The National Evaluation System for health Technology Coordinating Center (NESTcc) Announces New Real-World Evidence Test-Cases Solicited from Across the Medical Device Community

National Evaluation System for health Technology Coordinating Center
, 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
, 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:




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  


  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;
  Cardiology   Apple Watch Diagnostic + mHealth  


• 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


  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  


• Research Dataset

  Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in
Surveillance   Stress Urinary Incontinence   Urinary Mesh Software mHealth  


• Registry

  Creation of a Patient-facing Mobile App for the SUI Surgery Registry
Module within AQUIRE
Surveillance; Coverage   Mental Health   mHealth for Insomnia  




  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



  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:

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

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

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.


Leah McConnell
[email protected]
1 202-900-9099

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