1 Beth Staub and Joseph Sapiente FDA Case for Quality

2 2 The Medical Device Industry Projected $ 133 B 2016 More than 6,500 companies 80% less than 50 people

3 3 The Case for Quality Began the dialogue: Focus on Compliance vs Product Quality Measurement and Transparency Culture

4 4 The Case for Quality “ the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details” The Regulations Provide the “What”

5 5 The “WHAT” of CAPA PART Corrective and Preventive action: Establish and maintain procedures… Investigating the cause of nonconformities… Identifying the action needed… Verifying or validating the action … Implementing and recording changes ……

6 6 The “HOW” of CAPA Containment and Interim Corrective Action Problem Solving - DMAIC, 8D, 5 Whys, Fishbone diagrams Project Management Metrics Culture - Reward and Recognition

7 7 “I don’t know exactly what product quality even means” “OK, thanks for telling me what it means…how do I recognize it, measure it, know if I have it?” “Daunting! How do I figure out the practical ‘know how’ to implement this well in my company?” “How can we help the business people appreciate the value of quality so they will support our efforts?” “Is FDA going to support this approach?” The Questions We are all Asking

8 8 Case for Quality Framework Initiated from FDA’s 2012 Whitepaper: “Understanding the Barriers to Device Quality” ISO FDA QSR 21.CFR.820 Local Regulations Standards Product Quality Definition How to Measure How to Implement How to Derive the Value How Evolve Culture from Compliance to Quality

9 9 Product Quality Definition How to Measure How to Implement How to Derive the Value How Evolve Culture from Compliance to Quality Case for Quality Framework MDIC/Xavier Metrics MDIC Maturity Model MDIC Advanced Analytics: Customer Based Scorecard FDA Data Transparency AdvaMed Library of Successful Quality Practices MDIC Competency Training FDA Library of Practices FDA CTQ Battery Pilot FDA Inspectional CTQ Handbooks AdvaMed/FDA Definition

10 Your Input is Needed As you listen and interact today… What are your reactions? −Framework −Projects −Approach to working together What could be added, adjusted, re-prioritized? Any other suggestions? Any way you want to be more involved?