NEST

What NEST does

NESTcc (National Evaluation System for health Technology Coordinating Center) is a nonprofit coordinating center established in 2016 as an initiative of the Medical Device Innovation Consortium (MDIC) with $3 million in seed funding from the FDA under MDUFA. The organization operates a federated Data Network comprising 12+ Network Collaborators—including academic medical centers (Duke, Mayo Clinic, Vanderbilt, Yale-New Haven), health systems (MedStar, Lahey, Mercy), and data infrastructure providers (HealthCore/Carelon Research, PEDSnet, OneFlorida, STAR CRN, MDEpiNet)—with combined access to over 494 million patient records across 195+ hospitals and 3,942+ outpatient clinics. Data modalities span electronic health records, pharmacy and medical claims, device registries, and patient-generated health data, validated through NESTcc's published Data Quality Framework and Data Quality Maturity Model Self-Assessment Tools.

Its core offerings include NEST Mark (a collaborative program guiding fit-for-purpose RWE study design for FDA regulatory submissions), the NEST RWE Marketplace, a portfolio of 21 Test-Cases spanning 10 disease areas and all 5 stages of the Total Product Life Cycle, Demonstration Projects, Research Methods and Data Quality Frameworks, a UDI Center and Playbook, and a planned Active Surveillance Program built on a cloud-based federated learning architecture for safety signal refinement. The NEST Mark process has produced a documented FDA clearance (Intuitive Surgical's da Vinci Xi and X labeling revision for radical prostatectomy, 2024), and a Johnson & Johnson cardiac ablation catheter label-expansion Test-Case advanced to Phase Two.

NESTcc's business model combines FDA MDUFA grant funding with structured engagement programs that connect medical device manufacturers, health systems, regulators, payers, and patient organizations through its Governing Committee, Test-Case collaborations, Network Collaborator arrangements, and the NEST Mark program. Pricing is not publicly disclosed; the organization operates without external equity investors or venture capital. Its go-to-market is community-led and event-driven, with engagement structured through open calls for Test-Case concepts, governance participation, industry conferences (ISPOR), NEST Forum and RWE Forum events, and content marketing via NESTcc.org, blog/news, video, LinkedIn, and a subscriber newsletter.

Name

NEST

Legal name

National Evaluation System for health Technology Coordinating Center

Website

https://nestcc.org

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

NESTcc is a nonprofit coordinating center operating a federated data network of 12+ healthcare organizations covering 494M+ patient records to generate real-world evidence for medical device regulatory submissions and post-market surveillance, serving manufacturers, health systems, regulators, and payers.

Ownership category

akta.pro rank

Product category

Medical Device Real-World Evidence Coordination

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industry

De-identification, Tokenization & Privacy-Preserving Data Platforms (HLACAIAK)

Keywords

• Medical device real-world evidence
• Real-world evidence generation
• Post-market surveillance
• Regulatory science services
• Clinical data network

Headquarters

HQ city

Arlington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. FDA Funding (MDUFA): In 2016, the FDA awarded MDIC $3 million in seed funding to establish NESTcc. Funding was granted through MDUFA (Medical Device User Fee Amendments) for an initial five-year investment period. NEST is actively pursuing sustainability planning to develop funding mechanisms beyond the initial FDA investment.
2. Test-Case Collaborations: NEST facilitates collaborative research projects (Test-Cases) between Network Collaborators and industry partners to generate real-world evidence for medical device evaluation. These structured engagements involve medical device manufacturers, health systems, government organizations, and non-profit patient organizations.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

NEST (NESTcc) operates as a coordinating center that facilitates the generation and use of real-world evidence (RWE) for medical device evaluation across the total product life cycle. It curates a federated data network of 12+ health system collaborators with access to over 494 million patient records, runs collaborative research Test-Cases and Demonstration Projects with medical device manufacturers, and provides the NEST Mark program to guide fit-for-purpose study design and execution aligned to FDA regulatory standards. The organization also develops and disseminates Research Methods, Data Quality Frameworks, and active surveillance capabilities to support regulatory decision-making.

Product overview

NEST (National Evaluation System for health Technology Coordinating Center) is a coordinating center that operates as a platform for real-world evidence (RWE) generation and utilization in medical device evaluation. The core offerings include NEST Mark (a collaborative program for regulatory-grade RWE studies), the NEST RWE Marketplace, Test-Cases (research projects demonstrating RWE feasibility), Demonstration Projects, and the NESTcc Data Network (a federated network of 12+ collaborators with access to 494+ million patient records). Supporting capabilities include Research Methods and Data Quality Frameworks, Data Quality Maturity Model Self-Assessment Tools, UDI Center/Playbook, and an Active Surveillance Program. The NEST Mark process enables companies to evaluate real-world data quality and proceed to studies with confidence for FDA regulatory submissions.

