Revolutionizing Real World Evidence Generation for Medical Devices

In the complex landscape of medical device regulatory decision-making, the absence of a standardized medical device terminology presents a formidable challenge to generating Real World Evidence (RWE). The Observational Health Data Sciences and Informatics (OHDSI) community, renowned for its robust methodologies in drug and biologics studies using the Observational Medical Outcomes Partnership (OMOP) common data model, lacks equivalent standards for medical devices. This gap hampers the community’s ability to harness OHDSI methodologies and tools for RWE generation in the medical device domain.


Enhancing OHDSI Methodologies for Medical Device Safety and Efficacy Evaluation



Axle proactively addresses this challenge by sponsoring Dr. Asiyah Yu Lin to lead the OHDSI Medical Device Working Group (WG). With a mission to harmonize device standardization efforts with OMOP, the WG endeavors to develop and advocate best practices for utilizing medical device data in observational research. It also evaluates and adapts OHDSI methodologies for medical device safety and efficacy evaluation using Electronic Health Record (EHR) data. Moreover, the WG fosters collaborations and knowledge-sharing on OMOP data utilization in the medical device domain among OHDSI members and beyond.



Building Collaborative Networks for OMOP Data Utilization in Medical Devices



The collaboration between Axle and the OHDSI Medical Device WG yields transformative outcomes. Initiating UDI field modifications in the Device Exposure table of OMOP v5.4 enables accurate capture of Unique Device Identifier (UDI) elements. This ensures seamless automated data flow from the UDI system to OMOP data, enhancing data accuracy and reliability. Furthermore, increased visibility of medical device RWE efforts across the OHDSI community, with multiple WG members contributing to medical device terminology mappings in the OHDSI vocabulary management system Athena. This leads to the establishment of a committed WG relationship comprising active members from prominent institutions and organizations, fostering ongoing advancements in medical device RWE generation and standards development.


Establishing Active Partnerships for Sustainable Knowledge Sharing



Through Axle’s support and leadership, the OHDSI Medical Device Working Group drives monumental progress in standardizing medical device terminology and methodologies, unlocking transformative insights, and advancing healthcare outcomes.