Science & Research

Developing an Evaluation Framework for Measuring the Health and Efficacy of Intramural Research Programs in FDA's Medical Device Center

Performer: Deloitte Consulting LLP

Principal Investigator: Rich Cohen

Project Duration: 9/30/14 - 7/30/15

Regulatory Science Challenge

FDA’s mission is supported by a substantial intramural research program focused on testing, evaluating, and identifying emerging technology trends to inform FDA review processes. This type of research is commonly known as regulatory science. The size, scope, and complexity of FDA’s research program make it a challenge to summarize and quickly communicate research findings that could have an immediate effect on regulatory submissions and on public health.

Project Description

Using its expertise in performance metrics gained from previous projects, Deloitte is developing a framework for measuring the performance of FDA’s regulatory science research program, linking the mission of one FDA center, the Center for Devices and Radiologic Health (CDRH), to measurable research outcomes. In addition, Deloitte will gain insights from regulated industry to determine what external stakeholders think are the most important outputs of a regulatory science research program in CDRH. Finally, Deloitte will develop case studies of research programs to test the developed model and showcase the strength of two regulatory science research programs. The results will be made publicly available.

Project Goals

  • Develop regulatory science performance metrics that CDRH will implement to evaluate regulatory science programs.
  • Gain insights about CDRH regulatory science programs from regulated industry.
  • Develop case studies covering two regulatory science programs.


  • Developed a four-level logic model that ties research imperatives (elements that researchers control) to the CDRH mission. The logic model includes 65 performance metrics.
  • Completed 15 interviews with external stakeholders and gained insights that were incorporated into the logic model.
  • Developed case studies on two projects: the Bayesian Statistics for Adaptive Clinical Trials project and the Virtual Family project.
  • Developed report that included the following 5 actionable recommendations for FDA's Center for Devices and Radiological Health (CDRH) to achieve a successful performance evaluation capability:

1) Finalize, prioritize, and socialize organizational research objectives to aid in prioritizing research activities
2) Develop capability to capture, report, and visualize the health and effectiveness of CDRH research to better manage research program performance
3) Develop a strategy to communicate with internal and external groups to create a “force multiplier” for CDRH regulatory science research
4) Integrate the logic model into research project planning efforts to enable research programs to be evaluated on an apples to apples basis
5) Finalize performance metrics through a systematic prioritization process to ensure comprehensiveness and feasibility of metrics

Page Last Updated: 06/30/2016
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