Cambridge Biostability – Vaccine Rehydration System

Cambridge Biostability have developed a technology to stabilise vaccines onto membranes which overcomes the challenges surrounding the storage of vaccines which need to be temperature controlled. This technique allows storage at elevated temperatures for long periods of time and re-hydration at point of use with sterile water.

Working alongside their team of scientists we designed and engineered a housing around the membrane with minimum dead space and maximum flushing capability which could be cleanroom moulded, sterilized and then assembled in an aseptic isolator to cGMP.

Rapid prototypes were made to test the flushing capability. Once the housing design had been proven it was converted into a set of injection mouldings. Materials selection was critical for this medical application as it impacted the moulded part design and manufacturing method.

The fully detailed components were transferred to the toolmaker for production where we continued to support the project through tooling, cleanroom moulding and assembly.

The first cGMP trials were successful and the product was recently featured on the BBC.

Ranier Technology – Distractor

The Ranier Technology distractor is a surgical instrument used during spinal disc replacement which enables the surgeon to move apart the vertebrae and create a working channel to allow other instruments to be inserted as part of the procedure.

We created the surgical instrument design for the distractor which allows the surgeon to use a standard 5mm hex driver to adjust the moving distractor blade through a worm and wheel gearbox.

The device had to be as light as possible for ease of use yet strong enough to withstand the forces during distraction. The device is CNC machined from stainless steel and can be easily dissembled for hospital cleaning before re-assembly for gamma sterilisation.

The design was fully detailed in 3D with accompanying 2D drawings to allow transfer to prototyping, testing and manufacture.

The product is now a CE marked surgical instrument.

Ranier Anatom-C – Spinal Disc Replacement

The Ranier Anatom-C was designed to treat patients with degenerative intervertebral discs. The design satisfies both the needs of the patient and surgeon along with stringent high tech manufacturing requirements.

The device is an anterior cervical inter-body fusion cage and is implanted between the vertebrae of the cervical spine to provide mechanical stability and space for fusion to occur.

The design requirements were established through surgeon input which allowed a complex and fully parametric base 3D CAD model to be built using the advanced surfacing capabilities of PTC Creo.

To ensure optimum fit with the patient’s anatomy a single CAD model was created from which a range of sizes were parametrically generated. This model controlled all size variants to ensure that the design parameters were scaled in accordance with the anatomical needs and met the manufacturing requirement.

The design was optimised through collaboration with an FEA analysis consultant prior to manufacture and rigorously tested to achieve CE approval.

The Anatom-C was sold throughout Europe.