Navigating Regulatory Compliance in Medical Device Copywriting

Writing about medical devices is a unique challenge, where the need for creative copywriting must coexist with the strict regulatory landscape. As a marketer, you may find yourself navigating a regulatory gauntlet when tasked with writing copy for a medical device launch.

Staying “On Label” and Why It’s Important

In medical device copywriting, the goals of compliance and creativity can be challenging to reconcile. Regulations prohibit product claims that veer from approved product “labeling”. In the strictest sense, product labeling refers to the information that appears on the packaging, package inserts and labeling of a medical device. More broadly, product labeling also refers to any supporting marketing materials that contain product claims.

Why is it so important to stay “on label”? The statements made in product labeling have been rigorously vetted. These claims are substantiated, backed by scientific and clinical evidence, testing and regulatory processes. Whether the user is a clinician or a patient, following these statements ensures safe and effective use of the device.

There may be instances in which a clinician is using your device off-label, based on their own clinical judgment. Regardless, as the device’s manufacturer, it is illegal to promote an unapproved, off-label use. A manufacturer may promote only those claims approved by regulatory bodies.

If You Can’t Prove It, Don’t Say It

The reality is that the language in approved labeling—however dull—lays the groundwork for all downstream marketing language. The copywriter’s challenge is to transform that language into something “sexy” without altering its meaning. Even small wording changes, reasonable in a writer’s mind, may spin the claim in an unapproved direction in the mind of the regulator.

Writing and approving medical device copy is a collaborative, cross-functional and iterative process. Since marketing’s job is to bring the creative element to the process, I place few constraints on myself in early iterations, knowing these will likely be dialed back during regulatory review. I do keep the following caveats in the back of my mind during this process, however (not an exhaustive list, by any means):

Never make unsubstantiated claims. First and foremost, don’t make claims about the device’s performance, efficacy or safety that can’t be substantiated with scientific or clinical evidence.
Don’t exaggerate benefits. Using terms like “cure” or “improve outcomes” can be problematic. Never claim that a medical device can cure a disease or medical condition unless there is evidence that it can do so. Likewise, it’s tempting to claim improved outcomes, but unless there is clinical evidence of this fact, it’s best to avoid that language.
Avoid absolute terms. Be cautious with terms like “always” or “never”. These may be seen as definitive claims that require strong evidence to support.
Avoid superlatives. Describing the device as “the best”, “the only”, or the “most advanced” sets the bar high for providing evidence. Unless you can prove these statements, avoid them.
Be cautious when using testimonials. Make sure expert endorsements are accurate and on-label.

Make Friends with Regulatory

Not all situations are straightforward; in fact, I’ve found that most are not. There is a good deal of ambiguity involved in judging medical device marketing copy. So, unless you want your marketing copy to sound as dull as the IFU, it’s important to establish a good working relationship with your regulatory colleagues. These are the people who will be most influential in red lighting or green lighting your copy.

I’ve worked with regulatory managers who are very risk averse, as well as ones who are more amenable to a little creative writing. The personalities you deal with will determine how difficult it is to get copy approved.

Launch Readiness

If you’re developing copy for a medical device launch, the best approach is to be proactive. Here are a couple strategies that will help pre- and post-launch.

Core Claims Document

Even before tackling the copy, I would recommend working with the product manager to develop a core claims document that summarizes all approved claims about the device along with the evidence supporting those claims. The core claims document may be a simple table with linked references. Ideally a controlled document (versioned), the claims matrix should be signed by all relevant stakeholders, including marketing leadership, product management, clinical, R&D and regulatory. By getting buy-in at the start, many hours may be saved re-litigating claims down the road.

Launch Package Boilerplate

As we’ve already established, it’s not just agreeing on claims, but agreeing on how we express them in copy. Developing approved boilerplate language as part of a launch package will streamline your efforts going forward. This means applying your creativity to a claim and then working closely with R&D and other stakeholders to ensure no line has been crossed.

The product brochure is generally regarded as the reference document for other downstream collateral. In addition, I suggest developing short, medium and long product descriptions that can be easily copied and pasted into other marketing collateral, including catalog listings, webpages, flyers, and ads. Even when using boilerplate, every document will have to be reviewed and approved.

Writing copy for highly regulated medical devices requires a careful, collaborative approach, but the opportunities for creative expression are there.

For more information on medical device marketing and marketing claims, consult the Advamed Code of Ethics.