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 learning and applications. Through this, we advance the CRNs using innovative, scalable, and dynamic approaches and help them become foundational components of NEST.
Medical Device Epidemiology Network will advance the research and surveillance capabilities of coordinated registry networks through stakeholder roundtables, patient-facing mobile app development, and linkages of real-world data sources. We will also conduct advanced analytics to determine gender disparities, use machine learning for risk predictions, and implement active surveillance for devices and technologies.
