1. Office of Science Engineering Laboratories (OSEL) Center for Devices and Radiological Health Science Prioritization Process - - How it works and what are some results? Larry Kessler, Sc.D. Director, OSEL Subhas Malghan, Ph.D. William Herman Deputy Directors, OSEL

2. What we do? Direct review of regulatory documents that present new scientific issues, including –Product evaluations –Risk assessments and hazard analyses Development of generic techniques to enhance product safety and effectiveness –Test methods development –Development of consensus standards Scientific training for CDRH regulatory staff Technical consultations inside and outside FDA

3. Logistics Buildings: all over Rockville, including half of the life science building at White Oak Number of staff: 175 staff, 36 contractors We cover the enormous range of devices! Operating budget: less than $10,000 per person/year for ALL lab expenses [$2,000 for travel/training]

4. Medical devices are diverse, from contact lenses to condoms, from pregnancy test kits to MRI machines, and a wide assortment of radiological devices. Test Strips Infusion pump Patient Examination Table Heart Valve Contact Lens Hip Implant Pacemaker Biopsy Device Blood Pressure Cuff Stethoscope

5. Science Board Review A review of the science at CDRH conducted with the Science Board in 2001 Involved the work of the entire Center using TPLC model Recommendations for Office of Science and Technology (OST) –Separate review of OST –Increase involvement in CDRH –Focus efforts on emerging science/technology –Increase knowledge base documentation –Increase scientific collaborations with industry

6. Office of Science and Technology Strategic Goals: Fall 2002 Chart a course to becoming an exciting and dynamic organization for cutting edge regulatory research in medical devices Make OST organization and work more integrated with the mission and function of CDRH

7. Results from Program Review January 2003 Significant recommendations: a.Protocol Review and Project Prioritization b.External Science Review c.Organizational structure, communication, and staffing

8. OSEL structure and focus: 2004 Standards Management Staff Research Divisions 1. Division of Chemistry and Materials Sciences (DCMS) 2. Division of Electronics and Software Engineering (DESE) 3. Division of Biology (DB) 4. Division of Imaging and Applied Mathematics (DIAM) 5. Division of Solid and Fluid Mechanics (DSFM) 6. Division of Physics (DP) Each Division consists of 3-6 laboratories

9. OSEL has implemented a Science Prioritization Process (SPP): to prioritize its research activities to meet CDRH/FDA needs to enhance the scientific merit or our work “The SPP is the cornerstone of all science activities carried out in the office in support of Center’s regulatory processes.”

10. Major Goals of Science Prioritization Process (SPP) Seek input from stakeholders in CDRH, FDA, and external experts Use results for building a cutting-edge scientific laboratory performing regulatory science research Develop new collaborations in part by leveraging the participation of experts

11. Science Prioritization Process – Key Components Preparation of research proposals Review of research proposals by Technical Review Committee (TRC) Review at the Laboratory level by the Science Prioritization Oversight Committee (SPOC) Decisions by the OSEL Director OSEL Deputy Director (Dr. Malghan) manages the entire process, including chairing the SPOC

12. Major changes implemented for the 2006-2008 cycle Review of 1/3 of OSEL laboratories each year on a rolling 3-year cycle Inclusion of one academic member in each Technical Review Committee (TRC) Completion of the prioritization process in November preceding implementation

13. TRC meetings in 2005 consisted of Review of six laboratories in October 2005 Four separate OSEL locations Sixty five TRC members from CDRH, FDA, and other agencies Five academic members in TRCs

14. Laboratories Reviewed in 2005 One Example Project Per Lab Ultrasonics –Evaluation of New Thermal Safety Issues for Medical Ultrasound Electromagnetic and Wireless Technologies –Medical Device Electromagnetic Compatibility and Wireless Technologies Radiation Biology and Photosciences –Ultraviolet radiation (UV), skin color, and regulations

15. Laboratories Reviewed in 2005 One Example Project Per Lab Optical Diagnostics and Therapeutics –Mechanisms of optical spectroscopy-based diagnostic devices Electrical Engineering –Performance assessment of pulse oximeters in the presence of motion Cardiovascular and Interventional Therapeutics –Safety and Effectiveness of Emerging Interventional Therapeutics and Delivery Mechanisms for Treatment of Vascular Disease and Cancer

16. Major sub processes of SPP are standardized, including: Research proposal format Research proposal format Laboratory description format Laboratory description format TRC scoring and review format TRC scoring and review format SPOC evaluation of laboratory SPOC evaluation of laboratory In-house developed database houses data from all sub processes In-house developed database houses data from all sub processes

17. Laboratory Description Contents Main technical/scientific focus of the laboratory Goals of the laboratory Description of experimental/theoretical work planned to address each goal Medical device challenges/problems being addressed Approach to address these problems Relationship to Center’s Strategic plan Regulatory and scientific benefits to CDRH Abstracts of research projects

18. Research Proposal Contents Abstract of proposed research List of principal investigators and collaborators Three-year budget projection Technical/scientific needs of the Center Research objectives and methodology Major milestones Benefits to the Center and relationship with Centers’ strategic plan

19. Outcomes of SPP More focus on “regulatory needs driven” research Increased buy-in from Center staff since more research is directed to meet their needs Projects transforming research into publications into standards and guidance documents Almost all projects have undergone changes to address TRC comments/recommendations

20. Outcomes of SPP (cont.) >12 projects terminated or significantly redirected Major funding and infrastructure decisions based on TRC and SPOC evaluation of projects Collaborations within each laboratory, faculty, and other agencies increasing Beginning to attract new talent at the student and post-doc level Recognized within CDRH as an effective process of redirecting OSEL

21. A Work in Progress The Science Prioritization Process has served the Center very well by: –Focusing on high priority areas and redirecting away from low priority areas –Serving as a cornerstone of all budget and programmatic decisions in OSEL and CDRH –Increasing CDRH staff ownership in the process because they help OSEL direct the research toward Center’s high priority needs