A world-first system that keeps transplant livers alive
OrganOx, a university spin-out, needed help to develop their new transportable, performance-critical medical device. We were appointed to assist and take it through all stages, from specification to manufacture.
The device will increase the availability of suitable livers, by enabling successful transplantation of organs from non-heart-beating donors and reducing the number of discarded livers.
It operates by maintaining the organ in a fully functioning state during transport and storage, by providing blood flow, oxygen, nutrients and temperature control within physiological parameters.
This not only enables the liver to be stored safely for a longer period (up to 24 hours), but also provides the surgeon with real-time, cumulative data with which to assess viability and make a decision whether to transplant. This is a major advance over the current method of assessment, which is largely subjective.
Our primary focus was to turn the original, large, manual, clinician-dependent process into a robust, autonomous system controlled by embedded multi-tasking software with a safety-critical architecture – which meant that if a peripheral system component failed for any reason, then the core system would continue to function.
We had to create a small system which could survive road and air transport, a wide variety of weather conditions as it was moved around, and also – of great importance – a system which was quick and easy to set up and use, despite its complexity and sophistication.
Device transportation test
Within the first nine months we had developed an automated proof-of-principle machine that showed how the manual lab-based system could be developed for commercial use. The subsequent two years were spent taking the system from proof-of-principle to clinical investigation grade devices.
The system design and development work combined electro-mechanical systems engineering, sterile fluid circuit design, embedded PCB design, firmware coding, industrial design, touch-screen interface design, and specification and risk management.
While the complete process took four years between the original meeting and MHRA approval to conduct clinical trials, Team delivered the first fully autonomous proof-of-principle system in just nine months, which helped OrganOx to secure further funding.
The first transplant took place as part of a controlled clinical study at King’s College Hospital in London, home to Europe’s largest liver transplant centre which carries out over 200 transplants every year.
Mr. Wayel Jassem, Consultant Liver Transplant Surgeon who performed both transplant operations, was impressed:
“There is always huge pressure to get a donated liver to the right person within a very short space of time. For the first time, we now have a device that is designed specifically to give us extra time to test the liver, to help maximise the chances of the recipient having a successful outcome. This technology has the potential to be hugely significant, and could make sure livers are available for transplant and, in turn, save lives.”
Ian Christie (62), shown above, was the first person to receive a transplanted liver kept alive by the OrganOx metra® system as part of a controlled clinical study:
“In May 2012, I was told I had cirrhosis of the liver and without a transplant I had an estimated 12 to 18 months to live. I was placed on the waiting list but I was told there was about 12 to 18 months to wait for a liver of my type. I was very worried it was cutting it a bit too fine and I wouldn’t get a transplant. The waiting is horrible. You’re waiting for the phone to ring, wondering: ‘Are they ever going to call me?'”
“I took part in the trial because if the device can help more people in my situation in the future, it’s my duty to help. I feel better than I’ve felt for 10 to 15 years, even allowing for the pain and wound that’s got to heal. I’m getting better day by day. I just feel so alive!”
Although our work has often paved the way for step-change innovation, rarely has it generated the level of international publicity received by OrganOx.
In March 2013, the University of Oxford and King’s College Hospital, London announced that they had kept a human liver alive and functioning outside a patient’s body before successfully transplanting it into a new patient – and had done this twice. This ‘world-first’ was achieved using the OrganOx metra®.
By mimicking the body, the system can potentially store the liver for up to 24 hours while providing real-time and cumulative data which the surgeon can use to assess liver function and viability, something which has never been possible before.
At Team we are very proud of what we achieved with OrganOx. The project required us to pull together all of our expertise in electronics, mechanics, design, software and fluidics to deliver something that had never been attempted before.
When OrganOx announced that the first clinical studies had been conducted, it was picked up by the world’s leading media outlets:
BBC | Guardian | Reuters | NBC News | Sky News | Wall Street Journal | Financial Times | medGadget | New Scientist | Wired | Telegraph | Yahoo | Fox News | The Times | Daily Mail | The Engineer | New Electronics
A paper published in April 2018, detailing the results of a randomised trial of over 200 liver transplants, found that preserving livers in the metra device both improved liver quality and reduced the number of organs discarded.
At the beginning of May 2018, Addenbrooke’s Hospital in Cambridge became the first UK hospital to bring OrganOx into routine clinical use.
“Our technology will enable the number of suitable livers available for organ transplantation to be increased. For the product to arrive at market successfully with the correct technical specification, it was critical to select the right technical partner to work with. We are delighted to choose Team.”
“After 17 years of research and development, we have reached a critical juncture with our ground-breaking technology. We are confident that the system will play a major role in saving many lives around the world. Team’s empathy, expertise and insight have been invaluable to us throughout this journey.”
Dr. Les Russell, CEO