RegTech insights: Digitization of Post-Market Surveillance: Ramp-up for the AI service platform SmartVigilance.

Saarbrucken, January 2023: After two years of research and development work, the ramp-up phase for the data platform SmartVigilance is now starting. The platform uses state-of-the-art artificial intelligence and Natural Language Processing (NLP) techniques. Reports and publications from specialized databases can be reliably analyzed and used for the risk assessment of medical devices in the context of post-market surveillance.   

The SmartVigilance research project investigates how post-market surveillance (PMS) for medical devices can be simplified and improved using state-of-the-art artificial intelligence methods and technologies. The result of the project’s work after two years is a digital service platform for PMS that collects, evaluates, and analyzes relevant information, i.e., incident reports, publications, reports, etc., from public databases.  

Users of the service create search profiles for their medical devices. SmartVigilance searches the MAUDE and PubMed databases as well as the reporting portal of the German Federal Institute for Drugs and Medical Devices (BfArM) for information and events related to a company’s products. Advanced text analysis methods from the NLP domain make it possible to find considerably more and better information than with a simple keyword search. Information found is evaluated; the AI algorithm determines the relevance of additional search results and makes recommendations on other sources where even more interesting information can be found. With differentiated data analyses, trends are determined and comparative evaluations of, e.g., competitor products are carried out. The search profiles can be saved and reused for periodic searches.  

“We focus our innovation and research activities on efficiency and productivity gains for time-intensive, recurring, mandatory compliance and regulatory affairs tasks,” Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions points out. “The use of AI fosters a high degree of automation in post-market surveillance. As a result, the small-scale and tedious search for information, adverse events, anomalies, and other reports in a multitude of databases is eliminated from the work routine of Regulatory Affairs experts.” Of course, the task will remain; but in the future, it will be handled largely automatically by the SmartVigilance service platform. For small and medium-sized medical technology companies this represents an enormous reduction in the workload of their day-to-day operations.  

AI-based service platforms for the life sciences have even further advantages: They ease the acute shortage of specialists in Regulatory Affairs. Such specialists are rare; they are often trained “on the job” for years. “This human capital can be put to more sensible use, especially in innovation processes, compared to experts spending days on scouring databases for basic product information,” Kraemer adds.  

The easy access and convenient use of the service platform is also advantageous: There is no need for time-consuming software implementation and months of customizing; registration takes place in a cloud solution. After that, the AI-based PMS service can be used directly.  

The ramp-up phase for the service platform now begins: Interested companies can register for the platform and use the new procedures for post-market surveillance for their medical devices. Additional databases can be connected if needed.  

“We can show that artificial intelligence can add significant value to data search and analysis,” Kraemer added. “We invite interested companies to use the platform now and work with us to identify potential enhancements.” 

SmartVigilance is a joint project of DHC Business Solutions, Averbis GmbH and DFKI in Saarbrucken; it is funded by the German Federal Ministry of Education and Science (BMBF) as part of the “KMU innovativ” program. The platform can be used at special conditions during the ramp-up phase.