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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