RegTech Insights: Can artificial intelligence improve post-market surveillance? An industry survey is to provide answers.

2. February 2021

Post-market surveillance is a mandatory task for manufacturers of medical devices and involves a great deal of effort. Whether and how artificial intelligence methods can provide a remedy is the subject of an ongoing research project. An industry survey is now determining the needs and expectations of medical technology companies.

DHC Business Solutions, a RegTech specialist from Saarbrücken, Germany, is involved in a research project on technologies and automated processes for regulatory risk assessment and post-market surveillance in medical technology. The potential of methods and technologies from the field of artificial intelligence for improving the entire process and the expectations associated with them are now to be determined in an industry survey.

Can modern speech recognition search the relevant information sources and determine the correct messages? Will automatic learning methods make information searches more reliable and simpler? And can data analytics identify market trends that provide important insights for individual manufacturers and their products? These and other questions are the focus of the survey, in which manufacturers of medical devices from German-speaking countries can participate. The survey also examines the current practice of post-market surveillance in companies.

The results of the survey will be incorporated into further research and development work in the project SmartVigilance. The project is funded by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) (FKZ 01|S20028A); the German Research Center for Artificial Intelligence (Deutsche Forschungszentrum für Künstliche Intelligenz, DFKI) in Saarbrücken and the text mining specialist Averbis GmbH from Freiburg are also involved. It is also planned to have a publication in the form of a trend study.