Digital tools for Regulatory Science
Development of digital services for web-scraping, document classification, aggregation, safety signal detection and post-market surveillance of medical devices on the market.
Within the European Project CORE-MD (https://www.core-md.eu/), we conducted research in order to develop a Software As A Service capable to support post-market surveillance by aggregating and classificating by the European Medical Device Nomenclature (EMDN) data relevant to Safety Notices of medical devices from 15 EU countries and 6 extra-EU countries. A first prototype solution (Monimeds), based on Natural Language Processing and large-language models, has been awarded with the Start Cup Lombardy 2023 first prize in the digital services category (https://musascarl.it/startcup-lombardia-premiati-i-vincitori-delledizione-2023/), then classificating within the first 4 positions in the national competition. A second version is now available as a demonstrator for Governative Agencies and Notified Bodies that would like to test it, as well as we started regulary providing services to companies to help in their search for information for PSUR periodic activities.
Research projects and collaborations
CORE-MD project (Horizon 2020)
Quanta system (https://www.quantasystem.com/)
- Relevant publications
Ren Y, Caiani EG. Natural Language Processing for Regulatory Science: aggregating information about Safety Notices of Medical Devices across the EU Member States towards an improved vigilance system. npj Digit. Med. 7, 352 (2024). https://doi.org/10.1038/s41746-024-01337-9
Hoogervorst LA*, Ren Y*, Melvin T, Stratton-Powell AA, Lübbeke A, Geertsma RE, Fraser AG, Nelissen R, Caiani EG*, Marang-van de Mheen PG*. Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers. Acta Orthopedica 2024;95:667-676. DOI 10.2340/17453674.2024.42361
Ren Y, Fraser AG, Caiani EG. Quality evaluation of field safety notices of medical devices, across EU and non-EU countries. Eur Heart J 2024; 45 (Supplement_1):ehae666.3420. https://doi.org/10.1093/eurheartj/ehae666.3420
Ren Y, Bertoldi M, Fraser AG, Caiani EG. Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance. Therapeutic Innovation & Regulatory Science 2023;57(3):589-602. doi: 10.1007/s43441-022-00493-y
Gibello R, Ren Y, Caiani EG. Development of an AI-based IT tool to support medical device nomenclature standardization for post-market surveillance by automated mapping from GMDN to EMDN standards. Eur Heart J 2023;44(Suppl2):ehad655.3024. https://doi.org/10.1093/eurheartj/ehad655.3024
Fraser AG, Biasin E, Bijnens B, Bruining N, Caiani EG, Cobbaert K, Davies RH, Gilbert SH, Hovestadt L, Kamenjasevic E, Kwade Z, McGauran G, O’Connor G, Vasey B, Rademakers FE, for the CORE–MD consortium. Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives Expert Review of Medical Devices (IERD) 2023 Jun;20(6):467-491. doi: 10.1080/17434440.2023.2184685
Ren Y, Caiani EG. Development of a Framework Dealing with Partial Data Unavailability and Unstructuredness to Support Post-Market Surveillance. 2023 IEEE EMBS International Conference on Biomedical and Health Informatics (BHI), Pittsburgh, PA, USA, 2023, pp. 1-4, doi: 10.1109/BHI58575.2023.10313402
Ren Y, Bertoldi M, Caiani EG. Development of an IT tool to support post-market surveillance and expert panels in detecting sentinel signals relevant to serious incidents in high-risk medical devices: pilot on Italian data. (moderated poster presentation) European Heart Journal 2022; 43 (Issue Supplement_2: ehac544.2842. https://doi.org/10.1093/eurheartj/ehac544.2842
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P; CORE-MD Investigators. Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices). Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):249-258. doi: 10.1093/ehjqcco/qcab059
Fraser AG, Byrne RA, Kautzner J, Butchart EG, Szymański P, Leggeri I, de Boer RA, Caiani EG, Van de Werf F, Vardas PE, Badimon L. Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology. Eur Heart J. 2020 Jul 14;41(27):2589-2596. doi: 10.1093/eurheartj/ehaa382
Fraser AG, Butchart EG , Szymański P, Caiani EG, Kearney P, Van de Werf F. The need for transparency of clinical evidence for medical devices in Europe. The Lancet 2018;392(10146):521-530. doi: 10.1016/S0140-6736(18)31270-4