Medical Device Innovation Consortium Device Product Quality Metrics September 8, 2015 1
Presentation Outline Topics to be Addressed Team Members Timeline and Process Pre-Production Metric Development Production Metric Development Post-Production Metric Development Pilot Study Design and Next Steps 2
Team Members * Participated in initial work 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 Binion Director Regulatory Affairs/Corporate Clinical Development 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 Kara Carter Senior Director, QA Operations Abbott Vascular Division Vizma Carver Founder and CEO BD Carver Global Health Group Ryan Eavey Senior Manager, Quality Systems Stryker 3
Team Members * Participated in initial work 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 4
Team Members * Participated in initial work First Last Title Company Greg 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 DePuy Synthes Sam Venugopal Partner PwC Marta Villarraga Principal Biomedical Engineering Exponent Monica Wilkins * Divisional Vice President of Quality and Business Support Abbott 5
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
Power and Benefits of Measures Linkage to Total Product Lifecycle Linkage to Critical Quality Systems Patient Safety Linkage to Critical Requirements Design Robustness Process Reliability Quality System Robustness Failure Costs
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 Conversion of Measures into Metrics Pilot Pilot Analysis Finalization Competency Initiative Advanced Analytics Maturity Model FDA Risk Assessment Industry Risk Assessment
How we Chose the Top 3 Measures Enterprise-Wide Continual Improvement Post- Production Pre-Production Transfer Production R&D Continual Improvement & Risk Mgmt. Production Continual Improvement & Risk Mgmt.
Conversion of Top 4 Measures Process Steps 1. Reviewed the Pre-Work Packet for the Measure to be discussed 2. Aligned on Common Terminology 3. Revised/Improved Wording of Measure if Needed 4. Discussed Metric Ideas Provided 5. Proposed Final Metric(s) 6. Repeated the Process for the remaining 3 measures 10
Pre-Production Identification of design and process elements that eliminate, reduce, and prevent design failures throughout the product lifecycle (including transfer, production, and post-production failures) Metric: Design Robustness Metric Total # of product design changes driven by quality issues / total # of product designs *(factor for age) Product agnostic Measured by Design Center / Product Family / Business Unit (as determined by the company, for their design control process) 11
Pre-Production Evidence that customer input, both internal and external, is actively solicited, documented, and assessed, at all stages of design project. This includes early feedback from controlled market release (pilot) and post-launch VOC data from related products. It was determined that this would be better suited as a guidance than a metric Deemed out of scope for the work of this team 12
Production Tracking and trending of right first time data (i.e. product built with no non-conformance/rework/failed inspections). Metric: # of units mfg. without Non-conformances / # of units attempted excludes planned rework and set up scrap units can be changed out with lots if appropriate Timeframe: Monthly Metrics will be measured by site and if possible, by product Metrics can also be measured by value stream (i.e. category of products / work centers) and by site Track and trend on a rolling basis 13
Post-Production Trending/analyzing key post market surveillance data (e.g., complaints, FCAs, PHOs, HHEs) for overall QMS performance and feed into holistic QMS scorecard. Metric: Complaints * (0.20) + Service Records * (0.10) + Installation Failures * (0.10) + MDRs * (0.10) + Recalls (units) * (0.10) + Recalls (total) * (0.10) + Design Changes * (0.20) + Nonconformances (0.10) 14
Post-Production Index Metric 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 # of product Design Changes Count for the period Non-conformances - total # of NCs / # of units (produced, released, sold, etc.) 15
Pilot Study Design Each company chooses products/work centers to include in the study that have differing levels of complexity and success The study will only be retrospective, and participants have 6 months to complete the work Goal: demonstrate that the metrics are sensitive enough to differentiate between varying levels of product quality Companies will not be compared to each other Pilot Companies to date: Biomerieux, J&J Diabetes, Stryker, WL Gore 16
Immediate Next Steps Virtual meeting on September 10 th Establish NDA with pilot companies Pilot refinement with company input Refinement of metrics tailored to company-specific business Launch of retrospective pilot October - March 17
Pulling it All Together AdvaMed Best Practices FDA/Xavier MDIC Metrics MDIC Maturity Model MDIC Competency MDIC Advanced Analytics Risk Assessment