As 2017 quickly comes to a close, I would like to take a moment to share the progress of this year for NESTcc.

Over the course of the last year, we have built the foundational components for establishing NESTcc. We have hired the NESTcc team and put a governance structure in place, engaged the medical device ecosystem, launched NESTcc’s brand and vision, and developed the first public version of NESTcc’s Strategic and Operational Plan. Each of these activities supports NESTcc’s larger goal to establish functional and efficient pathways for key stakeholders to generate lower-cost, nearer real-time evidence of sufficient quality for regulatory, coverage, patient, and clinical decision-making.

New Team, New Governance

In April, I joined the Medical Device Innovation Consortium (MDIC) as the inaugural Executive Director of NESTcc, energized by the unique opportunity in the medical device ecosystem to catalyze activities around evidence generation in support of the shared goal among stakeholders to improve patient health and quality of life.

In an effort to effectively engage this ecosystem, in July, we announced the inaugural multi-stakeholder NESTcc Governing Committee after an open call for members and review process. The Governing Committee serves as a strategic advisory group to NESTcc, comprised of members representing diverse perspectives from across the medical device ecosystem—including industry, providers, patient groups, health systems, regulators, and payers. With this Committee’s support, NESTcc has developed a Strategic and Operational Plan that reflects the needs of the ecosystem.

As our operation has expanded this year, so has the NESTcc team. While still a lean organization, we now have four full-time staff. In August, Rachel Rath joined NESTcc as the Deputy Director, Hither Jembere joined us in September as a Project Manager, and we recently welcomed Rachel Stivers as a Project Coordinator in December.

Ecosystem Engagement

As part of our broader data strategy, NESTcc is collaborating with ten organizations, which collectively represent 55 hospitals, 250 outpatient clinics, and nearly 350 million unique patient encounters. We are looking forward to continuing to build and expand our data network partnerships in 2018 as we work to formally establish and test the NESTcc data network.

In addition to identifying data network partners, NESTcc has also designated a series of Demonstration Projects that will serve to develop, verify, and operationalize methods of evidence generation and data use; demonstrate scalability across healthcare systems, device types, and manufacturers; and build out critical functions and processes for a sustainable NESTcc. Several projects were selected this fall, and we are looking forward to announcing the remainder of the projects in early 2018.

New Opportunities

In addition to the Demonstration Projects, we released a Request for Information (RFI) from data network partners and solution providers over the summer. We received a broad range of responses from health systems based solutions, an academic electronic platform, CRO platform solutions, registries, a national research network, and others. We are looking forward to continuing to develop these partnerships as we move forward in implementing the strategic and operational goals of NESTcc.

Earlier this month, we announced three open opportunities for engagement. The first opportunity—open to medical device manufacturers—is a Call for Concepts for Real-World Evidence test-cases to better understand the opportunities and barriers associated with building and maintaining a NESTcc data network. The concepts are due January 17, 2018.

The next two opportunities are Requests for Proposals (RFPs) seeking support for (1) establishing the value of using RWE for regulatory and coverage decisions and (2) assessing the appropriate use of RWE for medical devices. Responses to both of these RFPs are due January 17, 2018.

Building Awareness through the NESTcc Brand

One of our key priorities this year was to increase awareness of NESTcc and to communicate the value of Real-World Evidence for the entire ecosystem. In July, we finalized development of NESTcc’s digital brand and have used our social media platforms (Twitter, LinkedIn) to stay in touch with NESTcc stakeholders like you. Just this month, we launched the new nestcc.org, which we designed to better engage and inform the NESTcc community.

Much of this year was also spent away from our Washington, DC area home office, on the road sharing and discussing NESTcc at conferences. In the past six months alone, the NESTcc team has contributed to more than 25 speaking engagements, including the 2017 RAPS Regulatory Convergence (Washington, DC), The MedTech Conference (San Jose, CA), the MDIC Annual Public Forum (Washington, DC), the IMDRF Stakeholder Forum (Ottawa, Canada), and the 29th Annual Scientific Symposium of Transcatheter Cardiovascular Therapeutics, TCT 2017 (Denver, CO).

At these conferences, we discussed the value of Real-World Evidence in regulatory and clinical decision-making, the challenges associated with our current fragmented health care model, and the need for NESTcc to serve as a catalyst for lower-cost, nearer real-time evidence generation. I heard from many of you the need for collaboration across the medical device ecosystem to build infrastructures for data-sharing that can advance device innovation and more quickly, efficiently, and safely deliver solutions to patients. These conversations were a fundamental part of the development of NESTcc’s strategy and the execution of our operation.

Preparing for the Future: NESTcc Strategic & Operational Plan

One of the most impactful achievements of this year was the development of NESTcc’s five-year Strategic & Operational Plan, which outlines our approach to building a fully-operational and sustainable NESTcc. To do so, NESTcc will focus on four primary strategic priority areas:

  1. Governance: NESTcc will establish an effective governance structure to support short-term activities and long-term goals.
  2. Role: NESTcc will develop its role to build a sustainable network of data network partners committed to advancing RWE generation and establish its standards for Data Quality and Methods.
  3. Value: NESTcc will establish its value in the ecosystem to achieve full operability and sustainability.
  4. Stakeholder Engagement: NESTcc will ensure effective communication to engage key stakeholders across the medical device ecosystem.

I’m happy to share the current version of the plan with you now. We’ve already begun making significant progress against these strategic priorities and are well-positioned to build on our current momentum in the New Year. We expect to update this plan throughout the year and will share our progress with you.

A Look to 2018

Looking ahead, 2018 is promising to be yet another productive year for NESTcc. Soon after the New Year, we will be excited to announce the remainder of the Demonstration Projects. In addition, we will be identifying test-cases via our posted Call for Concepts and awarding two contracts to help NESTcc work toward sustainability. NESTcc is also going to be growing in early January, as we welcome a new Program Manager to the team.

I will continue to post updates, but in the meantime, I invite you to bookmark the NESTcc Blog and NESTcc News, follow us on Twitter (@NESTccMedTech) and LinkedIn, or subscribe to receive periodic email updates. If you have any questions, please contact the NESTcc team at NESTcc@mdic.org.

Happy holidays! I look forward to speaking with you all again in the New Year.

 

Rachael Fleurence
Executive Director
NESTcc