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MDIC/Xavier University
Device Product Quality Metrics
October 8, 2015
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Team Members
First Last Title Company
Paul Andreassi Vice President of Quality & Regulatory Fisher & Paykel Healthcare
Pat Baird Director, Engineering Baxter Healthcare
Anupam Bedi Director of Quality AtriCure
Pankit Bhalodia Director PwC
KB Bheda Senior Associate PwC
Steve BinionDirector Regulatory Affairs/Corporate Clinical Development BD
Robin Blankenbaker Divisional Quality Operations Leader W.L. Gore & Associates
Gina Brackett Compliance Officer FDA
Patrick Caines Dir, Quality & Global post market surveillance Baxter Healthcare
Tony Carr Vice President, Global Quality Systems Boston Scientific
Kara Carter Senior Director, QA Operations Abbott Vascular Division
Vizma Carver Founder and CEO Carver Global HealthRyan Eavey Senior Manager, Quality Systems Stryker
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Team Members
First Last Title Company
Joanna Engelke Senior Vice President Global Quality Boston Scientific
Chris Hoag Director of Global CAPA and Quality eSystems Stryker
Frank Johnston Corporate Director, Regulatory Compliance BD
Jonathan Lee Senior Associate PwC
Bill MacFarland Director, Division of Manufacturing Quality FDA
Kristin McNamara Senior Advisor FDA
Rhonda Mecl Supervisory CSO FDA
Brian Motter VP Quality and Compliance, Diabetes J&J MD&D
Ravi Nabar Sr. Director Supplier Quality Management Philips
Steven Niedelman Lead Quality Systems and Compliance Consultant King & Spalding LLP
Pete Palermo VP Quality Assurance CR Bard
Marla Phillips Director Xavier University
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Team Members
First Last Title Company
Greg Pierce President and Founder Engisystems
Susan RolihExecutive Vice President, Regulatory and Quality Systems Meridian Bioscience, Inc.
Joe Sapiente VP Global Quality Operations Covidien
Benjamin SmithVice President, Global Quality System & Compliance Biomerieux
Isabel Tejero Quality System Workgroup Lead CSO FDA
Shelley Turcotte WW Director Quality Information Systems DePuy Synthes
Sam Venugopal Partner PwC
Marta Villarraga Principal Biomedical Engineering Exponent
Monica WilkinsDivisional Vice President of Quality and Business Support Abbott
Purpose and Goals
Purpose:
– To support the Case for Quality by increasing the assurance of product quality
Goals: 1. Identify, pilot and publicize predictive product quality metrics
2. Improve assessment of the evolving state of product quality
3. Enable FDA risk-based resource allocation decisions
4. Provide Payor visibility to product quality risk
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Final Metrics
• Design Robustness Indication– Identification of design elements that eliminate, reduce, and prevent design failures
throughout the product lifecycle
• Right First Time Indication– Tracking and trending production-related right first time data to eliminate, reduce, and
prevent repeat failures
• Post-Market Indication– Analysis of key post market surveillance data to eliminate, reduce and prevent on-
market failures
Pre-Market
Production
Post-Market
A Systems Approach
Pre-Production ProductionTransfer
ProductionContinual Improvement
& Risk Mgmt.
Enterprise-Wide Continual Improvement
R&DContinual Improvement
& Risk Mgmt.
Post-Production
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Pilot Study Design
Goal: to demonstrate that the metrics are sensitive enough to differentiate between varying levels of product quality
• Pilot Companies to date: – Abbott, Baxter, Biomerieux, Boston Scientific, J&J, Meridian Bioscience,
Stryker, WL Gore
• Pilot Details:– The study will only be retrospective, and participants have 6 months to
complete the work– Each company will choose products/work centers to include in the
study that have differing levels of complexity and success– Companies will not be compared to each other
Timeline and Process
Sept.2014
Oct. 2014 – Mar 2015
Mar – May2015
Jun – Sept2015
Oct. 2015 – Jun 2016
Beyond Jun2016
Kick-offCritical
Systems
Gold/Silver Activities
C&E Matrix
Finalization of Measures
Selection of Top 3
MeasuresPilot
Pilot Analysis
FinalizationConversion
of Measures into Metrics Advanced
Analytics
Maturity Model
FDA Risk Assessment
Industry Risk Assessment
CompetencyInitiative
Plan for Implementation
Potential Model of Alignment with Case for Quality Framework
AdvaMedSuccessful Practices
FDA/XavierMDIC Metrics
MDICMaturity Model
MDICAdvanced Analytics
MDICCompetency
Risk-Based Resource Allocation Decisions
Could be used for