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What Makes a Great Medical Device Idea?

Updated: Sep 25, 2023

Medical devices are changing the scope of healthcare worldwide. With new technologies like 3D printing, modern innovative medical devices are being introduced to healthcare facilities and patient’s homes. But the question is- what makes a medical device idea a good one? Here are a few pointers to consider when determining whether you have a good idea for a medical device.


Money is one of the most important factors when developing a medical device. Here are some things to consider when thinking about your device idea:

  • How much will it cost to develop? What are its COGs?

  • Will you be able to make a profit?

  • Will people invest their money in it?

  • Will people want to purchase it?

Funding can really make or break a project. You need funding just to get your project started- you’ll need to hire a whole team of engineers to develop it. Contemplate whether it’s financially worth bringing your idea to the market.

The Market-

To figure out whether your device idea is a good one, you’re going to have to do research on the current market. Look into what other similar devices are already released so you can determine where you can make improvements. For any innovation to be considered worthwhile, it needs to address a certain problem in the industry that will excite customers and make them want to spend their money on the product.


Your device idea should add some value to the industry. What about your device adds improvement to the current market? What makes it stand out, what makes it unique? For consumers to take notice of your idea, it must deliver some value. It must make something better, more effective. There’s two ways this can be achieved: either by being different to or improving upon an existing idea. Identify a problem in the current market and then create an innovative solution to address it.


How long development takes and how much money it costs depends upon the complexity of the idea. It’s best to keep the concept as simple as possible to make sure it’s even achievable to develop. The key is to make the device straightforward and efficient to accomplish its purpose. Keeping it simple saves time and energy in the longrun of development.

FDA Approval-

One of the longest parts of the development process is gaining FDA approval, so you should be thinking about whether or not your device idea will be more difficult to get approved. In order to meet regulatory requirements, companies must document and build risk reduction into the design, develop a safety assurance case, consider use environments and validate human factors (e.g., use error related to instructions for use, training, and other user interface issues), as well as develop verification and validation data. Developing a comprehensive design involves a multi-disciplinary team with a deep understanding of the regulatory, and the process can be long and painful, so it’s important to think about how difficult it will be to get your device FDA approved.

Now that you’ve read up on a few ways to make sure your device is a good idea, we hope you’ll take your idea and turn it into a reality. If you’re ready to take the next step in developing your innovative medical device ideas, book a call to meet with our CEO Jason Scherer.


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