Sector | MedTech
Project Scope
Electronics Engineering
Software Engineering
Mechanical Engineering
Fluidics
We worked with Sphere Medical throughout the development of the product, first designing a research version, followed by the CE-approved Pelorus 1000 and then the IVD, CE-approved Pelorus 1500.
The Challenge
Sphere Medical specialised in innovative medical monitoring and diagnostic equipment. Sphere approached eg technology with an emerging product which required additional development. eg technology were commissioned to develop the Pelorus instrument to make it suitable for CE approval as an in vitro diagnostic (IVD) medical device.
Sphere Medical’s goal was to allow near real-time measurement of blood gases, electrolytes and drug levels with laboratory accuracy, at the patient’s bedside. Sphere Medical approached eg technology with a challenge to deliver the redesigned Pelorus within four months to meet their business plan.
TIME CRITICAL PROJECT | CE APPROVAL | REAL-TIME MEASUREMENT | IN VITRO DIAGNOSTIC MEDICAL DEVICE
Our Approach
The project required a number of mechanical, electronic and fluidics changes to bring the Pelorus up to the approved IVD standard. In addition to these redesigned elements, the eg technology team completely reworked the software to achieve compliance with IEC 62304 and support CE marking. Software test documentation required for CE approval was also produced.
A team of eg technology engineers rewrote the software as a standalone Windows application using Microsoft .NET 4.0. The work encompassed user interface development, hardware communication interfaces and algorithm development, alongside unit testing and static code analysis.
To support the development process, eg technology implemented a formal specification structuring and tracking process, helping to ensure that requirements were delivered and could be verified. A project build server and source-control system were also used to produce nightly builds, giving Sphere Medical access to the latest code throughout development.
The teams worked closely throughout the project, with regular design reviews, interim validation within Sphere Medical’s test labs and a structured process for identifying software issues. Daily communication and transparency between the teams supported progress against the demanding four-month development schedule.
Our Results
The Pelorus 1500 has been CE marked as a fully approved IVD medical device and offers the unique capability to rapidly measure the concentration of the intravenous anaesthetic propofol in whole blood samples. Despite the significant time constraints, eg technology delivered the project on time and within budget.
The Pelorus Instrument was the world’s first commercially available device that allowed real-time measurement of the concentration of propofol, the powerful intravenous anaesthetic, in the patient’s blood.
Are you ready to develop your product or idea?
For further information on how eg technology can support in getting your technology or ideas to market or to chat with one of the eg team about your product design and development requirements, please get in touch.
