expensive and riskier.
Whoever builds a DTx today builds it either wrong (and fails the next audit) or right (and invests millions in regulatory infrastructure that doesn’t differentiate for the customer). That’s the gap a platform closes: compliance as shared infrastructure, not as repeated investment per product.
The second structural lever lies in expansion. A CE-marked, clinically validated DTx can hardly scale into emerging markets today – the investment hurdle per target market is too high. A platform operator with local re-implementation, approval and operations opens markets that remain closed to the manufacturer. Revenue share instead of flat licence – the model is clean for both sides.
Why now
BSI TR-03185 audited as the first company (process level, formal certificate pending) · BSI TR-03161 per DiGA (our DiGAs: passed without conditions) · ISO 13485-certified QMS (TÜV Hessen), DiGAV-aligned · ISO 27001 ISMS audited (under TR-03185, separate cert to follow) · MDR- and DiGAV-ready documentation pipeline
80+ pre-validated, indication-agnostic modules · FHIR and ePA integration · modular architecture rather than a toolkit · hosting in the EU legal framework · post-market surveillance & continuous compliance
Five DiGAs on the platform today · pharma, startup, DiGA-manufacturer and international DTx customers · demonstrable build references · active partner network
Compliance built once carries n products · low marginal cost per new customer · multi-market localisation without new development · revenue-share model in emerging markets
DACH as the entry ring · EU as the second ring · emerging markets as a structural growth option · partner-based go-to-market routes
14 years of mobile expertise · 7 years of SaMD specialisation · operational core across development, regulatory, business development · leadership continuous since founding
The model
DUX runs two revenue channels that rest on the same technical and regulatory foundations.
The first is Operations: customers who lease the mHealth Suite to build and operate their own DTx – in the Build model with a fixed-price engagement, in the Scale model with portfolio-specific configuration. Setup + monthly operations fee, predictable, long-term.
The second is Distribution (Go Beyond): as DTx Distributor for emerging markets – analogous to the pharma distributor – we licence, re-implement, certify and operate validated DTx of our customers nationally, with revenue share as the compensation model. The channel is currently in structured build-up; the technical and regulatory prerequisites are in place with the mHealth Suite, the first target markets are being prioritised.
Both channels share development team, compliance framework and platform investments. That keeps marginal cost per new customer low and creates operational leverage that a pure DTx developer can’t reach.
Team & history
DUX Healthcare grew out of fluidmobile GmbH. The mobile core goes back to 2012, the SaMD focus to 2019. The current platform thesis is the result of ~14 years of industry work – with the last seven focused on medical device software, with consistent leadership and no discontinuity in the technical core.
Details about the team – who carries which role, which regulatory certifications are anchored to which people – we communicate in direct conversation. Person-dependency is lower here than in typical startups: the certifications are attached to the company and to the QMS, not to individual titles.
Next step