Differentiator

Problem solved

Functional benefit

Products and services

• NEST Mark A collaborative program guiding the design and execution of real-world evidence studies for medical devices; helps industry partners evaluate real-world data sources and proceed to fit-for-purpose studies aligned with FDA regulatory standards.
• NEST RWE Marketplace Marketplace connecting medical device ecosystem stakeholders with high-quality real-world data sources and RWE capabilities within the NEST network.
• Test-Cases Collaborative research projects exploring how medical device ecosystem stakeholders can use real-world data to generate high-quality evidence for device evaluation; portfolio spans 21 projects across 10 disease areas and 5 Total Product Life Cycle stages.
• NESTcc Data Network (Research Network) Federated data network of 12+ Network Collaborators with access to over 494 million patient records from EHRs, claims, registries, and patient-generated health data sources.
• Demonstration Projects Projects demonstrating the feasibility and value of generating real-world evidence for clinical studies across the total product life cycle.
• Research Methods and Data Quality Frameworks Frameworks developed by NESTcc Data Quality and Methods Subcommittees providing clear guidance for ensuring rigor and reliability of real-world evidence used in regulatory decisions; updated versions released incorporating insights from early NEST Mark implementations.
• Active Surveillance Program Cloud-based federated learning environment for safety signal refinement and signal detection using real-world data via a planned data network, enabling proactive post-market safety monitoring of medical devices.

Quantifiable outcome

• NEST Mark helped Intuitive Surgical achieve FDA clearance of revised da Vinci Xi and X labeling on radical prostatectomy using real-world evidence
• +2 more outcomes

Named customers8 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

21 partnerships are on record, tiered core and secondary.

• Duke University Health SystemcoreTechnology or Integration · 1 January 2018Network Collaborator with research network spanning 195+ hospitals and 3,942+ outpatient clinics. Adrian Hernandez, MD, MHS serves as Vice Chair of NEST Governing Committee.
• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development Partner · 1 January 2016FDA awarded MDIC $3 million in seed funding in 2016 to establish NESTcc. FDA CDRH participates as member of NEST Collaborative Community - one of the first collaborative communities with FDA participation. FDA Commissioner Gottlieb noted NEST's important role in supporting the Agency's Digital Health Innovation Plan.
• Medical Device Innovation Consortium (MDIC)coreStrategic or Co-development Partner · 1 January 2012MDIC is the parent organization of NESTcc. Founded in 2012 as a nonprofit, public-private partnership to elevate regulatory science. MDIC leads in advancing scientific and technical foundations of medical device design, manufacturing, regulation, reimbursement and clinical integration.
• Mayo CliniccoreTechnology or IntegrationNetwork Collaborator participating in Test-Cases including cardiac ablation catheter evaluation. Represents major academic medical center with extensive real-world data capabilities.
• Mercy HealthcoreTechnology or IntegrationNetwork Collaborator participating in Test-Cases including cardiac ablation catheter evaluation with Mercy, Mayo Clinic, and Yale-New Haven Hospital.
• Vanderbilt University Medical CentercoreTechnology or IntegrationNetwork Collaborator contributing to NEST research network capabilities. Vanderbilt's Brad Malin serves on Active Surveillance Task Force.
• Yale School of Medicine / Yale-New Haven Health SystemcoreTechnology or IntegrationNetwork Collaborator participating in Test-Cases. Harlan Krumholz, MD serves on Active Surveillance Task Force. Mark Fellman represented FDA in discussing RWE for cardiac devices.
• MDEpiNet (Medical Device Epidemiology Network)coreTechnology or IntegrationNetwork Collaborator bringing device epidemiology expertise. Partnership includes VISION (Vascular Implant and Interventional Outcomes Network) demonstration project with Society for Vascular Surgery PSO and FDA.
• Lahey Hospital & Medical CentercoreTechnology or IntegrationNetwork Collaborator with 6 hospitals, 75 clinics, 3.4M patient population. Frederic Resnic, MD serves on Active Surveillance Task Force. Collaborated with Johnson & Johnson on lumbar interbody system post-market surveillance.
• HealthCore / Carelon ResearchcoreTechnology or IntegrationNetwork Collaborator. Kevin Haynes, PharmD serves on Active Surveillance Task Force. Sandra Siami joined NESTcc SVP from HealthCore where she led Clinical Research, Regulatory Affairs, and Quality Assurance.
• PEDSnetcoreTechnology or IntegrationNetwork Collaborator focused on pediatric data network bringing pediatric population real-world data capabilities to NEST.
• OneFloridacoreTechnology or IntegrationNetwork Collaborator bringing state-level health data infrastructure and research capabilities to NEST network.
• STAR CRNcoreTechnology or IntegrationNetwork Collaborator (Stakeholders Technology and Research - Clinical Research Network) contributing real-world data research capabilities.
• Regenstrief InstitutecoreTechnology or IntegrationJoined January 2021. Global leader in biomedical informatics, health services research, and improving health and healthcare. Brings expertise in clinical informatics and health data standards.
• MedStar HealthcoreTechnology or IntegrationJoined April 2021. Largest health provider in D.C. region expanding NEST research expertise and data capabilities with access to 4.2 million unique patients across MedStar facilities.
• CVS Health Clinical Trial ServicescoreTechnology or IntegrationNetwork Collaborator bringing pharmacy and retail health data capabilities to the NEST network.
• Johnson & JohnsoncoreStrategic or Co-development PartnerMichelle McMurry-Heath, MD PhD served as Governing Committee Chair and represents Johnson & Johnson and AdvaMed. Collaborated on cardiac ablation catheter Test-Case with Network Collaborators. Test-Case explored feasibility of RWD for label expansion supporting treatment of persistent atrial fibrillation.
• Intuitive SurgicalcoreStrategic or Co-development PartnerPartnered with NEST Mark for FDA clearance of revised da Vinci Xi and X labeling on radical prostatectomy. NEST Mark process demonstrated utility of RWE collaboration for regulatory science advancement.
• HologicsecondaryStrategic or Co-development PartnerJoined NEST Governance Committee in June 2025 to advance RWD use in medical device evaluation, bringing women's health expertise.
• Boston ScientificsecondaryStrategic or Co-development PartnerJoined NEST Governance Committee in October 2025 as newest member representing leading global medical device company perspective.
• BaxtersecondaryStrategic or Co-development PartnerDonielle Johnson, Global Head of Regulatory Affairs for Baxter's Advanced Surgery business, represents Baxter on NEST governance team.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• MDEpiNet (Medical Device Epidemiology Network): MDEpiNet is a Network Collaborator of NESTcc and operates as a parallel medical device epidemiology research network funded by the FDA. It shares the same mission of advancing RWE for medical devices and is directly comparable in scope and stakeholder composition.
• Flatiron Health: Flatiron Health is a real-world evidence company focused on oncology, providing EHR-derived data and analytics for regulatory-grade research. It is comparable to NESTcc as a coordinated RWE platform serving life sciences companies, although Flatiron is oncology-focused and for-profit while NESTcc spans multiple disease areas as a nonprofit.
• Aetion: Aetion is a real-world evidence analytics platform specifically designed to support regulatory-grade submissions and has FDA-aligned evidence frameworks. It is comparable to NESTcc's NEST Mark offering in purpose, though Aetion operates as a commercial SaaS platform rather than a coordinating center.

