FDA Science Board, April 2003

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FDA Science Board, April 2003
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• Committee Chair Robert M. Nerem, Ph.D.
• Parker H. Petit Distinguished Chair for
  Engineering in Medicine, Georgia Institute of
  Technology
• June Organizational Meeting
• Provide Internal Review Documents
• Go Over Interactive Assignment materials
• July CDRH Site Visit
• Day 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)

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Science Review Recommendations

• Quality 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.

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Performance Based Budgeting
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Review Performance 2001 - 2002
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Performance Scorecards

• Key Results Areas and Key Indicators
• Public Health Protection
• Monitoring Index Identifying Hazards
• Follow-up and Resolution Index Timely and
  effective
• Public Health Promotion
• Timely Availability of Novel Products
• Operational Accountability and Quality
• Application Activities
• Conformity Assessment
• Business Accountability

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Performance Scorecards

• Key Results Areas and Key Indicators
• Stakeholder Collaboration
• Collaborative Meeting Activities
• Workforce Excellence
• Scientific Development
• External Expertise Engagement
• Strategic Initiatives
• Total Product Life Cycle
• Global Products Global Quality

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SAMIE Model
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PMA Filing Process
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PMA Filing Process
Peer Review
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PMA Filing Process
Peer Review
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Cause and Effect Diagram
Internal Customers
Policy
Culture to file all PMAs
Not known to staff
Since FY 02 the interpretation of the minimum
filing criteria varies among internal customers
Vague/unclear criteria

Staff unaware of policy
Pressures Agency to file all
Infrequent Training
Insufficient Training

External Customers
Education
CONTINUOUS PROCESS IMPROVEMENT

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BrainstormPossible Solutions
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BrainstormPossible Solutions
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Science Review Recommendations

• Expertise
• CDRH 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.

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CDRH Medical Device Fellowship Program

• Physicians
• Visiting Scholar senior level clinicians,
  surgeons
• Fellow - physician during fellowship training
• Resident physician during residency training
• Medical student
• Consultant generally off-site experts available
  for consultation
• Engineers
• Visiting Scholar senior level engineer
• Consultant generally off-site experts available
  for consultation
• Students
• Biomedical Engineering Co-op Program
• Engineering internships
• Others

Contact information Susan A. Homire,
D.V.M. 301-827-7994 sah_at_cdrh.fda.gov
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Examples of expertise needed at CDRH

• Orthopedics / Neurology
• Clinical issues
• Mechanical testing issues
• Spine/biomaterials, novel spine products
• Bone void fillers and scaffolds for tissue
  engineering
• Engineering
• Electrical
• Mechanical
• Software
• Reliability engineering and quality systems
• Human factors
• Biocompatibility
• Sterilization
• Surgery
• Cardiothoracic surgery
• Neurosurgery - stroke management, stereotactic
  brain surgery, epilepsy procedures, cooling and
  brain injury
• Pediatric surgery
• Plastic surgery - materials, skin replacement,
  glues/sealants

• Vascular Surgery
• Noncardiac thoracic surgery - lung volume
  reduction procedures, thermal ablation of
  pulmonary lesions
• General surgery - robotic, minimally invasive,
  breast
• Urology - prostate surgery
• Bariatric surgery
• General medical
• Clinical trial design
• Pediatric clinical trial design
• Cardiovascular
• Cardiology
• Electrophysiology
• Heart failure
• Interventional cardiology
• Interventional pediatric cardiology
• Nephrology
• Dialysis

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Implementation