Soapbox

Why Is Quality Focusing on Compliance?

By Daniel R. Matlis
March 20, 2018


• Categories: 05-Quality/Regulatory, Business Analysis, Soapbox

Medical device organizations are continuing to sharpen their focus on developing high-quality medical devices aimed at improving patient outcomes. However, industry’s hyper-focus on compliance often becomes an obstacle to improving quality and innovation.

A recent study was conducted to assess the industry’s ability to build a culture of quality and innovation. For this research, trends were identified and analyzed, along with requirements and initiatives that organizations are undertaking to proactively manage products and platforms across the product lifecycle.

In support of the research, 110 medical device professionals were surveyed and one-on-one interviews and group discussions were conducted with 23 industry executives representing 59 medical device manufacturers from 12 countries.
Research shows that most organizations continue to identify the primary role of QA as compliance—ensuring documentation and adherence to regulatory requirements and with internal policies and procedures. However, the true focus of QA should be on improving product quality. Closing the loop allows quality and compliance events to influence the product engineering cycle in a timely fashion.

• 85% of respondents indicated the primary role of quality is ensuring compliance
• 10% of respondents said the primary role of quality is to drive product / process improvement
• 31% of executives report closing the loop most of the time when addressing a quality event

Key Research Takeaways

1. While quality is valued differently by different sets of stakeholders, quality and compliance are often confused. Different roles hold differing viewpoints on how quality is measured, who is responsible, and the role of compliance in ensuring quality.
2. Medical device makers are still struggling to close the quality gap. Industry’s approach to quality is changing as organizations work to harmonize business processes across business units.
3. Industry leaders are increasingly shifting to modern closed-loop quality platforms. A closed loop approach not only improves product quality across the total product lifecycle, but also encourages collaboration and visibility.
4. Engaging PLM and QM early in the design-to-release process drives down the cost of quality. Companies that effectively close the loop from quality and compliance processes and feed that information back into manufacturing and engineering systems will be best situated to meet patient needs.

To compete in today’s global markets, medical device companies must shift to modern, closed loop, product development approaches. They must also change their approach from simply meeting compliance requirements to managing critical to quality data with visibility across the total product lifecycle. A unified approach can help medical device makers make this crucial shift by enabling better collaboration, visibility and product quality across the total lifecycle.