We prove the process at low volume. Controlled production runs refine parameters, establish yields, and generate the data your device needs to enter validation with confidence.
Pilot Production is where a developed process is tested by running it. Builds move from samples to controlled production lots, revealing how the process behaves across operators, shifts, and material batches rather than under ideal conditions. Parameters are refined, yields are established, and inspection methods are proven. The output is a stable process with demonstrated repeatability, documented for validation, and units suitable for clinical, regulatory, and early commercial use.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that take a defined process and prove it can run.
Pilot Builds
Controlled production lots built to production intent, generating units for testing, clinical use, and regulatory submission.
Process Refinement
Parameters tuned against real production data, with operating windows narrowed to what the process reliably holds.
Yield & Capability Analysis
Yield, scrap, and process capability measured and analyzed to establish baseline performance and identify variation.
Inspection & Test Methods
Measurement systems and inspection methods proven and refined against actual production output.
Work Instructions
Work instructions drafted and tested by the operators who will use them, then revised against what production reveals.
Supplier Qualification
Suppliers assessed on delivered material at pilot volumes, with incoming inspection requirements established.
Process Risk Assessment
Failure modes identified from observed production behavior, with controls implemented and verified.
What You Walk Away With
A process ready to validate: refined and documented process parameters, established yield and capability data, proven inspection and test methods, tested work instructions, qualified suppliers with incoming inspection defined, a process risk assessment with implemented controls, and pilot units available for testing, clinical, and regulatory use.
Why This Phase Matters
A process that works once is not a process. Running controlled lots exposes the variation that sample builds conceal: differences between operators, between material batches, between a first run and a fiftieth. Reducing variation at this stage allows you to develop a stable process and avoid requalification.
NEXT PHASE
Manufacturing Transfer
With the process stable and its capability established, your device moves into Manufacturing Transfer, where the process is formally qualified and production readiness is established.
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