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Medical device labeling: You need to design it, too

August 3, 2017 By Chris Newmarker

medical device labeling intended use

[Image from FDA]

When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston.

Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives to the heart of a company’s regulatory strategy.

“High-level labeling will directly impact your regulatory strategy and your pathway to market,” Drues said. (See Drues moderate a regulatory panel at DeviceTalks Boston on Oct. 2.)

Depending on the high-level labeling, the same product could be a wellness device not regulated as a medical device – or a device requiring a 510(k), de novo or PMA. Companies also need to balance out how the labeling will affect winning reimbursement from public and private healthcare payers – not to mention product liability exposure.

The result is that medical device creators need to design their labels like they design their devices, according to Drues, who is president of Vascular Sciences and has worked with both medical device companies and FDA. “To me, design is design.”

Listen to Drues discuss the importance of label design – as well as his four-step design process.


(See Drues moderate a regulatory panel at DeviceTalks Boston on Oct. 2.)

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About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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