Having a revolutionary idea about a new medical device is only the starting point in a long and complex process to go through the design, development, verification, testing and finally the approval process.
For most companies starting out with an idea, the process of moving from concept to market is several years. With very simple devices it can be as short as three years, but for more complex devices or products that are very new, this process can be as long as seven years or more. Finding ways to streamline this process is critical for the company as years of design, development, and testing can leave limited ability to launch the necessary marketing and advertising to create a sales base for the medical device.
Start Early
A key factor in medical device design in this streamlining process is to turn to companies with expertise and experience in the specific type and class of device. This expertise is essential in moving the early aspect of the design along the correct path, avoiding costly mistakes in design that are not compatible with regulations, research or cost-effective production methods.
Ideally, by involving a company with extensive expertise in medical device design in the concept development phase, the entire process can move forward faster. Reducing the time to market is beneficial for the company and also for stakeholders and investors.
Functional Considerations
Having a clear understanding of the function of the device as well as the production options and costs is also an important part of the early design process. Often internal design teams not associated with production and specific quality considerations that must be in place to meet industry standards and regulations based on the type of device.
The early involvement of a medical device design service with a proven track record of confidentiality, ability to work to timetables and a creative approach to overcoming challenges in the process is critical for any OEM.
