Market Analysis and Stategy
Do you have a digital business idea or have you already developed a first prototype? Is your concept not ready for the market yet? We analyse the market relevant to you, your product, your customers and a possible reimbursement and financing potential. Strategy options form the foundation for further work.
Content Development & UX
With our experience of various services and products in the healthcare sector, we evaluate your digital care offer. A core element of our assessment is a tailor-made implementation in the German supply context for the important stakeholders. Together with you, we prepare the patient journey in order to work out benefit arguments as early as possible.
Approval as a Medical Device
The first step towards reimbursement within the SHI is done when your digital health solution is recognized as a medical device of risk class I or IIa with CE marking. With our experience in regulatory medical writing, we accompany you through the entire approval process.
Bfarm Directory
The first step towards reimbursement within the SHI is done when your digital health solution is recognized as a medical device of risk class I or IIa with CE marking. With our experience in regulatory medical writing, we accompany you through the entire approval process.
Evaluation of care relevance
A reimbursement of the DiGa by the GKV is closely linked to the proof of positive supply effects. This is to be demonstrated by the presentation of a medical benefit or by process and structural improvements in the
Care that is classified as relevant to the patient. This requires a solid evaluation, the conception and implementation of which we would be happy to develop
Fast Track Procedure
Upon request, DiGa's that have been approved according to the new MDR can be quickly included in the statutory health insurance via a so-called fast-track procedure. The procedure is similar to that of pharmaceuticals - but with less requirements for the proof of benefits. With our pharmaceutical experience, we are your companion on this path.
Price Negotiations and Reimbursments
These processes are also closely based on the market access of pharmaceuticals. With our market access experience, we also support these final steps towards reimbursement. We accompany your price negotiations with the GKV umbrella association. After a 12-month period in which you can set your own price, a reimbursement price will be set based on the negotiations.