New or improved medical devices, including wearable sensors, intravenous needles, or other equipment and instruments are important developments for the industry and the care of patients around the world. While many existing devices are helpful currently, improvements can be made to optimize the experience of the user.  But simply creating a new medical device isn’t a fast process.  It can take anywhere between 3 and 7 years to get your device to market.  The process is rigorous, iterative and requires diligent testing and improvements to ensure the final product is the best it can be.  The medical device development process consists of three main steps: Design, Prototype and Approval. These steps have dedicated requirements and steps along the way to bring a device to market on time and with the highest degree of efficacy and quality possible. 

Design and Plan

The first step in the medical device development process is to design the idea. This includes collaborating with UX/UI designers, engineers, and other developers to create a plan to move your project forward. The planning process should include representatives from every discipline your project will require.  Early input from a UX designer, along with an engineer who will be implementing these ideas, needs to come to the forefront of the conversation as early as possible to reduce potential snags and issues later down the road.  Designing and planning your medical device project can take anywhere from a few months to a year. This aspect of getting your medical device to market should be given plenty of time to prevent bigger issues from coming up during the development stages. 

Develop and Optimize

Developing and optimizing a medical device is easily the longest process to get your medical device to market. This is where engineers and developers hit the ground running in creating prototypes of your product and bringing it to life. The development stage is an exciting one, but it can also be rigorous and cyclical.  Just as the design phase requires enough time to start the project on the right foot, so too does the development phase necessitate diligence and plenty of time to accurately and effectively create a working medical device that will improve patient care.  Once your medical device is turned into a prototype, you can start testing the product and figuring out the kinks and issues that come to light. This is an iterative process, where you may have to redesign or recreate various components to optimize the final product. Testing your device can take months or years to complete. Overall, the development and testing phase is estimated to take anywhere from 1-5 years. 

Final Test and Approval

After the prototyping and testing phase, you can send your medical device for FDA approval. Depending on the class type of your invention, there are different ways to file for approval. While the least restrictive approval process can take a few weeks to 3 months, the most intense and restrictive FDA approval process for medical devices can take up to a year. This part of getting your medical device to market is critical and takes careful planning to complete the application process. 

How To Get Your Medical Device to Market

Once you have met the regulations set by the FDA, you can send your device to market and sell it to your end-users. Whether you are marketing your device to patients, doctors, clinics, or others in the medical field, completing the device development process is rewarding. After the development and approval of your project, the work has only begun. Getting your product into the hands of those who will benefit takes another kind of strategy and discovery process. Learn who your device will benefit and where they live. Conduct research into the medical device market and the trends, processes, and practices that will be most effective for you. When you partner with a medical device market expert, you will be able to efficiently and reliably sell your product and begin to improve the quality of patient care around the world.  Nextern has become an industry leader in the medical device development process, and we have experience getting medical devices to market around the globe. Contact us if you want to begin developing, or start marketing, your next great device idea.