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The Surprising Truth About Marketing Before FDA Approval

4 min read

There is a significant opportunity around market development that companies should be taking advantage of to prime the market for their product and still be compliant with FDA guidelines.

It’s one of the biggest mistakes companies make.

They think you can’t do any marketing for the product before receiving FDA clearance or approval. Wrong.

Yes, it’s true that a device that lacks FDA marketing clearance is considered "investigational," and therefore the company cannot promote, advertise or accept orders for it. The FDA considers such activities to be “commercialization of an unapproved device."

But there is a significant opportunity around market development that companies should be taking advantage of to prime the market for their product and still be compliant with FDA guidelines.

Great companies give us a better way of life. In the healthcare industry, this takes the form of significantly enhancing people’s lives and improving the delivery of healthcare. Unless your audience sees how your product or service advances their care model or life, they won’t use it and certainly won’t champion it.

If your product isn’t designed to address an important unmet need in healthcare, you might have a problem. But even if your product does, most companies woefully underestimate the effort required to overcome the consideration and adoption barriers. Creating behavior change—which is at the heart of market adoption—requires a carefully choreographed strategic market development plan that should be treated as a long-term investment. And it certainly should start before you receive commercial approval.

Too many companies believe that customers will buy when they learn about the features of their breakthrough technology upon FDA approval or clearance. They think a product speaks for itself, leaving it up to the market to figure out why their product matters.

But why take the chance? Why not condition the market to your advantage and make a case for why your new product or service is different than anything that has come before and is filling an important gap? When market development is done well, it creates a market pull by training an audience to recognize something is missing and preparing them to behave differently when a new solution is available. This causes customers to stop using the existing paradigm and demand what you offer.

Here are five tips for market development prior to FDA approval to increase your chances of rapid market adoption:

Building a great product is hard. Great marketing is hard too. You absolutely need both in order to win. But remember that like product development, market development takes longer than you think.

Need Market Development Help?

Grey Matter Marketing is a full-service, award-winning PR and marketing agency working exclusively with healthcare companies. With a knack for storytelling and content marketing that engages and drives action, we can help map out a market development plan to prime the market for your new product to increase your odds of a successful launch. Because what you do (or don’t do) matters. For more information, contact us.



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