Client
Sphere Medical
Sector
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.
Background
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.
The Challenge
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 it up to the approved IVD standard. In addition to these redesigned elements, the design team completely reworked the software in order to achieve compliance with IS06234:2006 and allow CE marking. The software test documentation required for CE approval was also produced.
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.
