Request for Information (RFI) 23-001
NESTcc Medical Device Real-World Evidence Marketplace
Summary of Information Requested
The National Evaluation System for health Technology Coordinating Center (NESTcc) is soliciting the interest of organizations to partner in generating high-quality solutions and expertise with real-world data (RWD) to support improved evidence for medical devices. Expertise is sought in five strategic areas to realize the vision of the NESTcc real-world evidence (RWE) Marketplace:
1. Data platforms: providing a foundation for data gathering and curation, especially platforms that put the patient in the driver’s seat, to gather health data into one place and share with the device community
2. Data sources: creating a national resource mirroring the experience of patient care in the United States and general experience of health throughout an individual’s life
3. Data connectors: deliver continuity of care and experience between data sources (e.g., via aggregation/ linkage) while maintaining patient privacy and protections
4. Data science and research methodology: design and analysis expertise and experience necessary to obtain the epidemiological, informatic and statistical rigor inherent in fit-for-purpose RWD analysis
5. Analytic cores: conducting analyses of ingested data or packaging analytics for data sources to conduct analyses, ensuring rapid, valid and verified analysis suitable for RWD research
Given the complexity of working with RWD and transforming it into RWE, it is understood that many entities involved with RWD/RWE may provide services and technologies that do not fit neatly into these five areas. NESTcc is interested in learning of any relevant service or technology which may improve the ability of RWE generation.
Overview of NESTcc
NEST was established in 2016 by a cooperative agreement between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and the Medical Device Innovation Consortium (MDIC), a 501(c)3, as the first public-private partnership created with the sole objective of advancing regulatory science of medical devices for patient benefit. The purpose of NEST is to increase quality and efficiency in the development of RWE to inform medical device development and evaluation, as well as support clinical, patient, regulatory, and reimbursement decisions throughout the total product lifecycle (TPLC). The Coordinating Center of NEST (NESTcc) catalyzes RWE generation for medical device and health technology for all members of the device ecosystem.
The NESTcc’s direction and operations are informed by a diverse range of stakeholders including, but not limited to, patients, clinicians, device manufacturers, regulators, health systems, and payers. The Coordinating Center facilitates development of NESTcc data quality and research methodologies for RWE and coordinates an established network of NESTcc collaborating institutions who leverage health data and advanced analytics to facilitate linkages among data sources that collect, curate, and analyze data to ensure that it is fit for purpose to generate RWE. NESTcc requires the effort of the community of stakeholders, strategic partnerships, and solution providers to exemplify fit-for-purpose RWE today and to envision best practice RWE generation in the future.
As part of the FDA efforts for RWE, user fee funding is distributed to the NESTcc. The Medical Device User Fee Amendment (MDUFA) V funding of NEST will (1) support the development of RWE resources to facilitate access for studies and (2) to convene experts and develop best practices to advance innovative methodologies with respect to RWE development and analysis.
Vision for NESTcc
NESTcc is positioned to build on its existing network and expertise to assist stakeholders in navigating the medical device ecosystem and accelerate their use of RWE. NEST’s approach to increasing use of RWE is three-pronged.
(1) Collaborative Community: The NESTcc brings together experts to consider and extend the frameworks for research methodology and data quality. NEST is maintaining a forward-looking approach and commissioning new tools to enhance utility of RWD. The frameworks and tools are being made available for use by NESTcc customers and collaborators including, but not limited to industry, FDA, and the other medical device stakeholders.
(2) Guide: The NESTcc is providing leadership and guidance throughout the process of conducting fit-for-purpose RWE studies, including design, analysis, reporting, and supporting interactions with FDA, Centers for Medicare & Medicaid Services (CMS), and payors. NESTcc will utilize best practices which have been developed in conjunction with our diverse stakeholders in research methodology and data quality to guide the appropriate use of RWE for sponsors and provide confidence in the relevance and reliability of the data and studies conducted based on NESTcc’s neutral status as a non-profit entity.
(3) Marketplace: NESTcc intends to create and will host a marketplace of organizations engaging in various aspects of RWE. NESTcc will understand the strengths of each organization and partner across organizations to garner the best fit solution for each RWE study using NESTcc. The goal of the marketplace is to provide the broadest range of solutions for all stakeholders.
