We support you in evaluating the market access strategy or potential reimbursement pathways for digital health solutions in the GKV system. The results of the readiness check serve as a basis for understanding processes and requirements as well as estimating efforts and risks.

We deliver study results based on a GCP-compliant, manufacturer-independent digital, decentralized clinical trial and offer services in the study planning, study conduct and study evaluation phases and combine them with our Digital Trials Manager as an innovative technology.

We provide you with argumentative support in price negotiations on DiGA/DiPA, in the initiation of selective contracts and contract negotiations with payers as well as with other relevant stakeholders.

We classify medical innovations in care processes/care pathways and thus provide the basis for health economic modeling and/or evaluation, preparation of proof-of-benefit and clinical trials, as well as argumentative support towards relevant stakeholders.

We prepare a comprehensive evaluation concept in advance of a clinical trial. The concept describes the medical background as well as the addressed gap in coverage of the application used and plans a detailed study implementation as well as the analysis of the study data.

We support you with our holistic expertise in the area of market access and reimbursement in a more generalistic approach and with short touchpoints in each case, but at regular intervals. You benefit from steady, uncomplicated, rapid and trustworthy access to an Advisor Team in a low-threshold, flexible approach that can be expanded as needed.

As a business developer, you want to run an innovation program for a digital health startup (e.g. from a certain region, a certain country) on the topic of market access Germany. We support you with our expertise.

We help you to decide on the German healthcare market or a sub-market (e.g. specific indications, GKV/PKV, sectors) and develop the market strategy.

We provide argumentative support in price negotiations for DiGA/DiPA or evaluation during the contract period for selective contracts (important for continuation and, if necessary, scaling of the contract to additional contract partners) as well as to other relevant stakeholders.

In this module, we delve into the area of marketing and sales of digital health solutions, remedy advertising law and related aspects, including the context of the various reimbursement channels in the German healthcare system.

In this module, we delve into the area of health economics, concept of care, health economic modeling, health economic evaluation or different types of analysis such as budget impact analysis, cost-effectiveness analysis, cost-utility analysis and related aspects.

In this module, we delve into the area of evidence, specifically the evidence base or evidence generation, requirements and design of clinical trials, e.g. to demonstrate positive care effects in DiGA and related aspects.

We provide you with knowledge on interoperability, data security/protection as well as the telematics infrastructure and the relevant components thereof that play a role in the Digital Health application (eGK, identity management, ePA, MIOs). In addition, more depth can be provided on technical standards such as 2-factor authentication, implementation of MIOs, ISO 27001 or the HL/-FHIR standard.

Together with you, we outline the processes for approving a medical device in accordance with the EU Medical Device Regulation (MDR). This includes the classification of the own medical device, clarification of the related standards and processes, calculation of costs and time for the implementation of a QM system according to ISO 13485 as well as a roadmap for the implementation.

We provide scientifically sound statistical study evaluations of available study data.

We interpret available study data and summarize them textually and graphically in a study report and publish it if necessary.