Micro Systems’ Latest Medical Mould Innovation Ensuring No-Fail Reliability

On a recent medical device project, Micro Systems has once again delivered ground-breaking capability across all dimensions on an 8-cavity medical mould to ensure a ‘no-fail’ requirement.

Tasked with achieving a CpK and PpK of greater than 2.0 on every single dimension on the component (over 30 dimensions in total), a collaborative effort from the entire Micro Systems team from mould design, mould manufacture, metrology and process development has enabled Micro Systemsto meet all requirements set out by customer to ensure the life-saving device can meet the stringent requirements set out by industry regulators.

For components for devices such as epinephrine auto-injectors, any failure would lead to severe consequences for patients, up to and including fatal anaphylactic shock. Extremely high Process Performance Index and Process Capability Index values across all cavities give a much higher confidence in the fail-safe performance of such critical medical devices.

Reliability is paramount in producing life-saving medical devices, where even the slightest deviation can impact performance and patient safety. High-quality, reliable mould tools play a crucial role in ensuring consistent, precise component manufacturing. Micro Systems’ latest 8-cavity medical mould exemplifies this standard, delivering ultra-accurate parts with minimal variation from cavity to cavity.

This level of consistency not only ensures regulatory compliance but also reduces downstream inspection and rejection rates. In medical applications, where precision is non-negotiable, reliable mould performance translates directly into safer, more effective devices. These are the projects in which Micro Systems excels, offering stand-out service to its customers, enabling an efficient and streamlined medical device development program from pre-production tooling design, manufacture, metrology, validation & initial component supply, through to manufacture of full production tooling of the highest quality, significantly reducing the time-to-market for the company’s customers devices.

Founded in 2003 with just a small team, Micro Systems has grown into a global operation with over 100 highly skilled professionals. The company now operates over 800 square metres of advanced manufacturing space in Warrington, UK, featuring clean manufacturing areas, Class 7 and 8 cleanrooms and white rooms, alongside a modern production facility in Singapore.

Serving hundreds of customers worldwide, Micro Systems is committed to delivering excellence through continuous investment in the latest technologies. From advanced design software and high-precision injection moulding machines to cutting-edge metrology equipment, the company ensures the highest standards in every aspect of its operations. Micro Systems is ISO 13485 and ISO 9001 accredited, with extensive experience and niche capabilities in mould manufacture for drug-delivery medical devices.

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