Tag: ITM News

Injuries to the surface of the eye – as a result of burns, infections, inflammation, trauma and surgery – are a leading cause of sight loss. Despite this, there are few therapeutic options to modify, minimise or reverse scarring to maintain corneal transparency and visual function, and these are not always effective. With a global prevalence of 5.1%, the incidence of visual loss is around eight million people per year – accounting for around £150 billion in annual healthcare spending. As such, the WHO has made this a priority area programme to prevent world-wide blindness.

Birmingham hosts the largest medical device cluster in the UK with an impressive and extensive infrastructure in addition to world class hospital trusts. Specialist facilities here at the Institute of Translational Medicine including the Medical Device Testing and Evaluation Centre (MD-TEC) and the NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC) provide academics, clinicians and industry with a perfect environment to bring multi-disciplinary teams together and rapidly mature their emerging technologies.

In this case, bringing together neurosciences and ophthalmology expertise with Professor Liam Grover’s healthcare technologies team led to an important discovery – that combining decorin and collagen results in enhanced anti-scarring bioactivities. The team found that as a result, scarless wound healing was possible thanks to a new microenvironment that enables anti-fibrotic and anti-inflammatory factors. In addition, clinician and/or patient-reported visual outcomes were improved.

This combination of academic, clinical and technological expertise secured over £5million of internal and external funding from MRC, Wellcome Trust and NIHR to accelerate development of a synthetic, transparent, anti-scarring eye drop for the management of patients at risk of corneal scarring.

We are currently leading the first in-human clinical trial to assess the treatment’s safety and efficacy in patients with microbial keratitis. This will create a unique collaboration between the University of Birmingham, Birmingham and Midland Eye Centre, Sandwell and West Birmingham Hospitals NHS Trust and the Queen Elizabeth Hospital Birmingham. The trial will also help move the technology along the translational pathway towards regulatory approvals and commercial realisation – already, the research team has consulted with patients, practitioners and regulatory bodies, and potential commercial partners have registered their interest in the technology.

The anti-scarring eye drop will not only have significant positive impacts for patients, but also socio-economic impacts – patients with ocular damage will carry a reduced cost-of-treatment burden as the eye drop may be self-administered in a home or community setting, negating the need for prolonged hospitalisation and clinic attendance. In the not too distant future, patients will be able to access this revolutionary sight-saving eye drop to prevent the devastating consequences of corneal damage.

Two trials, led by the NIHR Birmingham Biomedical Research Centre’s Gastroenterology team, are leading to changes in the diagnosis and treatment for patients with inflammatory bowel conditions.

The OPTIMA trial uses confocal laser endomicroscopy to detect a number of labelled  antibodies in patients, which acts as a reliable indicator for how well patients will respond to treatment, particularly in the early stages. The results from OPTIMA are also leading to better genotypic (genetic information) and phenotypic (physical characteristics) information.

Confocal laser endomicroscopy helps to increase the image quality of microscopes, which leads to a better understanding of cells and tissues in the body.

OPTIMA have currently recruited 30 patients with a range of inflammatory conditions. The results of OPTIMA could lead to stratified treatments, where a patient’s treatment plan is more closely tailored to them, rather than the conventional standard treatments, which may not work for all patients. The endocytoscope, a very high magnification endoscope, is also being used in parallel to the OPTIMA study to accurately detect the healing of the lining of the intestine upon treatment.

PICASSO is an ongoing trial that has so far recruited more than 300 patients across several centres. The trial is likely to lead to a new endoscopic scoring system, which will lead to a more effective assessment for how well patients with ulcerative colitis are recovering from their disease after treatment.

The team, based in the Institute of Translational Medicine on the Queen Elizabeth Hospital Birmingham (QEHB) site, are led by Dr Marietta Iacucci, Honorary Consultant Gastroenterologist at University Hospitals Birmingham and a Reader in Gastroenterology at University of Birmingham – both founding members of Birmingham Health Partners.

“Both OPTIMA and PICASSO are assessing how new technology could be used to provide improved outcomes for patients,” said Dr Iacucci.

“In fields like inflammatory bowel disease and cancer, treatment is going to become increasingly specific and tailored to individuals, which should lead to both reduced complication and better outcomes.

“The use of instruments like the endocytoscope and the confocal laser endomicroscope means we can clearly see at the histological level whether treatments are actually working, with the clearer, sharper, magnified images providing more information for healthcare professionals than ever before.”

