1. MDIC/Xavier University Device Product Quality Metrics December 8, 2015

2. Key Topics for Discussion I.Purpose & Goals of Quality Metrics Initiative II.Team Members III.Approach, timeline and milestones ─Approach and overall timeline ─Implementation Best Practices, soliciting input & timeline ─Metrics and Pilot Study IV.Questions 2

3. MDIC Initiatives 3 Device Quality MetricsMaturity Model Competency Advanced Analytics

4. Purpose and Goals Purpose: – To support the Case for Quality by increasing the assurance of product quality Goals: 1.Identify, pilot, plan how to implement, and publicize predictive product quality system metrics 2.Improve assessment of the evolving state of product quality 3.Enable risk-based resource allocation decisions 4.Provide greater visibility to product quality risk 4

5. Team Members (1 of 2) FirstLastTitleCompany PaulAndreassiVice President of Quality & RegulatoryFisher & Paykel Healthcare PatBairdDirector, EngineeringBaxter Healthcare AnupamBediDirector of QualityAtriCure PankitBhalodiaDirector, Health Industries Advisory PLSPwC KankshitBhedaManager, Health Industries Advisory PLSPwC SteveBinion Director Regulatory Affairs/Corporate Clinical Development BD 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 JoannaEngelkeSenior Vice President Global QualityBoston Scientific ChrisHoagDirector of Global CAPA and Quality eSystemsStryker FrankJohnstonCorporate Director, Regulatory ComplianceBD JonathanLeeSenior Associate, Health Industries Advisory PLSPwC 5

6. Team Members (2 of 2) 6 FirstLastTitleCompany 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 GregPiercePresident and FounderEngisystems SusanRolihExecutive Vice President, Regulatory & Quality SystemsMeridian Bioscience, Inc. JoeSapienteVP Global Quality OperationsCovidien BenjaminSmithVice President, Global Quality System & ComplianceBiomerieux IsabelTejeroQuality System Workgroup Lead CSOFDA ShelleyTurcotteWW Director Quality Information SystemsDePuy Synthes SamVenugopal Partner, Health Industries Advisory PLSPwC MartaVillarragaPrincipal Biomedical EngineeringExponent MonicaWilkinsDivisional Vice President of Quality & Business SupportAbbott

7. 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 Pilot Pilot Analysis Finalization Conversion of Measures into Metrics Advanced Analytics Maturity Model Competency Initiative Develop Implementation “Best Practices” MDIC Adoption Risk Assessment 7 Focus for today

8. A Systems Approach Pre-Production Production Transfer Production Continual Improvement & Risk Mgmt. Enterprise-Wide Continual Improvement R&D Continual Improvement & Risk Mgmt. Post- Production 8

9. Metrics for the Pilot Study SystemMetric / DefinitionMetric CalculationComments Pre- Production Design Robustness Indication (Identification of design elements that eliminate, reduce, and prevent design failures throughout the product lifecycle) total # of product changes total # of products with initial sales in the period Indicator of the time, resources and cost for products to reach a mature state Periods being 0-12 months, 12-24, 24-36 (or as determined by the company) Companies can include process changes as well if possible ProductionRight First Time Indication (Tracking and trending production-related right first time data to eliminate, reduce, and prevent repeat failures) # of units mfg. without Non-conformances # of units started “units” can be changed out with “lots” if appropriate Timeframe: Monthly Metrics will be measured by site and if possible, then by product Track and trend on a rolling basis Will include planned rework and set-up scrap Post- Production Post-Market Indication (Analysis of key post market surveillance data to eliminate, reduce and prevent on-market failures) Index: Complaints * (0.20) + Service Records * (0.10) + Installation Failures * (0.20) + MDRs * (0.20) + Recalls (units) * (0.20) + Recalls (total) * (0.10) Complaints: Complaints for the product / units sold (for the product) Service Records: Records per product / # of total units in service (for the period) Installation failures: # of installation failures/ total # of installations (for the period) MDRs: MDRs for the product / units sold (for the product) Recalls: # of units recalled / # of units sold (for the period) – worldwide (if applicable) Recalls: # of recalls (for the period) – worldwide 9

10. Implementation Best Practices Purpose: To help organizations understand how to best use the output from the metrics to inform decisions and trigger actions – Output can be used to understand root causes – Output can be combined with the output of other metrics to understand a more holistic picture, analyze trends, etc. – Goal is to provide a feedback loop to improve systems that allowed the failure to occur originally – Improve the systems from the earliest point possible 10 OctoberNovemberDecemberJanuaryFebruary March Kick-off and Champions identified Team members begin drafting and soliciting input. Gathering input - Includes feedback from firm SMEs Champions present key input received Champions present drafted processes to team members Recommended process finalized

11. Metric Implementation Input 11

12. Pilot Study Details 12 Pilot Study Goal: to demonstrate that the metrics are sensitive enough to differentiate between varying levels of product quality A total of 8 companies are participating in the pilot study The pilot study involves 36 months of retrospective data collection Each company will choose products that have differing levels of complexity and success Results will be presented in aggregate and at no point will company-specific data be made available to MDIC, FDA, or the public Trends, patterns, etc. coming out of the data analysis phase will be identified and presented in the final report

13. Pilot Study Details 13 Pilot Study Goal: to demonstrate that the metrics are sensitive enough to differentiate between varying levels of product quality

14. Thank you! Questions? 14