FDA Science Board, April 2003

Committee Chair: Robert M. Nerem, Ph.D.Parker H. Petit Distinguished Chair for Engineering in Medicine,

Georgia Institute of Technology

June: Organizational MeetingProvide Internal Review DocumentsGo Over Interactive Assignment materials

July: CDRH Site VisitDay 1: Focus on early life cycle (Twinbrook facilities)Day 2: Focus on mid life cycle (Corporate Blvd)Day 3: Focus on late life cycle (Piccard Blvd)

Science Review RecommendationsQuality Systems:

CDRH should develop and implement a quality evaluation and improvement program, and as part of this, the evaluation system should develop metrics for the assessment of quality as well as the timeliness of results. The focus of these activities should be to achieve high quality product reviews in a timely manner. Management should implement a system for recognizing, rewarding, and encouraging high quality product reviews and investigations.

Performance Based Budgeting

Review Performance 2001 - 2002

Performance Scorecards

Key Results Areas and Key Indicators1. Public Health Protection

Monitoring Index: Identifying HazardsFollow-up and Resolution Index: Timely and effective

2. Public Health PromotionTimely Availability of Novel Products

3. Operational Accountability and QualityApplication ActivitiesConformity AssessmentBusiness Accountability

Performance Scorecards

Key Results Areas and Key Indicators

4. Stakeholder CollaborationCollaborative Meeting Activities

5. Workforce ExcellenceScientific Development External Expertise Engagement

6. Strategic InitiativesTotal Product Life CycleGlobal Products — Global Quality

SAMIE™ Model

EVALUATE9. Assess impact

of processimprovements

10. Standardize processand monitor ongoing improvement

IMPROVE7. Set process

improvement goal(s)

8. Develop and implementimprovements on a “trial run” basis

MEASURE5. Gather “baseline”

process performancedata

6. Identify processperformance “gaps”

ContinuousProcess

Improvement

ANALYZE

3. Document “as is”process

4. Establish processmeasures

SELECT1. Define key

requirements for “core” customers

2. Determine process to improve

PMA Filing Process

Database: PMA Filing Decisions(FY'02 & 1st Q FY'03)

11%

89% Filed 63

Not Filed 8

PMA Filing Process

Peer Review Analysis - Filed PMAs (Clear, Not Clear, Not Analyzed)

62%

17%

21%

Clearly filed 39

Not clearly filed 11

Not Analyzed 13

Peer Review

PMA Filing Process

Peer Review Analysis: Reasons why PMAs were "Not C learly Filed"

18%

18%

64%

InadequateClinical Study 7

Disorganized 2

Poor/MissingDevice Descript 2

Peer Review

Cause and Effect Diagram

CONTINUOUS PROCESS IMPROVEMENT

Policy Internal Customers

Since FY 02 the interpretation of the minimum filing criteria varies among internal customers

ExternalCustomers

Education

Pressures Agency to file all

Insufficient Training

Staff unaware of policy

Infrequent Training

Culture to file all PMAs

Vague/unclear criteria

Not known to staff

Brainstorm:Possible Solutions

Options CommentSpecify Minimum Filing Criteria

Updated Filing Blue Book Guidance and Checklist (draft)

Provide feedback to external customers regarding submission content at time of filing

Include completed checklist with each FILE/NOFI letter

Create a rating system to score submissions based on content at time of filing

Education Increase frequency and adequacy of training of staff and industry

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Brainstorm:Possible Solutions

Options CommentTurbo Filing Design a template for electronic

completion of filing requirements

Operational Accountability Consistency Ratings

Institute assessment through quarterly Peer Review Analysis

Add measures to ODE/OIVD score cards

Stakeholder Collaboration Satisfaction Ratings

Finalize questionnaires to obtain additional feedback from internal and external customers

Add measures to ODE/OIVD score cards

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Science Review Recommendations

ExpertiseCDRH should encourage and facilitate the use of internal but non-ODE expertise and also external expertise, including the development of operational and budget policies that promote a more liberal use of external experts.

CDRH Medical Device Fellowship ProgramPhysicians

Visiting Scholar – senior level clinicians, surgeonsFellow - physician during fellowship trainingResident – physician during residency trainingMedical studentConsultant – generally off-site experts available for consultation

EngineersVisiting Scholar – senior level engineerConsultant – generally off-site experts available for consultationStudentsBiomedical Engineering Co-op ProgramEngineering internships

OthersContact information:Susan A. Homire, D.V.M.301-827-7994sah@cdrh.fda.gov

Examples of expertise needed at CDRH

Orthopedics / NeurologyClinical issuesMechanical testing issuesSpine/biomaterials, novel spine

productsBone void fillers and scaffolds for

tissue engineeringEngineering

ElectricalMechanicalSoftwareReliability engineering and quality

systemsHuman factorsBiocompatibilitySterilization

Surgery Cardiothoracic surgeryNeurosurgery - stroke management,

stereotactic brain surgery, epilepsy procedures, cooling and brain injury

Pediatric surgeryPlastic surgery - materials, skin

replacement, glues/sealants

Vascular SurgeryNoncardiac thoracic surgery - lung

volume reduction procedures, thermal ablation of pulmonary lesions

General surgery - robotic, minimally invasive, breast

Urology - prostate surgeryBariatric surgery

General medicalClinical trial designPediatric clinical trial designCardiovascular

CardiologyElectrophysiologyHeart failureInterventional cardiologyInterventional pediatric cardiology

NephrologyDialysis

Implementation