Accelerating Medical Device Trials with Data Harmonization
Hosted by the Medical Device Innovation Consortium (MDIC) in collaboration with CDISC and Veeva MedTech
The webinar, hosted by the Medical Device Innovation Consortium (MDIC) in collaboration with CDISC and Veeva MedTech, focused on accelerating medical device and diagnostic innovation through clinical data standardization.
Panelists included founding members of MDIC Data Standardization Working Group. This initiative comprised of major industry players, CDISC and FDA representatives, aims to develop and promote best practices for harmonizing clinical data standards for in vitro diagnostics. Leveraging a consensus-driven approach to review and publish findings on the adaptability of existing standards, the objective is to help influence and expedite the development of global standards, promote voluntary adoption, and build regulatory familiarity.
The discussion underscored the benefits of standardized data, noting that it streamlines study design and analysis for greater operational efficiency, accelerates regulatory review through consistent submission formats, and enhances data quality and interoperability to support real-world evidence and advanced analytics. It also highlighted that standardization creates a foundation for AI-driven automation and lifecycle traceability, giving early adopters a clear strategic advantage.
Calls to Action:
- Join in MDIC’s Data Standardization work to help shape best practices, participate in pilot studies to validate proposed standards, and adopt CDISC-aligned formats early to gain efficiency and prepare for future regulatory expectations.
- Join CDISC’s SDTMIG-MD v2.0 Review by registering as a volunteer via the CDISC Volunteer Portal, selecting “Medical Devices” as your preferred Standards Development Team. Upon registration, volunteers will receive a welcome email along with calendar invitations to the team’s recurring meetings.
- Panelists also urged organizations to engage regulators by submitting standardized data and support training and implementation resources to accelerate adoption across the ecosystem—efforts that will require not only collaboration but also sustained investment to ensure timely development and broad industry impact.
Webinar Q&A
SDTMIG v4.0 will not subsume SDTMIG-MD; the SDTMIG-MD will continue as a standalone implementation guide. However, SDTM v3.0, SDTMIG v4.0, and SDTMIG-MD v2.0 are being developed concurrently to ensure cross-domain consistency. For example, root variable definitions are being reviewed to confirm they accurately reflect usage within device domains. The SDTMIG-MD v2.0 is anticipated to be released for Public Review in Q2-2026. Please refer to additional information relating to the development of SDTMIG-MD on https://www.cdisc.org/standards/timeline
Capturing UDIs in real-world data remains inconsistent due to lack of standardized documentation and integration across systems. NEST is actively addressing these challenges through stakeholder engagement, best practice frameworks, and advocacy for structured UDI fields. However, widespread adoption will require coordinated efforts in policy, technology, education, and collaboration. While progress is underway, achieving reliable UDI capture across RWD sources will take time and sustained commitment from all sectors involved.
The Data Standardization Working Group is not working with medical schools at this time. Our focus is to continue building industry support for clinical data standards.
Clinical data standards can certainly help simplify and standardize the structure of a CIP/Protocol. Standard data elements for collection, submission, and analysis will help inform what data is collected for a study. CDISC has well-defined rules around controlled terminology (CT) that the industry can start to adopt.
Refer to the FDA website page Study Data Standards Resources for data submission requirements.
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