The medical device market is more saturated than you might think. With seemingly countless treatment options on the table, how can your device cut through the clutter and get in front of the right patients at just the right time? You need a marketing strategy that sets your medical device apart from the competition. How? You need to be more than a medical device company. You need to be a trusted partner for both patients and their providers alike. 

Bringing Your Medical Device to the Market

The first step to understanding medical device marketing is to learn how the U.S. Food & Drug Administration (FDA) classifies medical devices. They have regulatory controls and marketing pathways you have to follow based on the risk of your device and its overall safety and effectiveness.

How the FDA Classifies Medical Devices

The FDA classifies medical devices into one of three classes based on their risks and regulatory controls: 

• Class I: requires general controls with and without exemptions and poses the lowest risk. They are not obligated to submit data or information to the FDA. 
• Class II: requires general controls and special controls with and without exemptions and poses a moderate risk. They are cleared via a 510(k).
• Class III: requires general controls and poses the highest risk. They need a premarket approval application.

It’s important to note that the European Union (EU) and other countries have different classification systems for medical devices. 

FDA Premarket Requirements 

Although bringing your medical device to the market may seem complex, the FDA has broken it down into four simple steps to ensure your device gets approval:

1. Determine how the FDA has classified your device and understand its applicable regulatory controls. 
2. Select and prepare the correct premarket submission. 
3. Send your premarket submission to the FDA and interact with the FDA staff during its review. 
4. Comply with applicable regulatory controls, including establishment registration and device listing.

Marketing Your Medical Device 

You might not have to wait until the end of the premarket process to begin your marketing efforts for your medical device. Instead, you can use this time to develop your marketing strategies and start generating interest for your product. Here are a few steps to initiate your medical device marketing campaign: 

1. Determine Your Target Patient Audience 

Identifying your target audience is the most crucial step in your marketing campaign. By determining your audience, you can focus your marketing efforts on who is most likely to need, benefit and ask their provider about your product.

For example, if your medical device is a pacemaker, your target audience will likely be older patients with a history of cardiovascular problems. In contrast, your target audience will be very different if your medical device is an asthma inhaler. 

2. Understand the Problem Your Ideal Patient Faces 

When marketing your medical device, it’s vital to consider the problem your ideal patient faces and how your medical device can address that problem. For instance, if you developed a prosthetic device, consider these factors: 

• Is your patient looking for a device that will improve their quality of life and ability to function on a daily basis?
• Is your patient hoping to address more of a cosmetic concern?
• Is there a current device on the market that may cause complications, and does your product correct those issues?

Distinguishing the specific problem your ideal patients are facing will play a major role in the effectiveness of your marketing campaign.

3. Develop Your Marketing Strategy 

The next step is to develop a targeted marketing strategy to reach your ideal patient audience. Marketing strategies may include product placement and advertising on traditional and digital channels, such as television, print media, radio, and social media. When building these strategies, it’s critical to consider the different stages of the patient journey: 

1. Awareness and research: where the patient may have just been diagnosed with a condition requiring your medical device. 
2. Consultation and decision-making: where the patient is speaking with their doctor and exploring different options. 
3. Treatment and follow-up: where the patient has already chosen your medical device to help their condition. 
4. Ongoing care and support: where the patient needs ongoing care to stay healthy, manage their condition and live with their new medical device.

Your marketing strategy should adapt and evolve with your audience as they flow through their patient journey. 

Get Eyes On Your Medical Device with Levo Health

If you have recently developed a medical device and are interested in learning more about medical device marketing, contact Levo Health. Levo Health is a healthcare marketing agency that can help you optimize your marketing strategies. Working with physicians, medical practices, surgery centers, and hospitals all over the country, we can help you reach your ideal patient audience. Contact us online or call (813) 235-0830 to get started today.