We have designed a complex phase-based development and testing plan: The first two phases are the intermediate versions of the full system (phase 3) and act in open loops validating each of the AI and neurostimulation subsystems. These two generations already have high potentials to independently turn into medical device products with large market needs. Ultimately, in the third phase, we close the loop by integrating the AI and ultrasound vagus nerve stimulation and consequently validate the efficacy and the usability of the system.
We address the elaborate planning for integration of the developed hardware components (WP1). The integrated hardware will be further integrated with the AI-powered software (WP2). Furthermore, we test each integrated system from both clinical efficacy (WP3) and usability aspects (WP4). The whole project including development and testing will be supervised in terms of quality management required for medical devices (outlined in WP6).
