Referred to as stages or steps, there are 5 different phases or aspects of medical device product development. As there are significant regulations and requirements for all devices based on their intended use and their classification, it is essential to work with a medical device production company with an understanding of both the regulations as well as the production processes.
By choosing a company offering medical device product development as well as ISO 13485 certification, the original designer has the option to tap into the year of experience and expertise in the medical device development offered by the company. In most cases, the top manufacturers of injection molded parts also provide engineering services and full support for their customers throughout the process.
Stage 1: Research
It is essential for the inventor of the new medical device to fully research the market as well as the competition. Comparing what the proposed device will offer that is different or better than what is currently on the market is important. In addition, this is the first stage in the risk assessment of the device as well as to gain a clear understanding of all regulations and requirements.
Stage 2: Concept to Initial Prototype Development
This stage moves from concept through to the initial prototype. This will include the full scope of input from doctors and patients as well as the development of the drawings for the prototype and the analysis of that design. This is also where material selection and production methods are finalized and analyzed as to cost analysis.
Stage 3: Design and Development
This moves from prototype analysis and design to actual testing of the prototype along with verification and validation. In this phase, there is also a direct evaluation of the prototype by the end-users. It also includes the application for a patent and for regulatory approval.
Stage 4: Final Validation and Stage 5: Marketing Launch
These are the stages of medical device product development where the contract manufacturers are involved in ramping up to meet the anticipated market needs. At this time, approval has been received, and any clinical trials have been successfully completed.
Each stage of the process is critical for the company. Taking the time to select a medical device manufacturing company with the expertise to assist as needed in the development process has a very big impact on moving the process forward.