# Novel Approaches to Advance Coordinated Registry Networks (CRNs).

> **NIH FDA U01** · WEILL MEDICAL COLL OF CORNELL UNIV · 2022 · $53,717

## Abstract

Project Summary
The technological transformation of US health care with the explosion of new devices and iterative changes
mandates the acquisition of real-world evidence (RWE) to study devices and technologies pragmatically. The
US Food and Drug Administration (FDA) has spearheaded the RWE framework development in the pursuit of
sufficient evidence that is required for regulatory decision-making such as device approvals and surveillance.
With regulatory support since the launch of the National Medical Device Registry Task Force in 2015, the
Medical Device Epidemiology Network (MDEpiNet) created 15 national and international coordinated registry
networks (CRNs), which develop or link well-curated national RWE sources such as registries, administrative,
and electronic health records (EHRs) data. The MDEpiNet is a key partner of the National Evaluation System
of Technologies (NEST) coordinating center and is an international public-private partnership focusing on
building global infrastructure and methodologies to advance the use of RWE for medical device evaluation.
CRNs not only focus on prevention of harms but also the promotion of safer device innovation through the
development of study designs that expedites patient recruitment at lower costs than traditional clinical
research. MDEpiNet developed a maturity model for CRNs with various levels of achievements in seven key
domains: 1) device identification, 2) quality improvement, 3) total product life-cycle, 4) data quality, 5)
efficiency, 6) governance and sustainability, 7) patient engagement.
This proposal focuses on the creation of innovative tools and methods necessary to achieve maturation of the
networks through efficient curation of robust RWE. We will capitalize on established partnerships with
registries, professional societies, integrated health systems, and many academic institutions to advance this
critical national infrastructure as a foundational component of NEST. We will facilitate advancements of RWE
through stakeholder roundtables, patient-facing mobile app development, and continued innovative methods
development to link registries with Medicare, commercial, statewide, and EHR data to enable better research
and surveillance for devices. Our specific aims facilitate stakeholder engagement for device-specific core
minimum data development in women's health, prostate cancer, orthopedics, vascular disease, robot-assisted
surgery, and temporomandibular joints. We will also advance and enrich linked data capacities in vascular
disease, hernia repair, breast implant, prostate cancer, Women's Health, and gastrointestinal cancer CRNs.
Finally, we conduct advanced analytics to determine gender disparities in device outcomes and use machine
learning and active surveillance methods in hernia repair, orthopedics, stroke treatment, vascular disease, and
Women's health CRNs. The CRN community of practice will enable centralized knowledge sharing to support
cross-specialty and technology lea...

## Key facts

- **NIH application ID:** 10405497
- **Project number:** 5U01FD006936-03
- **Recipient organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** Art Sedrakyan
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $53,717
- **Award type:** 5
- **Project period:** 2020-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10405497

## Citation

> US National Institutes of Health, RePORTER application 10405497, Novel Approaches to Advance Coordinated Registry Networks (CRNs). (5U01FD006936-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10405497. Licensed CC0.

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