Work Streams

Registry/Consortia/Networks

National and International

  • Creating  new registries or new ways to work with registry data in order to enhance understanding of medical devices.
  • Building international collaborations between different health systems to combine data sets in a way that multiplies the power of the analysis through large populations.
  • Developing and implementing best practices for partnership governance and data access to ensure high quality data and patient data privacy and security,
  • Developing common data models for interoperability among all registries
  • Developing and implementing infrastructure for automatic capture of data from electronic health records
  • Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

Device Data Capture Efforts

  • Promoting the capture of unique device identification in health care data sources
  • Using automated methods and electronic systems for capturing detailed information on medical devices through the Unique Device Identifier
  • Acquiring and analyzing data collected and stored within medical devices.
  • Developing and implementing databases of clinical attributes for a deeper understanding of medical device design characteristics
  • Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

Evidence Synthesis

  • Evaluating  selected medical devices based on public health importance/need and availability of existing data sources
  • Obtaining safety and effectiveness estimates throughout the total product life cycle
  • Developing and applying modeling techniques to enhance understanding and context of medical device benefit/risk balance
  • Translating the results of modeling for regulators, physicians and patients and disseminate the results
  • Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

Comparative Effectiveness/Safety

  • Adapting existing patient centered total product life cycle framework to evaluate selected medical devices
  • Accounting for comparator selection, device characteristics, operator characteristics, procedure/intervention characteristics, intervention setting characteristics, patient characteristics and appropriate outcome measures selection
  • Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

Analytical Methodologies

  • Developing scientifically valid analytical methods for evaluating medical device exposure and clinical outcome characteristics across multiple data sets across different types of data systems
  • Utilizing appropriate statistical techniques to compare performance and clinical outcomes between comparator or exposure groups and translate the modeling results for regulators, physicians and patients and publicize the results
  • Evaluating  existing gaps in approaches to medical device studies of approved medical devices by developing innovative methodologies using existing data sources and infrastructure
  • Identifying  and describing unique challenges and gaps in studying various classes of medical devices
  • Identifying sustainable data and methods for evaluation of selected classes of medical devices
  • Validating endpoints/outcomes using variety of data sources
  • Communicating lessons learned/best practices  to inform National Medical Device Evaluation System