How Eastek’s FDA Certification led to our Growth in the Medical Device Manufacturing Industry

Eastek horizontal trade show booth image

When we exhibit at industry trade shows like MD&M West or MD&M East, several products seem to draw particular interest. One is a small, green handheld medical device. The device attaches to the back of a hospital patient’s wheelchair, and is clipped to the patient’s gown by a long string. If the patient leaves his or her wheelchair, the alarm is activated and the nursing staff is notified. It helps keep patients safe and hospital staff informed when they may be in danger.

The OEM (original equipment manufacturer) first started making alarms with microprocessors in the mid-1990s. We worked closely with an engineer there, who understands the industry as well as what his company was originally looking for in a contract manufacturer.

In recalling the company’s frustration working with CMs before meeting Eastek, he noted that many companies around the same size as his don’t have enough volume to go to billion-dollar manufacturers. Those manufacturers want customers who have the volume to support their lofty revenue figures. When a customer with lower volumes comes, they don’t see the same attention, responsiveness and lead times.

Since Eastek took over the manufacturing of this device, it has become one of our longest-running legacy products. Originally, it was Eastek’s vertical integration, U.S. presence and overseas economic advantages that won the program. Over time though, it was our company’s ability to respond to FDA challenges with integrity that strengthened the relationship.

While this customer entered the relationship knowing how their device should look, the first iteration and each one since then has been designed by Eastek. The OEM visited our Dong Guan (China) factory multiple times to review the product firsthand, conducted an audit and helped tweak some of the solutions.

The product was a Food and Drug Administration Class I medical device, which required FDA certification. At the time, Eastek was not FDA registered, and had never done an FDA project, which could have ended the relationship.

But, even early in its history, Eastek was building a culture that willingly bent over backwards, doing whatever it takes to make a project work for the customer. At the same time, many other contract manufacturers were turning away or underserving OEMs.

The previously mentioned engineer talked about his frustration with contract manufacturers who haven’t kept up their compliance. Eventually, he said, it surfaces through third party audits.

“The problem we’ve had—and the reason we’re not using other CMs now is that it’s one thing to say you’re FDA-registered and pass an audit, but you have to keep it up,” he said. “When the auditor leaves, you can’t go back to doing things the old way.”

Many contract manufacturers say it’s cost-prohibitive to maintain such strict FDA standards when no one is watching.

“You have to take it seriously and maintain it,” the OEM engineer said. “Good companies will build it into their business. It’s not just a philosophy, it’s ingrained in how you do your business.”

Even some of the companies who can work with the mega-manufacturers are also made to jump through hoops in order to qualify. The OEM engineer says his experience with Eastek has been dramatically different.

“I’ve never heard Eastek say we can’t do that or we don’t want to do that,” he said. “It’s always, we’ll find a way to do that.”

“The more you collaborate, the better the outcome will be,” Eastek’s VP of Engineering George Ashouri said. “There is a lot of collaboration between Eastek and our customers.”

This legacy product also represents a significant change in direction for Eastek. In fact, this particular device was the reason Eastek pursued FDA registration and began its growth in the medical device manufacturing industry years ago.

“That project forced us to get familiar with FDA requirements. It’s something most contract manufacturers wouldn’t do,” Ashouri said. “But, rather than focusing on the exceptions to the rule, we want to focus on what matters to our customers. What kinds of projects are important to them?”

As it turned out, that project would be just as important to Eastek. In fact, it changed the course of Eastek as a company. We now have as many as 15 FDA-certified projects and a large medical device portfolio.

Today, it’s the kind of project contract manufacturers love. It’s consistent and has very few changes, so we can produce as many of them as needed.

How does Eastek provide customers added value?

In this case, our customer has built a strong relationship with Eastek’s Mike Monroe, the U.S. point of contact for many years.

“I like the fact that there are so many aspects built and controlled in-house,” the OEM engineer said. “Eastek having its own tooling, box build and packaging has enabled higher quality.”

“We enjoy having a U.S. point of contact,” he said. “I’ve worked with [Monroe] for a long time, so I know I can get answers quickly. The relationship we’ve built over the years has been beneficial because we see Eastek as an extension to our company.”