National Evaluation System for health Technology Coordinating Center (NEST)

The role of real-world evidence (RWE) in medical device safety continues to grow, shaping regulatory decisions. On MD+DI's Let’s Talk MedTech podcast, Dr.?Jijo James?highlights how?Johnson & Johnson?worked with NEST to secure the first-ever FDA label expansion based entirely on RWE. This collaboration demonstrates the value of real-world data in advancing medical innovation and improving patient outcomes. As #RWE continues to gain traction, we’re excited to see its impact on the future of #medtech.

NEST is engaging the medical device ecosystem via a public comment period for feedback on version 2.0 of the Research Methods and Data Quality Frameworks. NEST encourages all stakeholders who may have experience with, or interest in, real-world evidence (RWE) methods or data quality to submit their comments regarding the Frameworks. Learn more, including how to submit comments by April 29, 2025: https://lnkd.in/eW5MeQKy

NEST is excited to partner with Premier Inc., the first partner announced through our Medical Device RWE Marketplace RFP process, to expand access to high-quality real-world data and strengthen real-world evidence in medical device evaluation. Together, we’re working to improve evidence generation and support better-informed healthcare decisions. Read more about this collaboration at https://lnkd.in/gF7WXZfF ?#RWE #RWD #HealthcareInnovation #RegulatoryScience

Real-world evidence (RWE) is becoming a critical component of medical device approvals, and NESTcc is helping set the standard. Our Medical Device RWE Marketplace provides access to high-quality data and methodological frameworks that support the generation of regulatory-grade evidence. Through our collaboration with Aetion, we’re ensuring manufacturers have the tools they need to navigate this evolving landscape. Check out Aetion’s blog for more on how RWE is shaping regulatory decision-making.

Intuitive's FDA clearance for labeling modifications on their robotic-assisted surgical devices, da Vinci Xi and X Surgical Systems, highlights the transformative power of real-world evidence (#RWE) in medical device development. The NEST Mark process demonstrated the immense value of leveraging fit-for-purpose data to streamline regulatory success. As Simon Mason, President of NEST, shared: “Building the momentum of the NEST Mark process through another success is encouraging... We look forward to empowering more companies by leveraging RWE that is truly fit-for-purpose.” This milestone reflects NEST’s commitment to enhancing regulatory pathways and accelerating innovation in #medicaldevices. Learn more about how NEST and its partners are driving efficiency and confidence in #premarket submissions through tailored RWE solutions: https://lnkd.in/eUynrd4f Read the full story of Intuitive's success: https://lnkd.in/grf6aknT

Listen as NEST President Simon Mason joins Etienne Nichols on the Global MedTech Podcast to discuss how NEST’s real-world evidence (#RWE) approach is driving down costs and accelerating market entry for #MedTech. Tune in here: https://lnkd.in/gfxvkgha

NEST was honored to support the?Consortium for Technology & Innovation in Pediatrics as they hosted the #2024CTIPSymposium in Chicago. The Symposium brought together key stakeholders, innovators, clinicians, patients, and industry leaders to discuss the latest developments in #pediatric medical devices and foster collaborations that can drive positive change in pediatric healthcare. NEST’s?Cori Maegley joined a panel discussion on Real-World Evidence (RWE) Opportunities to Advance Pediatric Medical Devices moderated by?Juan Espinoza, MD, Director, PI,?Consortium for Technology & Innovation in Pediatrics. The panel explored the role of RWE in supporting pediatric medical devices, including labeling expansion, and how RWE initiatives and sourcing real-world data can aid regulatory processes. Ready to learn more about NEST's work to advance RWE in medical device approvals? Be sure to check out their session at #APF2024: mdic.org/APF Thank you to the experts who participated in this engaging discussion: - Stacey Ellul, RN, MBA, Vice President, Quality & Regulatory at?NeuroPace - Cori Maegley, MS, MBA, Vice President, Partnerships Management,?National Evaluation System for health Technology Coordinating Center (NESTcc) - Katie Mues, PhD, MPH, Vice President, Science at?Aetion - Charles Viviano, MD, PhD, Chief Medical Officer, OCEA, CDRH,?FDA Learn more about the CTIP Symposium at https://lnkd.in/eZE7rW3x #medicaldevices #realworldevidence #patientsafety #regulatoryscience #premarketapproval