1 Suzanne Fiorino, MDIC CfQ Program Manager MDIC Case for Quality Open Forum October 8, 2015

2

3 A 501(c)3 - Public-Private Partnership collaborating on Regulatory Science to make patient access to new medical device technologies faster, safer, and more cost-effective 49 Members 5 Projects Leading resource on issues important to the Medtech innovation ecosystem Congressional testimony on modernizing clinical trials $500k funding from FDA for Patient-Centered Benefit Risk Implementation Framework- Project Completed $643k funding from FDA for Quality Engagement Forum MDIC Highlights Align Resources Accelerate Progress Achieve Results WORKING COOPERATIVELY to re-engineer pre-competitive technology innovation WORKING COOPERATIVELY to re-engineer pre-competitive technology innovation REDUCING TIME and resources needed for new technology development, assessment, and review REDUCING TIME and resources needed for new technology development, assessment, and review HELPING PATIENTS gain access to new medical technologies sooner HELPING PATIENTS gain access to new medical technologies sooner

4 The FDA Case for Quality – History Background: −Observations of repetitive quality issues among device manufacturers −Stagnant data regarding these quality issues Response: −Engaged McKinsey to analyze device quality issues −Reported on these findings in the 2011 “Understanding Barriers to Quality” white paper −Developed a plan to address these findings, aka the Case for Quality

5 The Case for Quality – Intent The Case for Quality initiative is intended to drive through the barriers to medical device quality identified in the white paper. Elevate the device sector focus from baseline regulatory compliance to a sustained state of enhanced medical quality. Achieve this by creating continuous engagement with a broad set of stakeholders in the device product quality arena.

6 MDIC Case for Quality Broad Agency Agreement (BAA) Goal: Develop a better understanding of what changes are necessary to catalyze industry movement towards improved device quality. Strategy: Conduct research through Quality Engagement Forums of medical device industry stakeholders and summarize the findings from those interactions in a comprehensive Change Action Plan. Objectives: 1.Conduct research on Quality Maturity Models,  2.Create a venue for Quality Engagement Forums,  3.Create a list of key topics to be used to generate discussion and interaction during these sessions,  4.Develop a Change Action Plan summarizing the results.

7 MDIC Case for Quality 2015* Schedule Open/Large Forums Forums SC MDICx June 24th October 8 San Diego, CA March 24 th Washington, DC May 20 th Washington, DC September 8 th Washington, DC Dec 8th Working Groups Current Updates SC Reviews/ Approves New Working Groups Steering Committee Meetings Regular Forum Meetings Periodic Open Forum Meetings Working Groups meet and make progress between Forum Meetings * First Forum date in 2016 will be March 8th

8 MDIC Case for Quality Program Program Manager Steering Committee Board Champion: Aran Maree Program Manager: Suzanne Fiorino FDA: Steve Solomon, Jan Welch Members: Sarah Deegan, Joe Sapiente (Industry SC head), Joanna Engelke, Beth Staub, Steve Binion [Tech Adv - Garth Conrad & Francisco Vicenty] MDIC Staff President – CEO – Bill Murray Support Staff Working Groups WG Competencies WG Quality Maturity Models Analytics (Early Development Work) WG Future - TBD WG Measures WG Future - TBD Chair: Kristin McNamara Marla Phillips Chair: Joe Sapiente Pat Baird Chair: Bill Murray;acting George Serafin Chair: Garth Conrad Joanna Engelke Chair: TBD Chair: TBD Quality Forum Industry Representatives, FDA, Customer[s], Other Stakeholders & Associations