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MD-TEC stresses importance of usability for medical devices

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

UK’s first remote ultrasound performed over 5G network

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.

Improving facemasks for frontline COVID-19 staff

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.

Centre for Trauma Sciences Research opened in Birmingham

The Centre for Trauma Sciences Research has been launched by Birmingham Health Partners members, aiming to advance the development of new technologies and clinical treatments for trauma patients.

Led by Ann Logan, Professor of Molecular Neuroscience at the University of Birmingham’s Institute of Inflammation and Ageing, the centre will focus on enabling the translational pathway from conception towards clinical adoption.

“Worldwide, trauma kills six million people every year and traumatic injury is the biggest killer of people under the age of 40, as well as being the greatest cause of permanent disability.

“With an ageing population, it is also now a leading cause of death and morbidity for elderly people, second only to Alzheimer’s and Parkinson’s disease.

“Each year in the UK over 16,000 people die from road traffic collisions, interpersonal violence or falls from height.

“Trauma research is vital to help us understand how the body responds to injury, leading to improvements and innovations in diagnosis, resuscitation, surgery and intensive care.

“Only through research can we reduce deaths from trauma and reduce suffering for all trauma survivors.

“We are delighted to open this new centre, which will provide a focal point that links pre-clinical and clinical researchers working across wide-ranging translational trauma science projects.”

Professor Ann Logan

The centre will be supported by Professor Liam Grover through his role as Director of the Healthcare Technologies Institute, based within the Institute of Translational Medicine, which is advancing new technologies and treatments that encourage better tissue healing and rehabilitation tools to ensure people live longer, healthier and happier lives.

Close work will also take place with the National Institute for Health Research (NIHR) Surgical Reconstruction and Microbiology Research Centre (SRMRC), the NIHR Trauma Management MedTech Co-Operative, the Scar Free Foundation Centre for Conflict Wound Research (all of which are based in the ITM), the Physical Sciences for Health Centre, and the pharmaceutical and biotech industry.

The centre will also act as the hub of a national network of trauma science research laboratories, becoming the ‘go to’ centre for near-patient testing, consultancy, information and access to key academic, commercial, regulatory and clinical partnerships.

In addition, it will build significant research capacity by training a substantive cohort of early career trauma research scientists, both clinical and non-clinical, who will drive future trauma research to address a research capacity deficit in trauma in the UK.

HRH The Duke of Sussex visits the world’s first conflict wound research centre

HRH The Duke of Sussex met scientists and clinical experts from BHP founder members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust during a visit to the world’s first specialist military and civilian wound research centre, hosted here at the ITM.

His Royal Highness visited the Scar Free Foundation Centre for Conflict Wound Research, a ground-breaking national facility based at Queen Elizabeth Hospital Birmingham, which aims to minimise the psychological and physical impact of scarring and limb loss among Armed Forces personnel injured in service and civilians wounded in terrorist attacks.

The Duke met with the University of Birmingham team behind one of the Centre’s flagship research projects, which is developing new treatments to reduce scarring.  The treatments, being developed by scientists at the University’s Institute of Inflammation and Ageing and College of Engineering and Physical Sciences, include a laser therapy to correct historic scars and a pro-healing protein called Decorin being developed within a new biomaterial gel for use as an anti-scarring dressing.

His Royal Highness observed veterans, seriously injured while serving in Iraq and Afghanistan, taking part in a workshop that is part of the Centre’s project piloting tailored psychosocial treatments to help them cope with life with an altered and scarred appearance.

Those taking part in the study have been recruited through The CASEVAC Club, which represents injured veterans, and the research is being carried out in partnership with the Centre for Appearance Research at the University of the West of England.

“The Trust has a long and proud history of collaboration between both military and NHS clinicians and patients. This combined experience of treating both civilian trauma patients and injured personnel has led to the development of pioneering surgical techniques in the management of ballistic, blast and burns trauma, including bespoke surgical solutions for previously unseen injuries.

“To further this work through research will leave a lasting legacy in the improved rehabilitation of our most seriously injured patients.”

Dr David Rosser, Chief Executive, University Hospitals Birmingham NHS Foundation Trust

Professor Sir David Eastwood, Vice-Chancellor at the University of Birmingham, was among those to welcome His Royal Highness to the Centre today.  He said: “We have a long and proud history of collaborating with partners to support life changing research and our work with the Scar Free Foundation and University Hospitals Birmingham NHS Foundation Trust sees us combine our expertise with the goal of achieving scar free healing within a generation. I was delighted to welcome His Royal Highness The Duke of Sussex today to see our crucial work in this area first hand.”

“Scarring not only has a lasting physical effect, but can have a serious emotional impact long after the wounds themselves have healed.

“The visible changes in appearance caused by conflict injuries that result in looking ‘different’ can be distressing for military personnel and their families.

“With the help of the people who have experienced this kind of life changing injury we can learn what support is needed by those affected, and develop tailored interventions for the armed forces community, an important part of our goal to deliver scar free healing within a generation.”

Brendan Eley, Chief Executive of the Scar Free Foundation

De-risking medical innovation with MD-TEC

MD-TEC, our Medical Devices Testing & Evaluation Centre, recently came together with a host of local medtech and life sciences organisations to showcase the unique insight, expertise and assistance the team can offer.

The MD-TEC Connect event included talks from industry experts; 1:1 advice sessions, and presentations on the Centre’s ability to bring medical devices to market quickly and at reduced cost.

One of of the presenters was Keith Fawdington, Managing Director of Uvamed Ltd, who spoke to attendees about his experiences of MD-TEC and the opportunities working with the Centre has provided.

Uvamed has developed an innovative method of storage for anaesthetic drugs, using standardised colour coding of different drug types to help avoid errors during the administration of medication.

Funding through the European Regional Development Fund 2014-2020 (ERDF) enabled Uvamed to conduct a usability study within the MD-TEC simulation theatre. During the study, the video footage captured an error that occurred during the standard practice scenario (with medication stored in the usual method), which was not replicated when the Uvamed colour coding method was used.

Conducting usability studies throughout the prototyping and development process of devices can help innovators save money on large commercialisation costs, as well as increasing its market success.

Also keen to share her positive experience was Dr Cat Anderson, founder of Focus Medical, who is working with MD-TEC to develop of her novel combination of a medical device with an anti microbial formulation to treat embedded chronic urinary tract infections.

“We were delighted to meet with so many local businesses, and look forward to working with a number of them in the near future.

“Since opening in January 2018, we have focused on supporting Small and Medium Enterprises through the process of testing, regulatory approval and commercialisation.

“Our facilities are also open to any and all staff interested in developing a medical product commercially.”


Dr Tom Clutton-Brock, MDTEC Clinical Director

MD-TEC has also supported early stage start-up companies such as Ostique, who are developing a range of temporary embossed stoma covers to improve quality of life for the thousands of people across the UK who require stomas.

MD-TEC, based in the Institute of Translational Medicine (ITM) on the Queen Elizabeth Hospital Birmingham site, is funded by ERDF to support industry, clinicians and academics develop their medical devices.

MD-TEC facilities, which include a simulated operating theatre, intensive care ward area and laboratories, as well as scientific, clinical and regulatory consultants, are available for any staff interested in bringing a medical product through the approvals and commercialisation process quickly and easily.

MD-TEC currently has funding to support any company or individual based in the Greater Birmingham and Solihull Local Enterprise Partnership (GBSLEP) area, with alternative grant proposals available for those not based in the area.

If you are interested in finding out more, visit the MD-TEC website or contact the team at MDTEC@uhb.nhs.uk