How Much Does It Cost to Bring a Medical Device to Market?

Author: Trinity M Consulting, LLC. |

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Behind every good medical device is a business plan. After the device has been developed, you need a plan for getting your product to market.

The FDA requires certain processes for new medical devices. FDA regulations can be time-consuming and expensive. But FDA approval is an essential step for any medical device.

If you are developing a medical device, you know what a hassle this process can be. Regulatory consultants streamline these procedures for their clients every day.

You might be familiar with the cost of a certain consulting project. But what about the entire cost of bringing a medical device to market?

This post will take you through the steps of bringing a medical device to market. You'll learn more about the costs associated with each step.

Keep reading to find out more about the true cost of bringing a medical device to market.

Setting the Stage for Your Medical Device

The FDA has a strict definition of medical devices. Before you can bring a device to market, you have to do some preliminary research. This initial work will help you determine whether your device fits the FDA requirements.

First, you should ask yourself why your product is unique. Does it solve a medical problem that's difficult to treat? Are there similar devices on the market already?

You should also take stock of your business plan. Your manufacturing costs should be reasonable. A great marketing plan can help get your product off the shelves.

Before you bring your device to market, you should have a good sense of appropriate pricing points. Your business plan would also outline the way your device would be sold.

Finally, you must be sure that you have the ability to take this product through the regulatory process.

Medical device consulting services can help simplify this process. Consultants have plenty of experience bringing devices to market.

Once you have a business plan and a good support team, you're ready to get started.

Five Steps to Market

When you're ready to take your product to market, the FDA lists five steps you must follow. Let's take a look at those steps now:

Classifying Your Medical Device 

The FDA lists three different classes of medical devices. These classes are based on how risky the device could be. Class I devices are the lowest risk. Class III devices are the riskiest devices.

Before you can bring your product to market, you need to know the correct class. This will give the FDA helpful information about your device.

Choose the Right Premarket Submission

Your device class determines the appropriate premarket submission. The most strict premarket submission is the PMA. This submission requires extensive scientific evidence for your device.

Before you prepare your premarket submission, make sure you have chosen the right one. Your regulatory consultant can help you find and confirm this information.

Get Your Premarket Submission Ready

There are several elements the FDA requires in premarket submissions. These submissions must contain information like clinical evidence and design controls.

Class III devices generally require even more information. The amount of information you have to include increases with risk.

Submit Your Device to the FDA

When your submission is ready to go, you can send it to the FDA. The FDA review process can take from 90 to 180 days depending on the device.

After you've submitted your device, the FDA carries out an administrative review. This review ensures that you've included all the required information.

Register and List Your Device

Once you've received FDA approval, you're ready to register and list your new device.

The FDA outlines this process for medical device companies. Registration must be updated on an annual basis.

How Much Does It Cost?

As you can imagine, bringing a medical device to market isn't cheap!

The cost of bringing a device to market can range from $31 million to $94 million. High-risk devices tend to fall on the upper end of that spectrum.

The most expensive parts of the process are the five FDA steps listed above. Certain fees are associated with the FDA submission itself.

But there are many other factors that can influence the cost of your device. In some cases, you have to engineer entirely new technology to manufacture your device. This extra work can come with a hefty price tag.

Your device might require a lot of clinical research. Scientists, laboratory space, and equipment can add to the cost.

It takes a long time to bring medical devices to market in the US. Studies have shown that it takes two years longer in the US than in other countries.

This longer timeline can also drive up prices. Any delays in the regulatory process can add further expenses.

With the right regulatory support, you can speed this process and cut costs.

Regulatory consulting services offer a range of options tailored to each company's unique objectives. From development to marketing, consultants are there every step of the way.

Streamline Your Process Today

Are you seeking top-tier consulting services for your medical device? Then Trinity M Consulting is here for you!

At Trinity M Consulting, we bring a wealth of experience to all our clients. Our top-of-the-line services are designed to give you an edge in today's competitive market.

We are also proud to offer premier technical writing services for all your clinical needs. Our team can take you through every aspect of the medical device development process.

If you're ready to streamline your process, get in touch! We look forward to helping you during this exciting journey.



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