Reflecting on my first year as the Executive Director of NESTcc, it is striking to see the changes and progress that have shaped the Coordinating Center’s priorities in such a short time. When I first arrived at NESTcc in April 2017, the three key areas of focus for our first year of operation were to establish and announce an inaugural Governing Committee, select key Demonstration Projects to provide proof of concept for scalable approaches to evidence generation, and develop a sustainability model for NESTcc.

During the course of the last year, we made great strides in these areas. The inaugural Governing Committee was launched in July and meets monthly to provide strategic guidance for NESTcc. In February, we were thrilled to announce a portfolio of Demonstration Projects that help shed light on challenges and lessons learned, identifying gaps where NESTcc can help accelerate the use of medical device real-world evidence (RWE). Meanwhile, sustainability planning has been an ongoing effort throughout the year — engaging with key stakeholders throughout the fall to gather their perspectives, launching a Sustainability Subcommittee of the Governing Committee this spring, and issuing a call for contractor support to advance sustainability planning during the remainder of 2018.

After a few months at NESTcc, I was proud to unveil the first version of a Strategic and Operational Plan for NESTcc in December. The plan outlines a five-year approach to building a fully-operational and sustainable NESTcc and includes a strategy for launching the NESTcc Data Network. As an initial step in launching the Data Network, we brought together stakeholders from health systems, industry, payers, and the FDA in February for an inaugural Data Strategy Convening to discuss current data capabilities, identify gaps for generating Real-World Evidence (RWE), and gain insights on key operating principles and processes.

Using February’s Data Strategy Convening as guidance, NESTcc is working to establish the processes and administrative infrastructure needed to develop a successful Data Network. NESTcc is connecting its 11 early Network Collaborators, who together represent more than 150 hospitals and 3,042 outpatient clinics, with industry to assess Data Network feasibility and understand Network Collaborator capabilities to answer the questions of importance to industry through our test-case initiative. These test-cases allow NESTcc to work collaboratively between industry partners and Network Collaborators to answer a range of questions in device areas along the medical device total-product lifecycle.

With the initial NESTcc Data Network in place, we are ready to facilitate the execution of projects that meet the needs of the medical device ecosystem. In the coming weeks, a consultation request form will be live on the NESTcc website, allowing individuals to more easily access NESTcc resources for answering important medical device research questions.

As the NESTcc Data Network begins to support more projects, establishing data quality and methods standards is a top priority. That is why NESTcc posted a public call for stakeholders to serve on its Data Quality and Methods subcommittees. These subcommittees will establish standards to address issues with data quality and will identify appropriate statistical methods for the use of Real-World Data (RWD). The membership for these committees is in the approval process, after which we’ll publicly announce the membership.

Already, my second year at NESTcc is proving to be exciting. We look forward to sharing the advances underway in the Data Network development, test-cases, and methods and data quality standards over the next few months. In order to stay informed of NESTcc activities, I invite you to bookmark the NESTcc website where you can find upcoming events, recent news, and my blogs; follow us on Twitter (@NESTccMedTech) and LinkedIn; or subscribe to receive periodic email updates.

 

Rachael Fleurence, PhD
Executive Director
NESTcc