Melory Johnson, Owner and Principal Medical Writer, MJ MedComm, LLC, contributed to this article.
Whether you’re an established medical device writer or another type of medical communicator hoping to advance your career by adding a new skill, it can be helpful to brush up on best practices of medical device writing. Below, we outline the defining qualities of this niche, then describe how to succeed as a medical device writer.
How Medical Device and Drug Writing Differ
It can be tempting to assume that writing about medical devices and medical drugs follows a similar process. However, there are a couple of crucial differences.
- Medical device writers address a much wider range of products and technologies than drug writers,
including technologies. The FDA defines a medical device as a product “which does not achieve its ... intended purposes through chemical action within or on the body...” Drugs and biologics can only achieve their intended purposes through chemical actions within or on the body. Thus, the FDA’s definition means that everything else, from bedpans and tongue depressors to implantable cardioverter-defibrillators and software programs, falls under the category of medical devices.
- Medical device writers must understand the concept of intended use. Because medical device compliance is about claims, medical device writers must know each product's Statement of Intended Use. How a device is intended to be used and how that intent is described by the manufacturer, distributor, or even consumer is the most important thing for a medical device writer to know.
So, in addition to covering a broad range of medical products, medical device writers must also understand how medical device labeling differs from drug labeling and how all written content must comply with FDA medical device regulation.
4 Best Practices for Medical Device Writing
1. Know Your Intentions
Medical device compliance hinges on claims of intent. Thus, it is critical for medical writers to remember that all written content must stay laser-focused on only FDA-approved claims. If medical device products and their manufacturers, suppliers, importers, or exporters do not comply with regulations and make claims beyond those in their Statement of Intended Use, the FDA can take action to enforce the law.
The FDA regularly checks all written content, including websites, for statements of intent and claims. As a medical device writer, it is critical for you to know each product’s approved claims and adhere to the explicit FDA guidelines.
2. Prepare to Educate Clients About FDA Regulations
Being a successful medical device writer depends on your ability to help your client remain compliant. Compliance requires a deep understanding of the device you’re writing about, its intended uses, and corresponding FDA regulation.
Medical device manufacturers and distributors (often the writers' clients) are sometimes new to FDA regulation. When clients attempt to exaggerate or invent claims because they do not understand the ethical and regulatory consequences of their actions, the writer should step in, help educate the client, and try to steer them in the right direction.
As medical device writer Melory Johnson says, “Careless writing is unethical. It can lead to medical errors and inconsistent interpretation—and this can have consequences that impact health outcomes. An experienced device writer will almost always be put in a position where they need to defend their decisions. Know FDA regulations well and do not waver.”3. Review the Risks of Product Promotion
Clearly, a writer should correct and educate a client who misunderstands FDA regulations, especially in internet marketing such as social media or blogs.
Medical device writers who craft content for online promotional materials or social media pages should be particularly aware of the risks of noncompliance. The FDA holds companies responsible for the accuracy of all branded content, including “likes,” comments, and exchanges on online forums, whether initiated by the company or in response to an unsolicited post. No matter how casual an online space feels, accuracy and compliance are paramount.
4. Stay current
For example, the FDA emergency use authorization (EUA) allows the use of previously unapproved medical devices or the unapproved use of approved medical devices during public health crises such as the COVID‑19 pandemic. These regulations can change regularly—sometimes on a weekly basis!
For medical writers, keeping up with current regulations such as the EUA is like chasing a moving target. It’s not easy, but it is necessary. To be a successful medical device writer, especially during health emergencies such as the current pandemic, you must keep up to date with both emergency and standard FDA regulations.
Device writing is often challenging, even for those with experience in regulatory writing. Medical device regulations differ from drug regulations, and device clients are sometimes unclear on compliance issues. Being successful in this niche requires continual learning, confidence, and a strong commitment to ethics and honesty.