Stephen Gilbert, PhD
Technische Universität Dresden, Germany
Stephen Gilbert is Professor of Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, where he teaches and conducts research on regulatory science with a team of colleagues. He worked in senior MedTech and Digital Heath roles in industry for 5 years, before returning to academia in 2022. His research goal are to advance the regulatory science of software as a medical device and AI-enabled medical devices. Innovative digital approaches to healthcare must be accompanied by innovative approaches in regulation to ensure speed to market, to maximum access of patients to life saving treatments whilst ensuring safety on market. His main research interests are in: (i) data sharing and the European Health Data Space; (ii) approaches to market approval of adaptive AI enabled medical devices; (iii) drug<->digital/AI-enabled medical device product realization; and (iv) digital/virtual twins: as an organizing concept of the future of healthcare.