PROFILE- 50 active years after 50®

14 December 2011

Recent research has shown that more than half the babies now born in wealthy nations will live for more than 100 years. Although improvements in medicine, nutrition and lifestyle allow us to live longer lives, our bones, joints and cardiovascular systems will continue to degenerate as we age. Medical engineering solutions and technology interventions have the potential to increase our active lifespan, quality of life and reduce levels of inactivity in the ageing population, with the potential to achieve '50 active years after 50®'.

Through its '50 active years after 50®' programme of research and innovation, led by Professor John Fisher CBE, Director of the Institute of Medical and Biological Engineering, the University of Leeds is taking an integrated multidisciplinary approach to delivering solutions to some of the major physical challenges our bodies face through ageing. Leeds' challenge-led research approach is developing interventions for tissue replacement, repair and regeneration to address problems with tissue degeneration in the ageing population.

Leeds is delivering healthcare impact through an integrated, multidisciplinary challenge-led research approach
Two major UK-funded initiatives founded around Europe's largest integrated multidisciplinary medical engineering centre, the Leeds-based Institute of Medical and Biological Engineering (iMBE), are progressing an innovative approach to delivering medical technology solutions with global healthcare impact.

Providing an integrated, multidisciplinary research platform in medical and biological engineering, the WELMEC Centre of Excellence in Medical Engineering encompasses a multidisciplinary research community of over 250 researchers spanning 10 departments across the University of Leeds and the Leeds Teaching Hospitals (NHS) Trust. Funded by the Wellcome Trust and the UK's Engineering and Physical Sciences Research Council, WELMEC will ensure that cutting-edge medical technology can effectively enter the clinic to improve the lives of patients around the world.

The global market for medical technology also presents a significant innovation opportunity (£200bn, Compound Annual Growth Rate 5.9%). Offering huge potential for high technology-led growth, the sector is growing rapidly in the UK, host to 25% of all European medical technology companies.

Medical Technologies, a University of Leeds-based Innovation and Knowledge Centre that promises to help the body repair and restore function, works closely with companies to accelerate innovation and translation and reduce the potential risk of investing in medical technologies. Funded by two UK Research Councils – the EPSRC and the Biotechnology and Biological Sciences Research Council (BBSRC) – and the Technology Strategy Board, the Medical Technologies IKC helps to bridge the gap between the fundamental research generated through research platforms such as WELMEC and external commercial investment. The Medical Technologies IKC works collaboratively with other universities and healthcare providers, including the Leeds Teaching Hospitals NHS Trust and the NHS Blood and Transplant Tissue Service, as well as local and global industry.

Creating an innovation culture to deliver healthcare impact
As the UK's largest medical engineering centre, Leeds has a history of developing scientists and engineers who are comfortable working at the interface between life science and engineering. More than 250 researchers are hosted in an environment rarely encountered in a UK university setting: the WELMEC and Medical Technologies IKC programmes provide support to academics who want to translate good opportunities into clinical use through a team of professional innovation managers from a variety of product development, intellectual property and innovation management backgrounds.

Working closely with researchers at every level, the team provides advice and practical support in delivering healthcare impact. The integrated multidisciplinary research environment creates new interfaces between disciplines, requiring researchers to interface with themes they previously may have limited experience or understanding of. Our goal is to create an academic culture where planning for healthcare impact delivery is as important as planning for the next significant publication.

Leeds can reduce the risk for companies of investing in medical technology development
By combining technology experts with specialists in innovation and commercialisation, the Medical Technologies IKC can appreciably reduce the risk for companies who traditionally invest in opportunities that are closer to market and promise short-term returns. It achieves this by accelerating promising opportunities, reducing the risk of company investment in these and increasing their chance of success. The Leeds approach uses short-term, preclinical simulations to predict long-term clinical performance and outcomes. Preclinical simulation and testing is essential to support industry research, technology and product development, product regulatory submissions and improvements in performance and reliability.

The world's largest independent academic facility for testing total artificial joints
iMBE, with support from the Medical Technologies IKC, is helping a UK company – Simulation Solutions – improve their bioengineering simulators to gain ground in India and China.

iMBE's simulation laboratory is the largest independent academic facility for testing artificial joints in the world – but to conduct research at the cutting-edge of the field requires simulators that can go further than industry standards.

Manchester-based Simulation Solutions – which designs and builds bioengineering simulators – has been working with Leeds, to develop machines that can meet their specific requirements. iMBE Principal Research and Innovation Fellow, Dr Louise Jennings explains: "Our research involves simulations that are much more rigorous than the ISO standards as we're constantly looking to push the limits in terms of what these joint replacements are capable of. This is critical in the preclinical testing of total joint replacements to meet the demands of younger and more active patients and so we need equipment that's able to go further and experimental procedures to match."

To conduct robust wear simulations on these state-of-the-art hip and knee simulators, iMBE created its own operating protocols, covering range of motion, loading, measurements and maintenance. The protocols feed into – and draw on – the huge store of simulation data held by the institute.

With the help of the iMBE and the Medical Technologies IKC, Simulation Solutions have now licensed these protocols to sell alongside the machines. This – together with the opportunity for staff training at the university – enables the company to put together a complete package, which is helping them to enter new markets in China and India.

Simulation Solutions Director, Nick Eldred, says: "There's been limited regulation of joint replacements in China to date, but that is set to change as regional governments are now being expected to take on responsibility for regulation. It will be a steep learning curve for the companies that make these products, but by offering both the tools and the know-how in one package, we can help them achieve it.

