When a medical device succeeds, much of the credit goes to designers, researchers, and clinicians. But behind every successful product lies an unsung group of professionals: manufacturing engineers. These experts ensure that coatings are applied with the necessary precision, regulatory compliance, and consistency – factors that are critical for devices used in life-saving treatments.

Addressing complex challenges with medical device

Unlike product designers who focus on a single device for years, manufacturing engineers must adapt to an ever-changing array of products and challenges. Each medical device has its own intricacies, requiring precise handling to ensure coatings adhere correctly and function as intended.

“The manufacturing engineers focus on the application of medical device coatings, which is its own realm of development,” says Todd Paulsen, vice-president of Formacoat, a company specializing in the supply of medical device coatings through a network of trusted vendors. “Formacoat’s long history as a contract manufacturer means a manufacturing engineer here comes across a variety of products and processes each week.”

The coatings used in medical devices serve a variety of functions, from reducing friction in catheters to enhancing biocompatibility for implants. This makes the role of the manufacturing engineer even more complex, as they must ensure that each coating performs as intended under strict regulatory guidelines. In industries such as cardiovascular and neurovascular medicine, where even minor inconsistencies can impact patient safety, precision is paramount.

Yet despite their critical role, manufacturing engineers often remain in the background. This is largely because their work is most visible when something goes wrong. But if everything runs smoothly, their contribution can be easily overlooked. “With all the work put into designing, testing and perfecting an initial product design, if a product is successful, the manufacturing process can continue for years after the design has been locked,” Paulsen explains. “This is where manufacturing engineers exist, working to ensure that thousands of devices are produced in accordance with the specifications necessary to ensure the conformance of the product.”

Innovative solutions for medical device coatings

If an unexpected issue arises, manufacturing engineers must quickly identify and resolve the situation without disrupting production. Their ability to find innovative solutions ensures that medical device coatings maintain the highest standards of quality and performance.

Problem-solving is what the Formacoat team is known for. “With the team of engineers that Formacoat has developed, across many disciplines, the manufacturing department has the opportunity to brainstorm and solve any complex problems they may come across,” Paulsen says. By working collaboratively, the team can approach problems from multiple angles, often uncovering creative solutions that might not emerge in isolation.”

“At the start of an investigation, working in an expanded group setting encourages broad and possibly innovative solutions,” Paulsen adds. “Sometimes a fresh set of eyes, or an approach from a new perspective, is a great way to ensure Formacoat comes up with the best possible solution.”

The work of a manufacturing engineer is not just about maintaining consistency, it’s about driving progress. By refining processes, improving efficiency, and tackling production challenges head-on, they play an integral role in advancing medical technology. While their contributions may not always be in the spotlight, they are fundamental to ensuring that coated medical devices perform safely and effectively, every time.

To find out more about what Formacoat’s team of manufacturing engineers can do for you, download the whitepaper below.