Deep expertise and world-class
facilities: unparalleled capabilities.

Deep mechanical, electrical and biomedical engineering expertise combined with specialised fabrication skills and regulatory experience combine to make an unparalleled implantable device development team. In close proximity to leading clinicians and researchers, our engineering teams and ISO7 manufacturing clean rooms are co-located to enhance the transition from concept to manufacture in world class facilities with state-of-the art technology.

The pathway from concept to clinical application is long and complex. Every aspect of a project, from design and prototyping to pre-clinical and clinical testing, requires specialised equipment, expertise and workflows. We coordinate the successful operation and integration of every aspect of the project, overseeing risk management, quality management principles, and verification and validation.

Our clients can access more capabilities through our global network of leading research organisations, hospitals, industry partners and suppliers. We leverage our long-standing relationships to link clients with clinical and surgical expertise, bionics science and applications, medtech researchers and innovators, entrepreneurship and start-up accelerators, clinical trials support, funding opportunities and R&D incentives.

Our system integration approach ensures that medical device components, from electronic hardware to surgical tools, work together seamlessly. We identify where trade-offs can be made while making sure that the complete system still meets its objectives.

We develop the electronics, firmware and software required for long-term neuromodulation. Our electrical engineers are also experts in signal processing and validating the electromagnetic compatibility (EMC) and electrostatic discharge (ESD) robustness of prototype materials.

We use computer-aided design (CAD), simulations and modelling to design neural interfacing electrodes and medical device prototypes. The design process includes feasibility evaluation, design verification and iterative prototyping. Prototypes are continually optimised throughout the device pathway, from initial design to pre-clinical and clinical testing.

Choosing the right materials is critical to ensure a medical device is safe, robust, long-lasting and effective. Our team has extensive experience selecting, sourcing and testing materials that are biocompatible, functional and manufacturable. This includes metals, alloys, silicones, polymers and adhesives.

Our fabrication specialists work side by side with our engineers – streamlining the transition from design to prototype, and improving the quality and long-term manufacturability of prototypes. Using the latest fabrication technology in our ISO 7 cleanrooms, we combine silicone micro-moulding, micro-welding and assembly to deliver subcomponents such as stimulators, electrode arrays and leads.

Our team has a track record of successfully taking medical device prototypes through pre-clinical testing. We work closely with pre-clinical researchers to design and deliver animal studies to validate the safety and efficacy of prototypes, providing surgical evaluation and assistance with pre-clinical ethics submissions.

With links to leading clinicians, we are uniquely positioned to carry out first-in-human studies. In addition to delivering human-grade prototypes, we help clients navigate ethics submission and regulatory approval processes. Our clients also have access to St Vincent’s Research Valet® service, which includes full HREC submission preparation and liaison.