A test bed for tomorrow's healthcare .

Hospitals of the University of Pennsylvania

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There’s much to admire about the Institute of Translational Medicine (ITM), at the heart of the sprawling Queen Elizabeth Hospital Birmingham complex, not least the delightful Art Deco public face of this innovative and ambitious organisation.

The latest element of its fast-growing internal structure is a medical devices testing and evaluation centre (MD-TEC), which only opened in January, but has already attracted an array of potential investors, partners and companies.

Like everything in modern healthcare, it has a complex structure; funded largely by the University of Birmingham (UoB) and the ERDF, and operated in partnership with the UoB and Aston University. There’s a project manager to ensure everything works efficiently, and a specialist small and medium-sized enetrprise (SME) engagement co-ordinator to help attract regional, national and international businesses.

Like the ITM itself, the central aim is to bring together clinicians, academics and funding together to support the development and delivery of healthcare innovations.

Tom Clutton-Brock, the ITM’s deputy director, leads the third-floor centre on matters related to testing new medical devices for safety and usability, as its clinical director. Some £7m of funding has enabled the MD-TEC to be fitted out with an operating theatre, intensive care unit, accident and emergency beds and all manner of hi-tech kit to create an authentic hospital environment, albeit with mannequins instead of live patients.

At more than 1,000 sq ft, its an imposing sight, and gives Birmingham an immediate lead in the global race to provide clinical test-beds suitable for manufacturers keen to prove that their products really will work in practice.

“Regulations covering the use of medical devices, here, in the United States and elsewhere, increasingly expect manufacturers to demonstrate their ‘usability’, not simply their safety and effectiveness,” says Clutton-Brock. “Over the years, incident reports involving devices have clearly indicated that many problems are down to user error. Manufacturers wanting their products to meet, and even exceed, the expectations of the regulatory bodies now need to test them using real doctors and nurses in a realistic, but simulated, setting.

“The data from those tests then goes into the manufacturer’s technical file, as well as informing design changes and modifications for their final clinical versions.”

However, although the demand is there – particularly from SME manufacturers of medical devices and products – very few locations worldwide are able to offer simulated hospital environments of the required quality.

“There’s a similar, but older, centre in Germany. US manufacturers typically rent a clinical simulator, which costs them a fortune. I genuinely don’t think anything anywhere can match this centre, and we even use top-end 4K video cameras, professionally lit and with top-quality sound systems to capture every detail,” he says.

Tom Clutton-Brock“Before MD-TEC opened, I’d led the NIHR trauma management healthcare technology co-operative (Trauma MIC) here, and we’d worked with 120 companies in five years, to help them bring new technology products to market more quickly, at less cost and with reduced risk.

“We saw the legislation coming with regard to usability quite a while ago, so were able to start looking at ways to fund and equip the centre well in advance. Half the space is the simulated hospital, the rest is for research into innovative bio-materials, but all of it is for the testing of new medical devices.

“We’re open to working with any form of technology in healthcare, and there was significant interest even ahead of the formal launch. We’re also looking to engage with investors and new sources of finance, as our target is to become self-funding by December 2019.”

The core remit of MD-TEC is to support SMEs in the Greater Birmingham & Solihull LEP area, whilst Trauma MIC will continue to work with manufacturers across the UK and overseas. Even before MD-TEC’s doors opened, Clutton-Brock was working with a company specialising in innovative neuro-technology devices based some 5,300 miles away in California’s Sillicon Valley.

The latest product devised by Cerebrotech Medical Systems is a portable wireless visor, designed for use by paramedics, ambulance staff and others who might initially assess patients requiring swift and accurate neurological assessment. Its chief execuitve, Mitch Levinson, began his working life as an engineer on the R&D side with Hewlett-Packard, but has spent the past two decades in start-ups, and accumulated an impressive track record of developing and bringing revolutionary new products to market.

