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The 4 Steps to Starting a Medical Device Business

The 4 Steps to Starting a Medical Device Business

Technology has entered so many industries that there is something of a revolution going on. It seems that the barriers to entry to certain industries have been removed and anybody can jump in and be successful. If you are looking for a business to start, then the medical device industry should be high on your list.

Of course, there are a lot of factors involved in anything healthcare related, but since technology is so specific to certain industries, just about anybody can run it. Of course, if you already work in healthcare and have a good idea, you can branch out on your own.

In this article, I will go over how you can start your own medical device company even if you have no healthcare experience.

Figure out the Logistics

One of the most important factors in starting a medical device company is going to be certifications and following detailed regulations. But that should come after you’ve already determined if your idea is viable.

Before you spend any money to get your company recognized, you need to figure out how your product is going to get to market and how much you think you’ll be able to make.

First, work out your shipping costs to sell your devices. Calculate the costs of running your own fleet of delivery trucks or outsourcing to a company like Florida Couriers. This will help you understand if you’ll be able to make money from this business before you proceed to the next step.

Comply with the Regulations

For good reason, the medical device industry is heavily regulated. Since these devices are used for people’s health and wellbeing, it makes sense that they would need to be proven safe and effective to use.

The process of getting certified with the FDA and even international regulatory bodies is quite complicated so you will likely need to have an agent that takes care of this aspect for you. Be prepared for this process to take a lot of time before you are approved.

Protect Your IP

Your device is unique and solves a problem in a different way than other devices out there. For this reason, it is going to be a target for copycats. You’ll need protection from intellectual property theft, and you can do this by trademarking and copyrighting your product.

The very first thing to do is to get a patent for it if you think the device uses a unique technology or design that hasn’t already been patented. This IP protection should also include your brand and logo as well as the actual product itself.

Market Research

One of the most important things to get right once you’ve got your product perfected is to research the market for it. Understanding the market will help you with pricing and your marketing campaign.

It will take an in-depth knowledge of what doctors or medical professionals are looking for so you can deliver the results they expect.


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by Lottie Pritchard // Lottie Pritchard is a contributor to Businessing Magazine.

Opinions expressed by contributors are their own.