
Concept Generation
We translate clinical ideas into device concepts. Before significant resources are committed, we assess whether your idea can be built, whether it can reach a market, and what the path forward actually requires.
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Phase overview
Concept Generation is where a clinical idea is evaluated for technical feasibility and commercial viability before significant resources are committed. The output of this phase is not a device but a well-defined concept supported by a compelling business strategy and a realistic development path. Most projects begin here, though concepts that are already well-defined can move directly into Concept Development.
What happens in this phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that turn a clinical idea into a defined concept with a realistic path forward.
Brainstorming
Collaborative sessions that generate a range of possible solutions to the clinical need.
Concept Generation
Ideas developed into concrete concepts through sketches, models, and preliminary designs.
Concept Evaluation
Concepts ranked and down-selected against feasibility, market potential, user needs, and technical requirements.
Feasibility Assessment
Early assessment of technical performance, manufacturability, and cost for leading concepts.
IP Support
Concepts documented in enough detail to serve as invention disclosures and support patent strategy.
Development Plan
Milestones, resources, and estimates for the next scope of work, with documentation started for the design history file.

What you walk away with
A defined device concept and a clear path forward: a concept summary capturing the device and its key features, recommendations for next steps, and a project plan and estimate for the next scope of work. Where appropriate, the concept is documented in enough detail to serve as an invention disclosure.
Why this phase matters
The decisions made here shape everything downstream. A concept grounded in a real clinical need, an honest feasibility assessment, and a viable business case gives a device its best chance of reaching the market. A concept that skips this rigor carries hidden risk into every phase that follows, where it becomes far more expensive to resolve.

Concept Development
Once the concept is defined and the development path is clear, the device is ready to enter Concept Development, where feasibility is tested and the concept is refined against real user needs.
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