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FDA Science Board, April 2003

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 Meeting Provide Internal Review Documents Go Over Interactive Assignment materials

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FDA Science Board, April 2003

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  1. FDA Science Board, April 2003

  2. 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)

  3. 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.

  4. Performance Based Budgeting

  5. Review Performance 2001 - 2002

  6. 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

  7. 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

  8. SELECT 1. Define key requirements for “core” customers 2. Determine process to improve EVALUATE ANALYZE 9. Assess impact of process improvements 10. Standardize process and monitor ongoing improvement 3. Document “as is” process 4. Establish process measures ContinuousProcessImprovement IMPROVE MEASURE 7. Set process improvement goal(s) 8. Develop and implement improvements on a “trial run” basis 5. Gather “baseline” process performance data 6. Identify process performance “gaps” SAMIE™ Model

  9. PMA Filing Process

  10. PMA Filing Process Peer Review

  11. PMA Filing Process Peer Review

  12. 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

  13. I Brainstorm:Possible Solutions

  14. I Brainstorm:Possible Solutions

  15. 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.

  16. 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@cdrh.fda.gov

  17. 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 Examples of expertise needed at CDRH

  18. Implementation

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