With the first version of the National Evaluation System for health Technology (NEST) set to open for business by the end of 2019, the shared vision among management at the US Food and Drug Administration (FDA) has expanded to a global scope.
“Regulators are always looking for scientific proof that your device does what you say it's going to do and is as safe as you say it is,” chair of the NEST Coordinating Center (NESTcc) Michelle McMurry-Heath told Focus
at the 2018 MedTech Conference in Philadelphia.
That scientific proof, however, evolves with the technology and there are different methods device firms take to test innovation, she added. McMurry-Heath—Johnson & Johnson’s worldwide VP of regulatory and clinical affairs and global head of evidence generation—took
the helm at the NESTcc earlier this month after serving as the associate director for science at FDA’s Center for Devices and Radiological Health (CDRH).
McMurry-Heath was instrumental in the development of the Medical Device Innovation Consortium (MDIC) while at CDRH, NESTcc executive director Rachael Fleurence said Monday during a conference session on leveraging real-world evidence (RWE) via test cases.
The idea for the public-private partnership stemmed from a goal under a regulatory science program at CDRH in consultation with the Centers for Medicare & Medicaid Services, the National Institutes of Health and the Medical Alley Association to examine regulatory science barriers facing device firms in the US, according to McMurry-Heath.
The creation of MDIC led to the idea for NEST to advance RWE use by establishing a safety net based on clinical evidence data generated through research collaborations. Today, the work involves 12 collaborators and more than 150 hospitals and 3,942 outpatient clinics.
NEST, once operational, will be crucial to drive down the time and costs associated with generating this evidence, CDRH Director Jeff Shuren noted at the session. The center has always been looking to strike the right balance between the use of pre and post-market data to inform regulatory decision-making, but this requires confidence in the data, he added.
Shuren argued there is consensus among regulatory authorities worldwide to facilitate market entry and CDRH now sees an opportunity for global harmonization in this area with NEST.
Building blocks that have already been put in place would enable this expansion, including new FDA draft guidance
on acceptable uncertainty in benefit-risk determinations.
Other building blocks were developed as part of the agency’s participation in the International Medical Device Regulators Forum (IMDRF). These include harmonized principles for using device registries and a new project proposed by China on clinical evaluations, Shuren noted.
The test cases
that shape the role of NEST will underpin these harmonization efforts, which in turn will create the efficiencies that are intended to provide for more timely access to devices in multiple jurisdictions.
Over the next 10 to 18 months, the NESTcc team intends to work out how the learnings from selected RWE demonstration projects can be applied at an industry level to promote long-term growth.
Yet the interest to determine how international NEST can be is already coming into effect as one of the NESTcc current priorities relates to clinical follow-up requirements under the EU’s new device regulation. With growing regulatory burden in foreign countries, NEST could help meet new requirements by providing participants reliable, high quality data, McMurry-Heath said.
In addition to earlier decisions on applications, McMurry-Heath intends to aid in the pursuit of other potential benefits over the course of her two-year term at NESTcc. These include informing price points in device development and providing a menu of studies that can be conducted, with the goal of NEST becoming a revenue source through a RWE-based process for selecting an appropriate approach to innovation testing, she added.
Yet another relates to required NEST use in place of postapproval study requirements since these have failed to fulfill its intended purpose over a lack of incentives for enrollment, according to McMurry-Heath. She argued, however, global application will likely be limited to about three countries as some of the essential building blocks have not been truly harmonized.
In the meantime, the NESTcc is calling for public input to address the challenges it continues to face. These include identifying the right time to engage FDA as well as incorporating patient-generated health data into participating health systems, Fleurence noted.