How To Start a Medical Device Manufacturing Company

active medical device with readings in manufacturing setting

When you begin your venture into creating a medical device, you’re also accepting that it will take a long time, and you will have to abide by many rules and regulations to do it the right way. Starting a medical device manufacturing company is a massive step in your career with high costs and high rewards.

Identification, Invention, Implementation

According to the National Library of Medicine, to start a medical device company, you must first work on identifying the need for a new device. Generally, physicians have the most potential in this endeavor as they are already presented with clinical problems daily.

Once you identify the issue, you must begin inventing the device. More success is found when you curate a team of people to work together to develop the solution. Lastly, you can start implementing the device into the market with the assistance of business experts.

Comply To Regulations

With a lucrative market comes piles and piles of regulations. Because medical devices are quite literally keeping people alive, you must become certified by the FDA and other international regulatory agencies. Complying with rules, you ensure your new device is reliable and consistent in helping medical conditions.

Patent Your Intellectual Property

Now that you’ve invented your intellectual property, in order to commercialize the device, you must receive a patent to avoid other competitors stealing your idea. Patent your brand, logos, processes, and device to guarantee you sell a unique product to a market that hasn’t seen anything like it before.

Seek Funding To Finance Your Business

You will never afford the funding and budget you need to create and manufacture the new medical device right away. Find investors to get a head start on the process and allocate money to specific process instances. Investors to search for include angel investors, crowdfunding, city/state/county resources, etc.

Begin the Manufacturing Process

You could not market this product without receiving money from investors. It is wise to consult with experts in this field to secure your products are of the best quality for your consumer. Remember, if you are manufacturing the products yourself, follow all rules and regulations set forth by the FDA.

Remember the Three Rules

The National Library of Medicine suggests three rules to follow when starting a medical device manufacturing company. Number one, you should focus on your product being better rather than cheaper. A cheaply made device puts the patient’s health at a greater risk.

Number two, choose revenue over cost. The success of your business is driven by the revenue to cost ratio. Strive for lowering the ratio by reducing production costs and increasing revenue.

Number three, there are no other rules. However, if you, the inventor, seek your invention throughout the entire process, you must assume a leadership role and help cultivate the success of the new medical device.

The rollercoaster of designing and manufacturing a medical device is intimidating. Surround yourself with like-minded individuals to get the job done successfully and who are up to date with regulations and compliance. The steps might take a long time, but changing the market and inventing a new medical device that attributes to research on disease and illness is a game-changer for the medical community and your career.


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