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Quality Staffing & Performance: Ensuring Quality and Safety While Managing Cost Effectiveness for Medical Device Companies


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This study provides insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research …

This study provides insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research establishes meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally.

Published in: Health & Medicine, Business
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  • 1. Benchmarking Quality Staffing & Performance: How Medical Device & Technology Companies Ensure Quality & Safety While Managing Cost Effectiveness Best Practices, LLC Strategic Benchmarking Research BEST PRACTICES, ® LLC
  • 2. TABLE OF CONTENTSI. Research Objective & Methodology p. 3-15II. Quality Organization Cost & Staffing p. 16-24III. Quality Organization Structure p. 25-37IV. IT Solutions for Quality Activities p. 38-46V. Managing Document Control p. 47-56VI. Employing Quality Audits & Management Reviews p. 57-67VII. Deploying Quality Training p. 68-72VIII. Managing Software Quality p. 73-79IX. Managing Supplier Quality & Incoming/Receiving Inspections p. 80-87X. Managing Manufacturing/Outgoing Inspections p. 88-95XI. Managing Laboratory Testing & Scientific Quality Processes p. 96-103XII. Complaint Management & Resolution Activities p. 104-118XIII. Managing NCE Activity p. 119-124XIV. Managing Corrections & Removals p. 125-127XV. Supporting R&D Clinical Trials p. 128-131XVI. Quality System p. 132-135XVII. Future Directions for Quality Organization p. 136-143 BEST PRACTICES, ® LLC
  • 3. Research Objective & Methodology BEST PRACTICES, ® LLC
  • 4. Research Background and MethodologyBest Practices, LLC conducted this benchmarking study to establish meaningfulbenchmarks for the resource levels and the activities scope of the Quality function formedical device companies. Background: Medical Device and Technology companies devote significant resources to ensure their products meet quality standards and regulations at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market activity. Increasingly, companies are challenged to ensure quality and safety while managing costs and assessing risk. This survey benchmarks how companies are addressing these critical quality, safety, regulatory and business requirements. Field Research & Insight Development: Objective:  Surveyed 11 leaders at 11 medical device To uncover resource and activity INFORM companies. benchmarks as well as forward-  Conducted five deep-dive executive interviews to looking insights about the collect qualitative insights from selected survey Quality function at medical participants. device companies. Deep Dive Interview Questions: 1. What improvement initiatives are you working on in the Quality function? 2. Where are you taking out headcount – why is this an area for cuts? 3. How are you approaching risk with fewer resources - fewer inspections, etc.? 4. What are the primary drivers of outsourcing or off shoring Quality activities? 5. What are your systems for effectively and efficiently managing complaints? 6. Does sustaining engineering include production line support and product design? BEST PRACTICES, 4 ® Copyright © Best Practices, LLC LLC
  • 5. Universe of Learning: 11 Companies EngagedResearch participants included 11 executives from 11 medical device companies. Fiveexecutives participated in interviews. Nitinol Devices & Components Participating Companies: Bausch & Lomb; Boston Scientific; Covidien; Edwards Lifesciences; Ethicon; Medrad; Medtronic; Nitinol Devices & Components; Roche Diagnostics; Terumo Medical; Zimmer BEST PRACTICES, 5 ® Copyright © Best Practices, LLC LLC
  • 6. Medical Device Revenue Averages $5.6BMedical device and technology companies of all sizes face regulatory changes and mustadapt resources to meet demand. Medical device revenue in the benchmark class averagesapproximately $5.6B. Q. Please estimate your companys 2010 annual revenue from medical device sales and relatedservices. (Provide figures in U.S. dollars, using data from 2010 or most recently completed fiscal year.) Estimated Medical Device Revenue ($USD): Max $16,000,000,000 75th Percentile $9,903,000,000 Mean $5,551,636,364 Median $4,300,000,000 25th Percentile $1,075,000,000 Min $62,000,000(n = 11) BEST PRACTICES, 6 ® Copyright © Best Practices, LLC LLC
  • 7. Nearly 2/3 Increased Quality’s Staffing during Past 3 YearsAlmost two-thirds of the benchmark class indicated growth in quality function staffingand only 18% of companies indicated a decrease in the number of FTEs over the pastthree years. The average percent change of total FTEs was positive 8%. The range ofpercent changes for staffing was -7 to 13%. Q. Staffing Change Trend: How has the total numbers of FTEs of your companys medical device Quality function changed during the past three years? (Choose direction, then fill in the % change.) Decreased, Increased, % Change of Quality 18% 64% FTEs in Medical Devices and Related Services: Max 13% 75th Percentile 12% Mean 8% Median 10% 25th Percentile 9%Remained the same Min -7% 18% (n = 11) (n = 7) BEST PRACTICES, 7 ® Copyright © Best Practices, LLC LLC
  • 8. Quality Span of Control Ranges from 5 to 12 Direct ReportsSome companies provide a robust span of control for managers and senior managers.Managers oversee twice as many direct reports as Vice Presidents, and more than fivemore direct reports than their counterparts. Directors in quality have the smallest spanof control, averaging around five direct reports. Q. Quality Span of Control: What is the average number of direct reports for a dedicated Quality employee at each of the following levels? Vice Director Senior Manager Manager President Max 8 8 20 60 75th Percentile 7 6 7 8 Mean 6 5 7 12 Median 6 5 5 6 25th Percentile 5 4 3 4 Min 1 1 2 3 (n = 9 9 7 10) BEST PRACTICES, 8 ® Copyright © Best Practices, LLC LLC
  • 9. Compliance/Document Control is Automated with SomeCentralizationAll medical device companies indicated some level of automation, with nearly halfresponding that they highly automate in order to achieve high performance. In contrast,centralization of this function is not as prevalent, as the benchmark class demonstratedvarying levels of centralization. Q. Organizational Approach For Achieving High Q. Organizational Approach For Achieving High Performance in Compliance/Document Control: Performance in Compliance/Document Control: How centralized is this function? (Choose one) How automated is this function? (Choose one) Highly 9% Completely centralized 0% automated Mostly 27% Highly centralized 45% automatedSome activities Some 36% 55% centralized automation Mostly 9% Mostly manual 0% decentralized Completely Completely 18% 0% decentralized manual(n = 11) (n = 11) BEST PRACTICES, 9 ® Copyright © Best Practices, LLC LLC
  • 10. Corporate Level Quality Management Reviews are CompletelyStandardized for 55%Over 90% of corporate quality management reviews are mostly standardized, with 55% ofthese reviews being completely standardized. More importantly, almost two-thirds ofbusiness unit and manufacturing sites have mostly standardized quality managementreviews as well.Q. Standardization of Quality Management Reviews: Please indicate the standardization of your Quality Management Reviews at each level. (Choose one per level.) N/A No standardization Some standardization Mostly standardization Complete Standardization n= Corporate 9% 36% 55% 11 Business 11 9% 27% 45% 18% units/divisions Manufacturing sites 18% 18% 45% 18% 11 Other 50% 50% 2 Other: • Operations Quality Management Review • Regions that dont have a manufacturing site BEST PRACTICES, 10 ® Copyright © Best Practices, LLC LLC
  • 11. About Best Practices, LLCBest Practices, LLC is a research and consulting firm that conductswork based on the simple yet profound principle that organizationscan chart a course to superior economic performance by studyingthe best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 BEST PRACTICES, ® LLC