MEDICAL DEVICE MANUFACTURE
PILOT TOOLING AND CLINICAL TRIAL BATCH PRODUCTION
REDUCING RISK AND TIME TO MARKET
Medical device manufacturers are always looking for ways to reduce time to market without compromising their stringent product optimisation and validation processes.
Hymid has worked with several global blue-chip medical companies to provide production-standard, one or two impression tooling that can bridge the gap between prototype and multi-impression full production tooling.
HERE'S HOW
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Tooling can be fully validated meaning that parts are of a high enough standard to be supplied to end users
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Reduced initial tooling cost to produce ready for market parts
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Reduced tooling time means that samples are available earlier for testing and evaluation
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The trialling and validation of assembly automation machinery can take place in parallel with the multi-impression production tool build
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Component design changes can be quickly implemented and verified in low impression tooling
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Tooling concepts can be fully tested and evaluated prior to committing to multi-impression tooling
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Keeping tool impressions low mitigates a high degree of risk than can be introduced when multiple part assemblies are built up with mouldings from multi-impression tools
Added value of two-shot injection moulding
This pilot mould tool approach replicates the design intent of the full production tools, meaning that many important lessons are learnt before commissioning the more expensive multi-impression production tools.
A huge benefit of this approach is that you gain validated pilot tools as a risk mitigation measure. The result is that validated components can continue to be produced to ensure continuity of supply even if there are delays with the production tool manufacture and validation programme.
An example of this approach is the production of the illustrated Cartridge Housing and Dose Knob components.
Outcomes
Each of these parts were produced in two impression, medical standard, fully validated tools. When the project was initially commissioned, the predicted required volume was for less than 50,000 parts but both of these tools ended up producing in excess of a million mouldings because required volumes increased far beyond the initial estimates.
This was not an issue as the tools were made to a specification that was able to accommodate this unexpected (but very welcome) extra workload.
