NESTcc identifies and selects key demonstration projects to provide proof of concept for scalable approaches to evidence generation across device types and across the total product life cycle. 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 both Demonstration Projects and their impact for NESTcc below. Please contact us with questions about these Demonstration Projects.

  • Developing and Implementing Sustainable Real-World Evidence (RWE) Infrastructure for In Vitro Diagnostics (IVDs) Through Systemic Harmonization and Interoperability for Enhancement of Laboratory Data (SHIELD)
  • Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION)
  • Feasibility Study to Evaluate the use of mHealth as Data Source in Post-Market Surveillance
  • ICD Registry DELTA Active Surveillance Pilot Study
  • Lung-RADS Assist: Artificial Intelligence Model Verification, Reporting, and Monitoring
  • Post-Market Medical Device Surveillance With a Novel mHealth Platform
  • Registry Assessment of Peripheral Interventional Devices (RAPID) ‐ Superficial Femoral and Popliteal Evidence Development (SPEED) as First Device Evaluation Project
  • SAFE STEMI for Seniors: An International CRN-Based Prospective Randomized IDE Study of Labelling for Diagnostic and Therapeutic Devices Used in Seniors Suffering Heart Attack
  • Use of EHR-Based Data Network to Support Evidence Generation Across the Total Product Life Cycle (TPLC)
  • Use of Linked Implantable Device/Medicare Data to Assess Association Between Device Diagnostics and Patient Outcomes
  • Vascular Implant Surveillance and Interventional Outcomes Network (VISION)

Developing and Implementing Sustainable Real-World Evidence (RWE) Infrastructure for In Vitro Diagnostics (IVDs) Through Systemic Harmonization and Interoperability for Enhancement of Laboratory Data (SHIELD)

Overview: A harmonization and mapping of in vitro diagnostic (IVD) related codes to create infrastructure to support IVDs for future pre-and post-market needs, this project includes pilots planned in antimicrobial susceptibility/resistance, opioid screening and confirmatory testing, testing for acute kidney injury, and diagnosis of sepsis.

Impact for NESTcc: This project could assist in the mapping of relevant codes to improve interoperability of information related to IVDs.

Organization(s): The U.S. Food and Drug Administration (FDA)

Collaborators Include: 5 government offices, 7 IVD manufacturers, 5 healthcare systems, and 10 professional organizations and standards developers

Principal Investigator(s): Michael S. Waters, PhD (FDA)

Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION)

Overview: The Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) aims to develop a sustainable mechanism to collect long-term performance across the Total Product Life Cycle (TPLC) of new and substantially modified cardiovascular devices (particularly pacing and defibrillation leads). EP PASSION is a demonstration project for new and substantially modified pacing and defibrillation leads that leverages extant data including potential use of administrative claims, electronic health records, available registries, and remote monitoring and periodic patient contact.

Impact for NESTcc: The use of Real-World Data (RWD) seeks to capture a larger, more representative assessment of device performance while increasing efficiency and lowering cost. It is the aim of the effort to reduce the time and cost of generating the types of evidence used to support the marketing authorization of FDA regulated products and to meet post-market study reporting requirements. The project will transition long-term direct patient follow-up assessment in post-approval studies (PAS) toward a Real-World Evidence (RWE) approach by potential use of administrative claims, electronic health records, available registries, and remote monitoring and periodic patient contact.

Organization(s): Abbott; American College Cardiology (ACC); BIOTRONIK, Inc.; Boston Scientific; Duke; Heart Rhythm Society (HRS); LivaNova (Sorin); Medtronic; U.S. Food and Drug Administration (FDA); Yale

Principal Investigator(s): Heidi Hinrichs, MS (Abbott); Kevin Mitchell (BIOTRONIK, Inc.); Rich Dujmovic, MSEM (Boston Scientific); Darrell Johnson, MBA (Medtronic); David Slotwiner, MD (Heart Rhythm Society)

Feasibility Study to Evaluate the use of mHealth as Data Source in Post-Market Surveillance

Overview: This project will compare the quality and reliability of data acquired via the mHealth app (Hugo) to data acquired in an industry-owned post-market surveillance registry, Medtronic’s Product Surveillance Registry (PSR). This study is enrolling 30 patients from Yale New Haven hospital who are also registered in Medtronic’s PSR.

Impact for NESTcc: The systematic process used to test and validate the mHealth app and validate its feasibility of use will provide insight and produce a framework for future use of mHealth apps in the post-market setting. Learnings will be extendable to pre-market evidence generation use-cases in the future.

