MDIC/Xavier University Device Product Quality Metrics October 8,

Team Members FirstLastTitleCompany PaulAndreassiVice President of Quality & RegulatoryFisher & Paykel Healthcare PatBairdDirector, EngineeringBaxter Healthcare AnupamBediDirector of QualityAtriCure PankitBhalodiaDirectorPwC KBBhedaSenior AssociatePwC SteveBinion Director Regulatory Affairs/Corporate Clinical DevelopmentBD RobinBlankenbakerDivisional Quality Operations LeaderW.L. Gore & Associates GinaBrackettCompliance OfficerFDA PatrickCainesDir, Quality & Global post market surveillanceBaxter Healthcare TonyCarrVice President, Global Quality SystemsBoston Scientific KaraCarterSenior Director, QA OperationsAbbott Vascular Division VizmaCarverFounder and CEOCarver Global Health RyanEaveySenior Manager, Quality SystemsStryker 2

Team Members FirstLastTitleCompany JoannaEngelkeSenior Vice President Global QualityBoston Scientific ChrisHoagDirector of Global CAPA and Quality eSystemsStryker FrankJohnstonCorporate Director, Regulatory ComplianceBD JonathanLeeSenior AssociatePwC BillMacFarlandDirector, Division of Manufacturing QualityFDA KristinMcNamaraSenior AdvisorFDA RhondaMeclSupervisory CSOFDA BrianMotterVP Quality and Compliance, DiabetesJ&J MD&D RaviNabarSr. Director Supplier Quality ManagementPhilips StevenNiedelmanLead Quality Systems and Compliance ConsultantKing & Spalding LLP PetePalermoVP Quality AssuranceCR Bard MarlaPhillipsDirectorXavier University 3

Team Members 4 FirstLastTitleCompany GregPiercePresident and FounderEngisystems SusanRolih Executive Vice President, Regulatory and Quality SystemsMeridian Bioscience, Inc. JoeSapienteVP Global Quality OperationsCovidien BenjaminSmith Vice President, Global Quality System & ComplianceBiomerieux IsabelTejeroQuality System Workgroup Lead CSOFDA ShelleyTurcotteWW Director Quality Information SystemsDePuy Synthes SamVenugopal PartnerPwC MartaVillarragaPrincipal Biomedical EngineeringExponent MonicaWilkins Divisional Vice President of Quality and Business SupportAbbott

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 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 6 Pre-Market Production Post-Market

A Systems Approach Pre-Production Production Transfer Production Continual Improvement & Risk Mgmt. Enterprise-Wide Continual Improvement R&D Continual Improvement & Risk Mgmt. Post- Production

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 Oct – Mar 2015 Mar – May 2015 Jun – Sept 2015 Oct – Jun 2016 Beyond Jun 2016 Kick-off Critical Systems Gold/Silver Activities C&E Matrix Finalization of Measures Selection of Top 3 Measures Pilot Pilot Analysis Finalization Conversion of Measures into Metrics Advanced Analytics Maturity Model FDA Risk Assessment Industry Risk Assessment Competency Initiative Plan for Implementation

Potential Model of Alignment with Case for Quality Framework AdvaMed Successful Practices FDA/Xavier MDIC Metrics MDIC Maturity Model MDIC Advanced Analytics MDIC Advanced Analytics MDIC Competency MDIC Competency Risk-Based Resource Allocation Decisions Could be used for