Congratulations, you’ve received your 510(k) clearance from the U.S. Food and Drug Administration (FDA)! You’ve worked for weeks, months, perhaps even years to get to this point, and I’m sure you can’t imagine working on one more plan – but you do need a marketing plan for your FDA clearance.

You and a team of researchers, engineers, scientists, developers, clinicians and countless others put so much into your product and this clearance process. You’ve conducted clinical trials, filled out applications and assembled hundreds or thousands of documents, making for some very long days and late nights. Some equate the clearance process to raising a child – challenging, exhausting, fulfilling and wonderful.

After all that hard work, it might be tempting to coast now that the finish line is in sight, but resist the urge. It’s tempting to not want to take on one more thing at this time, but you must now that your product is available on the market.

Here’s why.

Wait, what is FDA 510(k) clearance anyway?

Didn’t “Last Week Tonight” host John Oliver once say it didn’t mean much? Yes, as a matter of fact, he did, and yes, as a matter of fact, he’s wrong.

The 510(k) clearance is a premarket submission made to the FDA that demonstrates the product’s safety and efficacy. In the words of the FDA: “Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”

The length and intensity of the process varies based on the class of device. This is not a scientific definition by any means (for that, refer to the FDA), but a good rule of thumb is anything that delivers anything into a human body takes a good bit of scrutiny.

One of the companies we’ve helped with marketing and media outreach to announce their FDA clearance is Ivenix, a Massachusetts-based medical technology company that was the first – and only – large-volume infusion pump cleared under more stringent guidelines the FDA established five years ago. Their years-long journey involved more than 50,000 pages of documentation and results of thousands of hours of testing.

Ivenix CTO George Gray said about the process: “We had to demonstrate that our pump was safe under all conditions. Similar to other 510(k) clearance processes, we had to demonstrate the safety and efficacy of a predicate device, but the FDA challenged us to improve in those areas where they historically saw safety issues in the other infusion pumps, not just the predicate device we referenced.”

Will you be ready to announce your clearance news?

We’ve had clients who received clearance in a few weeks to a few months. It really depends on the device and what it’s doing in relation to a human being. But regardless of whether you’re fast-tracked or facing a longer haul for approval, what are you going to do once you receive it?

Some believe the day they receive FDA clearance their phones will start ringing, both from reporters and prospective customers. That’s typically not how it works, even with the most wide-reaching, impactful technologies. Every once in a while the FDA will announce an approval or clearance, but that’s not often. I can only think of a few instances of this in the past several years involving revolutionary treatments for Alzheimer’s, postpartum depression and a novel immunotherapy approved for the first time.

Generally speaking, the FDA will not announce your news. That’s up to you – and you only get one chance to make that first impression. But that’s ok, we’re here to help.

What does a healthy FDA clearance communications strategy look like?

There are many reasons to have a healthy and sound ongoing marketing plan, but your FDA clearance is a particularly critical time to have a strong strategy in place and a public relations (PR) and marketing partner ready to go.

While there are intricacies and tactics to consider depending on your product, goals and other considerations, a successful FDA clearance campaign minimally needs three main ingredients:

  • A strategic PR announcement plan with executive buy-in;
  • Prior media outreach to seed awareness of the industry need; and
  • Clear messaging detailing how your offering improves long-standing healthcare issues.

To receive media attention the day you announce your news, you have to first seed the market with executive thought leadership and general media outreach. Editors and reporters will care more about clearance news from companies and executives they’re familiar with rather than total strangers. They also don’t have to start at square one – you’ve already been vetted by them.

The media announcement strategy can vary from offering the news as an exclusive to a major media outlet to pre-briefings under non-disclosure with a variety of targets. The approach depends on the company, the product and problem it’s solving. Sure, The Wall Street Journal is always a great place to be, but sometimes a combination of top industry pubs and related verticals are where you need to be.

Keep in mind, timing is everything; breaking news can pull reporters away. So, having your spokesperson do pre-briefings not only gives reporters time to prepare a story, it gains their buy-in so your news is less likely to get bumped. Regardless, you should also follow up with your media contacts the day of the announcement.

Further, conduct analyst briefings to get the market and third-party validation your customers, prospects and media want to see. If possible, conduct these briefings in advance of announcing the news and try to enlist an analyst as a media reference. It strengthens your credibility and reporters will likely ask to speak to someone. A customer reference is important for that same reason.

As for marketing, you need to give thought to the product and sales collateral you’ll need for support, as well as the campaigns you’ll conduct to capitalize on your clearance news. You’ll want additional strategies to support the top-of-funnel awareness and pipeline you’re creating through media and PR, as well as a strategy to nurture and convert those leads through the marketing funnel.

Are there partnerships you need to cultivate? Will you drive prospect lead gen through a blog and content strategy? What about email campaigns to nurture new prospects or engage your existing database? Are there white papers you can create to reinforce thought leadership? What about webinars or product demos? What does your sales team need to win new customers?

There are a lot of marketing possibilities to consider but be careful not to spread yourself too thin. Creating a plan and executing it is most important – you can build upon this foundation moving ahead.

Is your FDA clearance marketing plan producing leads?

Ultimately, you want your media hits and marketing clicks to net you sales leads – and that’s contributing to the bottom line. A past FDA clearance news launch with international media coverage resulted in more than 50 quality, direct sales leads for one of our clients. Since, they’ve continued to build on this fast start, continually keeping news and messaging in front of targets to achieve further awareness and success.

Still, it all begins with getting as much traction as you can with that initial, crucial news; when you’re cleared, you’ve got to be ready to go. The hard work is done, you just need to let the world see and the leads will follow.