Organization(s): Medtronic, Yale University, Me2Health

Principal Investigator(s): Rachael Lampert, MD (Yale)

ICD Registry DELTA Active Surveillance Pilot Study

Overview: The Data Extraction and Longitudinal Trend Analysis (DELTA) surveillance system was developed to monitor ongoing clinical datasets to detect emerging differences in safety or efficacy of medical devices. This project is an observational study that assesses the validity of DELTA surveillance in monitoring high-energy implantable cardiac defibrillator (ICD) leads and utilizes the propensity-matched survival method applied dynamically to the National Cardiovascular Data Registry (NCDR) ICD Registry.

Impact for NESTcc: This project would validate time-dependent adverse event surveillance projects with possible alternatives to post-approval studies.

Organization(s): American College of Cardiology (ACC), Center for Devices and Radiological Health (CDRH), Lahey Hospital and Medical Center (Tufts University School of Medicine), NCDR ICD Registry

Principal Investigator(s): Frederic S. Resnic, MD (Lahey Hospital and Medical Center)

Lung-RADS Assist: Artificial Intelligence Model Verification, Reporting, and Monitoring

Overview: The American College of Radiology Lung CT Screening Reporting and Data System (Lung-RADS) is designed to standardize lung cancer screening and provide management recommendations. The Lung Cancer Screening Registry (LCSR) allows data to be captured for quality reporting as required by CMS for lung cancer screening payment. Designed as an artificial intelligence (AI) validation study and artificial intelligence surveillance model, this project evaluates pre-market model validation and post-market model performance for an artificial intelligence algorithm used for lung cancer screening.

Specific aims include the following:

    1. Utilize existing ACR technology to demonstrate the ability to collect validation data and perform local algorithm testing prior to market approval.
    2. Utilize existing ACR technology to facilitate interoperability between reporting and AI vendors to generate standardized data in a real world setting.
    3. Capture validation data and real world events in a national registry to enable both facility-level and cross-facility reporting.

 

Impact for NESTcc: The project allows for the testing and validation of an artificial intelligence algorithm. It will provide learnings that will be scalable to other disease areas. It will include the capture of performance metrics within a national registry linking both AI model validation and AI model surveillance, providing real world evidence to measure safety and effectiveness.

Organization(s): American College of Radiology

  • Implementation Sites include: Brigham & Women’s, Massachusetts General Hospital
  • Radiology Workflow Companies include: GE Healthcare, Nuance
  • Algorithm Vendors include: Aidence, Enlitic, Infervision, Mindshare Medical

 

Principal Investigator(s): Keith Dreyer, DO, PhD (Massachusetts General Hospital)

Post-Market Medical Device Surveillance With a Novel mHealth Platform

Overview: The project will test the feasibility of using a mHealth app for post-market surveillance in patients (1) after sleeve gastrectomy and (2) after catheter-based atrial fibrillation ablation. Outcomes collected will include enrollment times, patient participation, dropout, completion of patient-reported outcome measure queries, and user satisfaction and burden. This study is enrolling 60 patients at Yale New Haven Hospital and Mayo Clinic.

Impact for NESTcc: The systematic process used to test and validate the mHealth app and assess its feasibility of use will provide insight and produce a framework for future use of mHealth apps in the post-market setting. Learnings will be extendable to pre-market evidence generation use-cases in the future.

Organization(s): Johnson & Johnson, U.S. Food and Drug Administration (FDA), Me2Health, Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI)

Principal Investigator(s): Joseph Ross, MD, MHS (Yale); Nilay Shah, PhD (Mayo)

Registry Assessment of Peripheral Interventional Devices (RAPID) ‐ Superficial Femoral and Popliteal Evidence Development (SPEED) as First Device Evaluation Project

Overview: Registry Assessment of Peripheral Interventional Devices (RAPID) is a program that developed a global case report form that will allow for total product life cycle (TPLC) regulatory decisions. Under the RAPID program we aim to run a series of projects and studies (i.e. SPEED). The SPEED project is the first project under the RAPID program and it was designed to develop objective performance criteria (OPC) for devices used for the treatment of peripheral arterial disease (PAD) with the aim to support and likely accelerate label expansions of Peripheral Vascular Intervention (PVI) devices. More information about RAPID is available on the Journal of Vascular Surgery (JVS) or J-STAGE website.

Impact for NESTcc: Use of Real-World Data (RWD) to develop Objective Performance Criteria (OPCs) which once available could accelerate regulatory decisions for PVI Devices.

