Coordinating, Science, and Infrastructure Center (Weill Cornell Medicine)

 

 

The MDEpiNet Science and Infrastructure Center advances the framework for medical device  innovation and evaluation complementing existing efforts from the FDA whitepaper: Strengthening Our National System for Medical Device Postmarket Surveillance, and the multiple stakeholder Planning Board report: Strengthening Patient Care: Building an Effective National Medical Device Surveillance System.

 

 

This work includes:

  • Implementing the unique device identifiers (UDI) for medical devices.
  • Encouraging development of national and regional registries.
  • Promoting linkages between registries and routinely available data sources.
  • Advocating for enhancement of routinely available electronic, discharge and claims data to address National Post-market Surveillance.
  • Facilitating and leading  International registry consortia creation.

The Center conducts comparative outcomes studies and applies the results to informing clinical and regulatory decision making.

Cornell Internal Process

The Center collaborates with partners and creates forums for discussion, workshops, and conferences to bring external stakeholders with relevant data and expertise to share best practices and build collaborations. This collaboration develops peer-reviewed papers and white papers.

Science and Infrastructure Management

Weill Cornell Medical College

Art Sedrakyan, MD, PhD
Prof of Healthcare Policy, Research & Cardiothoracic  Surgery

 

Jialin Mao, MD, MS
Instructor, Healthcare Policy and Research

 

Samprit Banerjee, PhD
Assc Prof of Biostatistics in Healthcare Policy and Research

 

Joshua Henninger
Grants Administrator

 

Courtney Baird, M.S.
Research Data Analyst

 

Nadia Kim, M.S.
FDA ORISE Fellow

 

 

Molly Nowels, M.S., M.A.
Research Data Analyst

 

Tianyi Sun, M.S.
Research Data Analyst