Stage 0 is a thorough review of your existing concept to establish its feasibility and identify key modifications required to achieve a commercially viable, manufacturable product.

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 demonstrates the core functions of the device and sufficiently mitigates technical risks.

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.

During Stage 3 the beta design is subjected to verification testing to ensure that the detailed design specifications satisfy the design requirements including FDA and regulatory requirements.

This process results in a verification report for the validated and locked-down product design which will now be ready for production.

Stage 4 is the design, build, installation and wet commissioning of all pilot line infrastructure as per the manufacturing plan generated in earlier stages.

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.