Quality evidence by design.

Established by the U.S. Food & Drug Administration (FDA), NESTcc is an independent coordinating center driving quality and efficiency in the use of real-world data (RWD) to inform medical device development and evaluation.

We support clinical, patient, regulatory, and reimbursement decisions throughout the total product life cycle (TPLC), delivering quality evidence by design.

Medical Devices

Why is NESTcc a research partner that is different?

  • We curate the right data sources and research expertise to meet your specific objectives – across device types, disease areas, and the TPLC

  • We ensure transparent, traceable RWD provenance, leading to actionable evidence for clinical, regulatory, or reimbursement decision-making

  • We create a safe harbor for effective, objective research as a neutral, non-profit organization informed by diverse stakeholders, including FDA

Comprehensive research experience based on quality data and trustworthy outcomes.

Recent Studies

 

NESTcc has developed real-world evidence (RWE) studies across 10 disease areas, all device classes, and all stages of the TPLC.

Our Research Network

 

To deliver reliable RWE from a total population of 136 million patients, we curate partnerships with leading research institutions.

Aligned with the needs of stakeholders across the medical device ecosystem.

NESTcc’s vision is to be the the leading organization within the medical device ecosystem for conducting trustworthy, high-quality, and efficient RWD research throughout the TPLC.

Our independence, superior data access coupled with clinical and analytical expertise from world-class research institutions, and oversight by FDA on our methods and data quality, mean we convert your research investment dollars into progress for your organization.

Click on the stakeholders to explore how we can help advance your goals with RWE.

Delivering studies designed for device evaluation throughout the total product life cycle.

  • Label Expansion

    Investigate indications for use to support regulatory, coverage, and clinical decisions.

  • Post-market Safety

    Determine more accurate device performance, survivorship, and outcomes.

  • Historical Control Group

    Provide a standard-of-care control group alongside a single-arm trial of a new device.

  • Objective Performance Criteria

    Scientifically develop OPC for use in pre-market and label change decisions.

  • Academic Research

    Obtain quality of care information for device selection and procedural outcomes.

  • Measures Creation and Validation

    Develop scientifically sound measures to promote quality device assessment.

  • Safety Assessments

    Evaluate suspected adverse events and investigate causation.

  • Digital Health Studies

    Assess the impact of digital tools on patient-reported outcomes and clinical utilization.

  • Patient Diversification

    Characterize device safety and effectiveness across a broader demographic population.

  • Patient Outcomes

    Characterize device performance regarding outcomes of interest for patients.

  • Device Comparison

    Analyze safety and effectiveness across devices on the market.

  • Custom Research

    Consult with our specialists for your custom research project.

  • SaMD Algorithm Development

    Coming soon

  • Active Surveillance

    Coming soon

A consultative approach that brings quality and efficiency to evidence.

We guide the design and execution of studies to deliver results that are fit for purpose. Our team works across our Research Network to assess databases and identify the partners best positioned to answer the question of interest. With a deep understanding of evidentiary requirements and a rigorous approach to data quality and methodologies, we provide expertise in project and data management to drive a successful study from initiation through completion.

Reach out to discuss your research needs