With the in-house experiences from multiple DiGA projects, Digital Oxygen is the one-stop-shop for all manufacturers: From strategy to implementation and commercialization are we successfully supporting our clients. Same counts for future DiHAs (Digital Health Applications). ⬢
DiGA FAST-TRACK GUIDANCE
Despite the authority’s DiGA guide, the DiGA fast-track process still holds a multitude of implementation complexities.
The DiGA guide provides good orientation across BfArM’s regulatory requirements. However, the complexity often only becomes apparent during the implementing stage e.g. when working on accessibility, interoperability, data protection and security, ISO compliance and DiGA billing. Digital Oxygen supports its clients in compliant product development, preparation and execution of meetings with BfArM and preparation of all submission documents.
DiGA VALUE PROPOSTION DESIGN
A DiGA can only be as good as the underlying value proposition and product strategy.
As for any digital product, for DiGAs the key to success is a coherent product offering. This can be a well-thought feature portfolio within the application, but may also include on-top service offerings. Furthermore, in reality there are often dependencies to other already existing products or technically related products in other markets. With the official DiGA directory getting more and more crowded, a concise USP towards healthcare professionals as well as patients gains even more relevance. We support future DiGA manufacturers on defining suitable value propositions and give guidance on how to avoid common mistakes.
ECONOMIC BENEFITS & PRICING
For sustainable success a deliberate and strategic DiGA pricing approach is key.
The DiGA pricing framework already regulates various reimbursement aspects such as price groups, maximum amounts and threshold values in great detail. However, further aspects such as expected economic advantages for statutory health insurers or reimbursement amounts of comparable products are also subject of SHI price negotiations. Based on Digital Oxygen experience, we advise to address these issues at an early stage in order to be able to generate relevant data as part of your evidence generation strategy.
PATIENT FACING COMMER-CIALIZATION
Patients play a crucial role for DiGA’s sales success – digital wins
Unlike traditional medical products, patients play a crucial role in DiGA sales. Following the main digital functionality, directly convertible patient awareness can be generated via digital sales channels. With an existing indication, prescriptions may even be issued without an additional HCP visit. The Digital Oxygen team supports DiGA manufacturers in gaining an overview of effective patient-facing distribution channels and developing individualized commercialization strategies based on best practices.
Practices remain key to patient access and sustainable prescription volumes – addressing them is costly.
As prescribers and in many cases also co-users of DiGAs, healthcare professionals will remain a fundamental part of a successful DiGA sales strategy. After specialist offices, the sales focus of DiGA providers is now increasingly shifted towards General Practitioners. However, only in a few cases it makes sense to address them via a dedicated sales force. We support our customers in sustainably aligning their medical office-facing commercialization strategy – either via sales partnerships or through effective use of alternative communication means.
Providing adequate data protection is a major challenge in the DiGA listing process.
Due to prominent hacks, data security and protection related to DiGA have become a topic receiving widespread public attention. We run IT forensics for our clients and check that there is no accidental transfer of personal data to servers outside of Europe which could endanger the DiGA’s listing success. Because who would have thought that using a Google font can already disqualify you from becoming a DiGA?
Clients and Partners