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Benchmarking Quality: How Medical Device & Diagnostics Companies Manage Cost Effectiveness while Ensuring Quality & Safety

ID: POP-247


17 Info Graphics

92 Data Graphics

1380+ Metrics

4 Narratives

3 Best Practices

Pages: 136

Published: Pre-2016

Delivery Format: Shipped


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Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.

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Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are preparing to shift resources, automate and outsource activities, develop and retain key talent, and build business plans that justify their budgets.

This Best Practices, LLC, report delivers comprehensive survey benchmarks on how medical device companies are defining and allocating Quality spend, identifying factors that impact spending levels, and investing in future mission-critical Quality activities.

Quality leaders can use the evidence-based metrics and insights for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.

Industries Profiled:
Medical Device

Companies Profiled:
3M Health Care; Bard; Boston Scientific; Cochlear; Edwards LifeSciences; KCI; Lake Region Medical; Medtronic; Stryker; Terumo Medical; UreSil; WelchAllyn

Study Snapshot

Best Practices, LLC engaged 12 Quality leaders, nearly half of whom serve as vice presidents in Quality, from 12 medical device companies through a benchmarking survey instrument. Eleven of 12 benchmark companies represented are based in the United States.
Topics addressed in this report include:

  • Quality Spend Levels and Inclusions/Exclusions
  • Future Quality Spend Drivers & Normalizers
  • Acquisition & Integration Levels
  • Future Pitfalls & Challenges for the Quality Function
  • Quality Staffing Levels
  • Volume of Change Requests, Complaints, CAPAs, and NCEs
  • Budget Allocations for Key Quality Activities including: Compliance; Inspection/ Production; Non-conforming; Product Support; Other Quality Activities
  • Degree of Quality Responsibility Across Key Activity Areas
  • Use of Offshoring and Outsourcing in Low-wage Labor Markets for Quality Activities

Key Findings

Quality Spend/2012 Revenue: On average, participating companies spend about 1.8% of revenue on the Quality function. For large companies, the average was lower at 1.7% and maxes out at 4.3%.

Quality Span of Control: The average span of control for supervisory level staff in the Quality function ranges from 5.8 FTEs for Directors up to 6.9 for Managers. With slightly broader spans of control, Quality VPs in the large company segment oversee an average of 6.7 FTEs, while Managers have a span of control of 8.1 and Senior Managers have 6.6. Directors oversee an average of 6.1 FTEs in large companies.

Quality Budget Allocations for Key Activities: On average, benchmarked companies spend 30% of their Quality function budgets on product support, with an additional 25% going to inspection/production and 23% to non-conforming events. Compliance activities consume an average 16% of budgets.

Table of Contents

Executive Summary
  • Key Findings & Insights
  • Inclusions & Exclusions Impact Quality Spend Levels
  • Future Quality Spend Drivers: Complexity, High Change Rates & Increased Regulatory Scrutiny
  • Future Quality Spend Normalizers: Simplification, Standardization, Divestitures & Automation
  • Fully Integrating Independent Quality Systems & Acquisitions Supports Standardization & Simplification
  • Regulatory Scrutiny & Internal Complexity, Efficiencies & Cost Pressures Challenge Quality Leaders for Next Two Years
  • Quality Staffing Steadies After Three Years of Influx
  • Quality Budget Allocations for Key Activities Favor Product Support & Compliance Activities
  • Compliance: Quality Plays Leading Role in Compliance Activities with Help from Company Sites in Low-Wage Labor Markets
  • Compliance: Up to Half of Released Documents Changed or Updated in 2012
  • Inspection/Production: Quality Takes the Lead in Majority of Inspection/Production Activities with Help of Outsourcers in Low-Wage Labor Markets
  • Inspection/Production: Varied Size of Supplier Networks – Still Requires Detailed Inspection 60%+ of Incoming Batches for Most
  • Inspection/Production: Software Validation Activities Span Several Functions with Many Landing Under Quality's Purview
  • Inspection/Production: Centralized Labs & Outsourced Vendors Perform Majority of Sterilization, Toxicology, & Biocompatibility Qualification Tests
  • Non-Conforming: Quality Governs Non-Conforming Activities with Help of Company Sites in Low-Wage Labor Markets
  • Non-Conforming: Cycle Times for Processing CAPAs Can Take Up to A Year or More
  • Non-Conforming: Virtual Reviews & Automation Help Manage Thousands of Annual Complaints
  • Product Support: Pre-Clinical & Clinical Quality Assurance Activities Not Often Led by Quality
  • Product Support: Quality Is Involved in Many Aspects of Design Control & Cross-Charge Related Expenses
  • Additional Quality Activities: Quality Supports Many Additional Activities with Use of Company Sites & Outsourced Vendors in Low-Wage Labor Markets
  • Universe of Learning: Key Demographics of Participating Companies
  • Appendix