Our proven process
Our proven process
Our stage gate process
We move your ideas from concept to manufacture through a proven stage-gated process. This process of continual risk reduction delivers increased technical and commercial certainty at every step.
Our flexible engagement model is designed to allow you to engage with us at any point, depending on the existing maturity of your product. This is all achieved with the required regulatory documentation as per ISO 13485 or 21 CFR 820.30 at each stage of development.
Stage 0: Product definition and concept design
This stage commences with an onsite immersion workshop followed by a series of ideation sessions to generate and then prioritise concepts.
Key deliverables include risk assessments, design-for-manufacture analysis, manufacturing strategy, design change recommendations as well as COGS, NRE and CAPEX estimates.
Stage 1: Proof-of-principle for critical process steps
During this stage it is common for simple proof-of-principle devices to be built for laboratory testing.
Stage 2: Concept demonstrator prototype
Stage 2 involves the implementation of design change recommendations and production of machine first prototypes for verification testing.
Before committing to tooling, an initial set of prototypes will be machined to confirm fluidic flow and basic function. Once this function has been established, precision injection mould tooling will be produced.
In parallel to this, the initial jigs and assembly stations will be commissioned to allow the first batches of Beta prototypes to be built once moulded parts are available.
Stage 3: Design Verification
This process results in a verification report for the validated and locked-down product design which will now be ready for production.
Stage 4: Production line set-up
Where appropriate we will use existing pilot line facilities for initial production, leveraging common infrastructure to lower upfront CAPEX. This pilot line will be used to further characterise and stabilise processes before CAPEX commitments for the automated production line are required.