In June 2019, NESTcc announced twelve new Real-World Evidence (RWE) Test-Cases that reflect the diversity of types of medical devices available and the different uses of data in pre-market and post-market settings, in addition to the eight initial Test-Cases announced in November 2018.

NESTcc Test-Cases will address two primary objectives.  First, they will explore the feasibility for medical device ecosystem stakeholders to work Real-World Data (RWD) sources and NESTcc’s initial set of Network Collaborators.  Second, the Test-Cases will help identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies).

Test-Case concepts were solicited from stakeholders across the ecosystem, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers.  The projects below will be executed through collaborations with Abbott Diagnostics, Adhesys Medical, AventaMed, Becton Dickinson (BD), Cook Medical, Intrinsic Therapeutics, Johnson & Johnson Medical Devices Companies, Medtronic, Pear Therapeutics, and W.L. Gore & Associates, Inc. as industry partners, as well as the American Sleep Apnea Association (ASAA), U.S. Food and Drug Administration (FDA), the Women’s Health Technology Coordinated Registry Network (WH-CRN), and Yale-New Haven Health Center for Outcomes Research and Evaluation (CORE).

In addition to these groups working through independent collaborations, the American Academy of Orthopaedic Surgeons (AAOS) is serving as a neutral convener, bringing together DJO Global, DePuy Synthes, Smith & Nephew, Stryker, and Zimmer Biomet for a Test-Case that will bring together NESTcc Network Collaborators with the American Joint Replacement Registry (AJRR) which is housed at AAOS.

NESTcc’s twenty Test-Cases include projects along the 510(k) and premarket approval regulatory pathways, across nine disease areas, and throughout the medical device Total Product Life Cycle (TPLC).

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Data Source

NEW ADDITION: Use of Real-World Data to Evaluate Clinical and Patient Outcomes by Use of a Prescription Digital Therapeutic (delivered via mobile app) for the Treatment of Insomnia and Depression

NEW ADDITION: Use of Real-World Evidence to Characterize Patients with Uncontrolled Hypertension

The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters

Testing the Use of Real-World Data from Three Unique Sources to Expand Indications

Testing the Feasibility of Registry and Claims Data Linkages

NEW ADDITION: Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in Women

NEW ADDITION: Structured interviews of Lived ExperiencE in Patients (SLEEP study) Obstructive Sleep Apnea and Central Sleep Apnea

NEW ADDITION: RWE Analysis for Pre-Market and Post Approval Studies of Annular Closure Device

Real-World Clinical Outcomes in Patients with Mechanical Heart Valve Replacement and Anticoagulation Variability

NEW ADDITION: Pediatric Clinical and Health Services Outcomes following Tympanostomy Tube Insertion

Feasibility of Using Real-World Data to Evaluate Thermal Ablation of Liver Tumors

NEW ADDITION: Estimating and Validating Diagnostic Cancer Biomarker IVD Test Panel Characteristics and Clinical Utility for Indeterminant Pulmonary Nodule Risk Stratification in Patients with Lung Cancer

NEW ADDITION: Effect of the Apple Watch ECG and Irregular Rhythm Notification Detection Features on Patient-Reported Outcomes and Clinical Utilization: A Randomized, Controlled Trial

NEW ADDITION: Developing Objective Performance Criteria (OPC) for Outcomes after Hip and Knee Replacement

Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data

Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data

NEW ADDITION: Creation of a Patient-facing Mobile App for an SUI Surgery Registry

Comparative Effectiveness of Alternative Approaches for Wound Closure

NEW ADDITION: Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease

NEW ADDITION: Assessment of the Value of Electronic Health Records Data for Identifying Implantable Cardiac Lead Failures

Data Source Definitions

Claims

Encounter data from a range of healthcare sites (inpatient hospital, outpatient hospital, emergency room, physician’s office, surgery center, etc.) describing diagnoses, treatments, and billed and paid amounts for reimbursement purposes.

Electronic Health Records (EHR)

Patient data entered by healthcare providers in a range of healthcare delivery settings for routine care purposes. This data may include, but is not limited to, patient demographics, past medical history, prescribed medications, immunizations, physical examination and vital signs, diagnoses, laboratory and imaging data, procedure data, and healthcare provider notes.

Registry

An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).

Patient-Generated health Data (PGD)

Data that is generally captured outside of the clinical setting through patient reported outcomes (PRO), in-home or point-of-care monitoring devices, wearable technologies, fitness trackers, etc.

Demonstration Projects

NESTcc has identified and selected 11 key demonstration projects to provide proof of concept for scalable approaches to evidence generation across device types and across the total product life cycle. These early NESTcc Demonstration Projects are studies that contribute to the field of Real-World Evidence (RWE) within the medical device ecosystem. These projects range in size and scope but will:

  • Develop, verify, and operationalize methods of evidence generation and data use in the pre- and post-market space
  • Demonstrate scalability across healthcare systems, device types, and manufacturers
  • Demonstrate impact on patients by stimulating innovation in medical device innovation and decreasing the timeline for development and market launch
  • Inform NEST’s strategy as it builds out critical functions and processes for a future sustainable organization

Learn more about Demonstration Projects and their impact for NESTcc. Please contact us with questions about these Demonstration Projects.

Follow us @NESTccMedTech

At the MDEpiNet RAPID Phase III Pathways Meeting today, NESTcc Data Network Director @robbert_z presented an update on the current status of NESTcc as part of an expert panel. More: bit.ly/2uP1u9t pic.twitter.com/DaH4ylYjxh 4 days ago

We are hiring for a Business Development Manager to support NESTcc's growth and stakeholder engagement initiatives. Learn more about our open positions on the MDIC careers page: bit.ly/2Qy7k7T pic.twitter.com/dM6pIB4EF0 1 week ago

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