Broad incumbents

• Veradigm (formerly Allscripts): Veradigm operates large-scale real-world data assets from EHR networks used for clinical research and post-market surveillance. It provides comparable data infrastructure to NESTcc's Network Collaborator model, particularly for ambulatory and outpatient settings.
• Medidata Solutions (Dassault Systèmes): Medidata provides clinical trial technology and real-world data platforms used by life sciences companies, including for regulatory submissions. It is comparable to NESTcc as a technology-enabled evidence generation platform serving the medical device ecosystem.
• IQVIA: IQVIA is the largest life sciences RWE and clinical research services provider, operating proprietary data networks, analytics platforms, and consulting. It competes with NESTcc in the broader RWE-for-regulatory-submissions market with greater scale and commercial infrastructure.
• Medical Device Innovation Consortium (MDIC): MDIC is the parent organization of NESTcc and operates as the broader nonprofit public-private partnership for medical device regulatory science. While NESTcc is a focused coordinating center for RWE, MDIC spans the full medical device innovation lifecycle and shares overlapping governance, funding, and stakeholder relationships.
• Optum (UnitedHealth Group): Optum operates one of the largest commercial real-world data and research services businesses, integrating claims, EHR, and pharmacy data. It competes with NESTcc in providing RWE to life sciences manufacturers for regulatory and commercial decisions, though at much greater commercial scale.

Emerging players

• Clinerion: Clinerion operates a federated real-world data network of hospital systems for clinical research and post-market surveillance. It is comparable to NESTcc's federated Network Collaborator model, particularly for medical device evaluation across international health systems.
• Trinity Life Sciences: Trinity Life Sciences provides real-world evidence, evidence strategy, and medical affairs services to life sciences companies. It is comparable to NESTcc in serving manufacturers' need for regulatory-grade evidence, though operating as a commercial consulting/services firm.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/nest-cc
• Xx.com/NESTccMedTech

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NEST