Many companies that have experience in medical device design and development understand the complexities of the process. However, there are many companies that are moving into the area of medical device manufacturing, sometimes without the staff and expertise to understand this often complicated and challenging process.
By working with a medical device contract manufacturer that understands the critical nature of the design phase and stage of the process is easier to complete the necessary verification, and validation processes as well as have all data provided for the review.
The Product Development Process
While the medical device design may seem to be the initial step in the process, the action originating issues is the specific needs of a group of people. Unlike consumer goods, medical devices have to have a specific target user in mind so that the medical device design can be developed to meet those needs.
Once this step has been completed and the needs of the user established, the design input phase begins. This where data is collected to demonstrate how the design will be used and how it will be effective. Once it is reviewed and approved, the next step will be to convert this more generalized data into very specific systems and requirements.
This includes everything in detail about the materials, processes, systems and other factors in designing the device. This design process can be lengthy. With expert engineers and designer in the field of medical device manufacturing on the team engaged in developing the design process, errors, omissions and processes that are not right for the design can be avoided.
Once completed, the design output is reviewed and goes through a verification process to ensure it matches with the initial design input. Once this is approved the device is then developed into a prototype, validated and goes through final approval before becoming a medical device on the market.