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Donna GodwardChief Quality OfficerJohnson & JohnsonMedical Devices & Diagnostics

Medical Device Quality EnhancementAn Industry Perspective

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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 EnhancementAn Industry Perspective

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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

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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

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• 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 EnhancementAn Industry Perspective

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Medical Device Quality EnhancementAn Industry Perspective

Thank you