MDICXavier University Device Product Quality Metrics October 8

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 Atri. Cure Pankit Bhalodia Director Pw. C KB Bheda Senior Associate Pw. C 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 e. Systems Stryker Frank Johnston Corporate Director, Regulatory Compliance BD Jonathan Lee Senior Associate Pw. C Bill Mac. Farland Director, Division of Manufacturing Quality FDA Kristin Mc. Namara 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 De. Puy Synthes Sam Venugopal Partner Pw. C 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 Post. Production Transfer Pre-Production R&D Continual Improvement & Risk Mgmt. 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 Kick-off Oct. 2014 – Mar 2015 Mar – May 2015 Jun – Sept 2015 Oct. 2015 – Jun 2016 Beyond Jun 2016 Critical Systems Gold/Silver Activities C&E Matrix Finalization of Measures Selection of Top 3 Measures Conversion of Measures into Metrics Pilot Analysis Finalization Plan for Implementation Competency Initiative Advanced Analytics Maturity Model FDA Risk Assessment Industry Risk Assessment

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