Marketing a medical device in the US is a lot more complicated than meets the eye. This is largely due to the fact that it is often quite difficult to have a medical device approved by the FDA for legalised marketing in the first place. In addition to this, medical devices can be difficult to market because the ideal consumer group for such a product is incredibly defined and often difficult to reach.
You may find that taking a more traditional approach towards advertising will better improve your marketing efforts. Having a celebrity use your product in a TV advertisement will probably not do you any favours, unless perhaps if you have created a type of cosmetic device of some sort. So, what is the right way to market medical devices within the US?
You may wish to approach a professional marketing agency to assist with your efforts to expand your product to the furthest corners of the earth. Word of mouth is one of the most effective ways to market a medical device because this will allow you to establish a closer bond with your consumers. You may want to get involved with certain events in the industry. Meet like-minded people from various sectors that have the potential to take a keen interest in your product.
Show confidence in your device and make sure you give people enough reason to WANT your device. What can it be used for? Is it safe and effective? Why do they need your product and what makes it different and better than your competitors product? You must answer each of these questions and more if you wish to properly marketing your medical device in such a tough and competitive marketplace.
Defining your Consumer Group
It is a good idea to define which consumer groups t are most likely to be interested in your medical device. These are likely to be those within the common health sectors such as dental, general hospital, cardiovascular, anaesthesiology and others such as neurology and immunology etc.
Before you can legally market your device in the United States, you must complete and succeed in passing the FDA 510k Clearance submission. This is necessary in order to prove that your medical device is safe, effective and eligible for legal marketing.
How long does it take to get a FDA 510k approved?
The length of time it takes for your 510(k) submission to be completely cleared by the FDA depends on the application route you have taken. For example, applying to the FDA directly will take a longer period of time than if you were to apply via fdathirdpartyreview, who not only carry out a quicker review of your application, but will forward it to the FDA on your behalf. Upon receiving a 510(k) clearance submission from an Accredited Person, the FDA must hasten their reviewing process and provide results within 30 days.