UM Joins Partnership to Accelerate Evaluation of Medical Devices

medical device and patient

UM Joins Partnership to Accelerate Evaluation of Medical Devices

By joining a national collaborative partnership,  the University of Miami Institute for Data Science and Computing (IDSC) will contribute to the analysis and evaluation of new medical devices designed to improve patient care. “Our IDSC faculty will bring their extensive data skills, and knowledge of the health care industry as a new partner of the Medical Device Epidemiology Network (MDEpiNet),” said Nicolas Tsinoremas, PhD, Director of the Institute, who recently entered into a memorandum of understanding with MDEpiNet.

Art SedrakyanMDEpiNet is a global public-private partnership that brings together leaders in health care, academic medical centers, patient groups, payers, and government, to advance a national patient-centered medical device evaluation and surveillance system.

“We are excited to work with IDSC to conduct pilot and demonstration projects relevant for big data security and research,” said Art Sedrakyan, MD, PhD, Director of MDEpiNet’s Coordinating and Science Infrastructure Center, and Professor of Healthcare Policy and Research, leading the Institute for Health Technologies and Interventions at Weill Cornell Medicine in New York.

“As a unique global partnership, we developed the discipline of medical device epidemiology and outcomes research, and numerous national and international coordinated registry networks for technology research and surveillance.”

Yelena Yesha Yelena Yesha, PhD, UM Visiting Distinguished Professor and IDSC Innovation Officer will serve as a Co-Chair of MDEpiNet’s Artificial Intelligence (AI) and Blockchain task force, and Dr. Tsinoremas will be Co-Chair of the partnership’s COVID-19 rapid response task force.

Since its establishment in 2010, the MDEpiNet Coordinating Center at Weill Cornell Medicine supports activities under a cooperative agreement with the U.S. Food and Drug Administration (FDA), and the Center for Devices and Radiological Health.

MDEpiNet’s objectives include:

  • Advancing the development and testing of new approaches to patient-focused medical device evidence evaluation
  • Improving how medical device information is generated, synthesized, and appraised throughout the life cycle of a device
  • Facilitating broad-based collaboration as a part of the learning health care ecosystem to harness existing investments in real-world data systems for medical device evaluation
  • Building a strategically Coordinated Registry Networks (CRN) infrastructure through a collaborative CRN Community of Practice, and
  • Developing methodologies to support the use and creation of real-world evidence.

“We look forward to defining collaborative projects that will allow us to accelerate the evaluation of medical devices in terms of safety and efficacy,” said Dr. Yesha. “This new collaboration will support the evidence-based development and assessment of medical devices throughout the healthcare sector.”


By Richard Westlund