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Transcript of Office of Science Engineering Laboratories (OSEL) Center for Devices and Radiological Health Science...
Office of Science Engineering Laboratories Office of Science Engineering Laboratories (OSEL)(OSEL)
Center for Devices and Radiological HealthCenter for Devices and Radiological Health
Science Prioritization Process - - How it works Science Prioritization Process - - How it works and what are some results?and what are some results?
Larry Kessler, Sc.D.Larry Kessler, Sc.D.Director, OSELDirector, OSEL
Subhas Malghan, Ph.D. William HermanSubhas Malghan, Ph.D. William Herman
Deputy Directors, OSELDeputy Directors, OSEL
What we do?What we do?
Direct reviewDirect review of regulatory documents that of regulatory documents that present new scientific issues, includingpresent new scientific issues, including– Product evaluationsProduct evaluations– Risk assessments and hazard analysesRisk assessments and hazard analyses
Development of Development of generic techniquesgeneric techniques to enhance to enhance product safety and effectivenessproduct safety and effectiveness– Test methods developmentTest methods development– Development of consensus standardsDevelopment of consensus standards
Scientific trainingScientific training for CDRH regulatory staff for CDRH regulatory staffTechnical consultationsTechnical consultations inside and outside FDA inside and outside FDA
LogisticsLogistics
Buildings: all over Rockville, including half Buildings: all over Rockville, including half of the life science building at White Oakof the life science building at White Oak
Number of staff: 175 staff, 36 contractorsNumber of staff: 175 staff, 36 contractors
We cover the enormous range of devices!We cover the enormous range of devices!
Operating budget: less than $10,000 Operating budget: less than $10,000 per person/year for ALL lab expenses per person/year for ALL lab expenses [$2,000 for travel/training][$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 Strips
Infu
sion
pu
mp
Patient Examination Table
Heart Valve
Contact Lens
Hip Implant
Pacemaker
Biopsy Device
Blood Pressure Cuff
Stethoscope
Science Board ReviewScience Board ReviewA review of the science at CDRH conducted with A review of the science at CDRH conducted with the Science Board in 2001the Science Board in 2001Involved the work of the entire Center using Involved the work of the entire Center using TPLC modelTPLC modelRecommendations for Office of Science and Recommendations for Office of Science and Technology (OST)Technology (OST)– Separate review of OSTSeparate review of OST– Increase involvement in CDRHIncrease involvement in CDRH– Focus efforts on emerging science/technologyFocus efforts on emerging science/technology– Increase knowledge base documentationIncrease knowledge base documentation– Increase scientific collaborations with industryIncrease scientific collaborations with industry
Office of Science and TechnologyOffice of Science and Technology
Strategic Goals: Fall 2002Strategic Goals: Fall 2002 Chart a course to becoming an exciting and dynamic Chart a course to becoming an exciting and dynamic
organization for cutting edge regulatory research organization for cutting edge regulatory research in medical devicesin medical devices
Make OST organization and work more integrated Make OST organization and work more integrated with the mission and function of CDRHwith the mission and function of CDRH
Results from Program Review Results from Program Review January 2003January 2003
Significant recommendations:Significant recommendations:a.a. Protocol Review and Project PrioritizationProtocol Review and Project Prioritization
b.b. External Science ReviewExternal Science Review
c.c. Organizational structure, communication, and Organizational structure, communication, and staffingstaffing
OSEL structure and focus: 2004OSEL structure and focus: 2004Standards Management StaffStandards Management StaffResearch DivisionsResearch Divisions1. Division of Chemistry and Materials Sciences 1. Division of Chemistry and Materials Sciences
(DCMS)(DCMS)2. Division of Electronics and Software Engineering 2. Division of Electronics and Software Engineering
(DESE)(DESE)3. Division of Biology (DB)3. Division of Biology (DB)4. Division of Imaging and Applied Mathematics 4. Division of Imaging and Applied Mathematics
(DIAM)(DIAM)5. Division of Solid and Fluid Mechanics (DSFM) 5. Division of Solid and Fluid Mechanics (DSFM) 6. Division of Physics (DP)6. Division of Physics (DP)
Each Division consists of 3-6 laboratoriesEach Division consists of 3-6 laboratories
OSEL has implemented a OSEL has implemented a Science Prioritization Process (SPP):Science Prioritization Process (SPP):
to prioritize its research activities to meet to prioritize its research activities to meet CDRH/FDA needs CDRH/FDA needs
to enhance the scientific merit or our workto enhance the scientific merit or our work
““The SPP is the cornerstone of all science The SPP is the cornerstone of all science activities carried out in the office in support activities carried out in the office in support of Center’s regulatory processes.”of Center’s regulatory processes.”
