The National Evaluation System for health Technology Coordinating Center (NESTcc) seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using Real-World Data (RWD) that meets robust methodological standards, currently undergoing development by NESTcc’s Data Quality and Methods Subcommittees.
The current fragmented health care ecosystem does not support the seamless, near real-time, cost-effective use of health data to generate high-quality evidence for medical devices needed for regulatory decision-making in both the pre- and post-market spaces.
Stakeholders across the medical device ecosystem stand to benefit from improved use of RWE and RWD generated in the course of clinical care and everyday life by patients, providers, or payers. Opportunities include increased patient awareness of device safety issues, low-cost efficient evidence generation for regulatory review, and improved patient and provider ability to make care decisions based on robust data.
NESTcc Executive Director Dr. Rachael Fleurence has co-authored an update with NESTcc Governing Committee member Dr. Jeff Shuren on the role of NESTcc in advancing RWE for medical devices.
Read the full, open-access article here.