ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ability to generate high-quality RWE for a range of medical devices through the NESTcc Data Network.
“These twelve projects constitute an exciting and diverse portfolio that tests the capabilities of NESTcc’s Data Network in pre-market and postmarket settings and complements the projects selected in the initial round in 2018,” according to NESTcc’s executive director, Rachael Fleurence, PhD. She notes that, “This set of projects includes a number of firsts for NESTcc, including the first prospective research projects that will utilize patient-generated health data (PGD), the first active surveillance project exploring the safety of synthetic mesh slings, and the first question submitted from a patient advocacy organization.”
In this round of Test-Cases, NESTcc has selected projects that reflect the diversity of types of medical devices available and the different uses of data in pre-market and postmarket settings. Research questions were solicited through a call for both Broad (non-PGD) and Targeted PGD submissions posted in July 2018.
Overall NESTcc received 40 concept submissions (25 Broad and 15 Targeted PGD) from 26 different organizations including health systems, government entities, medical device manufacturers, non-profits including patient advocacy organizations, and academic institutions. This marked a nearly four-fold increase in the number of concepts submitted in the initial round, which were awarded in October 2018. The Test-Cases will be executed through collaborations between NESTcc’s Network Collaborators and the organizations that submitted the concepts for project development. These include the medical device manufacturers Abbott Diagnostics, AventaMed, Becton Dickinson (BD), Cook Medical, Intrinsic Therapeutics, Medtronic, and Pear Therapeutics, as well as the U.S. Food and Drug Administration (FDA), the Women’s Health Technology Coordinated Registry Network (WH-CRN), Yale-New Haven Health Center for Outcomes Research and Evaluation (CORE), and the American Sleep Apnea Association (ASAA).
The new Test-Cases span the medical device total product lifecycle (TPLC) and include projects that have regulatory (i.e., pre-market and postmarket pathways) and coverage applications. NESTcc Network Collaborators will contribute to the execution of the projects by leveraging multiple data sources – device registries, electronic health records (EHR), claims, mHealth, PGD, and Patient Reported Outcomes (PRO).
“As part of ongoing efforts to modernize our approach to device safety, the FDA is striving to meet an important and aggressive goal that we set for ourselves: Ensuring that the agency is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health and a board member of MDIC. “These new test cases help show the potential for NEST to help reach the goal of systematically using real-world data to enable the efficient development of new, innovative medical devices and rapidly identify and address safety signals in a postmarket setting to keep patients safe.”
The Test-Cases will address the following disease areas and technologies of interest:
|
TOTAL-PRODUCT |
DISEASE AREA |
TECHNOLOGY OF |
DATA SOURCES | PROJECT TITLE | ||||
| Pre-Market Submission | Oncology | Lung Cancer Diagnostic |
• Chart Review • Electronic Health Records (EHR) |
Estimating and validating diagnostic cancer biomarker IVD test panel characteristics and clinical utility for indeterminant pulmonary nodule risk stratification in patients with lung cancer | ||||
| Pre-Market Submission | Cardiovascular | Electrode Renal Denervation System |
• EHR |
Use of Real-World Evidence to Characterize Patients with Uncontrolled Hypertension | ||||
| Pre-Market Submission; Label Expansion | Cardiovascular | Cardiovascular Device |
• Claims |
Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease | ||||
| Pre-Market Submission; Postmarket | Orthopedics | Annular Closure Device |
• Claims |
RWE Analysis for Pre-Market and Post Approval Studies of Annular Closure Device | ||||
| Pre-Market Submission; Surveillance | Orthopedics | Objective Performance Criteria (OPC) for Knee and Hip Implants |
• Claims • Registry |
Developing Objective Performance Criteria (OPC) for Outcomes after Hip and Knee Replacement | ||||
| Pre-Market Submission; Label Expansion; Postmarket; Surveillance; Coverage | Cardiology | Apple Watch Diagnostic + mHealth |
• EHR • Patient-Generated health Data (PGD) • Patient-Reported Outcome Measures (PROMs) |
Effect of the Apple Watch ECG and Irregular Rhythm Notification Detection Features on Patient-Reported Outcomes and Clinical Utilization: A Randomized, Controlled Trial | ||||
| Pre-Market Submission | Ear, Nose, and Throat | Ear Tubes |
• Claims • EHR |
Pediatric Clinical and Health Services Outcomes following Tympanostomy Tube Insertion | ||||
| Postmarket; Surveillance | Cardiovascular | Cardiac Device Leads |
• CMS Claims • FDA MAUDE Database • Manufacturer Device Failure Data |
Assessment of the Value of Electronic Health Records Data for Identifying Implantable Cardiac Lead Failures | ||||
| Surveillance | Stress Urinary Incontinence | Synthetic Mesh Sling |
• EHR • Research Dataset |
Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in Women | ||||
| Surveillance | Stress Urinary Incontinence | Urinary Mesh Software mHealth |
• PGD • Registry |
Creation of a Patient-facing Mobile App for the SUI Surgery Registry Module within AQUIRE | ||||
| Surveillance; Coverage | Mental Health | mHealth for Insomnia |
• EHR • PGD • PROMs |
Use of Real-World Data to Evaluate Clinical and Patient Outcomes by Use of a Mobile App for the Treatment of Insomnia and Depression | ||||
| Coverage | Respiratory | Positive Air Pressure, PAP Therapy |
• Claims • EHR • PGD |
Structured interviews of Lived ExperiencE in Patients (SLEEP study) Obstructive Sleep Apnea and Central Sleep Apnea |
For a description of each Test-Case, please visit: https://nestcc.org/test-cases/
About the National Evaluation System for health Technology Coordinating Center
In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The Coordinating Center seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using Real-World Data (RWD) that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making. For more information, visit http://nestcc.org.
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.
Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (1 U01 FD 006292-01). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
