Stephen’s Biography
Stephen Gilbert is a veterinarian and professor for regulatory science at the University Hospital Dresden. Before that, he worked as a regulatory affairs manager specializing in clinical evaluation at Biotronik in Berlin, a large and established medical device manufacturer, and then for at Ada Health, also in Berlin, as director of clinical studies and clinical evaluation. Initially, after graduating as a veterinarian in 2001, he worked as a veterinarian and veterinary surgeon for around 10 years in the UK. In addition to studying veterinary sciences a the University of Glasgow, he did a Master’s Degree in Biomathematics, Bioinformatics and Computational Biology at the University of Leeds, and followed that up with a PhD in computational biology.
Things we talked about
- Why he stopped working as a vet: “List-based” work vs. “project-based” work
- Learning self-sufficiency as a vet while having to perform all sorts of operations after graduating
- How he was involved in handling the food and mouth disease outbreak and how that relates to project management
- Transitioning into “wet lab” scientific research and simulations
- How he joined Biotronik, a medical device manufacturer based in Berlin, and worked there to acquire the first-ever CE certificate for a medical device under the new Medical Device Regulation
- The benefits of doing a Master’s degree and/or PhD as a doctor and which sort of program / research area to look for
- We both talked about the German system of doing a “Dr. med” research degree
- What does a Professor of Regulatory Science do? And what is Regulatory Affairs?
- The “implant files” which led to the uncovering of implants which caused harm in patients and their effect on subsequent medical device regulation
- Are we over-regulating medical devices? Do we even have any data to answer that question?
- AI in Healthcare: Chances and risks of ChatGPT and large language models (LLMs)
- LLM medical software currently on the market, their features and considerations whether they are medical devices
