There is a long, complicated and highly regulated process is turning the concept of a new medical product into a reality. For most new designs, this is going to include months spent in design and pre-approval before even prototype development. Companies that develop medical devices typically work with highly specialized contract manufacturers to produce individual parts and components according to very exacting specifications.
In addition, the development of an already designed component or product, some contract manufacturers offer medical product design support as part of their services. This is an ideal option for many of the original product concept companies as it provides a design team that is well aware of the potentials and possibilities of both prototype development as well as larger volume production.
Pre-Design Research and Understanding
One of the earliest phases of medical product design is in determining specifically what the medical device or component will do as well as how it will be different from other products on the market. Often, an in-house design team is focused just on the overall design, which is really the big picture overview.
By taking this data and research, as well as the early design drafts, the medical product design company can then look at the design from a function and production aspect. There may be design elements that need to be changed to provide production costs that are within the budget or that are necessary to integrate with other design components.
In some cases, there may be design flaws or errors that will not meet the FDA requirements for medical design approval. Ideally, by involving the service offering medical design support as early in the process as possible, delays and times spend pursuing design options that will not meet these standards can be avoided.