Developing the OrganOx Automated Liver Perfusion Device

Transforming liver transplantation

Liver transplantation is typically a challenging process that can result in physicians being forced to discard once viable organs during transit from donor to patient. OrganOx, a University of Oxford spin-out, wanted to develop an automated, transportable liver perfusion device that would help protect the liver during transport – by keeping it alive outside the body.

Team helped the start-up take their initial idea from device specification through to manufacture. Our aim was to transform the liver transplantation process with a robust, autonomous system controlled by embedded multi-tasking software, along with a safety-critical architecture. The award-winning OrganOx metra® not only enables transplant livers to be stored safely for longer, but it also provides physicians with live data, helping them make better-informed decisions about when it’s safe to transplant.

The OrganOx metra®

Traditionally, livers in transplant are assessed by physicians to determine their suitability. This can result in many being discarded, in part due to a lack of data on their viability. The OrganOx metra® was designed to help address this challenge.

Fully transportable, the metra® 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, but it also provides the physician with more data to make an informed decision on whether to transplant.

mobile liver perfusion device next to ambulance

Transforming a manual process into a robust, autonomous system

One of the key challenges in the development of the metra® was how to transform a large, manual, clinician-dependent process into a robust, autonomous system. The device needed to be controlled by embedded, multi-tasking software with safety-critical architecture, which meant that if a peripheral system component failed for any reason, then the core system would continue to function.

Designed for safe transportation from donor to patient, the system also had to be small yet robust enough to survive road and air transport and a wide variety of weather conditions. It also needed to be quick and easy to set up, despite its complexity.

From proof-of-principle to commercial use

In just four years we helped OrganOx take its device from initial concept to clinical trials. This included an initial rapid development of an automated proof-of-principle machine in just nine months, which helped OrganOx prove their technology and secure further funding.

From there, the next two years were spent taking the system from proof-of-principle to clinical investigation grade devices. This included the full system design and development across:

Electro-mechanical systems engineering
Sterile fluid circuit design
Embedded PCB design
Firmware coding
Industrial design
Touch-screen interface design
Specification
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.
Oliver Sowerby, Head of Surgical Technologies, Team Consulting

Liver being transplanted in liver perfusion device

The first transplant – achieving successful clinical trials

The first transplant using the metra® took place as part of a controlled clinical study at King’s College Hospital in London, home to Europe’s largest liver transplant center, which carries out over 200 transplants every year.

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 maximize 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.
Mr. Wayel Jassem, Consultant Liver Transplant Surgeon

Patient testimonial

“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 were 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!”

Ian Christie, first person to receive a transplanted liver kept alive by OrganOx metra® as part of a controlled clinical study

Outcome

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 physician can use to assess liver function and viability, something that has never been possible before.

Our technology will increase the number of suitable livers available for organ transplantation. 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 have chosen Team Consulting.

After 17 years of research and development, we have reached a critical juncture with our groundbreaking 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, OrganOx

The metra®: multiple award winner!

OrganOx has since received multiple awards in recognition of its life-saving medical device, including the:

MacRobert Award 2019 (shortlisted)
Medtech Insight award 2019
Medawar Medal
IET Innovation Award

Media coverage

When OrganOx announced that the first clinical studies had been conducted, it was picked up by the world’s leading media outlets:

A paper published in April 2018, detailing the results of a randomized 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.