Collaborative Community

A Coordinating Center and a Collaborative Community.

The National Evaluation System for health Technology Coordinating Center (NESTcc) is an independent organization tasked with driving quality and efficiency in the use of real-world data (RWD) to inform medical device development and evaluation, as well as support clinical, patient, regulatory, and reimbursement decisions throughout the total product lifecycle (TPLC). In September 2019, NESTcc became one of the first Collaborative Communities with FDA participation, working to bring together diverse stakeholders to address common medical device ecosystem needs and initiatives.

NESTcc serves a dual role in the medical device ecosystem:

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

NEST Collaborative Community Objectives

Coalesce diverse medical device stakeholders around initiatives that further the utilization and beneficial impact of real-world evidence (RWE) to find common paths forward on tough and broad questions and present leadership and consensus-driven guidance to the community.
Provide a forum for stakeholders to work proactively to speed innovation and enhance the safety and effectiveness of medical devices and health technology.

FDA’s Center for Devices and Radiological Health (CDRH) is a participating member of the community, and individuals from patient groups, payers, the medical device industry, healthcare professional societies, other regulatory bodies, non-profit consortia registries, along with patients themselves are welcome to become members.

I am a NEST Collaborative Community stakeholder…

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
NESTcc is engaging the medical device ecosystem via a public comment period for a Playbook created to advance health system Unique Device Identifier (UDI) implementation at the point of care (POC) as part of our Collaborative Community UDI Adoption and Application project. NESTcc encourages all stakeholders who may have experience with, or interest in, the topic of health system UDI integration at the POC to submit their comments regarding the Playbook.

NESTcc will consolidate all submissions and send the de-identified comments to the project team for consideration in the design of the final Playbook. Public comments are non-binding, and the project team is not obligated to implement any recommendations submitted.

All comments should be submitted here.

Comments are due on Thursday, December 15, 2022.

The Playbook is posted here.

Topic of Interest
Unique Device Identification

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

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The NEST community is passionately committed to transforming the way medical device technologies are tested, approved and monitored.

Closing tomorrow! The deadline for NESTcc’s open call for Governing Committee members is 5:00 p.m. ET on March 31. This call seeks members representing a diverse range of stakeholders. Learn more about the opportunity: hubs.ly/Q014hqTq0 pic.twitter.com/vfyV1Jwo3y 2 days ago

Registration is open! NESTcc is excited to host a webinar in support of the pending release of the UDI Playbook.The meeting will include an overview of the Playbook and a discussion with Key Advisory Group Members and other stakeholders. To register, visit lnkd.in/e9ivmTHY pic.twitter.com/FOpimKWg3Z 4 days ago

National Evaluation System for health Technology Coordinating Center (NESTcc)
1655 N Ft. Myer Dr, 12th Floor, Arlington, VA 22209

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A Coordinating Center and a Collaborative Community.

NESTcc serves a dual role in the medical device ecosystem:

The NEST Collaborative Community is…

NEST Collaborative Community Objectives

I am a NEST Collaborative Community stakeholder…

Patient Groups

Patient Groups

Clinician Groups and Research/Health Systems

Clinician Groups and Research/Health Systems

Payers

Payers

Regulators

Regulators

Industry

Industry

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

Visibility

Vision

Collective Voice

Rapid Response

Community of Experts

How does the NEST Collaborative Community work?

Identifies Issues

Convenes Stakeholders

Engages the Ecosystem

Monitors Impact

Initiative Spotlight: Unique Device Identifiers (UDI)

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

Overview

Resources

Resources

Resources

Membership Registration

Why be a member?

Follow us @NESTccMedTech