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MDIC Case for Quality: Driving Medical Device Quality

MDIC is a leading resource on issues important to the Medtech innovation ecosystem. Through the Case for Quality initiative, MDIC is working cooperatively to re-engineer pre-competitive technology innovation, reduce time and resources needed for new technology development, and help patients gain access to new medical technologies sooner.

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MDIC Case for Quality: Driving Medical Device Quality

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

  2. MDIC Highlights • 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 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 WORKING COOPERATIVELY to re-engineer pre-competitive technology innovation Align Resources REDUCINGTIME and resources needed for new technology development, assessment, and review Accelerate Progress HELPING PATIENTS gain access to new medical technologies sooner Achieve Results www.MDIC.org

  3. 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

  4. 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.

  5. MDIC Case for QualityBroad 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: • Conduct research on Quality Maturity Models, • Create a venue for Quality Engagement Forums,  • Create a list of key topics to be used to generate discussion and interaction during these sessions, • Develop a Change Action Plan summarizing the results.

  6. MDIC Case for Quality 2015* Schedule SC Forums Dec 8th March 24th Washington, DC May 20th Washington, DC September 8th Washington, DC Open/Large Forums MDICx June 24th October 8 San Diego, CA Working Groups Updates Updates Updates SC Reviews/ Approves New Working Groups Current 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

  7. WG Future - TBD Program Manager Steering Committee Quality Forum MDIC Staff Analytics (Early Development Work) WG Competencies MDIC Case for Quality Program 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] President – CEO – Bill Murray Support Staff Industry Representatives, FDA, Customer[s], Other Stakeholders & Associations Working Groups WG Measures WG Quality Maturity Models WG Future - TBD Chair: Bill Murray;acting George Serafin Chair: TBD Chair: TBD Chair: Kristin McNamara Marla Phillips Chair: Joe Sapiente Pat Baird Chair: Garth Conrad Joanna Engelke

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