The seed idea can come from a variety of places - maybe a solution to a problem recognised by a medical professional or a gap in the businesses product offering highlighted by the sales and marketing team? The proposal is summarised using the minimal resource, ready for presentation to the Project Review Board (PRB).
4.0 product design
The Concept is defined - now the pre-tooling component development and advance supplier liaison can commence. Fundamental engineering process such as tolerance studies, BOM generation and engineering drawing creation are completed. Final Advanced prototypes reduce risk and build confidence prior to tooling commitment.
Stage 1 has determined the proposed project fits within the companies business model. Stage 2 see an increase in resource - reviewing key market data and regulatory pathways to establish commercial feasibility.
5.0 design, develop & detail
Tooling refinement and document preperation ahead of producing multiple off-tool, off-process production intent devices for V&V testing.
With commercial feasibility established a product development team can be assigned. The deliverable of stage 3 is a fully resolved concept proposal that satisfies that Design Inputs. This may include functional prototypes or photo realistic renderings depending on what is appropriate for the project.
Device performance testing to prove the Design Inputs have been achieved.
Clinical evaluation to prove the Design Inputs were correct and the product is suitable for the market.