Comprehensive Study Provides Key Benchmarks for Spending and Staffing of Quality Function within Medical Device Sector

Jan 29, 2016, 18:30 ET from Best Practices, LLC

CHAPEL HILL, N.C., Jan. 29, 2016 /PRNewswire/ -- The quality function is one of the most expensive roles within the medical device industry, and one of the most important. The role of the quality function is to ensure products meet quality standards at every stage of the product life cycle.

But tight budgets and escalating regulations have made it challenging for quality leaders as they balance quality and safety with costs and risk.

Research and consulting leader Best Practices, LLC used a primary research project to give medical device quality leaders insights into the critical aspects of running an effective quality group. Staffing metrics, current and future spending levels and drivers, and budget allocations for key quality activities are a few of the top-line topics addressed in "Benchmarking Medical Device Quality 2014-15: Managing Costs While Ensuring Quality & Safety."

This study is a comprehensive overview of the quality function that not only benchmarks specific quality functional spend and data but also the spend and metrics for any and all quality and compliance-related activities done by other functions, such as Regulatory Affairs, Operations, etc.

More than half of participating companies saw spending increase for the Quality function over the past three years with an average amount of increase in spending of 1.5% for the full benchmark class and 6.5% for the large companies in the study, according to the new report. Regulatory requirements, business expansion/new products, and integration activities were cited as some of the principal forces behind the increased Quality spend.

Key Topics addressed in the 158-page 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

For this study, Best Practices, LLC engaged executives at 21 leading medical device companies to participate in a comprehensive custom benchmarking survey. Almost half - 48% - of the participants were at the vice president level.

To access the full report or to download a complimentary summary containing insights found in this report, click on the following link:

For related research, visit our Best Practices, LLC Web site at

Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

SOURCE Best Practices, LLC