Medical device marketing helps companies advertise new products to the general public and appeal to a wider audience. However, marketers must follow the FDA advertising rules, which include completing premarketing, avoiding deceptive claims, and more.
The size of the medical device market continues to increase exponentially, with no signs of slowing down. According to Fortune Business Insights, the market is expected to grow to an astonishing 1,032.66 billion by 2034, highlighting the need for new marketing solutions to existing medical problems.
How Much Does It Cost to Bring a Medical Device to Market?
The total cost of bringing a new medical device to market varies widely. The first factor to consider is risk level. Class I risk level products are the cheapest to bring to market, while Class II and III progressively become more expensive.
There are also many budgetary items that you need to consider when figuring out the total price tag. You need to account for:
- Clinical trials
- Engineering
- Quality control and assurance
- Distribution
- Manufacturing
- FDA fees and assessments
Can You Market a Medical Device Without FDA Approval?
Technically, no. However, there are different types of FDA approval, both formal and informal. Most of the time, if you have informal approval, you cannot sell the product commercially or make any claims regarding its efficacy.
If the device is a Class I or Class II risk level, then you may be able to receive a premarket exemption from the FDA, but the product registration is still a requirement.
Ultimately, how you can market your medical device is on a case-by-case basis. It is important to work with a medical device marketing agency to determine which permissions you need and how you can market your product in the future.
What Is Intended Use?
Intended use is a term used by the Food and Drug Administration to describe the intent of the party in charge of labeling the medical device. In general, all supporting advertising material and documentation needs to reflect that intended use.
FDA Advertising Rules for Medical Device Marketing
What types of regulations does the FDA have surrounding medical device marketing? Here are some of the key rules to remember.
Fulfill the Premarketing Requirements
Whether or not you need to follow premarket guidelines depends on the class of your product. There are different approval levels depending on the risk rating.
Generally, for items that are considered high-risk, or Class III, you will need to go through all of the proper channels to receive premarket approval. You will likely need a large amount of data that shows safety and effectiveness.
Reposts Count as Authorship
Social media is a fantastic medium for advertising medical devices, but it comes with its own pitfalls. Take caution when reposting any content from an official account, as the FDA equates reposting with authorship. Essentially, if you repost something, it is viewed as coming directly from you as the manufacturer of the product.
Promotional Material Must Only Refer to “On-Label” Uses
When promoting your product, you may be tempted to cover all of its benefits. It is crucial to stick with on-label uses, or uses that have been explicitly approved by the FDA.
A product designed to reduce acne, for example, may also have other benefits for your skin. If those uses are not on-label, then they cannot be used in any type of advertising or promotional material for the product.
Information Needs to Be Presented Fairly
While it may seem tempting to focus on all of the positive traits associated with your medical device, you must present all information fairly. Make sure to cover the benefits and the drawbacks, giving potential customers the full picture.
Avoid Deceptive or Exaggerated Claims
Exaggerating claims is a form of deception. When in doubt, pull your information directly from the label. Do not create false claims or exaggerate results. Any exaggerated claim could be considered a promise, which might land you in legal hot water.
Include All Risk and Disclosure Information
With sites such as X including character limits, medical device marketers may not be able to fit all of the text required by the FDA into a single post. However, this is not an excuse; all regular disclosure information needs to be shared on any type of advertising platform, including social media.
Frequently Asked Questions
What Are the Fastest-Selling Medical Device Markets?
The medical device market is ever-changing based on consumer needs and current health trends. Here are some of the leading medical devices in 2026.
Diabetes Care
Americans continue to receive diagnoses of Type 2 diabetes, a disease that forms when the body is unable to process sugar correctly. Therefore, insulin accumulates in the blood.
Diabetics rely on blood sugar trackers, medication, and supplemental insulin to manage their Type 2 diabetes. Since the disease has no cure, the diabetes market represents an expanding opportunity for medical device companies.
Mobility Aids
When you think of mobility aids, you might think of wheelchairs and walkers. However, there are plenty of other options for those who want to stay active and independent but just need a little bit of extra help. Some other mobility aids include:
- Crutches
- Canes
- Rollators
Wearable Trackers
Nowadays, it seems like everyone wears an Apple Watch or some other type of fitness tracker. Wearable tech helps users monitor important statistics such as heart rate. Devices can often also give estimates for calories burned during physical activities.
How to Get Into Medical Device Marketing?
Typically, you will need some sort of degree in business or marketing. Many roles also require experience with life science marketing or previous positions in marketing roles.
What Are the Five P’s of Healthcare Marketing?
The five P’s of healthcare marketing are:
- Promotion
- People
- Place
- Price
- Product
Stay Within Healthcare Compliance
Medical device marketing can be tricky when complying with FDA requirements and guidelines. Whether you are interested in pursuing medical device marketing or you are a veteran in the field, this guide can help you determine your advertising strategy and ensure that everything you do is legal.
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