The Methodology Center is located in the Department of Health Care Policy at Harvard Medical School and is charged with advancing statistical and epidemiological methods to improve the understanding of the safety and effectiveness of FDA-regulated medical devices. The Center is comprised of methodological investigators from Harvard Medical School, Harvard School of Public Health, and clinical investigators from Brigham and Women’s Hospital, Lahey Hospital & Medical Center, and the Sisters of Mercy Health System.
Exploiting the power of large clinical and administrative databases, including billing claims data; clinical data found in international, national and state registries; and electronic medical record data, the Center is developing a comprehensive set of methodological approaches for continuous evaluation of premarket and post-market device data through evidence synthesis. The Center, established in January 2012, is collaborating with epidemiologists located within the FDA’s Center for Device and Radiological Health and with investigators at the MDEpiNet’s Science and Infrastructure Center, focusing on statistical methods for inferring device safety and effectiveness based on heterogeneous high-dimensional observational data sources; and piloting the implementation of a unique device identifier within a hospital system.
Methodology Center Members
The Center is composed of methodological investigators from Harvard Medical School, Harvard School of Public Health, and clinical investigators from Brigham and Women’s Hospital, Lahey Hospital & Medical Center, and the Sisters of Mercy Health System.
Harvard Medical School—Health Care Policy
Sharon-Lise Normand, PhD
Professor of Health Care Policy (Biostatistics)
Laura Hatfield, PhD
Assistant Professor of Health Care Policy
Vanessa Azzone, PhD
Project Manager and Biostatistician
Robert W. Yeh, MD, MBA
Assistant Professor of Medicine & Interventional Cardiologist, MGH
Brigham & Women’s Hospital
Laura Mauri, MD,MSc
Associate Professor of Medicine &
Chief Scientific Officer, HCRI
Lahey Hospital & Medical Center
Frederic Resnic, MD, MSc
Chairman of the Department of Cardiovascular Medicine
Michael E. Matheny, MD MS MPH
Director, Center for Population Health Informatics