What is the timetable for the project?
Prinz: The ThrombUS+ project, which was launched in January, consists of nine work sections that are being worked on by 18 interdisciplinary and international project partners in eight countries. It is being funded for a period of three and a half years with 9.5 million euros in the EU's Horizon Europe program. This not only includes technical development but also includes clinical studies with which we want to generate data for training the AI models and ensure their safety and performance during use in patients.
The VDE is also providing regulatory support for the project from the outset. This medical device in development is not only subject to high regulatory hurdles from the European Medical Device Regulation (MDR), but also the recently adopted Artificial Intelligence Act.
What are the development challenges?
Prinz: There are technical hurdles, for example in terms of miniaturization, the positioning of sensors or pressure control for compression. The second technical challenge is that the AI models need to be able to be evaluated in real time.
On the regulatory side, there are currently no specific standards or official guidelines for AI-based medical devices. This is a kind of regulatory vacuum. At VDE, we developed processes and documents early on to describe the development of medical AI models, data management and the corresponding technical evaluation of these AI models. We are now incorporating these and using them to support our partner institutions in the project. Another task for us is to identify and analyze the regulatory requirements for this very complex medical product and to efficiently coordinate the resulting tasks.