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Jon Speer

FDA Compliance

Three Myths Engineers Believe About Quality

There’s always a way for medical device engineers to create and focus on true quality

Published: Wednesday, April 1, 2020 - 12:02

Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works together to produce and sell medical devices that improve the lives of end users. Still, many medical device companies struggle to embrace the mentality that quality is a shared responsibility across the entire organization.

The best-of-breed medical device businesses have embraced the idea of “true quality” within every aspect of their business. They realize creating a foundation of true quality is not just the quality department’s responsibility.

Unfortunately, the quality creation function is more often viewed as a hurdle to overcome when completing tasks, and this mindset leads to several myths about quality.

Here are three of the most common myths engineers believe to be true about quality along with how to eliminate these unfounded beliefs from emerging within your organization.

1. Documentation and design controls provide little to no value

Too many engineers have told me they view design controls and product development documentation as a burden.

Let’s rephrase the issue. The whole purpose of design controls is to ensure products are designed and developed safely and effectively, and meet necessary indications for use. All of which are core values that product engineers genuinely care about.

When an engineer claims to loathe design controls, they most likely mean they despise the quality processes and procedures that are associated with product development documentation.

An unfortunate reality is that many organizations implement poor processes that are presented to engineers who perceive them as menial tasks, several steps down from the otherwise strategic, enjoyable aspects of their jobs.

For engineers to realize the true value of design controls, they must be willing to put in the time and due diligence that the documentation process demands. Although this process is tedious, it is also critical to ensure high-quality products are designed and developed.

All in all, the design control documentation process helps device makers answer:
• 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?

The answers to these questions lead you into design validation, which is the checkpoint to ensure a product meets the needs of the end-users and confirms that the product development engineers designed a high-quality device that functions as intended.

2. Medical device regulations are just more hurdles to navigate

Due to the evolving medtech landscape, medical device regulations around the world are continually changing to keep up with new trends. Although there is an effort to simplify the process, it doesn’t always feel that way when you’re heads down in the development process.

However, the most successful engineers will leverage these changes to streamline their processes and build a foundation of “true quality” throughout the entire device life cycle.

Rather than resisting the inevitable state of regulatory flux, engineers should embrace them and explore new opportunities for innovation that can creatively transcend from these changes.

3. Once the device reaches post-market, it’s not the engineer’s responsibility

An engineer should always keep device quality top of mind, even after the product is transferred to manufacturing and then into the marketplace.

Major post-market quality events include:
• Customer feedback
• Corrective and preventive actions (CAPAs)
• Product or process changes
• Nonconformances

Each and every change that occurs post-market demands an investigation and accountability. For example, if a product goes through six or seven changes in its first month, it indicates the engineering process is not robust enough and is likely impacting the device quality.

Other companies may design a device that uses similar indications. Instead of repeating issues, learn from others’ mistakes. Do thorough research to uncover any publicly available reporting information that can help you avoid these issues within your product design and development process. Mitigating potential issues early on will simplify the entire process and improve device quality and efficacy.

Final takeaway

Engineers are quite capable of contributing to medical device quality management systems (MDQMS) with product development designs and processes that foster continuous improvement and quality.

Whether it be a cultural mindset shift or adoption of industry-specific tools, there is always a way for medical device engineers to create and focus on true quality.


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.