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with the mHealth Suite

High-speed technology for the digitalization of therapies

This is what the mHealth Suite by fluidmobile offers:

  • A modular system for digital product development – fast and MDR-compliant, including DiGAV requirements, data protection and data security.
  • Based on your therapy concept, the mHealth Suite provides you with a marketable app for your business case in the shortest possible time.
  • Support your analog drug therapies with innovative Beyond the Pill offers.

Software as a medical device

Would you have thought that it is possible to digitize
so cost-effectively?

Indication-specific DTx / DIGA / mHealth app

Your CE-ready mHealth product in 8 weeks

Digitize your therapy concept

  • Market entry in a few weeks
  • Cost certainty
  • Medical device standard
  • Flexibility for your specific requirements

Costs & conditions

Rethink your digital strategy

Your therapy concept - our technology

Over 50 functions and features are available immediately – specific components are available as additional services on request.

Getting started or scaling up – simply and securely with the infrastructure of the Next Generation of Digital Therapeutics.

The mHealth Suite supports a wide range of digital health applications:

  • Stand-alone digital therapeutics (DTx): Fully developed digital health products that can be used independently or as a complement to existing treatments.
  • DiGA (Digital Health Applications): Stand-alone digital therapeutics developed specifically for integration into the German healthcare system to enable reimbursement.
  • Companion apps: These apps supplement and expand drug therapies or medical technology applications in the homecare sector by increasing the effectiveness of traditional therapies.
  • Marketing and promotional apps (digital giveaways): These apps not only promote engagement and awareness of healthcare products, but can also increase customer loyalty and repeat sales through demonstrable improvements in therapy effectiveness.
  • Lifestyle apps: Offer health-related functions to promote general well-being with the option of later being certified as medical devices, making them a strategically interesting option.
  • Early market entry strategies for not yet approved drugs: This strategy is used towards the end of Phase 3 trials and allows to talk about an indication and present the product to physicians without directly mentioning the drug, which ensures regulatory compliance.

Each of these concepts benefits from the modular and flexible nature of the mHealth Suite, which enables rapid adaptation to specific medical and regulatory requirements.

Yes, we will give you an insight into the growing list of more than 50 modules and functions of the mHealth Suite in a personal consultation. We would be happy to check with you whether we already meet your specific requirements with our modular system.

Yes, thanks to the high configurability and combinability of the mHealth Suite, many individual requirements can already be implemented directly. Our platform was designed from the outset with a high degree of flexibility and modularity, which makes it possible to address specific needs effectively. In addition, we can develop special components tailored to your specific requirements, for which we also grant exclusive rights of use. These individual developments integrate seamlessly into the existing system, allowing us to offer both standardization and tailor-made solutions. An individual offer and cost estimate can be prepared based on the specific needs and requirements.

The mHealth Suite uses a scalable development methodology that is specifically designed for software as a medical product. In contrast to traditional development approaches, which often require a unique, extensive concept design, we rely on modular, configurable components. These were fully documented in advance and can be verified automatically, which speeds up the process considerably. Our platform follows a structured requirements and documentation management system that streamlines the usual time and bureaucratic hurdles of software development in the medical device sector. This approach makes it possible to react quickly to changing requirements and significantly reduce time-to-market, while at the same time complying with strict regulatory requirements.

CE-ready means that we can provide the complete technical documentation (in accordance with IEC 62304/82304, IEC 62366 and ISO 14971) within 8 weeks, including the medical purpose and the associated risk management. This enables the distributor (customer himself or externally) to carry out the necessary clinical evaluation and the declaration of conformity. Even if a product is initially designed as a lifestyle product, it is developed and documented according to the same high standards of medical norms, only with a non-medical purpose and corresponding risk assessment.

What is conceivable is suddenly also feasible

Scale horizontally
with the mHealth Suite

You can introduce a whole range of digital therapeutics in quick succession – for example for a specific series of medicines. In doing so, they are sending a visible signal for patient-centered innovation.

Advantage through
technology

With the technology of the mHealth Suite, it no longer matters whether you realize one indication-specific therapy product digitally or several. The infrastructure platform allows several parallel projects or publication in quick succession.

For your digital strategy
this means

You can support your drug therapies quickly and securely with customized digital products, plan within a reliable cost framework and move agilely on the market.

For your patients
this means

The indication-agnostic development of the mHealth Suite ensures user-friendly and familiar operability, which can easily be transferred to an entire product family.

