MDIC/Xavier University
Device Product Quality Metrics
October 8, 2015
1
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
Binion
Director 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 Health
Ryan
Eavey
Senior Manager, Quality Systems
Stryker
2
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
3
Team Members
First
Greg
Last
Title
Company
Pierce
President and Founder
Engisystems
Susan
Rolih
Executive Vice President, Regulatory and
Quality Systems
Meridian Bioscience, Inc.
Joe
Sapiente
VP Global Quality Operations
Covidien
Benjamin
Smith
Vice 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
Wilkins
Divisional Vice President of Quality and
Business Support
Abbott
Monica
4
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
Final Metrics
Pre-Market
• Design Robustness Indication
– Identification of design elements that eliminate, reduce, and prevent design failures
throughout the product lifecycle
Production
• Right First Time Indication
– Tracking and trending production-related right first time data to eliminate, reduce, and
prevent repeat failures
Post-Market
• Post-Market Indication
– Analysis of key post market surveillance data to eliminate, reduce and prevent onmarket failures
6
A Systems Approach
Enterprise-Wide
Continual Improvement
PostProduction
Transfer
Pre-Production
R&D
Continual Improvement
& Risk Mgmt.
Production
Production
Continual Improvement
& Risk Mgmt.
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
8
Timeline and Process
Sept.
2014
Oct. 2014 –
Mar 2015
Mar – May
2015
Jun – Sept
2015
Oct. 2015 –
Jun 2016
Beyond Jun
2016
Kick-off
Critical
Systems
Gold/Silver
Activities
C&E Matrix
Finalization
of Measures
Selection of
Top 3
Measures
Conversion
of Measures
into Metrics
Pilot
Pilot Analysis
Finalization
Competency
Initiative
Advanced
Analytics
Plan for
Implementation
Maturity
Model
FDA Risk
Assessment
Industry Risk
Assessment
Potential Model of Alignment with
Case for Quality Framework
AdvaMed
Successful Practices
MDIC
Competency
FDA/Xavier
MDIC Metrics
MDIC
Maturity Model
MDIC
Advanced Analytics
Could be used for
Risk-Based Resource
Allocation Decisions