The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

Big Data, National Device Evaluation System Take the Spotlight at MDIC

Oct. 21, 2016
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Patients will play a bigger role in device assessments, and more data will come directly from patients in the future, FDA Commissioner Robert Califf told devicemakers.

“As a clinical investigator, I was always limited because of the amount of data you had to collect,” he said. But now, patients are wearing devices that could provide continuous information. “The secretive clinical world needs to wake up,” he said during a meeting of the Medical Device Innovation Forum.

The FDA and the Centers for Medicare & Medicaid Services are interested in getting the best technology to patients earlier, he said, so there is a real need to create an ecosystem where quality systems and self-governance are built in.

The vision that the commissioner and CDRH Director Jeffrey Shuren painted is one in which a network enables the sharing of real-world evidence that comes from electronic health records, unique device identifiers, clinical data and postmarket information.

“We expect more evidence than the rest of the world,” said Shuren, “which can create disincentives to bringing products to the U.S.”

By sharing critical data, devicemakers can help reduce the time and cost of the total product lifecycle so that manufacturers find the U.S. market attractive without compromising safety and efficacy.

Postmarket Surveillance Coming

The agency has been talking about creating a national postmarket surveillance system for a number of years, but it is now ponying up the funds to make it a reality.

The FDA awarded MDIC $3 million in seed funding to establish the Coordinating Center for the Medical Device National Evaluation System for health Technology (NEST).

The initial phase will include demonstration projects piloting methods for tracking medical device data and patient-reported outcomes through the use of real-world evidence.

This use of real-world evidence to support product approvals has the potential to shift premarket data collection to the postmarket setting and to meet postmarket data collection commitments through a modern system that leverages electronic health information generated in the clinical and home setting.

Mark McClellan, director of the Duke-Margolis Center for Health Policy, outlined the next steps for the project, which will “become the national lynchpin” of the FDA’s strategy for collecting real-world evidence.

The former commissioner said the following issues will be critical in building an effective network:

  • Broad-based support and public confidence on why data are being pulled together and how the information is being used;
  • Core financial support for governance and establishing standard practices and continuous learning for best practices;
  • Leveraging the growing number of networks to pull data together for real-world use;
  • Distributed capabilities and reliance on virtual networks to build a shared commitment using common data models and common shared methods; and
  • Starting in a realistic way with a feasible pilot program and building on capabilities. The first projects will work on balancing premarket and postmarket data and increasing efficiency and the quality of safety surveillance.

Balancing postmarket data could be accomplished by relying on existing registries and using the real-world evidence that already exists, he said. Increasing quality surveillance could also reduce the reporting burden on devicemakers by making that process automated.

The data that comes out of NEST could also be used to help build out the data needed for the MDIC Case for Quality metrics.

After 13 of years of the same old, same old, manufacturers will need to make adjustments — new emphasis has been placed on the validation of Quality Management System (QMS) software. Sign up for FDAnews upcoming webinar on Oct. 31: Device Software Verification and Validation to be in the know.

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