
Process Development
We develop the process that will produce your device. Before tooling or validation investment is committed, we establish how your device can be manufactured repeatably, at what cost, and at what scale.
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Phase Overview
Process Development is where a design becomes a manufacturable device. We assess manufacturing feasibility, characterize the process, identify the parameters that drive quality, and build samples that prove the approach before significant investment is committed. The output is a defined manufacturing process with documented parameters, a sourcing strategy, and a cost model, giving you a realistic path to production and the information to decide whether to proceed.
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 design into a process capable of producing it.
Manufacturing Feasibility
The design assessed against real production constraints to determine how, and whether, it can be manufactured at target volumes.
Design for Manufacturability
Manufacturability issues identified and returned to the design team while changes are still inexpensive to make.
Manufacturing Feasibility
The design assessed against real production constraints to determine how, and whether, it can be manufactured at target volumes.
Material & Component Sourcing
Materials and components identified and evaluated against performance, regulatory, and supply requirements.
Tooling & Fixtures
Tooling and fixture requirements defined, with concepts developed and investment scoped.
Sample Builds
Representative units built to demonstrate the process and generate data on performance and repeatability.
Cost Modeling
Unit cost, tooling investment, and volume assumptions modeled so production economics are understood before commitment.
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What You Walk Away With
A defined manufacturing process and the information to commit to it: documented process parameters with critical variables identified, a material and component sourcing strategy, tooling and fixture requirements with scoped investment, sample builds that demonstrate the process, and a cost model covering unit cost, tooling, and volume.
Why This Phase Matters
Unit cost, yield, and quality are largely determined by decisions made in this phase, before the first validated unit is produced. A process developed while the design is still in reach can be changed inexpensively. A process found to be inadequate after validation requires requalification, and often redesign. Developing the process deliberately is what makes the cost of your device knowable and the phases that follow predictable.

Pilot Production
With the process defined and demonstrated, your device moves into Pilot Production, where the process runs at controlled volumes to refine parameters, establish yields, and prepare for validation.
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