Pelorus 1500 instrument

Sphere Medical

Sphere Medical is a Cambridge-based company responsible for a range of monitoring and diagnostic products. Their goal is to allow near real-time measurement of blood gases, electrolytes and drug levels with laboratory accuracy, at the patient's bedside.

Their Pelorus instrument is the world’s first commercially available device that allows real-time measurement of the concentration of propofol, the powerful intravenous anaesthetic, in the patient’s blood. Being able to rely on accurate, real-time readings of the actual, rather than merely predicted, concentration is hugely significant in delivering safer, more appropriate treatment.

Industrial Design, Mechanical Engineering, Electronics Engineering, Software Engineering

Medical & Diagnostic

"I was very impressed with the close support and flexible approach demonstrated by eg, as well as the range of technical capability they brought to the project. All this combined to help deliver the project on time and within budget."

Dave Walters, Sphere Medical

Our Approach

Sphere Medical is a Cambridge-based company responsible for a range of monitoring and diagnostic products. Their goal is to allow near real-time measurement of blood gases, electrolytes and drug levels with laboratory accuracy, at the patient's bedside.

Development

eg technology worked with Sphere Medical throughout the development of the product, first designing a research version, followed by the CE-approved Pelorus 1000 and, most recently, the IVD CE-approved Pelorus 1500.

CE Approval

To achieve CE approval as an IVD medical device, the produce product required a number of small but crucial mechanical, electronic and fluidics changes. In addition, the software was completely reworked to comply with ISO 62304:2006. eg also produced all of the software test documentation required for CE approval.

The Result

Despite significant time constraints – the project had to be delivered within four months to meet Sphere’s funding agreement – it was completed on time and within budget. The Pelorus 1500 has been CE-marked as a fully approved IVD medical device.

eg Technology