Whitepaper
Raising the standard for device evidence
Medical device companies face rising expectations to demonstrate safety, performance, and value using real-world evidence. Yet the data sources traditionally used for device research—such as claims, chargemaster data, and registries—were created for billing or narrow reporting, not for understanding device use or patient outcomes across the full care journey. Truveta delivers the most representative, complete, and timely patient journey data, with unique device identifier (UDI)–level detail and linked clinical context updated daily for research.
The challenge: Legacy real-world data cannot support modern device evidence
Designed for billing or narrow reporting, traditional datasets lack the device-specific identifiers, linked outcomes, or timely updates. These limitations make it difficult to evaluate real-world safety, understand device performance across iterations, or generate evidence at the speed regulators, payers, and clinicians expect.
Because they were never built for device-level inquiry, traditional data sources offer only fragments of the full clinical picture. They cannot reliably show which device was used, how it was used, or what outcomes followed. These gaps make it difficult for device teams to monitor safety, study performance across product iterations, or generate timely evidence for regulators, payers, and clinicians.
Truveta provides regulatory-grade, research-ready device data
Truveta delivers a complete and transparent view of device use across diverse US populations and care settings.
With Truveta Data, device teams gain:
- UDI-level device identity across tens of millions of device uses, with clear provenance.
- Daily updates to study safety signals, performance trends, and adoption in real time.
- Omnimodal clinical context, including clinician notes, imaging, labs, procedure logs, and admission–discharge–transfer (ADT) data.
- Linked outcomes and cost data to assess both clinical and economic value across the full patient journey.
What’s inside the whitepaper:
- Why legacy RWD sources can no longer meet regulatory and market expectations for device evidence.
- How Truveta achieves device-level precision—mapping 45M+ device uses to UDIs with full provenance.
- The breadth of clinical, operational, and financial data available to study device use across real-world practice.
- Examples of how device companies are using Truveta Data to inform design, accelerate trials, demonstrate value, and expand adoption.
