Work Streams

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