Overview

In November 2018, NESTcc announced 8 Test-Case projects that reflect the diversity of types of medical devices available and the different uses of data in pre-market and post-market settings. In November 2019, 12 additional Test-Cases were announced.

NESTcc’s 20 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). Test-Case concepts were solicited from stakeholders across the ecosystem, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers.

  • Objective 1

    Explore the feasibility for medical device ecosystem stakeholders to work Real-World Data (RWD) sources and NESTcc’s initial set of Network Collaborators.

  • Objective 2

    Help identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies).

Partners

NESTcc Test-Cases are being executed through collaborations with the following organizations from the medical device ecosystem:

Abbott DiagnosticsAdhesys MedicalAmerican Sleep Apnea Association (ASAA)AventaMedBecton Dickinson (BD)
Cook MedicalIntrinsic TherapeuticsJohnson & Johnson Medical Devices CompaniesMedtronicPear Therapeutics
U.S. Food and Drug Administration (FDA)W.L. Gore & Associates, Inc.The Women’s Health Technology Coordinated Registry Network (WH-CRN)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 for a Test-Case that brings together DJO Global, DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet, NESTcc Network Collaborators, and the American Joint Replacement Registry (AJRR), which is housed at AAOS.

Test-Case Snapshots

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All 20

TPLC

Data Source

Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia and Depression

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

Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in Women

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

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

Pediatric Clinical and Health Services Outcomes following Tympanostomy Tube Insertion

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

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

Effect of Wearable Devices on Patient-Reported Outcomes and Clinical Utilization: A Randomized, Controlled Trial

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

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

Comparative Effectiveness of Alternative Approaches for Wound Closure

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

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

Data Source Definitions

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.

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.

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).

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.

Follow us @NESTccMedTech

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: bit.ly/2RM654T pic.twitter.com/tvpzCJd35v 13 hours ago

Sandra Siami, a leader in corporate management, clinical and #RWE research, and strategy and business development, has joined MDIC as SVP of NESTcc. Learn more about @FSSiami: bit.ly/3gGPUAL pic.twitter.com/BSNV8vG7in 2 days ago

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