Benchmarking Regulatory Affairs Staffing & Performance Excellence in Medical Devices

Best Practices, LLC conducted this study to establish evidence-based benchmarks describing performance levels, approaches and boundaries - as well as to capture forward-looking insights about high-performance in the Regulatory Affairs function at medical device companies. In particular, the study identifies key performance indicators for regulatory budget, staffing, submissions trends, management factors, critical regulatory roles, responsibilities and off-shoring/outsourcing trends. Also, it highlights current and future trends shaping the Medical Device Regulatory Affairs function.

Study Snapshot

Best Practices, LLC recruited Regulatory Vice Presidents and Executives at 32 leading medical device companies to share quality data and regulatory insights regarding current and future trends influencing Regulatory Affairs.

Segmentation analysis was key to examining trends and effective practices. Primary analysis concentrates on larger companies, often segmenting them by product portfolio complexity. Portfolio complexity was assessed by Ratio of Class III products, which emerges as a key driver of regulatory resources employed. Participating companies range in size from $300 milllion to more than $25 billion. Response data from some smaller companies (less than $300 million in revenue) were considered to analyze general regulatory trends and emerging issues.

Key Findings

• Size Drives Regulatory Affairs Structure: Company size significantly impacts Regulatory Affairs operational structure in a predictable evolutionary way. Smaller companies have centralized structures with only a few Regulatory Affairs FTEs, hence they don’t have separate corporate groups. Middle-sized companies typically have centralized structure as well, but they also have a strong regulatory group to form a separate corporate group that would oversee the function. Global giants have corporate groups setting standards with decentralized or distributed Regulatory Affairs functions to better support respective business units or divisions.
• Leadership Reporting: Among all sized-companies, more than two-thirds report directly to the CEO. As companies get very large, a leadership reporting level is often inserted between RA and the C-level. Among the very largest companies, only 50% report that Regulatory Affairs still reports directly to the C-level.

• Executive Summary, pgs.3-10
• Research Overview, pgs.3-6
• Regulatory Landscape: Executive Summary, pgs. 7-10
• Detailed Research Findings, pgs. 11-87
• Regulatory Structure & Management, pgs. 11-33
• Regulatory Submissions & Functional Trends Benchmark Analysis, pgs. 34-50
• Investment & Staffing Efficiency Benchmarks, pgs. 51-62
• Roles & Responsibility Benchmarks, pgs. 63-74
• Regulatory Outsourcing & Offshoring Benchmarks, pgs. 75-87
• Benchmark Profile, pgs. 88-94
• About Best Practices, LLC, pg. 95

• Achieving Efficient and Effective RA Operations
• Internal & External Factors Affecting RA Resource Levels
• Structure of Regulatory Affairs Function
• RA Staffing Efficiency Segmented by RA Group Structure
• Organizational Level Reported into by the Highest Leader of the Regulatory Affairs Function
• Number of Global FTEs Working within Participating World-wide Medical Device Companies/Division
• Ratio of RA Staffing to Total Company FTEs
• Unique Device Identification
• RA Staffing Efficiency Reviewed by Unique Device Identification (UDI) #s and Product Families
• Organization of Product Portfolio to Best Serve the Market
• Manufacturing System Profiles
• SOPs & Improvement Programs Covering RA Employees
• Regulatory Staffing Distribution
• RA FTE Ratios by Therapeutic Area & Market Type
• Median Mix of RA Specialist vs Generalists
• Managerial Span of Control Benchmarks
• RA Executive Reporting
• Company Revenues vs Number of Countries where Regulatory Submissions Have Been Filed
• Submission Fee Increases between 2011-2016
• Median Number of New Submissions Filed vs. Existing Submissions Maintained in 2014
• Number of U.S. Submissions Filed
• Change in US Market Submission Trends during the Past 2 Years
• Number of EU, Canada & Japan Submissions Filed
• Change in EU, Japan & Canadian Markets Submissions Trends during the Past 2 Years
• Number of China & Brazil Submissions Filed
• Change in China & Brazil Submissions Trends
• Number of U.S., EU, Japan & Canada Regulatory Submissions Actively Maintained
• Number of China & Brazil Submissions Actively Maintained
• Change in Submission Volumes in the Past 3 Years in the US and "High-growth" Developing Markets
• Number of Pre-submissions and the Resources Required for Managing Them
• Approval Date Predictability
• Regulatory Spend Trend vs Filing Volume Trend
• Company Size vs Consultants Ratio
• Regulatory Staff Time Allocated to Reviewing Change Notices & Documenting the Assessment
• Impact of Resource Changes on the RA Organization over the Next Three Years
• Regional Regulatory Investment
• Number of In-house FTEs and External Consultants for RA
• Change in Overall Regulatory Spend/Budget
• Change in Overall Regulatory headcount
• Regulatory & Quality Functional Roles
• Regulatory Organizations’ Leads Roles
• Experience Levels of Regulatory Affairs Executives Who Engage or Interact with External Regulators for Different Activities
• Primary Responsibilities of Corporate Regulatory Affairs Group
• Global IT Solutions
• Effectiveness of Key Approaches Employed to Monitor and Track the Changing Regulatory Requirements across the Organization
• Effectiveness of Approaches Employed to Communicate and Respond to the Changing Regulatory Requirements in the Market
• Platforms for Monitoring and Responding to Regulatory Changes
• Primary Ownership of Publishing Regulatory Documents (i.e., Submissions or Filings)
• Outsourced Activities
• Offshored Responsibilities
• Percentage of Product Registrations Obtained Through Distributors/Agents Outside the US
• Regulatory Growth Planning
• Regulatory Growth Planning with Internal or External (e.g., Third Party) Resources
• Key Factors Expected to Impact the Regulatory Affairs Organization over the Next Three Years
• Percentage of US Regulatory Spend Allocated to US Consultants / US Outsourcers
• Percentage of Regulatory Spend Allocated to Offshore Third Party Consultants and Vendors
• Anticipated Outsourcing Trends In the Next Three Years
• Anticipated Offshoring Trends In the Next Three Years