Medical Device Quality Enhancement An Industry Perspective

1. Medical Device Quality EnhancementAn Industry Perspective Donna Godward Chief Quality Officer Johnson & Johnson Medical Devices & Diagnostics

2. Medical Device Quality EnhancementAn Industry Perspective Goal • To improve product safety and quality, at lower total quality cost Engagement: • How can Industry and FDA interact to identify way to focus on Quality

3. Medical Device Quality Enhancement: An Industry Perspective • Clear priorities, aligned goals and objectives • Shifting the focus to quality from compliance • Evolve regulatory models to promote device quality and aligning industry and FDA to “Focus on Quality” • Achieve a preventative model with agreed Risk-Benefit framework • Improve our ability to measure quality and early indicators • Improve education and awareness within industry, • Clarify and communicate the “Case for Quality” • Identification and validation of Quality practices

4. Medical Device Quality Enhancement: An Industry Perspective • FDA and Industry engagement • Coalition for • Enhancing medical device quality • Transparency • Engagement • Work streams • Risk-benefit decision making • Quality benchmarking, CTQ & root cause • National and Local forum planning

5. Medical Device Quality EnhancementAn Industry Perspective • Leadership from FDA and Medical Device companies • Strong foundation for “productive relationships” • Dialogue between FDA and Medical Device companies • Focus on Quality

6. Medical Device Quality EnhancementAn Industry Perspective Thank you