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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. What we do?. - PowerPoint PPT Presentation


  • 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, OSELSubhas Malghan, Ph.D. William HermanDeputy Directors, OSEL

  • What we do?Direct review of regulatory documents that present new scientific issues, includingProduct evaluationsRisk assessments and hazard analysesDevelopment of generic techniques to enhance product safety and effectivenessTest methods developmentDevelopment of consensus standardsScientific training for CDRH regulatory staffTechnical consultations inside and outside FDA

  • LogisticsBuildings: all over Rockville, including half of the life science building at White OakNumber of staff: 175 staff, 36 contractorsWe cover the enormous range of devices!

    Operating budget: less than $10,000 per person/year for ALL lab expenses [$2,000 for travel/training]

  • Medical devices are diverse, from contact lenses to condoms, from pregnancy test kits to MRI machines, and a wide assortment of radiological devices.Test StripsInfusion pumpPatient Examination TableHeart ValveContact LensHip ImplantPacemakerBiopsy DeviceBlood Pressure CuffStethoscope

  • Science Board ReviewA review of the science at CDRH conducted with the Science Board in 2001Involved the work of the entire Center using TPLC modelRecommendations for Office of Science and Technology (OST)Separate review of OSTIncrease involvement in CDRHFocus efforts on emerging science/technologyIncrease knowledge base documentationIncrease scientific collaborations with industry

  • Office of Science and TechnologyStrategic 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

  • Results from Program Review January 2003Significant recommendations:Protocol Review and Project PrioritizationExternal Science ReviewOrganizational structure, communication, and staffing

  • OSEL structure and focus: 2004Standards Management StaffResearch Divisions1. 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

  • 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 Centers regulatory processes.

  • 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 researchDevelop new collaborations in part by leveraging the participation of experts

  • Science Prioritization Process Key Components

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

  • Major changes implemented for the 2006-2008 cycle

    Review of 1/3 of OSEL laboratories each year on a rolling 3-year cycleInclusion of one academic member in each Technical Review Committee (TRC)Completion of the prioritization process in November preceding implementation

  • TRC meetings in 2005consisted of

    Review of six laboratories in October 2005 Four separate OSEL locationsSixty five TRC members from CDRH, FDA, and other agencies Five academic members in TRCs

  • Laboratories Reviewed in 2005One Example Project Per LabUltrasonicsEvaluation of New Thermal Safety Issues for Medical UltrasoundElectromagnetic and Wireless TechnologiesMedical Device Electromagnetic Compatibility and Wireless TechnologiesRadiation Biology and PhotosciencesUltraviolet radiation (UV), skin color, and regulations

  • Laboratories Reviewed in 2005One Example Project Per LabOptical Diagnostics and Therapeutics Mechanisms of optical spectroscopy-based diagnostic devices Electrical EngineeringPerformance assessment of pulse oximeters in the presence of motion Cardiovascular and Interventional TherapeuticsSafety and Effectiveness of Emerging Interventional Therapeutics and Delivery Mechanisms for Treatment of Vascular Disease and Cancer

  • Major sub processes of SPP are standardized, including:

    Research proposal format Laboratory description format TRC scoring and review format SPOC evaluation of laboratory In-house developed database houses data from all sub processes

  • Laboratory Description Contents

    Main technical/scientific focus of the laboratoryGoals of the laboratoryDescription of experimental/theoretical work planned to address each goalMedical device challenges/problems being addressedApproach to address these problemsRelationship to Centers Strategic planRegulatory and scientific benefits to CDRHAbstracts of research projects

  • Research Proposal Contents

    Abstract of proposed researchList of principal investigators and collaboratorsThree-year budget projectionTechnical/scientific needs of the CenterResearch objectives and methodologyMajor milestonesBenefits to the Center and relationship with Centers strategic plan

  • Outcomes of SPPMore focus on regulatory needs driven researchIncreased buy-in from Center staff since more research is directed to meet their needsProjects transforming research into publications into standards and guidance documentsAlmost all projects have undergone changes to address TRC comments/recommendations

  • Outcomes of SPP (cont.)>12 projects terminated or significantly redirectedMajor funding and infrastructure decisions based on TRC and SPOC evaluation of projectsCollaborations within each laboratory, faculty, and other agencies increasingBeginning to attract new talent at the student and post-doc levelRecognized within CDRH as an effective process of redirecting OSEL

  • A Work in ProgressThe 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 Centers high priority needs