Collaborative Community

Collaborative Community Update – May 20, 2025

In September 2019, the U.S. Food and Drug Administration (FDA) announced that the National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), was one of the first collaborative communities with participation by the FDA’s Center for Devices and Radiological Health (CDRH).

The Collaborative Community convened medical device stakeholders in a forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities, with the aim to advance the US healthcare system and improve patients’ lives through real-world evidence (RWE) development.

The Collaborative Community identified limited adoption of Unique Device Identifiers (UDIs), which identify device manufacturer and device- and production- specific information, in healthcare settings as a chief challenge for monitoring ongoing safety and effectiveness of medical devices in real-world settings. To enable healthcare systems and networks to electronically capture this critical UDI data, the Collaborative Community released a UDI Playbook to advance UDI implementation at the point of care and increase UDI availability in real-world data (RWD) sources. The UDI Playbook powers health systems with the tools and resources to implement UDI capture both consistently and accurately and sets the foundation for stakeholders to rally peers to champion and further the work.

With the accomplishments of the UDI Playbook and other key initiatives, the Collaborative Community has demonstrated the powerful impact of advancing RWE-centered solutions to address medical device innovation challenges. Building on this foundation, NEST continues to expand these efforts through its Governance Committee, specialized working groups, and targeted initiatives.

In cooperation with the FDA, NEST will be sunsetting the Collaborative Community to focus resources and expertise on these evolving channels—enhancing our ability to drive meaningful progress in medical device innovation.

We are deeply grateful for the engagement and contributions of the Collaborative Community members and invite all interested stakeholders to stay connected and explore new opportunities to engage with NEST. To learn more, please visit our Contact Us page.

A Coordinating Center offering services that catalyze real-world evidence (RWE) generation for medical device and health technology research sponsors.

A Collaborative Community comprised of representatives from across the medical device ecosystem working together to develop thought leadership and coalesce diverse stakeholders to advance innovation and understanding on initiatives of importance.

The NEST Collaborative Community is…

A convening of diverse stakeholders from the medical device and health technology ecosystem

An ongoing forum tackling the toughest and most urgent issues facing
the ecosystem

A community addressing medical device issues that are larger than any one stakeholder can solve

An advocate for applying real-world evidence (RWE) to streamline the regulatory process for medical devices and health technologies

A driver of consensus on medical device ecosystem priorities and solutions

A provider of thought leadership on real-world data (RWD) research, methods, and application

The NEST Collaborative Community comprises diverse participants sharing common objectives and addressing common challenges.

The NEST Collaborative Community provides a variety of functional benefits.

Convening Power

Using our leverage and objectivity to bring stakeholders to the table

Visibility

Providing a platform where consensus and debate on critical issues can be shared

Vision

Identifying areas for future innovation and defining ecosystem-wide aspirations

Collective Voice

Proactively seeking perspectives of all stakeholders and giving equal voice to each

Rapid Response

Mobilizing stakeholders for quick action on emergent issues

Community of Experts

Assembling thought leaders and knowledge producers

How does the NEST Collaborative Community work?

Identifies Issues
within the medical device and health technology ecosystem for collective action
Convenes Stakeholders
and builds evidentiary basis, outlines strategy
Engages the Ecosystem
to act upon recommendations, standards, implementation guidelines
Monitors Impact
for follow-on efforts

Initiative Spotlight: Unique Device Identifiers (UDI)

The NEST Collaborative Community has announced UDI adoption and application as its inaugural initiative because of the topic’s broad relevance across the medical device ecosystem, the importance of policy decisions to multiple stakeholders, and the urgent need for cooperative engagement.

The Collaborative Community hosted its first annual meeting on October 15, 2020, identifying emerging issues in UDI and announcing the launch of a key research project outlined below.

Evaluation of Uptake of Unique Device Identifiers (UDIs) by Health Systems

Overview
This project seeks to understand the implementation and use of UDIs in clinical care to address barriers to implementation so as to improve research employing real-world data to evaluate medical device safety and effectiveness.

Adoption and use of UDIs across health care systems could help enhance the ability to generate high-quality real-world evidence for regulated medical devices as well as improve local and national safety surveillance and tracking efforts by facilities, clinicians, manufacturers and regulators, including management of product recalls and purchasing. However, UDIs are not routinely collected and available in existing Electronic Health Record (EHR) data at most health systems. Further, when UDIs are used they are often only collected for a limited number of clinical care settings.

Aim 1 of this project consisted of conducting semi-structured key informant interviews with NESTcc Network Collaborators to characterize the current use of UDIs within electronic data sources, including availability within EHRs and other health information technology systems and within structured data extractions. Interviews addressed perceived benefits of UDI availability and challenges met, including administrative, financial and organizational.

Aim 2 of this project will develop a UDI Implementation Playbook for health system stakeholders in order to ensure the data integrity and scalability of RWE studies on medical devices through the adoption of the UDI.

This project is being conducted as a NEST Collaborative Community initiative and, as part of that initiative, will seek feedback from the community at various points throughout the project.

Resources
Sanket Dhruva, M.D., MHS, assistant professor of medicine at UCSF School of Medicine, provided an overview of the UDI project as part of the NEST Collaborative Community event “Emerging Issues in UDI” on October 15, 2020. Watch the recording.

Resources
NESTcc engaged the medical device ecosystem via a public comment period for an interview guide for our project evaluating Unique Device Identifier (UDI) adoption by health systems. NESTcc encouraged all stakeholders who may have experience with, or interest in, the topic of UDIs to submit their comments regarding the interview guide.

The public comment period closed on Thursday, March 4, 2021. The research team’s response to the public comments is posted here.

Resources
On April 17, 2023, NESTcc published ‘A Playbook for Health System Unique Device Identifier Implementation at the Point of Care’.

Download the Playbook here.

Topic of Interest
Unique Device Identification

Research Team
Arizona State University, Mayo Clinic, Mercy, UCSF, Yale New Haven Hospital