The Surprising Truth About Marketing Before FDA Approval

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:

• Tip #1: Know the problem.
  If you aren’t crystal clear about what’s missing in the market that you can uniquely solve, you’ve got work to do. You must be able to succinctly communicate what’s wrong with current options—and that problem better be top of mind to a target customer.

• Tip #2: Know the impact of the problem.
  Document it. Make it real. Make it shameful to ignore. The human is the only animal who uses data to justify the emotional driver behind their decisions. So, while you need to be able to quantify the impact (whether that’s cost, lives, satisfaction, etc.), you have to lead with the emotional pain point that keeps them up at night and fills their life with frustration. This is not about making any product claims. This is simply focused on the impact of the problem.

• Tip #3: Know where to influence your target audience.
  One way to think about how to condition the market is to look at which moments your target audience is most receptive to the story. As a starting point, we recommend focusing on your audience’s 3Ps: Points in Time (when), Places (where), and Paths of Influence (ways to reach them). This clearly varies by audience, but you should identify a spectrum of options.

• Tip #4: Know how to evangelize the problem you intend to solve.
  Start by marketing the problem. Make them believe they shouldn’t tolerate this problem any longer. Make them demand a better solution. Find people who believe what you believe and want to join your cause—and talk about it. Again, this is not making any product claims or promises. It’s igniting awareness about a problem that exists in the market, which you just happen to believe you can uniquely address.

  This well-orchestrated plan could include bylined articles “authored” by KOLs to shine the light on the market problem, a survey with published results about attitudes around this market problem, a roundtable discussion on inclusion criteria for a solution to the market problem, or KOLs interviewed on healthcare podcasts about what’s missing in the market. None of the above items constitute promoting, advertising, or accepting orders for a product. It’s all focused on bringing attention to the problem, so your target audience is more open to your product when it’s available for commercial sale.

• Tip #5: Know that driving market adoption requires a process.
  You need to focus on base hits that influence over time instead of trying to hit home runs. Because guess what? Those small base hits will take you much farther. You have to change the way people think, which changes the way they buy.

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.