VitaTalk Ep. 22

elliebecker35
Aug 25, 2025
3 min read

In this VitaTalk episode, host Eli Rehmann sits down with Ken Meyer, VitaTek’s in-house regulatory expert, to discuss how he helps medical device innovators break through the complexities of global compliance. With decades of experience spanning engineering, quality systems, and regulatory strategy, Ken knows exactly what it takes to get devices to market, safely, effectively, and in the right regions.

From Engineering to Regulatory Leadership

Ken’s career started with an electrical engineering degree, which, surprisingly, laid the groundwork for his regulatory expertise. After working in quality systems, specifically under ISO 13485 standards, he inherited the regulatory function at a medical device company. That’s when he discovered two things: he was good at it, and he enjoyed it.

His advice to others, including his own children, is simple: “Find something you’re good at and that you’re passionate about, and you’ll always be happy.” For Ken, regulatory work checks both boxes.

Listening First, Advising Second

While formal education in regulatory affairs is valuable, Ken believes one of the most overlooked skills is active listening. Every new product has nuances, risks, and use cases that can impact its regulatory path.

“Go in ears first,” Ken says. “Learn the product, ask intelligent questions, and confirm your understanding with the client. Only then can you confidently chart the best regulatory route.”

Defining “Market” Before the Path

When clients say they want to “get to market,” Ken’s first question is: Which market?Regulations vary by country and region, and pursuing global approvals all at once can waste time and resources, especially if expansion plans are years away. By clarifying timelines and target geographies, Ken helps clients focus only on the most relevant compliance steps for their immediate goals.

Avoiding Common Classification Pitfalls

Even when a device appears to be exempt from certain U.S. FDA requirements, Ken digs deeper. Many exemptions have strict limitations based on intended use, user type, or technological differences. “Just because it’s 510(k) exempt doesn’t mean you’re in the clear,” he explains. If a device involves a new risk, new technology, or a new environment of use, it may still require a full submission.

Leveraging FDA Interactions

Ken often recommends the FDA’s presubmission process to confirm key details—like whether the right predicate device or product code has been chosen—before investing in costly testing. “The FDA used to have a reputation for being tough to work with,” he says, “but they’re much more collaborative now. You can get valuable guidance before you’re too far down the wrong path.”

Human Testing: The Right Way

Before conducting human trials, Ken ensures clients understand the rules. High-risk devices require an Investigational Device Exemption (IDE), with FDA oversight on study design, reporting, and safety. Lower-risk devices may only need approval from an Independent Review Board (IRB), which can be faster and more flexible. For basic user preference testing, the process can be even simpler.

Navigating Global Markets

While each country has its own process, Ken and his team can guide clients through approvals in markets like Europe, Canada, Brazil, Mexico, Japan, Korea, Taiwan, and India. In some cases, this means working with an in-country sponsor or agent to handle the local submission requirements.

The Power of Proximity

Ken’s role is deeply embedded in VitaTek’s R&D process. Sitting just feet away from engineers and participating in daily development meetings ensures seamless communication and quick decision-making. “It’s one of the joys of being here,” he says. “You can spot potential issues early, and you’re part of the solution from day one.”

The Takeaway

Regulatory strategy isn’t just paperwork, it’s a critical, ongoing part of medical device development. By asking the right questions, focusing on the right markets, and staying embedded in the product team, Ken helps VitaTek clients move from concept to commercialization with confidence.

🩺 Interested in learning more about life at VitaTek or how we’re reshaping the medical device space? Stay tuned for more episodes of the VitaTalk Podcast!

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