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Stage 2

Development and market approval as a medical device

Challenges on the path to market approval

In order to be reimbursed as a DiGA, a mobile application must meet certain criteria for a medical device as defined by law. Medical devices are applications that can be used to detect, prevent, monitor, treat or alleviate illness, injury or disability. This does not include the mere collection and display of data. However, if recommendations for action are derived from the collected data, it is a medical device within the meaning of the MDR (Medical Device Regulative).

We work with you to develop the appropriate planning and help you overcome the challenges on the path to creating an approved medical device.

We develop a solution that suits you based on the outcomes of the brainstorming and design phase. We build your digital health application using application lifecycle management (ALM) tools under consideration of data protection and data security. adesso offers you a full-service package from a single source – from project management, to requirements engineering, to the right architecture in the mobile app and backend, to testing and the development of an accompanying quality management system in accordance with ISO 13485. This not only provides you with a software solution, but also with all the relevant and documented information you need for approval as a medical device.

Leverage particular technical options

Wearables – especially smartwatches – are already deeply integrated into the health ecosystems provided by Apple (Apple Health) and Google (Google Fit) out of the box. These provide a valuable set of extra data dimensions in addition to those from the smartphone’s sensors that can significantly expand what a DiGA can do.

adesso provides you with support in mobile app development as an expert partner. Our specialists have the expertise needed for medical application scenarios
Google Fit

Two key aspects are crucial for the future success of your digital health application: developing the right brand and implementing the right marketing measures. You should make creating an appealing brand name and matching design a top priority. We provide you with support from development to marketing to make your DiGA memorable.

Developing a brand name

The right name is crucial for the success of an app on the market. It must appeal to the target group and be memorable in equal measure. Since the patients, doctors and multipliers of the app are an incredibly diverse mix of people, the pronunciation, association and how easy it is to remember must be factored in, as well as socio-cultural backgrounds. Given these factors, friendly user tests are used to verify the acceptance of the respective target group.

Trademark application at the German Patent and Trademark Office (Deutsches Patent- und Markenamt, DPMA)

After the brand name has been developed, the name and the registration of the rights to the name or the rights to a word/design mark undergo a legal review. The scope of protection of a word mark registered independently of a particular font may therefore tend to be wider than that of a word/design mark, which may be limited to an individual font.

Appealing design and intuitive UX and UI

Just as with the name, the design should also fit the bill and be memorable. The first step here is to develop a word/design mark. There are also success criteria specific to apps when it comes this, too: in terms of benefits and the target group, your DiGA needs a stringent design that ensures all of the features are intuitive to use. A user-centred design creates a comprehensive customer journey in this production step, guaranteeing that the app is well thought-out and easy to use, even when dealing with complex topics.

Our experts develop the appropriate design, depending on the setting and based on the respective guidelines for accessibility and user guidance.

We support you in brand development, brand design and market entry and perfectly match these points to the DiGA’s respective digital target market.

An important step on the path to an approved medical device and a basic prerequisite for reimbursement is the CE marking. This is not considered a seal of quality, but it does confirm that all of the legal requirements for the medical device have been met.

Developing a quality management system according to ISO 13485, keeping documentation in conformity with standards and controlling the required verifications using harmonised standards are also essential on the path to an approved medical device.

As an ISO-13485-certified partner, adesso successfully helps you in gaining approval for medical devices. Our experts take care of the documentation and validation and get you safely through the audits.

The fast-track review procedure of the BfArM as part of the adopted DVG enables doctors and psychotherapists to prescribe ‘apps on prescription’, which are reimbursed by the health insurance provider. After successful approval, the DiGA is listed in the BfArM directory and can be prescribed by (e-)prescription.

The basic prerequisite for this approval is that the DiGA is classified as a class I or IIa medical device, it fulfils data and information security requirements, as well as proof that it delivers a ‘positive care effect’.

adesso uses application lifecycle management (ALM) tools and its rich experience to professionally accompany, support and evaluate the development and approval process in order to quickly and efficiently create quality-assured documentation and prepare the optimal market entry for your app.

We use our professional and technical expertise to support you on the path to developing your DiGA and take care of its operation and market launch

Specific challenges

Data protection, data security and usability should be prioritised when developing a digital health application. As part of this, additional data protection aspects covering all of the organisational levels from the Digital Health Applications Ordinance (Digitale-Gesundheitsanwendungen-Verordnung, DIGAV) in Annex 1 must be met in addition to the General Data Protection Regulation (GDPR).

GDPR

The demand for a high level of data and information security is made clear by the requirement for a full-fledged information security management system (ISMS). A documented protection requirements analysis is also required to determine the scope of measures needed.

User-friendliness also plays an important and central role. The associated obligation to provide information not only covers aspects of data protection law, but also concerns other topics. These include the intended medical benefit, the description of the functional scope or the supported devices.

Networking the DiGA

The networking of the digital health application within the German health system as well as the ‘Integrating the Healthcare Enterprise’ (IHE) are additional important focal points in the development process of the DiGA. Here, it needs to be considered early on as to whether and to what extent additional benefits may be derived from using IHE interface technologies.

The interoperability of the DiGA with the systems of the service providers, the integration of the telematics infrastructure (TI), the electronic patient file (ePA), the e-prescription and the automation of the invoicing processes from manufacturers to health insurance providers are of particular importance.

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Positive care effects and providing proof of these

The BfArM guide prescribes the PICO process (Patient/Population, Intervention, Comparison, Outcome) for existing (or still to be provided) proof of positive care effects. Here, it is necessary to plan, prepare and conduct the appropriate studies. This requires a well thought-out conceptual study design, a suitable study database as well as for your study to be carried out by professionals and have a statistical analysis done.

The digital health application’s auto-complete guide provides instructions on how to enter the data. This must be well thought out and designed by the manufacturer of the DiGA in advance. adesso provides you with all the necessary documents for the BfArM and supports you during the approval process.

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The third stage: Identify and use market access

The health market is so heavily regulated and interspersed with so many different conditions to an extent to which almost no other target market can compare. The access route into standard care is clearly laid out. You will find out how to do this in the third stage.

Continue to stage 3

Do you have any questions?

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