NESTcc is a sustainable national resource that utilizes fit-for-purpose RWD to generate RWE for medical devices in a robust yet streamlined fashion. The NESTcc is guiding those wishing to engage in RWE generation throughout the process – honing a question, designing and conducting studies, reporting and dissemination, and regulatory submissions.
NESTcc provides a consistent, seamless experience to generate RWE which can support FDA premarket regulatory decisions and postmarket regulatory requirements and those of other national jurisdictions, collaborations in the Total Product Life Cycle Advisory Program (TAP), and data-generation for CMS Coverage with Evidence Development (CED) or full coverage in Medicare. By managing evidence generation needs across the diverse landscape of expertise and input necessitated by each project, NESTcc is reducing the timeframe, resources, and costs in conducting high-quality RWD studies and increasing the reliability of study results.
The Concept of the NESTcc RWE Marketplace
A medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man.” Thus, medical devices cover a vast array of medical products, therapeutic areas, and risk profiles. Gathering and evaluating data on patient and provider real-world experience across the spectrum of devices is a major undertaking.
NESTcc created a Research Network as part of its initial work under the MDUFA IV Performance Goals, generally referred to as MDUFA Commitments. The NESTcc Research Network has been an invaluable resource for NESTcc to complete RWE test-cases which were also part of its MDUFA IV Commitments5 and to begin to work on sponsored research projects. These experiences have demonstrated that using the NESTcc Research Network alone for some projects leaves gaps that may benefit from the participation of additional strategic partners. NESTcc is currently working on methods to improve its infrastructure and capabilities and build on the strengths of its existing Research Network. As part of this work, NESTcc intends to create a RWE Marketplace which will allow a process for wider participation of the RWE ecosystem in Nestcc RWE projects.
The intent of this Request for Information (RFI) is to identify organizations who wish to partner with NESTcc in such a marketplace. It is not designed to replace the existing NESTcc Research Network, it is designed to enhance it. In addition to payment for their work, organizations selected to join the marketplace will have the opportunity to showcase their skillsets, contribute their expertise to RWD studies, and participate in collaborations which set the standard for best practice RWE generation.
Collaborating to Create the Future State
To design an ecosystem in which the right data sources are paired with best-in-class research techniques and platforms, NESTcc is soliciting interest in partnerships to access and generate high-quality RWD solutions and expertise in research with RWD in order to support improved evidence for medical devices. NESTcc has identified five strategic areas for partnership to realize the vision of the NESTcc RWE Marketplace:
1. Data platforms: providing a foundation for data gathering and curation, especially platforms that put the patient in the driver’s seat, to gather health data into one place and share with the device community
2. Data sources: creating a national resource mirroring the experience of patient care in the United States and general experience of health throughout an individual’s life
3. Data connectors: deliver continuity of care and experience between data sources (e.g., via aggregation/ linkage) while maintaining patient privacy and protections
4. Data science and research methodology: design and analysis expertise and experience necessary to obtain the epidemiological, informatic and statistical rigor inherent in fit-for-purpose RWD analysis
5. Analytic cores: conducting analyses of ingested data or packaging analytics for data sources to conduct analyses, ensuring rapid, valid and verified analysis suitable for RWD research
6. Other Services: any services that do not fall into the five areas above can be provided in this section
Information Requested
Organizations with expertise in any or all of the six areas defined above are invited to indicate their interest in joining the NESTCC Marketplace by submitting their response here. Please do not provide confidential information.
Terms and Conditions of this RFI
• The issuance of this RFI does not constitute a commitment nor an obligation for NESTcc to contract services or conduct any additional follow-up to respondents.
• Any costs associated with responding to this RFI are the sole responsibility of the respondent. NESTcc will not bear any responsibility for any such costs.
Next Steps
• At its discretion, NESTcc will conduct follow-up with various respondents to seek clarification on information provided.
• NESTcc will update the Medical Device ecosystem when any decisions are made regarding the NESTcc RWE Marketplace.
• For questions, please contact nestcc@mdic.org
Submission Deadline - 5:00 p.m. ET on June 30, 2023