A world-first system that keeps transplant livers alive

Challenge

Transforming a large, manual process into an automated, transportable liver perfusion device.

Approach

Combining expertise from across all our disciplines, we developed a small system suitable for commercial use and transport from the original manual lab-based system.

Outcome

Following the delivery of a proof-of-principle device, we took the system through to successful use in clinical trials. This device can now preserve liver transplants for up to 24 hours and provide real-time data which the surgeon can use to assess liver viability. The metra® is now a multi award-winning commercially available product.

Project background

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 increases the availability of suitable livers, by enabling successful transplantation of organs from non-heart-beating donors and reducing the number of discarded livers.

More

Robust, autonomous
system

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. This meant that if a peripheral system component failed for any reason, then the core system would continue to function.

The metra® was going to be moved around so we had to create a small system that could survive road and air transport and a wide variety of weather conditions. Also of great importance, the system had to be quick and easy to set up and use, despite its complexity and sophistication.

Proof-of-principle

We delivered the project in four years and 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 the following:

  • 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.

Sandrine Cuney, Programme Director, Team Consulting

Clinical trials

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.

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.

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 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.

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.

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, OrganOx

Media coverage

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

BBC | Guardian | NBC News | Wall Street Journal | Financial Times | medGadget | New Scientist | 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.

Nature | The Engineer | BBC | DailyMail | MedGadget | New York Post | The Sun | Sky News | The Times | Express

At the beginning of May 2018, Addenbrooke’s Hospital in Cambridge became the first UK hospital to bring OrganOx into routine clinical use.

BBC | Cambridge Independent | Cambridge News

Award wins: MacRobert Award 2019 (shortlisted)| Medtech Insight award 2019 | Medawar Medal

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