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Else Kröner Professorship for Medical Device Regulatory Science

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

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.

Portrait Prof. Dr. Stephen Gilbert

2021 |

The quality of condition suggestions and urgency advice provided by the Ada symptom assessment app evaluated with vignettes optimized for Australia
Stephen Gilbert, Shubhanan Upadhyay, Paul Wicks and Claire Novorol; Australian Journal of Primary Health (accepted 2021-05-11). doi: 10.1101/2020.06.16.20132845

Can symptom and history recording patient apps help optimize patient flow in urgent care centers?: A Simulation Study; Montazeri M, Multmeier J, Novorol C, Upadhyay S, Wicks P, Gilbert S; JMIR Formative Research. 14/04/2021:26402 (forthcoming/in press)

2020 |

How accurate are digital symptom assessment apps for suggesting conditions and urgency advice? A clinical vignettes comparison to GPs; Stephen Gilbert, Alicia Mehl, Adel Baluch, Caoimhe Cawley, Jean Challiner, Hamish Fraser, Elizabeth Millen, Maryam Montazeri, Jan Multmeier, Fiona Pick, Claudia Richter, Ewelina Türk, Shubhanan Upadhyay, Vishaal Virani, Nicola Vona, Paul Wicks, Claire Novorol; BMJ Open2020;10:e040269. doi:10.1136/bmjopen-2020-040269

Contact |

Prof. Dr. Stephen Gilbert |


+49 351 458 7558


Vita |

Stephen Gilbert received his PhD in computational biology from the University of Leeds. He was a researcher in cell physiology, specializing in clinical evaluation and testing of medical products and the underlying regulatory requirements and implementation. Since May 2019 he was Clinical Evaluation Director in the medical department of Ada Health in Berlin and from 2017 – 2019 Clinical Evaluation Manager at Biotronik in the regulatory department. During this time, he worked on regulatory/clinical aspects for novel implants and AI-based digital health technologies. He fills the newly created Else Kröner Professorship for Medical Device Regulatory Science at the EKFZ for Digital Health at TU Dresden. Here, he will conduct research on the development of automated, assertive, and responsive methods for regulatory compliance and advancement of digital health technologies and innovative medical devices.

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.