Dr Iacucci and her team were also recognised for their innovative work at the recent Birmingham Health Partners Research Showcase, with their exhibit awarded the Best Stand prize.

In a recent BMJ article, Dr Tom Clutton-Brock, clinical director of the ERDF-funded Medical Devices Testing and Evaluation Centre (MD-TEC), commented on new European regulations and the effect they may have on the design of medical devices.

Dr Clutton-Brock told a Clinical Human Factors Group (CHFG) meeting in London that new EU medical devices regulation that will come in force in May 2020 form “an excellent basis for much safer design but it remains to be seen how these new rules are interpreted and enforced.”

A key change in the new regulation is the additional requirement to demonstrate the ‘usability’ of a device, as well as provide clinical data for performance and safety claims.

“We need to get away from the idea of ‘user error’ where fault is laid at the door of the practitioner,” Dr Clutton-Brock added.

“Manufacturers can no longer hide behind complex instructions for use and then blame users for not reading them. Of course we need instructions, but medical devices should be inherently easy to use.”

Other speakers at the CHFG meeting warned that dangerous usability errors can often be built into device designs, such as unclear labelling about which button to press or whether to pull, push or twist.

Doctors have also been advised to inform their trusts when medical devices are difficult to use or have confusing instructions.

MD-TEC, based here at the Institute of Translational Medicine, provides expertise and support to clinicians, academics and industry to develop their medical devices from initial idea through the approvals and commercialisation process into the NHS.

The BMJ article is available to read at https://www.bmj.com/content/365/bmj.l4446.full

The Institute of Translational Medicine recently hosted the UK’s first demonstration of a remote-controlled ultrasound scan over a public 5G network, at an event which showcased how 5G can transform healthcare and the emergency services.

The demo, in partnership with BT and WM5G, was hosted by the Medical Devices Testing and Evaluation Centre’s (MD-TEC) prestigious simulation lab, located in the ITM. The showcase brings the concept of a 5G Connected Ambulance to life and provides new technologies to frontline staff, creating a facility for patients to be diagnosed and triaged in the most appropriate settings. It enables remote diagnostics to be performed by paramedics who are supported by clinicians back at the hospital.

This is a real-world example of how 5G will support digital transformation in the delivery of public services and enable care delivery to be streamlined. It is just one example of how activities which can only be performed in static environments today can become mobile tomorrow.

The demonstration simulates a paramedic in the field performing an ultrasound scan on a patient, under the remote guidance of a clinician who is able to interpret the ultrasound image in real-time. The ultrasound sensor is manipulated locally by the paramedic under the remote direction of the clinician, who uses a joystick to send control signals over the live 5G network to a robotic or ‘haptic’ glove worn by the paramedic. The glove creates small vibrations that direct the paramedic’s hand to where the clinician wants the ultrasound sensor to be moved, allowing the clinician to remotely control the sensor position, while seeing the ultrasound images in real time. In addition, there is a camera in the ambulance which transmits in high definition a view of the inside of the ambulance covering the patient and paramedic to a second screen located on the clinician’s workstation.

The images are relayed over a high-bandwidth 5G connection, so the clinician is able to view both the ultrasound examination performed by the paramedic and keep an eye on the overall scene inside the ambulance.  The superfast speeds of 5G ensure sharper and more reliable imagery for the clinician than could previously be achieved.

Enabling ultrasound scans to be performed by paramedics in the field and reviewed remotely by an expert clinician should bring a number of advantages to patients and to the NHS. As well as speeding up diagnoses for patients, it has the potential to reduce the number of ambulance journeys and emergency department visits. This will improve the overall experience for patients while freeing up ambulance resources and reducing pressure on emergency departments. Faster diagnoses can also assist in triaging patients, ensuring more effective outcomes for the patient, and increasing overall efficiency for the hospital.

Tim Jones, Chief Innovation Officer at UHB, commented: “We are immensely excited about the potential of 5G to support transformation in healthcare. As a Global Digital Exemplar, we are always looking into new technologies and how we can use them to improve patient care. 5G will help us to roll out this next generation of healthcare technologies.

“Our clinicians will in the future be able to deliver holistic specialist advice in real time, potentially forming virtual multi-disciplinary teams to provide the best patient care using intelligent IT links. Information would be accessible at the point of need, ensuring informed decision making leading to improved patient safety, quality of care and patient/clinician experience.”

