With the product story or specifications as basis—and in many cases in parallel to exploring these—we’ll come up with a number of alternative concept designs. This tends to be iterative: We come up with concepts that fulfil some of the requirements, but these will throw up their own questions which we then need to answer to modify or discard the concept. Some design elements will have to be treated as a given (e.g. the design needs to incorporate your IP or meet regulatory requirements), but in other areas there will be significant design freedom. In the concept design phase the product lay-out will be determined, and choices regarding key components, materials and production methods will be made.
The questions that the exploration of concept designs throws up can sometimes be answered easily, but in other cases we’ll need to either use a virtual model for simulation, or build and test a physical proof-of-concept model or breadboard. Quick turnaround, low-cost prototyping—which we can usually make in-house in our workshop and lab—is instrumental in answering feasibility questions.
Apart from exploring functional concepts we’ll also look at matters of handling and styling, in the process creating mood boards, sketches and renderings and sometimes non-functional handling- or presentation models to obtain user input. Getting early feedback from users—even from crude prototypes—is most valuable early in the design process when we still have a large degree of design freedom.
Medical device regulations
When developing medical devices subject to regulatory approval there is a requirement to document design input (specifications) and design output (engineering documentation), and to show how the output fulfils all requirements. There is also the need for the quality system to have document control. I believe it is best to take the regulatory process into account during definition and concept design phases, but to only start working with document control when technical feasibility is clear and the frontrunner concept chosen. Before this point the design is still too fluid, and the activity too exploratory.