Seeking expertise on the German DiGA pathway for Neural and Neural XR

Roboter Schlafen Nicht is developing Neural, a mindfulness-based digital wellbeing platform, and Neural XR, its immersive WebXR extension. We are participating in the DigiCare Accelerator and exploring a future healthcare application.

We are looking for experienced partners to help us assess whether, and under what conditions, a DiGA pathway would be appropriate.

We would particularly value guidance on:

- Identifying a suitable clinical indication, patient population and intended medical purpose.

- Assessing the regulatory implications of the software and XR components.

- Planning clinical evidence and studies relevant to a future DiGA application.

- Understanding expectations for data protection, information security, accessibility and interoperability.

- Mapping the application process, resources, costs and realistic timelines.

- Understanding reimbursement and integration into clinical care.

We welcome connections with advisers who have supported DiGA applications, clinical researchers, healthcare providers and specialists in medical software regulation.

We can contribute software development, testing and quality assurance expertise, alongside ongoing product development. Our aim is to establish a practical roadmap and identify suitable clinical and research collaborations.

An initial exploratory meeting would help us understand the main gaps and agree useful next steps.