Benchmarking Medical Device Quality: Spending and Staffing Trends and Ratios

STUDY OVERVIEW

Medical device and diagnostics companies spend millions of dollars and hire hundreds of staff to ensure their products meet quality standards at every stage of the product lifecycle. And with quality organizations facing new products and escalating regulations, spending and staffing are areas that quality leaders continually evaluate.

This study presents data and benchmarks that review current quality spending and staffing trends. Also, quality spend is examined in terms of activities and administrative charge inclusions and exclusions., and as a percent of total revenue. In addition, quality staffing is studied in terms of total FTEs, as a percent of the total work force and spending per FTE. The study also reviews the extent of quality spending for critical quality sub-groups such as compliance, product support and others.

This study includes a Large Company and a Total Benchmark Class segment

KEY TOPICS

• Inclusions & Exclusions Impact Quality Spend Levels
• Quality Staffing Steadies After Three Years of Influx
• Quality Budget Allocations for Key Activities Favor Product Support & Compliance Activities
• Universe of Learning: Key Demographics of Participating Companies

• Quality Spending Trend over Past 3 Years
• Quality Spend for 2012 - Inclusions and Exclusions
• Quality Spend as a Percent of Total Revenue
• Percent Change of FTEs over Past Three Years
• Total Number of Quality FTEs
• Quality Staffing as a Percentage of Total Workforce
• Quality Spend per FTE
• Staffing Trend for Quality for Next 12 to 24 Months
• Span of Control for Four Supervisory Functions
• Percentage of Quality Budget Allocated for Four Critical Quality Sub-Groups
  

• Quality Spend/Quality FTEs: Benchmark participants spend an average of $104,239 on the Quality function per FTE in the organization. For large companies, the ratio was lower at $102,919 per FTE.
  
• Quality Spending Trends: Nearly 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 6% for the full benchmark class and for the large companies within it. Regulatory requirements, business expansion/new products, and economic conditions are commonly cited forces for increased Quality spend.
  

Industries Profiled:
Manufacturing; Medical Device


Companies Profiled:
3M Company; KCI; BARD; Cochlear; Boston Scientific; Lake Region Medical; Edwards Lifesciences; Stryker Neurovascular; Medtronic; UreSil; Terumo Corporation; WelchAllyn

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