Development of sensor technology within rehabilitation: pathway to clinical investigation and implementation

Research Project, 2026

There is a significant need to introduce digital solutions in rehabilitation due to limited resources and an increasing demand for rehabilitation services. Sensor technology and AI enable advanced analysis and monitoring in both clinical settings and at home, supporting continuous follow-up, preventive interventions, and evaluation of rehabilitation outcomes. The goal of our collaboration is to develop a medical device system for early identification of fall risk and personalized rehabilitation based on sensor technology. Conducting tests on patients is crucial for further developing the solution into a CE-marked medical device.

Currently, there is a lack of clear step-by-step instructions on how to conduct clinical trials for non-CE-marked medical devices, both for commercial products and in-house developed prototypes. There is also uncertainty regarding the division of responsibilities between technical and clinical stakeholders, as well as a lack of practical guidance on risk and data management. In addition, collaboration between different organizations—universities, hospitals, and companies—is often unclear in terms of roles related to sponsor responsibility, data processing, medical responsibility, and documentation requirements.

The project addresses these challenges by developing regulatory, ethical, and collaborative guidelines for future clinical trials and implementation.

The project will not only directly support our ongoing research by paving the way for upcoming clinical trials, evaluations, and future clinical implementation, but will also generate transferable knowledge that can benefit other medical technology research projects facing similar regulatory, ethical, and organizational challenges.