The National Evaluation System for health Technology Coordinating Center has set out its goals for 2019 in a strategic and operational planning document, including moving toward a model where medical device companies pay for goods and services.
NESTcc, which is developing a medical device data network to collect real world data and evidence, plans to spend 2019 assessing how to become a sustainable organization before its FDA funding runs out.
FDA gave NESTcc an additional $3 million last year but believes "considerably more funding" is needed to fulfill the potential of the data network.
NESTcc has spent the past few years sourcing clinical registries, electronic health records and other types of real-world data with a view to establishing a resource that supports the development and evaluation of medical devices. FDA provided $3 million to support this work in 2016 and chipped in the same amount again last year.
While FDA requested more funding for NEST in the president's budget for fiscal year 2019, in the long term the coordinating center will need to bring in money to support itself. The move to a sustainable operating model was envisioned in the previous strategic plan but 2019 is the year the idea takes off.
Having sought out a contractor to support sustainability planning last year, NESTcc is set to use 2019 to develop a business plan. That will lead to the creation of products and services that it plans to sell to the medical device industry. The rollout of the services will mark a move away from collaborative test cases and toward paid-for access to the data network and services to cut transaction costs.
To make the model work, NESTcc will need to offer something of value to the industry. The real-world data network established to date goes some way toward that goal but the center thinks improvements are possible. Such improvements are another of the center's strategic priorities for 2019.
With all current members of the data network hailing from the U.S., NESTcc wants to expand into new geographies in the coming year. In parallel, NESTcc will work to create and adopt data quality and methods frameworks that “promote a shared understanding of data quality” across members of the data network. Such shared understanding will be increasingly important as the network expands.
The other two strategic priorities — governance and stakeholder engagement — were also goals in a previous plan. The specific activities NESTcc will undertake in these areas are changing, though, in part because of the broader evolution of the organization.
Notably, NESTcc's assessment of how it can become financially sustainable may affect its governance. The coordinating center intends to perform a "mid-year staffing assessment" based on the outcome of its sustainability planning.