Else Kröner Professorship for Medical Device Regulatory Science

Prof. Dr. Stephen Gilbert

My clear research goal is to advance regulatory requirements, especially for software as a medical device and artificial intelligence in medical devices. It is essential to keep pace with technological developments. Therefore, innovative approaches to healthcare of the future must be accompanied by innovative approaches to regulation. Getting medical devices into patient care faster, responding more quickly to technological changes, and at the same time ensuring patient safety is the goal.

Portrait Prof. Dr. Stephen Gilbert

The market for medical devices is very diverse. The areas of application range from band-aids and artificial heart valves to AI-supported assistance systems in the operating room. However, the innovation cycle from the initial idea to the approved medical device is taking increasingly longer, due to ever more complex systems on the one hand and ever more demanding approval processes on the other. Medical devices must meet a large number of legal requirements for approval and use. This is similar to the situation with cars or toys. These regulatory requirements form the legal framework and are intended to ensure the safety, performance and effectiveness of a medical device. After all, medical personnel and patients want to use medical devices that improve health and are safe to use. However, many of the latest innovations in medical technology are based on artificial intelligence or rely on algorithms that can change within months, weeks or days. Especially for these AI-based medical devices, the regulatory framework is too rigid. To keep pace with technological developments, approaches to medical device certification must also become more innovative. The newly appointed professor has extensive practical experience in the field of medical device certification as well as comprehensive knowledge of medical device law through his previous work as Clinical Evaluation Director. His diverse career also makes him ideally suited for the interdisciplinary and innovative research environment at the EKFZ for Digital Health.

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