Marketing Stage

Marketing has the formidable job of turning engineering-speak into decipherable features and benefits that will help sell the medical device. Highlighting the unique and novel attributes of the device that differentiate it from the competition is an important part of that process. However, since the majority of devices in the United States are cleared through the “me too” 510(k) process, those attributes can’t be too different from currently marketed predicates without opening the company up to FDA scrutiny and warning letters.

By planning ahead and coming up with potential claims and message points while the device still is in the early concept and prototyping stage, and then running those concepts by regulatory affairs, marketing increases the likelihood that its claims won’t raise red flags with the FDA (even though FDA does not, technically, review and approve claims). For example, if marketing decides on certain performance claims while still in the early stages of product development, RA can help guide the preclinical team on testing methods and strategies that will help substantiate those claims. In other cases, RA might determine that adding something as simple as a qualifier (e.g., “data on file” or device “may” or “is intended to”) to the marketing piece will be sufficient.

From an RA perspective, it’s never about just staying, “No, you can’t make that claim.” It’s about working collaboratively with marketing to figure out what needs to be done in order to substantiate a claim so the company won’t find itself in legal or regulatory crosshairs.