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.
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.