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