- Developing and applying novel statistical and epidemiological methods to monitor the safety and effectiveness of medical devices.
- Advancing statistical and epidemiological methods to improve understanding of medical device vulnerabilities to chemical, biological, radiological, and nuclear events.
- Developing a comprehensive set of methodological approaches for continuous evaluation of pre-market and post-market device data.
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.
Established in January 2012, the Center is
- Developing a comprehensive set of methodological approaches for continuous evaluation of premarket and post-market device data through evidence synthesis by 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.
- Collaborating with CDRH epidemiologists and MEDpiNet investigators focusing on statistical methods for inferring device safety and effectiveness based on heterogeneous high-dimensional observational data sources.
- 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
Assistant Professor of Health Care Policy
Brigham & Women’s Hospital
Lahey Hospital & Medical Center
Vanderbilt University Medical Center
Coordinating, Science, and Infrastructure
The Coordinating, Science, and Infrastructure Center is responsible for
- Facilitating the implementation of 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.
- Conducting comparative outcomes studies and disseminating the results to inform clinical and regulatory decision making.
- Collaborating with partners and creating 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.
The Coordinating, Science, and Infrastructure Center is located in the Weill Cornell Medical College in New York City. The purpose of the Center is to provide a strong foundation for collection, analysis, and dissemination of medical device data by leveraging resources to create new registries and improve existing ones.
- International Consortium of Orthopedic Registries (ICOR)
- Claims Based Research Initiative (CBRI)
- International Consortium of Cardiovascular Registries (ICCR)
- Helped to form the International Consortium of Vascular Registries (ICVR) in November 2014, which held its second executive committee meeting on May 25-26, 2015 in Uppsala.
- Held a symposium on implant outlier detection at the American Academy of Orthopedic Surgeons’ Annual Meeting in Las Vegas, March 2015.
- In December of 2014, published an International Consortium of Orthopaedic Registries (ICOR) supplement to The Journal of Bone and Joint Surgery.
- Continuing research projects within ICOR with application of a Decentralized Distributed Data Network approach to analyze data from registries. www.icor-initiative.org.
- Established the scientific infrastructure for the International Consortium of Cardiovascular Registries (ICCR). The International Consortium of Trans-catheter Valve Replacement Registries (ICTVR) is the pilot for the ICCR; in partnership with registry representatives from the U.S., Canada, France, Germany, The Netherlands, England, and Japan. Three projects are underway in collaboration with the American College of Cardiology and the Society of Thoracic Surgeons.
- Continuing work on medical countermeasure-associated devices in conjunction with the ECRI Institute and faculty at Cornell; conducting horizon scans to evaluate the existing data sources on how disasters (natural disasters, pandemics, technological and accidental events, and terrorist events) affect the effectiveness and safety of medical devices.
- Developed the Claims Based Research Project (CBRI) in 2013 which publishes medical device safety and effectiveness findings in four important clinical areas.
- Partnering with the IDEAL Collaboration to advance regulation and evaluation of surgery and devices. In April 2014, organized a workshop in NYC to discuss methodologies for device innovation and evaluation leading to IDEAL for devices (IDEAL-D). www.ideal-collaboration.net
- During 2013, initiated three series of meetings on medical device registry scientific questions and standards in conjunction with The Pew Charitable Trusts and Blue Cross and Blue Shield Association Technology Evaluation Center (TEC).
Coordinating, Science, and Infrastructure Management
Weill Cornell Medical College
Prof of Healthcare Policy, Research & Cardiothoracic Surgery
Instructor, Healthcare Policy and Research
Assc Prof of Biostatistics in Healthcare Policy and Research
Courtney Baird, M.S.
Research Data Analyst
Research Data Analyst
Tianyi Sun, M.S.
Research Data Analyst