Case study: Developing the world's first patient-attached blood gas, electrolyte and metabolite monitoring system
The NIHR supports medical technology, device and diagnostic companies in the innovation and translation of new medical technologies and diagnostics.
The NIHR Trauma Management MedTech Co-operative (NIHR Trauma MIC) collaborated with Sphere Medical Ltd on the development of the Proxima system - a patient-attached arterial blood gas analyser that supports rapid and frequent measurements at critical times. Regular measurement of physiological variables is a routine part of the monitoring of patients but the continuous monitoring of critically ill patients, in particular, can be both demanding and time consuming to health practitioners.
The Proxima system provides a solution to this by enabling near real time analysis, with laboratory accuracy, at the patient’s bedside. It can be used on all patients with indwelling arterial cannulae, along with widespread applications in Emergency Departments, during major surgery and in adult/paediatric critical care settings. It enables faster clinical decision making and the potential for improved patient outcomes whilst cutting costs for healthcare payers.
The NIHR Trauma MIC supported Sphere Medical Ltd by facilitating the provision of a simulated critical care bed and operating theatre with equipment for ISO62366 testing; recruiting 45 clinical staff volunteers (Consultant Anaesthetists, Operating Department Practitioners, and ICU Nurses) for a usability study; providing AV equipment for scenario recording; assisting through the stages of clinical trials which took place within the ICU at Birmingham’s Queen Elizabeth Hospital; and facilitating the testing of the new model of the device to produce pilot data for its use in humans.
The device is now fully ISO62366 tested and CE marked, allowing Sphere Medical Ltd to sell to national and international healthcare providers. The Trauma MIC is also creating a business case for the device to be taken up in the NHS.
“The help Sphere Medical received from NIHR Trauma MIC was invaluable in providing the evidence required for the successful regulatory submission. The access to clinicians and facilities to carry our usability studies on site was vital in the development of the support materials to assist clinicians in the safe and effective use of Proxima.” Sphere Medical Limited