Medical devices and wearables are among the most revolutionary developments in healthcare. Both are examples of modern and innovative medical equipment that require a significant amount of time and work to achieve.
The exact process of medical device development might vary from place to place and country to country. However, you’re expected to adhere to the rules and regulations of your area. However, the overall process is very similar no matter where you are. It typically starts with an idea, which grows into a concept, which turns into reality. However, the road between these three destinations is complicated and full of roadblocks. Let’s take a closer look at the medical device development process.
Stages of Medical Device Development
The medical field is one of the most complicated and safety-based industries globally. Because of that, any new medical devices that hope to hit the market have to go through a stringent design process. There are a series of tests and requirements to ensure that only the safest and most efficient devices make the cut.
All medical devices require some level of FDA approval since their method is often the gold standard of medical device development. The FDA has five stages for processing and testing medical devices to determine if and when they’re ready for commercial use. If you hope to produce a medical device that becomes available for widespread use, here are the five stages of medical device development that you’ll have to pass.
Medical device development starts with the initiation phase. During this development phase, your device’s potential impact on the medical field is examined. Potential problems and risk factors are also considered, and your device is adjusted accordingly. Risk management is the most critical aspect of medical devices. No matter how great or revolutionary a medical device is, nobody is willing to use it if there’s a chance that it could harm them.
During this stage, there is a complete exploration of who will be using the device the most, how they’ll be using it, and where they’ll be using it. The overarching goal for a medical device is to be as practical and usable as possible. The more people who can implement your device, the more likely it is to make it in the medical market.
Design and Development
Design and development include all the technology, design work, engineering work, testing, and documentation into developing your device. It’s considered by some to be the most crucial step in the medical device development process. The goal is to ensure that the design output is greater than the design input and that your medical device is soundly designed and clearly defined.
Preparing to launch your medical device is one of the most significant and most nerve-racking experiences that you’ll go through. All of your preparation, testing and countless hours of work have all been for this moment.
Of course, before you can officially launch your device, you have to secure product validation and approval from the FDA. Your device will also have to pass through certain regulatory compliances, both nationally and internationally.
Launch and Postlaunch Assessment
Finally, after months or years of hard work, your product is ready for launch. In the period that follows the initial launch and testing, your medical device will be subject to assessment, studying, and careful examination. It must be determined whether or not your device delivered on its promise and lived up to its potential. If not, it’s back to the drawing board or onto a whole new device.
Why Choose DeviceLab for Your Medical Device?
If you’re serious about taking your medical device from a dream to a reality, contact us at DeviceLab. We use a foolproof six-step process that includes intellectual property support, product design, risk management, manufacturing, human factors and usability, and compliance and regulatory support to ensure that your product is ready for launch.
We’ve been in the medical device development business for over 20 years and have made excellent contacts and partners along the way. Your journey will start with a simple discussion where you tell us your vision and goals. Our experts work with you to formulate a plan to begin the process of medical device development. Reach out to us today to schedule your initial consultation.