SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Confidential. For J&J internal use only. | 1 Donna Godward Chief Quality Officer Johnson & Johnson Medical Devices & Diagnostics Medical Device Quality Enhancement An Industry Perspective

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Confidential. For J&J internal use only. | 2 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 Medical Device Quality Enhancement An Industry Perspective

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Confidential. For J&J internal use only. | 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

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Confidential. For J&J internal use only. | 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

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Confidential. For J&J internal use only. | 5 Leadership from FDA and Medical Device companies Strong foundation for productive relationships Dialogue between FDA and Medical Device companies Focus on Quality Medical Device Quality Enhancement An Industry Perspective

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Confidential. For J&J internal use only. | 6 Medical Device Quality Enhancement An Industry Perspective Thank you