Dive Brief:
- The National Evaluation System for health Technology coordinating center, or NESTcc, selected 12 additional test cases to evaluate the use of real-world evidence in medical device regulatory and clinical decision-making.
- The new projects include a number of firsts, including a case involving the Apple Watch and a project proposed by a patient advocacy organization.
- This round of cases builds on eight initial projects chosen in November 2018 and will test NESTcc’s capabilities in pre and postmarket settings.
Dive Insight:
NESTcc is a real-world evidence center with a mandate to develop methods for improving product safety and patient access to the latest medical technology while reducing cost and time to market.
The effort is an initiative of the Medical Device Innovation Consortium (MDIC), a public-private partnership created in 2012. The FDA-supported program aims to transition to an independent business model, wherein medical device companies pay for products and services, as government funding is set to run only through 2022.
Device makers Abbott and Johnson & Johnson and the American Academy of Orthopaedic Surgeons participated in the inaugural round of eight test cases, which mostly cover postmarket activities. Projects range from monitoring the safety of orthopaedic devices using electronic health records to using real world evidence to support label changes.
The new round of 12 cases attracted projects from Abbott, AventaMed, BD, Cook Medical, Intrinsic Therapeutics, Medtronic and Pear Therapeutics. Other organizations involved include FDA, the Women’s Health Technology Coordinated Registry Network, Yale-New Haven Health Center for Outcomes Research and Evaluation, and the American Sleep Apnea Association.
Among the projects are surveillance of a synthetic mesh sling for stress urinary incontinence in women and the creation of a mobile app for a surgery registry for the condition. Another project will study the effect of the Apple Watch EKG and irregular rhythm notification detection features on patient-reported outcomes and clinical use.
Other research will focus on evaluating a biomarker test panel for lung cancer diagnosis, an electrode renal denervation system for uncontrolled hypertension, therapeutic cardiac devices for children with congenital heart disease, an annular closure device, outcomes after hip and knee replacement, identifying implantable cardiac lead failures, a mobile app for treating insomnia and depression, and positive air pressure therapy for sleep apnea.
NESTcc’s health system network collaborators reportedly represent more than 195 hospitals and 3,942 outpatient clinics with access to over 494 million patient records and data sources including EHRs, pharmacies, public and private claims, registries and patient-generated data.