"Both China and India are likely to be substantial markets in the future as living standards and healthcare improves in both countries. Selling the operating procedures into China alongside the simulators will bring financial and wider benefits to both ourselves and to the university."

The successful combination of the skills, expertise, capacity and capability of the organisations involved has resulted in many benefits. Simulation Solutions is now ranked as the number two company in the world (number one outside the USA) for the supply of joint simulation equipment for preclinical testing. The work has influenced international industry and regulatory standards by highlighting the need for more aggressive artificial joint testing. The successful co-development of the simulators and protocols has improved implants of other medical device companies, which will benefit patients worldwide.

The collaboration also helped establish the research base and infrastructure, which attracted signification additional funding to support the '50 active years after 50®' initiative. The aim of this initiative is to make the last 50 years of our lives as comfortable as the first 50 by developing longer-lasting joint replacements through multidisciplinary research, innovation, knowledge creation and translation.

This work has enabled Simulation Solutions to break into emerging markets in India and China. The research is also contributing to the development of new technologies that could benefit huge numbers of people in the future. As John Fisher explains: "It's estimated that by 2030 there'll be five times more knee replacements in the world than there are currently. So what we've got to do is produce interventions that will last for 50 years. That could mean, for example, for an artificial knee joint, a joint that undergoes over a hundred million steps in a single patient during that patient's lifetime."

Leeds has changed lives through its impressive track-record of translating research into clinical use
University of Leeds' expertise in testing joint replacements has helped global orthopaedics company DePuy validate the performance of a new knee joint able to accommodate the needs of today's younger, more active and high demanding knee patients.

With support from the Medical Technologies IKC, University of Leeds researchers provided DePuy, a manufacturer and distributor of medical devices, with independent expertise and product verification testing on the company's new Sigma® CR150 total knee femoral component.

As people live longer and expect to remain active for more of their life, the demands made on knee joint replacements are continually increasing. The Sigma® CR150 is a femoral component that accommodates deep flexion and is able to cover a wider range of movement than most standard knee joint replacements.

Working with innovative products like the Sigma® CR150 requires testing beyond industry standards and for this the University of Leeds – with its world-leading Institute of Medical and Biological Engineering (iMBE) – is an ideal partner.

To conduct research at the cutting-edge of the field, iMBE has developed new procedures and protocols to test innovative joint replacements. Working with Leeds University enabled DePuy to access this expertise and gain independently verified data on their new design, which they were able to publish in peer-reviewed journals and present at conferences. iMBE's extensive track record meant DePuy could also benchmark their product against a wealth of existing data.

Although these are key elements in new product development, they aren't the only benefits that working with iMBE have brought the company. "We also work with the University of Leeds to test existing products as well as new designs, to benchmark our data across the whole portfolio," says Tribology Manager at DePuy, Cath Hardaker.

Delivering healthcare impact into the future
These case studies provide just two examples of how Leeds continues to deliver significant healthcare impact. Looking forward, Leeds has prioritised five areas of unique and world-class research and innovation excellence. These include:
•Medical devices, implants and tissue replacements. For example, we are seeking to deliver longer lasting joints for hip, knee and spine.

We aim to intervene earlier in the joint degeneration process, offering alternatives to current treatments and developing early stage interventions that delay the need for total joint replacement. We are working on improving joint replacements so that they last for 50 years;
•Biological scaffolds which form the structural basis in the body for tissues requiring replacement, eg degenerative joint tissues or heart valves. These scaffolds have the same biomechanical and biological functions as natural tissue, offering enormous applications in orthopaedic and cardiovascular applications;
•Patients' own stem cells. The potential use of therapies based on stem cells offers exciting promise for the treatment of challenging clinical problems in musculoskeletal and cardiovascular repair and regeneration – for example, populating scaffolds implanted into the body with the individual's own cells removes the risk of rejection and integrates the implant into the body very effectively;
•Biomarkers and biosensors used for example in disease diagnosis and improved patient targeting. To monitor all the biological molecules that are associated with a disease – the diagnostic biomarkers – we need to be able to measure the presence of, and variation in, hundreds of proteins at the same time. The ability to do this will enable us to, for example, monitor a patient's response to implants and biological and biomimetic scaffolds;
•Enhanced medical imaging to help facilitate earlier diagnosis and intervention. For example, it is essential to be able to understand the complex biotribology (the interaction of biological surfaces in motion) in joints affected by osteoarthritis, and to measure and non-invasively assess cartilage damage before treatment and during and after repair. WELMEC is advancing magnetic resonance imaging and digital pathology techniques to enable non-invasive assessment of function and morphology in the clinic;
•Enabling technologies to support product development and the supply chain. Preclinical simulation and evaluation is required in order to deliver safe, reliable and effective medical technology interventions to the patient population.

WELMEC is developing advanced computational and experimental simulation methods to support a stratified approach to preclinical testing, which is supported by banks of clinical data on the target populations. For example, in the spine, the variances in patient anatomy have limited the success of some current treatments. Here, advanced high resolution imaging techniques are being used to build computational models that represent the variation across patient groups. This will enable new interventions to be more robustly evaluated and optimised during preclinical testing.

Through these strategic areas of focus, underpinned by enhanced medical imaging and experimental and virtual preclinical simulation systems, WELMEC's challenge-led fundamental research will continue to deliver healthcare impact through the development of robust, stratified and strategically targeted medical technology interventions to 2020 and beyond.