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 NESTcc governance,
- Develop NESTcc’s role,
- Establish NESTcc’s value, and
- Ensure NESTcc stakeholder engagement.
As we look to 2018, we’ll be working to advance each of these goals.
I’m encouraged by the opportunities that lie ahead in 2018 for NESTcc to advance toward establishing ourselves as the leading organization in the medical device ecosystem for conducting efficient and timely high-quality Real-World Evidence (RWE) studies to enhance regulatory, coverage, and clinical decision-making.
Enhancing NESTcc Governance Developed in 2017
In 2017, NESTcc built a strong foundation by announcing its multi-stakeholder Governing Committee and approving the NESTcc charter. Within the charter is a methods consultation—a group of methodological experts that will ensure NESTcc’s activities are using the most appropriate and rigorous methods of analysis. We’re looking forward to working with the Governing Committee to establish this consultative group in the first half of the year to expand the NESTcc governance structure in a meaningful and impactful way.
Another key governance activity that will launch in the next few months is an assessment of the strengths, limitations, and appropriate use of RWE for informing pre-market and post-market decision-making for multiple device types and to determine whether current methods, systems, and programs for RWE can generate reliable and timely evidence about the effectiveness or safety surveillance of devices. This assessment is outlined within the FDA Reauthorization Act of 2017 and MDUFA IV. We’re excited to work collaboratively with a contractor to complete this assessment of the broad RWE ecosystem for medical devices. This is a long-term engagement that will continue for several years, providing an opportunity to explore the changes that take place within the ecosystem.
Developing NESTcc’s Role to Build a Sustainable Data Network
We’re establishing NESTcc’s role through three levels of development: engaging, leveraging, and ultimately transforming the current ecosystem.
In order to engage with the ecosystem as it exists today, we are engaging with projects that were already underway through designating a portfolio of NESTcc Demonstration Projects. This portfolio will provide a set of projects through which we can learn opportunities and challenges of using RWE to meet regulatory and coverage requirements. We look forward to announcing the final slate of NESTcc demonstration projects in early February. Around the same time, we’ll be initiating a value analysis of up to 10 case-studies with analyses of the returns on investment, uses of Real-World Data (RWD) for regulatory decisions, and, if available, coverage decisions.
The next step is to leverage the existing capabilities in the current ecosystem, primarily to develop the initial NESTcc data network. We’re working with a coalition of willing data collaborators to launch the NESTcc data network this spring. When the network opens this spring, it will be a preliminary opening with a limited number of contributing data collaborators that we will expand over time. We’re launching the network on a smaller, scaled basis so that the network is open to you, our stakeholders, as soon as possible and you can help shape the directions in which we expand. The first projects the NESTcc data collaborators will undertake is the test-cases that will test the capabilities of the initial data collaborators to meet the needs of industry stakeholders. The test-cases will be announced in the spring after they are reviewed for alignment and feasibility.
The third pillar of developing NESTcc’s role is to transform the current ecosystem. Here, we will be working with the data collaborators and other stakeholders to identify barriers for research-ready medical device data infrastructure and work to address these. In 2018 we’ll establish data quality and methods standards for NESTcc studies and data collaborators. This is a highly engaged process, where data collaborators are working collaboratively with industry, regulators, and payers through NESTcc to develop the NESTcc data strategy.
Achieving Full Operability and Sustainability to Show NESTcc’s Value in the Ecosystem
In an effort to achieve full operability and sustainability, NESTcc needs to outline a viable sustainability plan and NESTcc services and pricing in 2018.
Since the last few months of 2017, we’ve been working with consultants to develop the preliminary business model for developing NESTcc as a sustainable structure. The model has been reviewed by Governing Committee members and is still being reviewed by additional stakeholders. After the model is solidified, it will be developed into a financial model, operating model, and business plan. These are being developed with continuous feedback and input from key stakeholders both on and outside the Governing Committee. We’ll be rolling these plans out over the summer and they are critical to determining the path for NESTcc moving forward.
Engaging NESTcc Stakeholders
One of our top priorities last year was to establish what NESTcc will be and how it will contribute to the ecosystem, to increase awareness of NESTcc, and to communicate the value of RWE. In undertaking these efforts, we have seen tremendous success and are well-positioned to continue this momentum in 2018. We are leveraging social media platforms (Twitter, LinkedIn) to stay in touch with key stakeholders, and are continuing to improve design and functionality of the new www.nestcc.org to engage and inform the NESTcc community.
Following last year’s trend, we plan to be active at conferences in 2018, fostering lively discussions on the value of RWE 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.
Reflecting on 2017 and looking ahead to the New Year, I appreciate that—while we have achieved so much in so little time—we have great opportunities in front of us. I will continue to post updates, but in the meantime, I invite you to bookmark the NESTcc website where you can find our recent news and my blogs, follow us on Twitter (@NESTccMedTech) and LinkedIn, or subscribe to receive periodic email updates.