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FDA has awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the coordinating center for the medical device National Evaluation System for Health Technology (NEST). The funding will also be used to set in motion the group’s first demonstration projects, piloting methods for tracking medical device data and patient-reported outcomes through the use of real-world evidence.

NEST is designed to help improve the quality of real-world evidence that healthcare providers and patients can use to make better-informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access.

MDIC says this use of real-world evidence to support product approvals has the potential to shift premarket data collection to the postmarket setting.

“There is great potential in using real-world data to foster innovations in medical device technology that will lead to optimized outcomes for patients and improved quality of life,” said MDIC Board Chairman Mike Minogue, president, CEO, and chairman of Abiomed. “In addition, real-world evidence will help measure the cost-effectiveness of these new technologies.”

Former FDA Commissioner Mark McClellan, M.D., Ph.D., spoke about the next steps for NEST at MDIC’s annual public forum in September. McClellan is now director of the Robert J. Margolis Center for Health Policy; the Margolis Professor of Business, Medicine and Health Policy at Duke University; and is a NEST planning board member.

“We focused on a number of issues that are starting to play a bigger role in real-world evidence development,” said McClellan. “Critical to success is broad-based support and public confidence for not only the mission and why we are trying to put data together but also how it’s being executed.”

McClellan says the next key step for the new coordinating center is to establish a governing board to oversee the national network as it gets off the ground. Short-term projects that the group plans to focus on include effective and efficient balancing of pre- and postmarket device evidence development and improving safety surveillance of medical devices.

He pointed to the existing real-world evidence networks and individual registries that are all dealing with the same issues and underlying potential sources of data, noting that these networks could be used as a model to build a national network of registries. That national registry would be used to learn about how medical treatments could be used more effectively. In addition to building on existing activities, he said, it will be critical to demonstrate the value of the coordinating center and to set performance metrics to track its progress.

“Within a few years, we’ll have a different view reflecting the FDA’s strategic vision for how pre- and postmarket regulations work, as well as a much higher expectation about the quality of evidence of medical devices and much higher expectations about the efficiency and the timeliness of the biomedical process involving medical devices,” he said.

Sherrie Trigg, Editor and Director of Medical Content