Digital help for tinnitus – How Infectopharm Digital Health & BAYOOMED are shaping the future together

A digital health product that really helps: The “My Tinnitus App” (hyperlink to website) offers those affected scientifically sound support in everyday life – individually, around the clock and available everywhere. BAYOOMED GmbH and Infectopharm Digital Health GmbH have been working closely together since January 2023 to further develop this app as a recognized DiGA (digital health application) and make it future-proof.

At the heart of the collaboration is the aim of providing patients with subjective tinnitus with a reliable, digital tool. With BAYOOMED’s expertise in software development for regulated medical products, the app was technologically embedded in a structure that meets the growing requirements.

Since August 2023, BAYOOCARE has acted as the legal manufacturer, while BAYOOMED is responsible for technical development.

As part of the project, BAYOOMED initially took over the complete technical migration of the application from the previous provider to its own infrastructure. The existing architecture was fundamentally revised and converted into a powerful, maintainable microservice structure.

Important milestones in the cooperation:

  • Connection to the electronic patient file (ePA)

  • Integration of authentication via health ID

  • Ensuring compliance with BSI TR-03161 guideline for data protection and IT security

Development of the app: medical device-compliant & future-proof

Parallel to the technical development, BAYOOMED created and continuously supplemented the medical device-compliant documentation – a central component for regulatory safety and sustainable DiGA approval.

Thanks to the continuous support of the software, compliance with regulatory requirements and integration into the telematics infrastructure, the “My Tinnitus App” is now ideally positioned: a digital medical product that continues to be certified and combines innovation with patient orientation.

We would like to expressly thank Infectopharm Digital Health for the excellent collaboration. The partnership-based, transparent and goal-oriented cooperation not only contributed significantly to the success of the project – it was also a valuable learning journey for us at BAYOOMED.

Adrian Nötzel, CPO of Infectopharm Digital Health GmbH:

“Working with BAYOOMED was a real stroke of luck right from the start. Rarely have I experienced a team that is so committed, professional and human at the same time. Together with BAYOOMED, we have refined our vision and the demanding DiGA requirements step by step and translated them into a product that combines the best of both worlds.

What particularly impressed me: Their technical expertise meets a deep understanding of regulatory processes, medical content and user needs. Every coordination was characterized by real team spirit, reliability and the common goal of creating the best possible solution for our users.

In short: BAYOOMED is far more than just a service provider for us – they are a partner at eye level. Thank you for this exceptionally good cooperation!”

The combination of technological know-how in the development of apps and sales and strategic market expertise has made it possible to create a digital product that meets the high demands of the healthcare sector and at the same time meets the needs of patients in their everyday lives.

Jörg Land, Managing Director of Infectopharm Digital Health GmbH:

“Especially in the complex environment of digital health applications, it is crucial to be able to focus on your own strengths. By working with BAYOOMED, we were able to do just that: outsource responsibility for technical implementation, regulatory requirements and quality assurance with confidence – and at the same time concentrate fully on our core tasks.

This clear division of tasks has enabled us to focus our resources on the strategic development, marketing and expansion of the DiGA Meine Tinnitus app.”

This type of collaboration between an experienced manufacturer that understands and actively develops the market and a specialized software service provider that delivers regulatory and technological excellence impressively demonstrates how future-proof digital healthcare solutions can be created.

We are very much looking forward to the next steps and are convinced that the best is yet to come.