Medical Device Innovation Consortium Device Product Quality Metrics - PowerPoint PPT Presentation

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

* Participated in Team Members initial work First Last Title Company Andreassi * Paul 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 Steve Binion 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 Kara Carter Senior Director, QA Operations Abbott Vascular Division Carver Global Health Vizma Carver Founder and CEO Group Ryan Eavey Senior Manager, Quality Systems Stryker 3

* Participated in Team Members 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

* Participated in Team Members initial work First Last Title Company Greg Pierce President and Founder Engisystems Executive Vice President, Regulatory and Susan Rolih * Quality Systems Meridian Bioscience, Inc. Joe Sapiente * VP Global Quality Operations Covidien Vice President, Global Quality System & Benjamin Smith 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 Divisional Vice President of Quality and Monica Wilkins * 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 Linkage to Critical Requirements Patient Safety Design Process Quality System Failure Costs Robustness Reliability Robustness

Timeline and Process Sept. Oct. 2014 – Mar – May Jun – Sept Oct. 2015 – Beyond Jun 2014 Mar 2015 2015 2015 Jun 2016 2016 Kick-off Critical Systems Gold/Silver C&E Matrix Activities Selection of Finalization Top 3 of Measures Pilot Measures Competency Pilot Analysis Conversion Initiative of Measures Finalization Advanced into Metrics Analytics Maturity Model FDA Risk Assessment Industry Risk Assessment

How we Chose the Top 3 Measures Enterprise-Wide Continual Improvement Post- Production Transfer Production Pre-Production Production R&D Continual Improvement Continual Improvement & Risk Mgmt. & 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) + Non- conformances (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 FDA/Xavier MDIC Best Practices MDIC Metrics Maturity Model MDIC MDIC Competency Advanced Analytics Risk Assessment