Benchmarking Quality: Maneuvering the FDA Regulations Obstacle Course


The Quality function within Medical device & diagnostics companies is critical for ensuring that products meet the tough standards put in place at every stage of the product lifecycle. Although the tasks completed by executives are increasing in importance, the challenges are also growing in numbers, making it more and more difficult to achieve set goals. With tighter budgets and escalating regulations, Quality leaders must find ways to develop their programs effectively and efficiently in order to maintain the quality of products.

Best Practices, LLC’s Senior Research Consultant, Kim Hardin, reflected on the importance & challenges being faced by Quality sectors across various companies. She explains, “The challenge for today’s quality organizations is to balance risk while managing quality spend. Although the target level of spend is set by senior management, the level of acceptable risk is often unknown for quality leaders tasked with this balancing act, making the challenge especially difficult under increasing regulatory scrutiny.”

Despite the obstacles that Quality leaders are facing, including budget constraints, nearly 1/2 of all the companies that participated in a recent research report actually saw spending increases for the function over the past three years. The reasons given for these increases included regulatory requirements, economic conditions, and business expansion/new products. Respondents are often faced with the task of tackling how to use their allocated budgets effectively to achieve the desired results.

Knowing the challenges that leaders in the Quality function are constantly faced with, Hardin offered some words of wisdom. “Examining potential quality cost drivers, and benchmarking against the best-in-class, can help quality organizations prioritize where to adjust their risk profiles for the greatest cost savings,” she explained.

By analyzing recent research reports, becoming familiar with FDA regulations guidelines, as well as staying up-to-date on industry trends, executives can become leaders in the Quality function. Following these trends will help to keep costs down, efficiency high, as well as encourage a higher standard of quality for consumers.

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