We turn promising concepts into proven ones. Through feasibility work, user feedback, and alpha prototypes, we establish whether your concept can be built and refine it until it's ready for controlled development.
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Phase Overview
Concept Development is where a concept is tested against reality. Feasibility studies, breadboard and alpha prototypes, and early user feedback establish whether the concept can be built and how it needs to change. The output is a refined, down-selected concept with documented user needs and the foundation of design controls in place, ready to enter formal design and development.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that prove a concept can be built and prepare it for controlled development.
Feasibility Assessment
Technical and commercial feasibility tested through analysis, breadboard models, and early prototypes.
Prototyping
Alpha prototypes built and iterated to evaluate form, function, and performance against the intended use.
User Research
Clinicians and end users engaged to validate assumptions and surface the requirements that shape the design.
Design Inputs
User needs and intended use translated into documented, testable design inputs under design controls.
Risk Management
Initial hazard analysis and risk assessment established and maintained as the concept evolves.
Development Plan
The development plan refined with updated scope, milestones, and cost, and the design history file formally opened.
What You Walk Away With
A validated concept ready for formal development: a down-selected design supported by alpha prototypes, documented user needs and design inputs, an initial risk assessment, and an updated development plan and estimate for the next scope of work.
Why This Phase Matters
This is the last phase where changing direction is inexpensive. Feasibility problems caught here cost a prototype iteration. Caught after design controls tighten, they cost redesign, retesting, and schedule. Proving the concept now, against real users and real physics, is what makes the phases that follow predictable.
NEXT PHASE
Design & Development
With feasibility proven and user needs documented, the concept is ready to enter Design & Development, where the design is completed, specified, and frozen for manufacturing.
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