With a proven track record of success in product development, we pride ourselves on our ability to develop an entire medical device from nothing more than a problem statement or napkin sketch. This starts in the concept development phase, where initial ideas are developed into viable concepts.
Concept development begins by conducting a number of brainstorming sessions with our cross-functional engineering teams. Rapid iteration of concepts will happen through a series of brainstorming sessions, concept sketches, early CAD, and technical reviews. Each iteration will further refine the concept(s).
The next step will be to prove whether or not these concepts will actually work in practice. We often develop proof of concept prototypes at this stage. These early-stage prototypes could include individually prototyped and tested sub-systems if the device is complex, one or more specific mechanisms of the device, or if the design is simple, we may create a prototype of the whole device. Concepts will be iterated and down selected until there is one concept that meets all criteria, at which point we will enter a concept freeze and begin designing the device under design controls.