By Nick Tippmann

Jimi Hendrix once said, “Knowledge speaks, but wisdom listens.” While we don’t tend to talk too much about rock legends at Greenlight Guru, we have plenty of rockstar-level speakers slated for our True Quality 2022 conference, which takes place from June 6-8 in San Diego. 

Whether you’re familiar with True Quality as a movement or from our event, you know that medical device manufacturers do best when we make quality our focus. With such a breadth of knowledge from the presenters at True Quality, we thought we’d take a page from Mr. Hendrix’s book and listen in for these three invaluable lessons about quality from the folks who know it best.

Lesson 1: Quality Is Not Compliance.

While they’re both essential to medical device manufacturing, quality and compliance mean two very different things. Compliance is the process of meeting legal regulatory requirements, such as those set forth in FDA 21 CFR Part 11. Quality, on the other hand, is a measurement of functionality and how well your device fulfills its intended use. Unfortunately, all too often medical device companies aim solely for fulfilling the bare minimum requirements of compliance. 

Jon Speer, founder of Greenlight Guru, says that while compliance is important, it should never replace a quality-focused mindset. “I think with a lot of companies, their quest is toward compliance,” Speer says. “And in doing so, they design their processes, procedures, and approach in a thoughtless checklist-type of mentality. “It’s like they lose the ability to think for themselves of what’s good for them and what makes the most sense for their company.”

When companies are compliance-focused, they tend to view quality as being the sole responsibility of the quality department. They look at design controls as being a hassle and roll their eyes at risk management documentation. 

Instead, Speer says that medical device manufacturers need to embrace a quality-mindset. “The best medical device companies in the business have embraced the mindset that quality is a cross-functional responsibility.” 

Lesson 2: True Quality Is Within Your Control.

With a quality-minded approach, medical device companies can focus on achieving true quality. However, to do so there has to be a sense of ownership when it comes to risk management. Kyle Rose, president of Rook Quality Systems, explains that much of this comes down to honoring device users and the potential product risks you need to mitigate. “There’s no getting around it,” he says. “You’re the one responsible. It’s your company, it’s your product.”

To help medical device manufacturers build their quality management systems and fulfill the risk-based approach set forth in ISO 13485:2016, Rose and his team at Rook Quality Systems focus heavily on the internal audit process.

“The internal audit is created to protect your company and make sure that you have control over all the processes internally,” he says. “You’re reviewing those on an annual basis to make sure that everything is up to speed, they’re within your procedures, and that your procedures are up to spec with the regulations. Rose adds, “If you stick with the standard, you improve your company and your product.” 

Lesson 3: Regulations Make Quality Possible.

Rather than viewing quality as a checkbox activity, medical device companies should try leveraging regulations to achieve true quality. After all, these legal requirements are put in place by agencies like the U.S. FDA or with EU Medical Device Regulation for a reason: to minimize risk and ensure that safer medical devices are brought to market. 

Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation, says that the folks at the FDA are not the enemy, but there to help you help your users. “At the end of the day, we all want to help patients,” she says. “We all want to get the best device on the market.”

Komiyama, who now is the Principal Consultant for AcKnowledge Regulatory Strategies, stresses leveraging the master file, specifically the use of real-world evidence and or clinical testing that you’ve gathered. Why? Because, she explains, it’s all about the wellbeing of the users. “Don’t use [regulations] as a checklist,” Komiyama says. “Really try to understand what the important questions are. Is there something that could be toxic on the material that’s a residual left-behind?”

She says when it comes to how the FDA views the industry, reviewers firmly believe they’re here to protect and promote public health. They think, “That’s my job,” according to Komiyama.

In that vein, true quality is everyone’s job, and by including risk controls like audits, as well as leveraging regulatory requirements for better products, we can all continue the push for safer medical devices. Want to learn more about quality and how to get there? Register for True Quality 2022 here.

 Nick Tippmann is chief marketing officer at Greenlight Guru. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at [email protected].