As we wrap up NESTcc’s busiest year to date, I’d like to reflect on the landmark achievements and milestones that have been accomplished over the past twelve months, guided by NESTcc’s 2018 Strategic & Operational Plan.
2018 was marked by firsts for NESTcc, starting with our first Data Strategy Convening meeting in February where we brought together the initial NESTcc Network Collaborators forming the NESTcc Data Network, selecting and announcing our first Real-World Evidence (RWE) Test-Cases, and launching our first targeted call for Test-Cases making use of Patient Generated Data (PGD). These activities were key components to fulfilling NESTcc’s mission to accelerate the development and translation of new and safe health technologies, leveraging RWE and innovative research.
Governance & Growth
This year NESTcc has grown both internally and externally, with the addition of new NESTcc staff, expanded in-house expertise at MDIC to support NESTcc, and an increasingly robust NESTcc governance structure. After serving as the inaugural Chair of the NESTcc Governing Committee during the first year of the Governing Committee, I was pleased to transition the role of NESTcc Governing Committee Chair to AdvaMed representative Dr. Michelle McMurry-Heath from Johnson & Johnson, and help usher in the Governing Committee’s new Vice Chair and Treasurer positions, currently held by Dr. Adrian Hernandez from Duke University and Vance Moore from Mercy Health, respectively. In the spring, we were excited to announce the creation and scope of four new NESTcc subcommittees, including the internal Charter and Sustainability Subcommittees and the external Data Quality and Methods Subcommittees. The Data Quality and Methods Subcommittees include a diverse group of stakeholders from across the medical device ecosystem and have been working diligently over the last six-months to create a data quality framework and methods playbook. The NESTcc Governing Committee has also been leveraging its business expertise in the Sustainability Subcommittee to conduct a market analysis and develop a business plan to map out NESTcc’s future sustainability post-MDUFA funding.
Launching the Test-Cases
The NESTcc Test-Case initiative, which one year ago was barely in its initial Call for Concepts stage, now has a slate of eight Round 1 Test-Cases that have been approved for funding by the MDIC Board of Directors. Contracting is underway between MDIC and the appropriate health systems and the teams are eager to begin in earnest. Meanwhile, Round 2 Test-Cases are in the proposal development stage with our Network Collaborators. Our second round of Test-Cases saw a nearly four-fold increase in the number of submissions, the number of organizations submitting, and the types of stakeholder groups, and included both broad RWE questions and questions requiring the use of Patient Generated Data. These Test-Cases, intended to explore the feasibility for the medical device ecosystem to work with Real-World Data (RWD) sources and help identify how NESTcc can be leveraged to reduce transaction costs, are cornerstones of our strategic vision for NESTcc moving forward.
Developing the Data Network
Our Data Network saw growth in 2018 as well, with the addition of Mid-South as NESTcc’s twelfth Network Collaborator. As we end the year, the Data Network represents more than 195 hospitals and 3,942 outpatient clinics and have RWD sources including electronic health records (EHRs), pharmacies, public and private claims, registries, and PGD. All of the Network Collaborators are working on Round 1 Test-Cases and have been critical partners for NESTcc in providing the technical insights to advance the use of RWE for medical device projects. We were proud to end the year by taking a major step in supporting the safety of medical devices with the approval of the establishment of an Active Surveillance Task Force by the NESTcc Governing Committee. This multi-stakeholder Task Force will help NESTcc in its charge to address the timely and robust identification of safety signals for medical devices.
Engaging the Medical Device Community
As part of our goal of increasing stakeholder engagement, NESTcc revamped its online properties via an MDIC-wide branding refresh and has continued to grow our presence and engagement activities on our Twitter and LinkedIn pages. Continuing our efforts to share NESTcc’s innovative work at major events and conferences, the NESTcc team participated in over 40 presentations and speaking engagements across the country, most notably at MDIC’s 2018 Annual Public Forum in Washington, DC.
A Look Ahead to 2019
Thank you to all of our stakeholders and those who have engaged with us over the course of 2018. The 2019 NESTcc Strategic & Operational Plan will be posted in the coming weeks and I very much look forward to sharing additional exciting updates next year as we strive to make 2019 an even greater success.