At this year’s DMEA – Connecting Digital Health, Europe’s leading trade fair for digital health, fluidmobile GmbH will be presenting its mHealth Suite. The modular platform solution enables companies to technically implement their digital health solutions – ready for operation within a few weeks instead of months. mHealth products, DTx, DiGA – the mHealth Suite supports various product formats for indication-specific, digital therapy products, so-called Digital Therapeutics: as a lifestyle product, as a CE-certified medical device or as a medical device prepared for DiGA approval. Development is carried out in accordance with the regulatory standards of the MDR and, on request, also in accordance with the DiGAV. Regulatory conformity favors scaling and further development – so even after a release as a lifestyle product, subsequent certification as a medical device and/or DiGA is possible without new development (step-by-step release).
“We want more patient-centered healthcare to become feasible – and that includes making it affordable,” says Christoph Eberhardt, CEO of fluidmobile GmbH, explaining the cost model based on a monthly license fee.
The development of the platform solution was funded by the Federal Ministry for Economic Affairs and Climate Protection (BMWK) on the basis of a decision by the German Bundestag and makes use of the company’s many years of SaMD (Software as a Medical Device) experience. The provider’s experience is demonstrated by service add-ons such as medical content, operation, first-level support and much more.
To the online configurator of the mHealth Suite
Risk minimization for business cases
For pharmaceutical and medtech companies, the mHealth Suite opens up new perspectives for patient-centered healthcare and research and – not to be underestimated – for sales. By effectively addressing the critical aspects of product development, the offering removes a major stumbling block to digital innovation. The mHealth Suite reduces time to market, increases cost efficiency and optimizes the use of big data.
Use pharmaceuticals
mHealth Suite Solutions can be advertised within the framework of the Therapeutic Products Advertising Act (HMWG) independently of the therapeutic product and even before its approval. They support an increase in adherence, therapy-related follow-up care with OTC products and insights into patient needs as well as real-world data. For orphan drug providers, they can mean a confidence-building step in the patient community and brand positioning.
Use of MedTech
mHealth Suite Solutions can create patient-centered added value as an extension of medical devices, as well as support adherence improvement and insights through real world data.