Science
Our scientists include biochemists and molecular biologists with broad experience across medical device development.
With experience in immunoassays, cell culture, biochemistry and microbiology, our scientists work as an integral part of the product development team to help create complex systems with life science components. Our scientists work across our project management, engineering, device testing, human factors groups and clinical trial testing to ensure your project is backed by the best scientific methodologies.
Our approach to science focuses on delivering realistic solutions that meet your product requirements and deliver on your value proposition. We work with you to ensure your product delivers on its scientific goals, while also considering factors such as manufacturability, usability, and cost to achieve the best commercial outcome.
Certified laboratories
Our onsite PC-2 certified laboratories support medical device development by providing a dedicated space for testing chemistries, reagents, and biologicals. The laboratories house a vast range of equipment including environmental chambers, centrifuges, microscopes, analytical balances, fume hoods as well as temperature monitored fridges and freezers.
Embryo and cell testing
Our tissue culture lab enables onsite culture of mouse embryos and cells, supporting biological testing throughout the product development lifecycle.
Assay development
Our scientists have expertise in molecular and protein-based assay development including:
- PCR – reverse transcriptase
- Real-time and multiplexed
- Electrophoresis
- DNA/RNA extraction
- Immunohistochemistry and enzyme-linked immunosorbent assay (ELISA)
Design support for benchtop and automated platforms
Whether you are developing a device for accurate and targeted diagnostic testing, or one for culturing human tissues and keeping them viable prior to transplantation, we have the expertise to ensure robust design and development solutions.
Clinical trial support
Human clinical trials may be required for certain medical devices prior to approval by regulatory bodies in the United States and European Union. We are experienced in supporting verification and validation trials including human ethics applications.
Case Study
Geri: an innovative incubator with integrated embryo monitoring system
- Mouse embryo collection, vitrification and culturing
- Development of vitrification protocols for oocytes, zygotes, cleavage and blastocyst stage embryos
- Consumable design and development
- Optimising fluid exchange to minimize impact on embryo
- Supporting human embryo validation
Related Capabilities
Great product design is not an option; it’s critical for success. In each project we consider the bigger picture. We utilize a human-centred design approach to inform innovation allowing us to bring meaningful products and services to market.
The Digital Experience Design team are capable of designing end-to-end digital experiences that transform businesses at scale, unlock value in complex data sets, enable new revenue streams, streamline user workflows, and optimize experiences with physical products.
Our qualified Human Factors & Usability experts will humanize your designs. We have proven experience optimizing and validating safe and effective designs for uses, users, and regulatory bodies like yours. We know and apply the human factors that provide the necessary assurance to your device.