Dr Omkar Chana, Programme Director at WM5G said: “We are in a unique position where we are beginning to understand how developments in technology can be leveraged to change and improve the way in which some healthcare services are delivered. High definition clinical imaging is one example that lends itself well to digital transformation owing to the large amounts of data transferred in a short space of time.

WM5G’s role is to ensure there is a focus on delivering benefits that will have high levels of impact on the patient, the clinician and the hospital or organisation providing the service. This early demonstrator puts the technology in the hands of clinicians, and we want to work with them to continue to prove, test and scale this and other applications in the region.”

Gerry McQuade, CEO of BT’s Enterprise unit, said: “We’re really excited to be working with WM5G and University Hospitals Birmingham on the first 5G healthcare trial to take place in the UK over a live public network.

“BT has a long and proud heritage of working with the NHS to better connect patients and healthcare professionals and the characteristics of 5G will deliver a huge-step change in speed, capacity and reliability. We are focused on delivering new, innovative services which will make lives better and firmly believe in using the power of 5G to bring potentially life-saving benefits to patients. There’s no better place to start realising this vision than in Birmingham, part of the UK’s first multi-city 5G test bed.”

Ultrasonography is the second most common diagnostic test reported by the NHS, with more than 9.5 million carried out last year in England alone. On average, 408,000 patients attend UHB Emergency Departments each year, with 113,500 of these patients using an ambulance.

With BT’s EE mobile arm recently switching parts of Birmingham on to the UK’s first 5G services, the company is working with WM5G to illustrate how the technology can deliver significant benefits to the NHS and the wellbeing of citizens across the West Midlands region.

Scientists at Birmingham’s Healthcare Technologies Institute and King’s College London are working on a solution to improve the seal and fit of facemasks used in hospitals during the COVID-19 crisis.

Since the onset of the crisis, the subject of personal protective equipment (PPE) has become a key discussion point. Over recent days the focus has been on the supply of facemasks that allow healthcare workers to interact safely and perform procedures on COVID-19 patients. As the crisis continues to evolve, it is clear there are additional issues with prolonged wear of these masks, (i.e. abrasion and bruising of facial tissues) which has generated much interest on social media, with images of distressed healthcare workers circulating widely.

Drawing on the experience and ingenuity of the Academic Centre of Reconstructive Science at King’s College London, the teams have initiated a collaborative project to explore the feasibility of providing person-specific reusable, medical grade silicone seals to fit with the generic facemasks currently used in the NHS.

The silicone interface, which is being designed by researchers from the Centre for Custom Medical Devices at BHP founder-member the University of Birmingham, would help to improve the mask seal thereby reducing exposure risk. In tandem, personalisation has the advantage of reducing fitting time and improving comfort while reducing skin abrasions for NHS users.

Making use of the 3D capture technology at the Academic Centre for Reconstructive Science, individual faces would be digitally captured and the silicone seals 3D printed to fit the individual’s face.

Professor Owen Addison from King’s College London said: “We are exploring a number of novel approaches to improve facemask effectiveness. It is crucial we collaborate to push these vital projects forward, to better protect frontline healthcare workers during the pandemic.”

“Bringing together our collective expertise has enabled us to rapidly push forward these potential live saving innovations” added Dr Sophie Cox who leads the Centre for Custom Medical Devices at the Healthcare Technologies Institute in Birmingham.

“Our researchers brought together their 3D printing expertise and design knowledge to rapidly create a promising prototype customised mask seal.”

Led by Dr Trevor Coward and Professor Owen Addison from King’s College London, and Dr Sophie Cox and Professor Liam Grover from the Healthcare Technologies Institute at the Institute of Translational Medicine, in the past week their teams have:

i) Developed a promising approach to capture facial form digitally using a smartphone to provide a highly accessible method to complement their established 3D camera techniques that are used clinically.

(ii) Initiated computer aided design to identify how to fix a person-specific silicone face seal that matches an individual’s face to the periphery of masks being used by NHS workers.

(iii) Manufactured a prototype version of their custom interface ring capable of affixing on to a model mask.

Over the coming week, the team plans to begin 3D printing their novel design in silicone and conducting feasibility testing. The team which includes young UK scientists from the University of Birmingham; Luke Carter, Morgan Lowther and Dan Wilmot, are also looking at adaptions of their approach to develop new mask designs that could be manufactured quickly in a distributed supply chain and deployed during this crisis.