Medical Device Commercialization Overview
Determining the Feasibility of the Concept Design
Can your concept be made?
Once you’ve proven that you have a viable product concept, the next step will be to determine that the design is technically feasible, and can be produced in a way that makes sense economically. This step is more rigorous than developing the proof-of-concept prototype (depending on product complexity, it is sometimes more economical and efficient to forego proof-of-concept activities in favor of moving directly into feasibility).
Forma can help you determine the feasibility of your medical device concept by developing preliminary product specifications and designing and developing a concept prototype that will be representative of what the ultimate marketed product will be. We can perform preliminary mechanical, electrical and software engineering, and preliminary industrial design to address user interface issues and aesthetics.
The determination of feasibility is significant in that, once feasibility is established, all design efforts moving forward must be done under Design Control, as specified in the FDA’s Quality System Regulation.