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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations.
The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST originated from the realization that MDEpiNet would require greater industry collaboration to achieve its intended purpose and apply its services on a more global scale, NESTcc Chair Michelle McMurry-Heath previously told Focus.
Version 1.0 of the envisioned network of data collaborators for the advancement of real-world evidence (RWE) generation—NEST— is set to launch before the end of 2019, CDRH Director Jeff Shuren said apologetically to Fleurence and her team at the Medical Device Innovation Consortium (MDIC). The agency granted $3 million in seed funding in 2016 for MDIC to work on NEST, followed by $30 million over five years committed to under the fourth reauthorization of Medical Device User Fee Amendments in support of NEST’s continued development.
The skeleton of NESTcc version 1.0 is centered on RWE studies, regardless of whether it is in the pre- or post-market setting as the framework will be extended across the total product lifecycle.
Shuren offered a few more details during a meeting session on what will constitute the bare bones of NESTcc next year. In addition to serving as an RWE aid in premarket regulatory decision-making, other factors Shuren pointed to as potential measures of success relate to applicability in a broad range of devices and whether RWE-based questions can be answered.
NESTcc should at least be able to answer questions around clinical evaluations and payer reimbursement decisions by next year, according to Shuren.
The ultimate goal of NESTcc, beyond version 1.0, is to change the model for evidence generation and improve the overall impact on patient care by informing treatment decisions through electronic health record (EHR) systems. “But this won’t come in 2019,” Shuren said.
From messy data, to a lack of unique device identifiers’ (UDI) integration into EHR systems, to inconsistencies in patient reported outcomes contained in databases to the need for capital investment, several issues need to be addressed prior to achieving NEST. The issues were raised Wednesday in discussions between participants in NEST test cases and payer representatives and other stakeholders and NESTcc governance, including Shuren.
Further, breaking down barriers to the intended evolvement of NESTcc has become more and more of an imperative for sustaining a growing body of CDRH initiatives. These include the digital health Pre-Certification program, as well as the ongoing work with the International Medical Device Regulators Forum to create a medical device single review program (MDSRP).
NEST will be “fundamental” for establishing MDSRP and “create a ‘global passport’ for worldwide patient access to safe and effective devices,” Shuren argued. The program, when and if it becomes operational, is intended to serve as a mechanism for regulatory agencies across multiple jurisdictions to rely in whole or in part on a device submission to expedite market entry.
A barrier that applies to the agency’s internal processes involves the lack of a systematic approach to considering real-world data to be used as RWE for regulatory decision-making. Shuren said a framework is in the works internally for consistency across different device types and RWE studies prior to clarifying this process to industry.
Other CDRH efforts hinging on NEST’s success relate to striking a pre- vs. post-market balance, reducing the time and costs associated with burdensome requirements, identifying safety signals for early interventions, as well as fostering innovation and patient-centered care.
The good news is the ongoing studies and projects that will shape the RWE and innovation safety net build off the work started by others in the healthcare and academic communities years ago. For example, patient enrollment in device clinical studies is one of the focuses of the NEST demonstration project on mobile health. This is intended to also be beneficial for clinical studies on investigational devices with exemption statuses.
A common theme in three other demonstration projects relate to achieving true interoperability given the use of a wide range of data sources from a variety of data owners, including the plethora of coordinated registry networks hosted under MDEpiNet. These include the projects on implantable cardiac defibrillators tackling data linkage using common leads surgically implanted in patients, on harmonization of laboratory data through RWE for in vitro diagnostic devices and on a common set of data elements for consensus around proactive surveillance.
Tags: NEST, NESTcc, RWE, Surveillance, UDI