Conversation with the NESTcc Governing Committee Interim Chair: Michelle McMurry-Heath, MD PHD

“I love the challenge of making scientific arguments around technology and the positive impact of getting that challenge right. Learning something new each day, working with bright and engaged people, and positively impacting patients is what gets me up every morning.”  Michelle McMurry-Heath, MD PhD Worldwide Vice President of Regulatory and Clinical Affairs and Global […]

National Evaluation System for health Technology Coordinating Center (NESTcc) Selects Medical Device Real-World Evidence Demonstration Projects

Projects support NESTcc’s mission to establish functional and efficient pathways for medical device evidence generation Arlington, VA – (January 29, 2018) – The National Evaluation System for health Technology Coordinating Center (NESTcc) has selected eleven demonstration projects for their potential to provide proof of concept for innovative and scalable approaches to real-world evidence (RWE) generation […]

A Look Ahead to What’s Next for NESTcc in 2018

I am happy to share that NESTcc has hit the ground running in 2018. One of our key achievements last year was developing and finalizing the first version of the NESTcc Strategic and Operational Plan and already, we’re starting to see progress in executing against it against the four goals outlined in the plan: Establish […]

Funding Opportunity from the FDA Includes Collaboration with NESTcc

The U.S. Food and Drug Administration (FDA) recently released a Funding Opportunity Announcement (FOA) to facilitate the development, production, and distribution of pediatric medical devices through the funding of nonprofit consortia. The FOA includes efforts to leverage real-world evidence for regulatory evaluation of medical devices that will foster collaboration between NESTcc and external stakeholders to […]

NESTcc UPDATE: Call for Concepts Deadline Extended to JANUARY 31, 2018

*Please note that this update extends only to the NESTcc Call for Concepts and is NOT applicable for anyone wishing to submit a response to separate NESTcc opportunities. NESTcc is seeking recommendations from industry for Real-World Evidence test-cases that could be implemented with early data network partners. If you are a medical device manufacturer interested […]