# Presentation: 147825

## 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?

**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

## 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]***

## Medical devices are diverse, from contact lenses to condoms, from pregnancy test kits to MRI machines, and a wide assortment of radiological devices.

**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**

## 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

## 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

## Results from Program Review January 2003

- Significant recommendations:
- Protocol Review and Project Prioritization
- External Science Review
- Organizational structure, communication, and staffing

## 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**

## 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.”

## 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

## 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

## 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

## 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*_

## 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

## 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

## 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 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

## 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

## 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

## 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

## 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