Getting medical devices into patient care faster

Unique at a Medical Faculty in Germany - We welcome Stephen Gilbert as Professor for Medical Device Regulatory Science
Professor Dr Stephen Gilbert, Else Kröner Professorship for Medical Device Regulatory Science at the EKFZ for Digital Health

Dresden - Stephen Gilbert will fill the new Else Kröner Professorship for Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health at Dresden University of Technology starting in March 2022. The native Northern Irish is moving from industry back into academia and will use his expertise in this field to strengthen interdisciplinary research at Dresden University Medical Center.

For the first time in Germany, a medical faculty is conducting research into how innovative medical devices can reach patient care more quickly. “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,” said Professor Gilbert.

Interdisciplinary and innovative research environment
The focus on digital health at the Carl Gustav Carus Medical Faculty will be strengthened and further developed with this professorship. “Across Germany, there are only a few academic structures in this field and none of the existing professorships are located at a medical faculty. With the appointment of this professorship, the university medicine of the TU Dresden is a pioneer in Germany,” explained Prof. Dr. med. Dr. Esther Troost, Dean of the Medical Faculty. With this professorship at the TU Dresden, the Else Kröner-Fresenius-Foundation continues its commitment in the field of digital health. “By establishing this new professorship, we want to ensure that important research findings are given greater consideration in the regulation of medical devices in the future and improve both patient safety and innovation,” adds Prof. Dr. Michael Madeja, Chairman of the Board of the Else Kröner-Fresenius-Foundation.

Turning innovative ideas into marketable medical devices       
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. “I am very much looking forward to working in this excellent research environment of Dresden University Medicine,” said Professor Gilbert.

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