Organization(s): MDEpiNet Executive Operations Committee;

Over 36 organizations including 3 registries/societies, 7 federal agencies, 12 device manufacturers, and 16 other related companies/organizations (A list of partnering organizations can be found under ‘Phase I’)

Principal Investigator(s): Jose Pablo Morales, MD (U.S. Food and Drug Administration), Jack Cronenwett, MD (Society for Vascular Surgery), Robert Thatcher, MBA (4C Medical Technologies)

SAFE STEMI for Seniors: An International CRN-Based Prospective Randomized IDE Study of Labelling for Diagnostic and Therapeutic Devices Used in Seniors Suffering Heart Attack

Overview: This is a prospective randomized investigational device exemption (IDE) study for regulatory labelling of two devices, instantaneous flow reserve (IFR) diagnostic wires and therapeutic drug eluting stents in seniors undergoing urgent radial percutaneous coronary intervention (PCI) for ST-Elevation Myocardial Infarction (STEMI). Electronic data capture leverages international compatibility with the cardiac catheterization/percutaneous coronary intervention (NCDR CathPCI) registry and Medicare Claims data, including potential to auto-populate case report forms from registry and Claims sources.

Impact for NESTcc: Prospective randomized study using Real-World Data (RWD) for acute and follow-up “coordinated registry network” or CRN efficiencies in an IDE study.

Organization(s): Duke University/Duke Clinical Research Institute (DCRI); Center for Devices and Radiological Health (CDRH); Harvard University Quantitative Angiographic Core Laboratory; MDEpiNet Predictable and Sustainable Implementation of the National registries (PASSION) Cardiovascular Programs; Medtronic; National Cardiovascular Data Registry (NCDR); Terumo; The Center for Medicare and Medicaid Services (CMS); Volcano/Philips

Principal Investigator(s): David F. Kong, MD (DCRI); Roseann White, MA (DCRI); Mitchell W. Krucoff, MD (DCRI)

Use of EHR-Based Data Network to Support Evidence Generation Across the Total Product Life Cycle (TPLC)

Overview: A collaboration between a medical device manufacturer and a large hospital health system, this project aims to develop, test, and validate the use of an electronic health record (EHR)-based data network to support evidence generation for medical devices across the total product life cycle (TPLC). A test case involves retrospectively extracting longitudinal data for all heart failure patients across the health system, some of whom will have received Chronic Resynchronization Therapy (CRT).

Impact for NESTcc: The systematic process deployed to validate and test the pathways for evidence generation is producing a scalable model to inform an industry-wide roadmap toward the use of EHR-based data networks for the responsible access and use of practice data, in both the pre-market and post-market space. While the test case is in the post-market space, the infrastructure and learnings will be used to inform future applications in the pre-market environment.

Organization(s): Medtronic, Mercy

Principal Investigator(s): Darrell Johnson, MBA (Medtronic); Joseph Drozda, MD (Mercy)

Use of Linked Implantable Device/Medicare Data to Assess Association Between Device Diagnostics and Patient Outcomes

Overview: This retrospective observational study examines label expansions and post-market assessments of implantable cardioverter defibrillators and pacemakers. The project has two distinct aims. First, the project aims to demonstrate the feasibility of linking Abbott implantable cardioverter defibrillator (ICD) and pacemaker remote monitoring (Merlin.netTM) data with The Center for Medicare and Medicaid Services (CMS) Medicare data. Second, the project will assess the association between stored device diagnostics and clinical and economic outcomes.

Impact for NESTcc: The use of the link between remote-monitoring data with CMS Medicare data will explore association between stored device diagnostics and clinical and economic outcomes, which will lead to the novel exploration of linkages of device-generated data with claims data to support clinical evidence generation.

Organization(s): Abbott, Department of Population Health, Duke Center for Arrhythmia Research & Treatment Innovation, Duke University/Duke Clinical Research Institute (DCRI)

Principal Investigator(s): Brett Atwater, MD (Duke) and Jonathan Piccini, MD (Duke)

Vascular Implant Surveillance and Interventional Outcomes Network (VISION)

Overview: VISION is an observational study that observes post-market reporting and post-market surveillance in patients over the age of 65 who utilize vascular devices such as those used for endovascular abdominal aortic aneurysm repair. VISION matches procedures in the Society for Vascular Surgery Patient Safety Organization (SVS-PSO) registry – more than 400,000 to date – with Medicare claims and New York State Registry data (SPARCS). VISION has two aims from these results: a) to expand VISION by introducing under-65 all-payer populations, and b) validating against trials for a novel, inexpensive path to real-world evidence.

Impact for NESTcc: The use of Real-World Data (RWD) through Registry and Medicare Claims Data will increase efficiency, validity, and cost of device surveillance.

Organization(s): Society for Vascular Surgery Patient Safety Organization, U.S. Food and Drug Administration (FDA), Weill Cornell Medical Center

Principal Investigator(s): Philip Goodney, MD, MS and Art Sedrakyan, MD, PhD for the Society for Vascular Surgery Patient Safety Organization (SVS-PSO)