Major Goals of Major Goals of Science Prioritization Process (SPP)Science Prioritization Process (SPP)
Seek input from stakeholders in CDRH, Seek input from stakeholders in CDRH, FDA, and external experts FDA, and external experts
Use results for building a cutting-edge Use results for building a cutting-edge scientific laboratory performing regulatory scientific laboratory performing regulatory science researchscience research
Develop new collaborations in part by Develop new collaborations in part by leveraging the participation of expertsleveraging the participation of experts
Science Prioritization Process –Science Prioritization Process –Key ComponentsKey Components
Preparation of research proposalsPreparation of research proposalsReview of research proposals by Review of research proposals by Technical Review Committee (TRC) Technical Review Committee (TRC) Review at the Laboratory level by the Review at the Laboratory level by the Science Prioritization Oversight Science Prioritization Oversight Committee (SPOC)Committee (SPOC)Decisions by the OSEL DirectorDecisions by the OSEL DirectorOSEL Deputy Director (Dr. Malghan) OSEL Deputy Director (Dr. Malghan) manages the entire process, including manages the entire process, including chairing the SPOC chairing the SPOC
Major changes implemented for the Major changes implemented for the 2006-2008 cycle2006-2008 cycle
Review of 1/3 of OSEL laboratories each Review of 1/3 of OSEL laboratories each year on a rolling 3-year cycleyear on a rolling 3-year cycle
Inclusion of one academic member in Inclusion of one academic member in each Technical Review Committee (TRC)each Technical Review Committee (TRC)
Completion of the prioritization process in Completion of the prioritization process in November preceding implementation November preceding implementation
TRC meetings in 2005TRC meetings in 2005consisted ofconsisted of
Review of six laboratories in October 2005 Review of six laboratories in October 2005
Four separate OSEL locationsFour separate OSEL locations
Sixty five TRC members from CDRH, Sixty five TRC members from CDRH, FDA, and other agencies FDA, and other agencies
Five academic members in TRCsFive academic members in TRCs
Laboratories Reviewed in 2005Laboratories Reviewed in 2005One Example Project Per LabOne Example Project Per Lab
UltrasonicsUltrasonics– Evaluation of New Thermal Safety Issues for Medical Evaluation of New Thermal Safety Issues for Medical
UltrasoundUltrasound
Electromagnetic and Wireless TechnologiesElectromagnetic and Wireless Technologies– Medical Device Electromagnetic Compatibility and Medical Device Electromagnetic Compatibility and
Wireless TechnologiesWireless Technologies
Radiation Biology and PhotosciencesRadiation Biology and Photosciences– Ultraviolet radiation (UV), skin color, and regulationsUltraviolet radiation (UV), skin color, and regulations
Laboratories Reviewed in 2005Laboratories Reviewed in 2005One Example Project Per LabOne Example Project Per Lab
Optical Diagnostics and Therapeutics Optical Diagnostics and Therapeutics – Mechanisms of optical spectroscopy-based diagnostic Mechanisms of optical spectroscopy-based diagnostic
devices devices
Electrical EngineeringElectrical Engineering– Performance assessment of pulse oximeters in the Performance assessment of pulse oximeters in the
presence of motion presence of motion
Cardiovascular and Interventional TherapeuticsCardiovascular and Interventional Therapeutics– Safety and Effectiveness of Emerging Interventional Safety and Effectiveness of Emerging Interventional
Therapeutics and Delivery Mechanisms for Treatment Therapeutics and Delivery Mechanisms for Treatment of Vascular Disease and Cancer of Vascular Disease and Cancer
Major sub processes of SPP are Major sub processes of SPP are standardized, including: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 laboratorySPOC evaluation of laboratory
In-house developed database houses In-house developed database houses data from all sub processesdata from all sub processes
Laboratory Description ContentsLaboratory Description Contents
Main technical/scientific focus of the laboratoryMain technical/scientific focus of the laboratoryGoals of the laboratoryGoals of the laboratoryDescription of experimental/theoretical work Description of experimental/theoretical work planned to address each goalplanned to address each goalMedical device challenges/problems being Medical device challenges/problems being addressedaddressedApproach to address these problemsApproach to address these problemsRelationship to Center’s Strategic planRelationship to Center’s Strategic planRegulatory and scientific benefits to CDRHRegulatory and scientific benefits to CDRHAbstracts of research projectsAbstracts of research projects
Research Proposal ContentsResearch Proposal Contents
Abstract of proposed researchAbstract of proposed research
List of principal investigators and collaboratorsList of principal investigators and collaborators
Three-year budget projectionThree-year budget projection
Technical/scientific needs of the CenterTechnical/scientific needs of the Center
Research objectives and methodologyResearch objectives and methodology
Major milestonesMajor milestones
Benefits to the Center and relationship with Benefits to the Center and relationship with Centers’ strategic planCenters’ strategic plan
Outcomes of SPPOutcomes of SPP
More focus on “regulatory needs driven” researchMore focus on “regulatory needs driven” research
Increased buy-in from Center staff since more Increased buy-in from Center staff since more research is directed to meet their needsresearch is directed to meet their needs
Projects transforming research into publications Projects transforming research into publications into standards and guidance documentsinto standards and guidance documents
Almost all projects have undergone changes to Almost all projects have undergone changes to address TRC comments/recommendationsaddress TRC comments/recommendations
Outcomes of SPP (cont.)Outcomes of SPP (cont.)
>12 projects terminated or significantly redirected>12 projects terminated or significantly redirected
Major funding and infrastructure decisions Major funding and infrastructure decisions based on TRC and SPOC evaluation of projectsbased on TRC and SPOC evaluation of projects
Collaborations within each laboratory, faculty, Collaborations within each laboratory, faculty, and other agencies increasingand other agencies increasing
Beginning to attract new talent at the student and Beginning to attract new talent at the student and post-doc levelpost-doc level
Recognized within CDRH as an effective process Recognized within CDRH as an effective process of redirecting OSEL of redirecting OSEL
A Work in ProgressA Work in Progress
The Science Prioritization Process has The Science Prioritization Process has served the Center very well by:served the Center very well by:– Focusing on high priority areas and Focusing on high priority areas and
redirecting away from low priority areas redirecting away from low priority areas – Serving as a cornerstone of all budget and Serving as a cornerstone of all budget and
programmatic decisions in OSEL and CDRH programmatic decisions in OSEL and CDRH – Increasing CDRH staff ownership in the Increasing CDRH staff ownership in the
process because they help OSEL direct the process because they help OSEL direct the research toward Center’s high priority needsresearch toward Center’s high priority needs