Regulatory Affairs Excellence: Resource Benchmarks and Staffing Trends for Medical Device Companies

STUDY OVERVIEW

Regulatory Affairs groups help guide their organizations through the regulatory labyrinth that companies must navigate as part of developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies to remain productive. Optimal resourcing and staffing help Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.

Best Practices, LLC conducted this benchmarking study to establish metrics around Regulatory Affairs' budget and FTEs for medical device companies. In addition, this study gleans insights from regulatory leaders at device organizations regarding anticipated future resource trends in Regulatory Affairs.

This study presents spend, FTE and consultant benchmarks for the medical device industry. Specifically, the research includes spend, FTE and consultant ratios, such as regulatory spend per FTE, FTEs per $100M in revenue, and consultants per $100M in revenue. In addition, the study contains quantitative benchmarks and qualitative insights around anticipated Regulatory Affairs staffing trends in the medical device sector, including the use of outsourcing and offshoring.

Medical device regulatory leaders can use this study to compare their spend, FTE and consultant ratios and benchmarks with those of leading medical device companies.

KEY TOPICS

• Executive Summary
• Participant Background
• Regulatory Function Investment and Staffing
• Regulatory Function Outsourcing and Offshoring Trends

• How many regulatory FTEs are in Corporate Regulatory Affairs
• Estimate the number of in-house FTEs and Consultants for Regulatory Affairs in 2010
• How has Regulatory Affairs spend changed in past three years
• How has overall Regulatory Affairs headcount changed in past three years
• In the next three years, how do you expect Regulatory Affairs staffing to change
• In the next three years, do you expect Regulatory Affairs to grow its internal or external resources
• Percentage of Regulatory Affairs spend allocated for outsourcing
• Responsibilities outsourced by Regulatory Affairs
• Over next three years, do you expect outsourcing levels to grow, shrink or stay the same
• Percentage of regulatory spend allocated to offshoring
  

Regulatory Affairs 2010 Staffing: Regulatory Affairs staffing averages 2.3 FTEs per $100M in medical device revenue. Headcount has remained the same for half of the benchmark class during the past three years as pressures to cut costs are mounting.

Outsourcing Levels: Regulatory leaders don’t expect outsourcing levels to grow in the next three years – in fact a third believe they will shrink.

METHODOLOGY

For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eight regulatory leaders representing eight leading medical device organizations. In addition, executive interviews were conducted with selected participants to produce qualitative insights.

Industries Profiled:
Consumer Products; Medical Device; Chemical; Technology; Health Care; Pharmaceutical; Orthopaedics


Companies Profiled:
Bausch & Lomb; Edwards Lifesciences; BD; Roche Diagnostics; Boston Scientific; Ethicon; Johnson & Johnson; Medtronic; Zimmer

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