Always up to date

Scale vertically
with the mHealth Suite

You can concentrate fully on your market strategy, therapy concepts and medical content. The mHealth Suite supports you in the sustainable development and expansion of your digital portfolio in medical device quality. This gives you maximum flexibility and agility on the market with needs-based expansion stages for your indication-specific health apps.

Advantage through
technology

As the cumbersome process of making changes is no longer necessary, you can gradually expand your products, extend their content and transfer them to new locations in a highly efficient manner – and are always up to date from a technical and regulatory perspective.

For your digital strategy
this means

Every change is on the safe side in regulatory terms. Every further development can be checked for cost-effectiveness in the full run. And you can easily certify lifestyle products as medical devices at a later date.

For your patients
this means

For your patients, this means faster integration of their feedback, regular technical updates and the possibility of constantly expanding the content on offer.

1. lifestyle apps:

Lifestyle apps focus on general health promotion and wellness, such as fitness tracking or nutrition tips. As a rule, they are not developed in accordance with medical device law requirements and therefore cannot simply be recertified. The situation is different with lifestyle products from the mHealth Suite, which are developed from the outset in accordance with medical device law principles and thus enable subsequent certification.

2. medical apps:

Medical apps are designed to support healthcare services, such as the diagnosis, treatment, monitoring or prevention of diseases. These apps are developed in accordance with the requirements of the Medical Device Regulation (MDR).

3. digital health applications (DiGAs):

DiGAs are special medical apps that are developed for the diagnosis, treatment, monitoring or prevention (not primary prevention) of diseases. They must meet the requirements of the DiGAV incl. data protection certificate and information security certificate and approved by the Federal Institute for Drugs and Medical Devices (BfArM) in order to ensure reimbursement by the statutory health insurance funds. DiGAs are thus directly integrated into the German healthcare system and can be prescribed by doctors.

Yes, following approval in accordance with the EU Medical Device Regulation (MDR), our product can easily be registered as a medical device in other EU countries (registration costs are usually several thousand euros per country).

For a rollout outside the EU, including the USA, South America and Asia, specific adaptations are necessary to comply with local regulatory requirements, sometimes less complex, sometimes more complex. For each target country, we initially plan one person-day of work to check the respective product-specific requirements. This enables us to efficiently plan and offer the necessary steps to comply with local legislation.

The mHealth Suite usually starts with one or two languages and can easily be expanded to include additional languages. Support for right-to-left languages is also integrated to meet global requirements. Preparatory translations can be supported with the help of Large Language Models to facilitate localization.

Platform for Software as a Medical Device

Designed as a service for digital health

The creators of the innovative infrastructure platform mHealth Suite have been successful with user-friendly software development for 12 years. Its sophisticated and structured process management not only does justice to patient-centered care, but also to the pharmaceutical therapy provider’s business model.

The product company’s innovative approach consists of a combined system of indication-agnostic software with the individual tailoring of the digital product. The scalability of digital products is considered from the outset thanks to an innovative license-based pricing model that integrates cost drivers such as development and maintenance.

Effective digital strategies

Successful business cases

  • Greater adherence can increase the effectiveness of therapy
  • Direct channel to the patient community
  • Insights and real world data
  • Competitive advantage as an innovator
  • Increase in sales

Solutions for listed DiGAs

  • Compliance update data protection and data security
  • Carefree package hosting, operation, maintenance and much more.
  • Simple further development and scaling as an option
View case

Solutions for new DiGAs

  • Product development in full DiGAV conformity
  • Including data protection and data security requirements
  • Carefree package with hosting, operation, maintenance and much more.
View case

Digital solutions for MedTech

  • Bringing medical devices for homecare use into reimbursement
  • With DiGA-capable digital solution in full DiGAV conformity
  • Fast time-to-market
View case

Digital solution
for Rx preparations

  • Indication-specific companion app or standalone app
  • Therapy support
  • Application aids
  • Medication management
  • Connection to online pharmacies if necessary
View case

Digital solution
for OTC products

  • Indication-specific companion app or standalone app
  • Therapy support
  • Increase in the repurchase rate
  • Adherence optimization
  • Insights into purchasing behavior
View case

Digital solution
for orphan drugs

  • Indication-specific app
  • Therapy support
  • Positioning in the patient community
  • Application before drug approval, if applicable
  • Generation of real world data
View case

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