Less than a month in, 2019 is shaping up to be another landmark year for the NESTcc.  In an effort to further advance our mission to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE), and innovative research, NESTcc’s Governing Committee has approved our Strategic & Operational Plan for 2019, which includes four strategic priority areas:

1. Establish NESTcc’s Governance
2. Develop NESTcc’s Data Network
3. Establish NESTcc’s Sustainability
4. Ensure NESTcc Stakeholder Engagement

While our goals are always evolving to match the needs of the medical device ecosystem and our stakeholders, two key areas where NESTcc has refined its direction are in developing the Data Network and planning for sustainability.  Prioritizing these areas will allow NESTcc to grow its role as the preferred resource for RWE studies within the ecosystem and ensure continued viable growth for the Coordinating Center beyond its existing MDUFA grant funding.

Enhancing Governance

After enhancing NESTcc’s governance structure in 2018, including the establishment of new executive leadership positions on the NESTcc Governing Committee and four new subcommittees, we look forward to continuing to refine the governance structure and decision-making processes in 2019.

NESTcc’s staffing structure will also be assessed mid-year based upon the findings of our forthcoming sustainability plan, which is being developed to support the long-term sustainability of NESTcc and will ultimately be approved by the MDIC Board of Directors.

NESTcc’s Data Network Advances

In the first few months of the year, we will be releasing an initial Data Quality Framework and a Methods Playbook, developed by our Data Quality and Methods Subcommittees.  These critical documents will help promote a shared understanding of data quality across the different Network Collaborators through a maturity model, as well as develop a playbook for utilization of real-world data (RWD) in NESTcc studies.  After initial versions of these documents are reviewed internally by the NESTcc Data Network they will be made available for public comment prior to a final release this summer.

This year will also yield interim results and lessons learned from our Round 1 RWE Test-Cases and will see the launch of Round 2 Test-Cases, currently in the selection process.  In addition to these NESTcc-funded Test-Cases, we will also be developing a process for the first non-NESTcc funded project to utilize the Data Network in an effort to expand the Data Network’s scope and test its scalability.

As we work to implement the Data Quality Framework and scale the Data Network through lessons learned from the Test-Cases, we will also be considering the expansion of the Data Network and exploring the option of incorporating data sources from outside the United States.

A new activity for the Data Network will be taking place as we start 2019, with the launch of a new Active Surveillance Task Force, tasked with developing and implementing a blueprint for active surveillance.  The initial charge of the Task Force will be to establish a system to demonstrate the feasibility of deploying active surveillance tools within NESTcc, resolve methodological issues, and explore scalability of active surveillance to include a large number of devices.  We look forward to announcing the Task Force membership by the end of January.

Beyond 2019:  Ensuring a Sustainable NESTcc

As I touched upon in my 2018 NESTcc Retrospective, we are coming off our busiest year to date and have an exciting vision for where to take the Coordinating Center in the years to come.  While NESTcc is currently funded by FDA funding through a grant to MDIC, we are diligently working to create a sustainable business plan to continue our mission beyond the duration of the initial funding.  By completing a detailed market analysis and developing this sustainability plan, NESTcc intends to develop valuable products and services and engage with our stakeholders to utilize these offerings.

Stakeholder Engagement:  NESTcc as RWE’s Front Door

Our key strategic priority in the area of stakeholder engagement for 2019 is to firmly establish NESTcc with a front door to conduct RWE studies.  This goal will be achieved through enhancing the NESTcc brand by strategically targeting key stakeholders and soliciting feedback on our aforementioned Data Quality and Methods Frameworks.  NESTcc will look to pioneer the adoption of RWE by stakeholders from across the ecosystem and become synonymous with high-quality, Real-World Data (RWD).

We will also be engaging stakeholders by disseminating learnings from the Round 1 RWE Test-Cases and additional progress through peer-reviewed publications, and plan to feature the dynamic work of NESTcc at a number of conferences and speaking engagements this year.

As I look ahead to the remainder of 2019 and beyond, I am energized by the knowledge that we have so many groundbreaking opportunities for innovative growth.

Rachael Fleurence
Executive Director
NESTcc