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.