Did you know the US medical device market is worth around $156 billion?
The medical devices that are sold in the US go through a rigorous development process before they hit the market. Without this process, there’s a good chance the medical devices on offer wouldn’t be up to standard.
Read on, and you’ll learn about the medical device development process and how it works. Whether you want to develop your own device, or you’re just curious, this post will help you understand how medical devices are developed.
The Discovery Stage
The first part of the device development process is ‘the discovery stage.’
During this stage, researchers identify a specific problem that could be alleviated by a medical device. Once researchers identify a problem, they go about developing something known as a ‘proof of concept.’
This is a document that outlines the problem and the proposed device that could address this issue.
This document will describe how the device works and how long it will last. It will also describe the dimensions of the device and the materials it will use.
The Prototype Stage
The next stage of this process is to build a prototype of the medical device.
Researchers might do this by approaching an existing medical supply company. This is often a good idea because such companies are already familiar with developing medical devices.
Researchers will then test the prototype in a laboratory so that they can make the device more effective and less risky.
The Application Stage
Eventually, the researchers will have a product that looks as though it is effective and safe. They will then approach the FDA in order to get approval for this medical device.
During this phase, the researchers will have to submit evidence that the device is effective and safe. To make things easier, researchers might work with firms that focus on ‘health economics and outcomes research (HEOR).’
With the help of a HEOR pharma firm, researchers can gather evidence from a wide range of sources. This then increases the likelihood of the FDA approving their device.
The FDA Review Stage
During this stage, the FDA will review the evidence it has received in order to determine whether the device is fit for sale. They will also compare the device to the best medical equipment that already addresses the issue in question.
The amount of time this process takes can vary depending on the nature of the device.
The Monitoring Stage
Even after the FDA approves the device, it will still be under heavy scrutiny.
That is because the FDA will be monitoring patient outcomes to see how well the device is performing. If the results are subpar, or if there are a significant number of negative outcomes, they will withdraw approval.
Do You Understand the Medical Device Development Process?
This post has explored how the medical device development process works.
Note that a lot of firms publish official documentation that explains how they developed a given medical device.
Companies must have undergone Complete Compliance Solutions’ medical device licensing, which will prove their products’ efficacy and protect them from hefty financial penalties and lawsuits.
If you have the time, you should take the time to read this content. That’s because, by doing so, you’ll develop a better understanding of how this process works in reality.
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The Editorial Team at Healthcare Business Today is made up of skilled healthcare writers and experts, led by our managing editor, Daniel Casciato, who has over 25 years of experience in healthcare writing. Since 1998, we have produced compelling and informative content for numerous publications, establishing ourselves as a trusted resource for health and wellness information. We offer readers access to fresh health, medicine, science, and technology developments and the latest in patient news, emphasizing how these developments affect our lives.