Medical device companies must operate on a best-of-breed level, meaning the idea of “true quality” is at the core of every aspect of the business. True quality is a foundation to build upon, not just a departmental responsibility or afterthought. Unfortunately, many medical device organizations still struggle to adopt this mentality and share responsibility across their business.

Frequently, the quality control process is viewed by outside departments as burdensome and a hurdle to clear rather than a cultural factor, which creates several myths about quality.

In this column I outline the common myths medical device engineers believe about quality and how you can curb such beliefs, so quality can be adopted across your entire business.

Device Regulations Are Tedious and Burdensome

The medtech landscape is continually evolving, which means the regulatory landscape is, as well. Regulatory changes can feel overwhelming and stressful, especially for engineers who prefer to be heads-down in their natural design and development habitat.

This is where the importance of having a foundation of true quality comes into play. The most successful medical device engineers are ones that subscribe to this idea by incorporating it in all aspects of the device, effectively easing compliance concerns.

Instead of pushing back on the inevitable regulatory changes, product development engineers should seek out industry trends that could lead to new opportunities that push innovation forward to transcend from the changes.

Design Controls Are Not Valuable

Over the years, many engineers have shared with me a similar sentiment about documenting design and development activities being a burdensome task.

But, let’s rephrase the issue. Design controls exist to ensure devices are created safely and effectively and meet indications for use. These factors happen to be core values product engineers genuinely care about.

When engineers claim to despise this type of busywork, they mean they loathe the processes and procedures associated with product development documentation. Unfortunately, many businesses put poor processes in place that present as menial, non-strategic tasks to engineers.

To help engineers realize the actual value of design controls, they must be willing to invest time and diligence in the documentation process. Yes, this process is tedious, but it’s also essential to create high-quality products.

Ultimately, the design control documentation process helps device makers answer the following questions:

• What is the device intended to do?
• What does the user need the device to do?
• What are the user requirements, and how do they define specific product requirements?
• What components, pieces, materials, parts, specifications, drawings and manufacturing instructions are needed for the device to operate as intended?

Answering these questions leads to design validation, during which engineers will ensure their device meets the needs of patients and that they have designed a high-quality, fully functional device.

Once the Device Is Post-Market, It’s Not an Engineer’s Problem

Device quality should always be top of mind for an engineer, even after it’s moved from the manufacturing stage into the marketplace.

Major post-market quality events include:

• Customer feedback
• CAPAs
• Product or process changes
• Non-conformances

If a product issue arises during post-market surveillance, an internal investigation may ensue. If it’s determined that a change must be made to the product, then those same design and development engineers who were initially involved will be expected to participate in resolving the issue and making any necessary design improvements to ensure true quality.

The goal should be to prevent these post-market events from the onset, which starts with mitigating potential issues during the development process. One example is to look for other medical device companies that may have designed a product with similar indications for use as your product.

Rather than guessing what may go wrong with your product in the field, do thorough research to uncover any publicly available reporting information that can help you avoid related issues once you launch your product.

Conclusion

The contributions made by engineers to its company’s medical device quality management system (MDQMS) throughout product development is paramount to fostering continuous quality.

No matter if it’s a mindset shift or adoption of best-of-breed industry tools, there’s always a way to create and maintain true quality at the center of operations.