Quality Staffing & Performance: Managing Cost, Structure and Staffing for Medical Device Companies

STUDY OVERVIEW

Medical Device and Medical Technology companies often devote significant resources to ensuring that 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. Consequently, optimal resource levels, staffing, and structure can help quality function leaders in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth and sustainability.

Best Practices, LLC conducted this benchmarking study to provide 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.

The study also contains insights from five medical device leaders around the quality function and its future direction. Medical device leaders in quality or a related function can use this study to compare their spend and FTE levels as well as their organizational responsibility with those of leading companies.

KEY TOPICS

• Executive Summary
• Quality Organization Cost & Staffing
• Quality Organization Structure
• Quality Systems
• Future Directions of Quality Organization

• Number of products on the market, Class I, II and III
• Regions in which medical devices directly sold and sold through a distributor
• Percentage of medical device revenue from outside the United States
• Total cost of Quality function for medical devices and related services
• Number of FTEs working on medical devices and related services within the Quality function
• Percentage of Quality function budget allocated to critical Quality sub-groups/ processes
• Organizational structure of quality function
• Number of direct reports for a dedicated Quality employee at each level
• Responsibility allocation for tracking the risk of specific products through the lifecycle
• Expectations for staffing within the Quality function the next three years
  

Quality Structure: Almost half, or 45%, of benchmarked Quality function structures are Distributed-Quality Centric. Only 18% of the benchmark class reported a Business-Unit Centric function.

Future Directions for the Quality Organization: Only 9% of benchmark companies expect staffing to decrease substantially in the next three years. Regulatory scrutiny is expected to increase substantially. Critical success drivers for the future Quality function will focus on having adequate resources, the impact of proposed regulations, achieving improved performance, and implementing better tools.

METHODOLOGY

For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.

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