MDIC Xavier University Device Product Quality Metrics Team and Goals
This document captures the team members involved in the MDIC Xavier University Device Product Quality Metrics project, highlighting their roles and companies. The purpose and goals of the project include enhancing product quality assurance and enabling resource allocation decisions by identifying predictive metrics, improving quality assessment, and providing visibility to product quality risk. The final metrics focus on pre-market design robustness and production efficiency.
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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 Director Regulatory Affairs/Corporate Clinical Development Steve Binion 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 Last Title Company Greg Pierce President and Founder Engisystems Executive Vice President, Regulatory and Quality Systems Susan Rolih Meridian Bioscience, Inc. Joe Sapiente VP Global Quality Operations Covidien Vice President, Global Quality System & Compliance Benjamin Smith 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 Divisional Vice President of Quality and Business Support Monica Wilkins Abbott 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 on- market failures 6
A Systems Approach Enterprise-Wide Continual Improvement Post- Production Transfer Production Pre-Production Production R&D Continual Improvement & Risk Mgmt. 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 Selection of Top 3 Measures Finalization of Measures Pilot Pilot Analysis Competency Initiative Conversion of Measures into Metrics Finalization Advanced Analytics Maturity Model Plan for Implementation FDA Risk Assessment Industry Risk Assessment
Potential Model of Alignment with Case for Quality Framework AdvaMed FDA/Xavier MDIC Metrics MDIC Successful Practices Maturity Model MDIC MDIC Competency Advanced Analytics Could be used for Risk-Based Resource Allocation Decisions
