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The Methodology team is leading the development of advanced statistical and epidemiological methods to improve the understanding of safety and effectiveness of FDA-regulated medical devices. The team is comprised of methodological investigators from Harvard Medical School, Harvard School of Public Health, clinical investigators from Brigham and Women’s Hospital, investigators from Weill Cornell Medicine and Duke University.


The Methodology program was established in January 2012 and is focusing on statistical methods for inferring device safety and effectiveness based on heterogeneous high-dimensional observational data sources and piloting the implementation of unique device identifiers within the hospital system.


The expert team is developing a comprehensive set of methodological approaches for the continuous evaluation of pre-market and post-market active surveillance through evidence synthesis of large clinical and administrative databases, including billing claims data; clinical data found in international, national and state registries; and electronic medical record data.

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