1. National Evaluation System for health Technologies Coordinating Center (NESTcc) Update
Rachael Fleurence, PhD
Executive Director, NESTcc
September 7, 2018

2. NESTcc’S ROLE IN THE ECOSYSTEM
NESTcc Mission Statement
To accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE), and innovative research.
The NESTcc Ecosystem
Regulators
Health Systems
Patient Groups
Clinician Groups
Payers
Industry
NESTcc
History of NESTcc
NEST envisioned as a voluntary data network of collaborators by Planning Board
2015
FDA awarded grant for NESTcc to Medical Device Innovation Consortium (MDIC)
2016
Executive Director of NESTcc named
2017
NESTcc Governing Committee selected
NESTcc Strategic and Operational Plan developed
Initial NESTcc Data Network formed and testing initiated
2018
NESTcc Data Quality and Methods Subcommittees formed

3. ESTABLISHING NESTcc GOVERNANCE
The NESTcc Governing Committee was formed in represents stakeholders across the medical device ecosystem.
Naomi Aronson
Adrian Hernandez
Jeffrey Shuren
Blue Cross Blue Shield Association (BCBSA)
Duke Clinical Research Institute (DCRI)
FDA, CDRH
Sharon Terry
Kathleen Blake
Harlan Krumholz
Genetic Alliance
American Medical Association (AMA)
Yale University
Diane Wurzburger – MITA Nominee
Elizabeth McGlynn
Mark Deem – MDMA Nominee
Kaiser Permanente
GE Healthcare
The Foundry, LLC
Michelle McMurry-Heath – AdvaMed Nominee
Marc Boutin
PAMELA GOLDBERG
National Health Council
Medical Device Innovation Consortium (MDIC)
Interim Governing Committee Chair
Tamara Syrek Jensen
Johnson & Johnson Medical Devices
Center for Clinical Standards and Quality, CMS
Bill Hanlon – ACLA Nominee
Vance Moore
LabCorp/Covance
Mercy Health
Trade Association Nominees

4. NESTcc DEVICE NETWORK KEY 2018 ACTIVITIES
Establish initial NESTcc Data Network with 12 Network Collaborators
Implement test-cases with manufacturers and NESTcc Network Collaborators
Work with stakeholders to establish data quality and methods standards as well as operating processes
Identify gaps in data infrastructure to support robust medical device studies and find solutions
Expand NESTcc Data Network

5. DEVELOP NESTcc’S ROLE: NETWORK COLLABORATORS
NESTcc has established relationships with Network Collaborators that represent more than 195 hospitals and 3,942 outpatient clinics to advance evaluation and use of high-quality RWD from various sources.
To date, memoranda of understanding (mous) have been signed with 12 Network collaborators:

6. Network Collaborators
BUILDING NESTcc’S DATA NETWORK
NESTcc surveyed its Network Collaborators to determine current capabilities, gaps, and priority areas. 12
Duke University Health System • HealthCore • Lahey Clinic • Mayo Clinic • MDEpiNet • Mercy • Mid-South • NYC-CDRN • OneFlorida • PEDSnet • Vanderbilt University • Yale New Haven Health System
Network Collaborators represent:
Hospitals
195
Outpatient Clinics
3,942+
Network Collaborators
Patient data represents:
Common data models:
I2b2
OMOP
PCORnet
Sentinel
Network Collaborators report regular data refreshes:
Most cited expertise:
Cardiovascular and Cardiac Surgery
Women’s Health
Neurosurgery
Gastroenterology
Orthopedic
4 Quarterly
2 Daily
Patient Records
494M+*
3 Mixed Rates
3 Monthly
*Does not account for duplicate records
Numbers reflect data as of February 2018

7. DEVELOP NESTcc’S ROLE: TEST-CASES
High-level concepts of each test-case that is currently in development are summarized below:
TOTAL-PRODUCT LIFE CYCLE (TPLC) ALIGNMENT
REGULATORY PATHWAY
PRODUCT(S)
PARTICIPATING NETWORK COLLABORATORS (n)
DISEASE AREA
Pre-market Submission
510(k)
Wound Closure Devices (topical skin adhesives, staples, sutures) 2
Dermatology
Label Expansion
PMA
Endovascular stent 3
Vascular
Catheters used in Rx of Cardiac Arrhythmias
Cardiology
Mechanical Aortic Heart Valves
Label from General to Specific Indication
Microwave Ablation Device 4
Surgery
Post-market Surveillance
Total Knee Arthroplasty
Orthopedics
Craniomaxillofacial Bone Distractors 1
Intervertebral Lumbar Body Fusion Devices