Companies within the medical device industry often have to work under a strict regulatory environment. This environment arises from the plethora of local, national and global regulations which govern the development and marketing of medical device products.

To ensure regulatory compliance, most companies put together Regulatory Affairs groups. These groups are charged with two major tasks. The first is paying attention to the various regulations that govern the medical device industry. The second is creating internal policies and practices which can enable a company to comply with the relevant regulations.

A study recently released by Best Practices LLC – a research and consulting firm – revealed the latest staffing benchmarks and trends for Regulatory Affairs groups in medical device companies. The study findings were released in a 91-page report entitled “Regulatory Affairs Excellence: Staffing & Performance in Medical Device Companies.”

The study was carried out with two major goals in mind. The first was to establish metrics and insights regarding staffing benchmarks like the structure, activities, roles and responsibilities of Regulatory Affairs groups. The second goal was to identify key staffing trends in the medical device industry. The trends considered included off-shoring and outsourcing.

To achieve its objectives, the study profiled eight (8) categories of industries involved either directly or indirectly in the manufacture and marketing of medical device products. These industries profiled included Medical Device, Technology, Health Care, Pharmaceutical, Orthopedics, Chemical and Consumer Products.

From each of the industries, a company was selected to be profiled. As such, a total of 8 companies were selected. These include Bausch & Lomb, Johnson & Johnson, Roche Diagnostics, Ethicon, Edwards Lifesciences, DB, Zimmer, Medtronic and Boston Scientific.

In each of the companies, top executives at the helm of Regulatory Affairs Groups were selected to participate in the study. These executives underwent both quantitative interviews and in-depth qualitative interviews.

The interviews centered around key benchmarks which are critical for regulatory affairs. These include: organisational structure, span of control, staffing allocations, regulatory submissions, regulatory affairs roles &leadership; and off-shoring/outsourcing.

The insights from the executives were collected, analyzed and compiled into the study report mentioned above. The key findings of the study can be summarized into three major categories.

The first deals with the current status of Corporate Regulatory Affairs Groups (CRAGs) in the medical device industry. In this respect, the study found that these groups average seven FTEs. Their major roles include promoting standards, monitoring the global regulatory environment, coordinating policy advocacy efforts both internally and externally; and advising Regulatory Affairs staff.

The second category of findings deals with the roles and responsibilities of Regulatory Affairs staff. Their roles include handling regulatory submissions, conducting quality audits, handling FDA listings/registrations, handling complaints, responding to FDA 483 observations, and dealing with other regulatory agencies.

The final category considers the future trends in regulatory affairs staffing. The study projects that within the next three years, there will be a growth in the regulatory affairs function using a combination of internal and external resources. The external resources will include off-shoring and outsourcing. However, the levels of off-shoring and outsourcing are unlikely to increase beyond the current industry levels.

The study results can benefit companies which are operating within the medical service industry. It can provide their regulatory affairs groups with evidence-based insights and benchmarks for staffing, budgeting and other regulatory activities. Such insights are currently unavailable in contemporary journal articles and market research databases.

The results can also help regulatory affairs executives and leaders to gage their organization’s performance. They can do so by comparing their companies to the medical device organisations featured on the study. This can provide an effective benchmark for evaluating regulatory function within organisations.

In order to fully benefit from the study findings, medical service companies need to access the full findings of the report. A summary of the findings – as well as a copy of the full report – can be viewed by visiting the Best Practices LLC website. (