His current vehicle was established five years ago, based on technology developed at the University of California’s famed Berkeley campus, which passes low-power electromagnetic waves through the brain and delivers a neurological assessment of a patient’s condition in around 30 seconds.

“We can get a lot of information out of the tissue, then use machine-learning algorithms to identify several brain pathologies, including stroke, cerebral bleeding, trauma and swelling,” says Levinson. “The visor is easy to use, battery-operated and not fragile, and can be used in a range of environments; typically at a patient’s home, in ambulances, hospitals or within an intensive care unit. We received clearance from the Food & Drug Administration in January, and now we’re raising funds in the US, the UK and Europe for commercialisation.

“Our initial application will be in stroke stratification and triage, where we see a big, glaring and unmet need which we know we can improve. Usually, when an ambulance arrives at an emergency caller’s home, a patient might shows symptoms of a stroke, but it could also be due to other conditions.

“It could be a small vessel stroke, or a large vessel stroke, a small clot, or a large clot, but the condition needs to be identified very rapidly and precisely, as the patient might need to be taken to a specialist unit, but even a neurologist might struggle to identify exactly what should be done immediately.

“Everyone working in neuro-critical care needs to know when they can intervene, and its very difficult to assess a patient in real-time without accurate data.

“Everything is time-sensitive about strokes, so the visor needed to be fully assessed, which is where Tom and his team have been so useful. We have data to show the device is more than 90% accurate in determining if a large or small vessel has been affected, and now a usability study of tangible benefit to us.

“Our chief medical officer visited Birmingham to meet Tom for all the tests, he’s a great guy, has a very British sense of humour, and our visor was tested by his colleagues in the critical care team at the QE and paramedics in Coventry, which was exactly what we wanted.”

Clutton-Brock was equally pleased by both the outcome of the project, and the relationship with Mitch and chief medical officer Ed Shusterman. “We were introduced through a company called Device Access UK, and I wrote two study protocols, one for neuro-critical care staff and one for paramedics. We recruited a dozen staff here, and they used the Cerebrotech visor on a mannequin whilst being filmed.

“We then analysed the videos, wrote a detailed report with still images and videos uploaded securely to the web. We then repeated the tests with 16 paramedics at an ambulance simulator in Coventry, and have just completed a similar report.”

However, he wasn’t able to escape the arctic British weather to visit them both in the Californian sunshine. Shusterman visited the ITM five times for face-to-meetings, and they also held another five tele-conferences.

DummyRather closer to home, Clutton-Brock and his team have also worked with a London-based manufacturer, Braidlock, whose innovative catheter securement device removes the need for sutures to be used during surgical procedures. “We have developed a range of sizes in two different configurations, but they all work on the same basic premise, that catheters or drains no longer need to be secured by stitches or tape,” says Heather Cameron, the company’s sales and marketing manager.

“We want to help save money, time and lives, and believe our product (which is very patient-focused) will do all three, and its also better for care workers. Sutures often cause tears, which lead to infections, and anything which reduces the number of holes made in patients obviously has to be a good thing.

“We are also confident that our device will be even more interesting to procurement teams, because they can reduce the number of products they use, and also standardise procedures between different NHS Trusts.

“At the moment, there are around 80 different products on the market, and all require the use of sutures that typically take between 15 and 20 minutes for each patient, and of course, it later takes time to remove them all.

“Our device takes only seconds to adhere to the patient’s skin, so there’s an immediate and significant time saving for each procedure, which of course means saving money.”

Cameron had known Clutton-Brock before joining Braidlock, so was keen to commission his team to carry out tests and usability trials. “We wanted to ensure we ticked all the boxes with regard to legislation, and also wanted to discover if the product was as intuitive and as easy to use we thought.

“We got detailed reports and observations, and are now using the points he highlighted to inform the work of our research and development department. Development of version two of the device is now in progress, and we are also carrying out clinical trials in other locations.

“As we move closer toward the product launch, we’ll likely work with Tom and his team again to get further feedback, because it was such a productive and proactive collaboration with his group.”