SixGate

Product design and engineering for medical devices

Device mechanisms, housings, fluid paths and laboratory instruments developed from specification to production, with forces and flows understood on the model well before prototypes are built and the design is frozen.

A laboratory microscope beside a rack of sample tubes.

Medical devices and laboratory equipment have to work every time, often in the hands of people who are not engineers. An auto-injector has to fire with the right force after months in storage, and a diagnostic instrument has to hold its samples at temperature while fans and motors run beside it. Much of that behaviour is set by spring rates and moulded tolerances chosen long before the first build.

More about life sciences and healthcare

The specification records who uses the device, the forces they can apply, the volumes it will be made in and the standards your regulatory route calls for, so concepts can be compared against it. In detail design, FEA shows forces and stresses in springs, plastic housings, latches and snap fits, and estimates fatigue life for parts that cycle. Drop studies show what happens when a device falls from a bedside or bench. CFD covers flow and pressure through fluid paths and mixing in chambers.

Analysis supports design decisions and test planning, and the regulatory route stays with your organisation. Prototypes can be printed in polymers or machined in aluminium and stainless steel, from functional test parts to presentation models, and production drawings are prepared for your moulding and machining suppliers.

Typical products: auto-injectors and pens, inhalers, infusion and wearable pumps, diagnostic analysers, laboratory instruments, centrifuges and hospital equipment.

Device and laboratory problems we help with

Will the mechanism deliver the right force every time?

Spring forces, contact and friction through the mechanism’s travel, with stresses in the plastic parts that carry load during firing, dosing or locking.

What happens when the device is dropped in use?

Stresses in housings, windows and internal components for drops from a bed, trolley or bench, so the features that crack first are known before drop testing.

Which tolerances control dose and sealing?

The dimensions that set dose, travel or sealing identified and toleranced on the drawings to suit moulding or machining at your production volume.

Is flow through the device consistent?

Pressure drop, flow rate and velocity through channels, valves, needles and nozzles, and where recirculation or dead zones could trap air or let material settle.

Will repeated use crack a part?

Fatigue life of latches, hinges, clips and springs in reusable devices that are opened, loaded or cleaned many times.

Will the instrument hold its temperature?

Temperature uniformity across sample blocks, incubators and reagent stores, with heat from motors, electronics and the room taken into account.

Stages and studies most used in life sciences and healthcare

Specification

User forces, use environment, production volume, cost and the standards your regulatory route calls for, agreed before concepts are drawn.

Non-linear analysis

Contact, friction, large deflection and plastic yield in mechanisms, snap fits and seals, with hyperelastic models for elastomers.

Drop test and impact simulation

Drops of handheld and bench devices, including glass, cartridges and internal electronics.

CFD

Flow through fluid paths, chambers and nozzles, and airflow through instruments and enclosures.

Prototype & Test

Functional prototypes and presentation models, printed or machined in polymers, aluminium or stainless steel, for bench testing and for putting in users’ hands.

Engineering Pack

Drawings for moulded and machined parts with the critical dimensions and materials called up, ready for suppliers to quote.

Before you start

What to send us

  • CAD, sketches or an existing device (STEP or native)
  • Materials and grades, including plastics and elastomers
  • Use forces, spring rates and cycle counts for mechanisms
  • Flow rates, fluid properties and pressures for fluid paths
  • Heat loads and temperature targets for instruments
  • Expected volumes and the standards your device has to meet
Can you model elastomer seals and plungers?

Yes. Rubber-like materials are modelled with hyperelastic material laws, which capture the large strains in seals, plungers and stoppers.

Can you model fluids other than water?

Yes. Density and viscosity are set to suit the fluid, and non-Newtonian behaviour can be included for fluids such as blood or gels where the material data exists.

What about parts that are autoclaved?

Parts can be assessed at sterilisation temperatures using property data for the grade at that temperature, since many plastics lose much of their stiffness well below their melting point.

Does your work cover the regulatory submission?

No. Design and analysis feed your own technical file and test programme, and the submission and the evidence it rests on stay with your organisation.

Do you work on laboratory equipment as well as devices?

Yes. Centrifuges, analysers, incubators and automated handling equipment raise the same structural, thermal and flow questions as devices, often with motors and fans adding heat and vibration.

Tell us about the device

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