By Mike Cowley
It was tough going for an apparent no-brainer…until an inspired AHSN rode to rescue.
Richard Kirk is chief executive of a leading North East medi-technology company which has created a treatment that can reverse sight loss in patients with diabetes, with the potential to save the NHS up to £1 billion a year.
He is also a member of a Government steering committee in his sector, and hence has the ear of many ministers. His company, PolyPhotonix, has already received £14 million in research grants from various public bodies including the NHS – which also happens to be the company’s main research partner.
With all of these significant endorsements, you might think that Mr Kirk was a shoo-in to get his clinically effective product adopted easily throughout the whole NHS. Well, you would be wrong.
In fact, without the Academic Health Science Network (AHSN) for North East and North Cumbria effectively having opened the door to the NHS marketplace, Mr Kirk would still be “hacking his way through the jungle with a machete” – as he puts it – to gain a foothold, and then only one which “would rapidly close in behind so that no one else could follow”.
Here, however, is a treatment that effectively ticks all the boxes in term of ophthalmology. It takes the form of a sleep mask – similar to those used on planes, only this one is intelligent as it contains sensors which emit light into the eye while the person is asleep in a way that is able to not merely stop the disease but also to reverse it.
Unlike the current laser treatment it is seeking to replace, the Noctura 400 sleep mask is non-invasive and does not cause additional harm with long-term use. Lasers are used to cauterise the leaky blood vessels in the eye that cause the condition, but have been shown to cause loss of peripheral vision after a handful of treatments. Just as significantly, laser treatment effectively wipes out night vision, meaning that the patient will have to give up their driving licence.
With 280,000 new diabetes patients being registered each year, and with many of them likely to have eyesight problems in due course, there is currently a huge cost to the NHS for laser treatment of around £6,500 per eye. This market is certain to expand further, as 90 per cent of type 1 diabetes sufferers will go on to develop diabetic retinopathy within ten years.
In the case of type 2 diabetes – the most common form and increasing most rapidly as it is brought on by obesity linked to sugar and lack of exercise – two-thirds of sufferers will develop the condition within the next decade.
Hypoxia, or oxygen starvation, is the underlying cause of the disease which affects the sensors at the back of the eye. These are made up of rods and cones: the cones are used during the daytime and the rods at night, with rods outnumbering cones by a ratio of 20 to one.
The PolyPhotonix team worked out that when people wake up during the night – and find they can effectively see in the dark – it is because the rods are dark-adaptive. Everyone hypoxiates at night and the body counters this by producing a protein that regulates the growth of new vessels behind the eye. However, if you are a diabetic, that growth is compromised.
“So we decided if we could control the light in the eye, we could reverse the process,” says Richard Kirk. The resulting trials showed that the light-emitting mask stopped the blood-vessel bleed, so halting the disease in its tracks and allowing the eye to start to repair itself.
There was also an additional benefit in that it was found to improve the sleep pattern – and all this at about one-twentieth of the cost of the most intrusive treatment used previously, which involved an unpleasant injection into the eyeball.
With the Noctura 400 sleep mask able to be used – and monitored – at home (which is where the intelligent sensors help to record use, as trial patients do not always tell the truth), this appeared to be a no-brainer in terms of it soon being embraced by the NHS.
But it simply didn’t happen, as is so often the case for small and medium-sized enterprises (SMEs) attempting to bring innovations to the NHS table. Mr Kirk became frustrated to the point of ruing the day he had tried to get access to the NHS – until, that is, the AHSNs – including that for the North East and North Cumbria – rode in to the rescue.
The regional AHSN has been pioneering what is known as the Innovation Pathway, considered so successful that it is being taken up by the other 14 AHSNs throughout the UK. The Innovation Pathway has been created to deliver services to support the SME community, as well as to NHS organisations, with the aim of contributing to regional wealth and improving patient care.
While some SMEs have been able to penetrate the NHS market in terms of uptake of new products and services, many have struggled. To address this, the regional AHSN – in collaboration with some of its partner organisations including NHS Innovations North, the National Institute for Health Research Clinical Research Network, RTC North Limited and the Newcastle upon Tyne Hospitals, City Hospitals Sunderland and South Tees Hospitals NHS Foundation Trusts – now provides a seamless provision of services spanning the innovation life cycle.
Bespoke services – from conception, to early stage protection of any associated intellectual property, through to facilitation of clinical trials with industry, health informatics, assistance with diagnostic evaluation and subsequent adoption and dissemination of the innovation – are provided to the regional SME community as well as to NHS organisations.
This provides a unique opportunity for public and private sector organisations to benefit from the vast expertise within the healthcare sector. Moreover, it provides expertise to enable NHS organisations not previously involved in the commercialisation of new products and services to take advantage of this opportunity.
“The Innovation Pathway is an articulation on what’s on offer to business – an open door for business to engage the NHS,” says Seamus O’Neill, chief executive of the AHSN for North East and North Cumbria. “If you are a company wanting to develop a product, aren’t you going to want to know if anybody is going to need it? Perhaps it can diagnose a particular illness, but you’ll need to know how many patients a year suffer from that illness.
“Is it worth mortgaging your house to work on a diagnostic test if there are only 5,000 cases a year in the UK? If there are 500,000 cases, that’s a different situation. Also, you’ll need to establish who treats them. Is it GPs, or is it secondary care? – that’s the market who is going to buy it. How will you get the product to the consumers? Will it be sold through Lloyds the chemist, or will it have to be prescribed? You need to understand that and more as a company.
“Once it is tested and validated, does it have to go to NICE [the National Institute for Health and Care Excellence], does it need a CE [Conformité Euro- péene] mark? If you get a CE mark, is it going to be adopted, promoted? These are all questions that can be answered by services provided by different parts of the NHS under agreement with the AHSN – that’s the Innovation Pathway.”
The first benefit that PolyPhotonix saw from dealing with the AHSN for North East and North Cumbria was a loan to enter the loop for Food and Drug Administration approval to get into the US. Then the work began on opening the door to the NHS, which has seen the company putting its sleep mask into 35 NHS hospitals.
“We simply couldn’t have done it without the AHSN,” Richard Kirk says. “The fact that we worked with the NHS and had been funded by them meant we felt we knew them intimately. But we didn’t. When you find yourself dealing with 180 Trusts and 220 CCGs [clinical commissioning groups], the conversation and the cost is extraordinary.
“What they want are endless in-clinic evaluations which have to be supported and paid for by the supplier. Each of these could cost £150,000, so as an SME you simply can’t afford to do it. Other countries will look at you as a result of clinical trials and say ‘Great, come on in’; the NHS doesn’t work like that.
“What the AHSN for North East and North Cumbria has done is help us to address all of these issues. They have given us visibility, given us a voice. Without them, I don’t think we would have bridged the gap, not only in funding but in terms of credibility. They have given us a much deeper knowledge. The fact you have passed their due diligence processes proves you are demonstrating economic viability and clinical competence. They are the only way to open the door to the NHS.”
A long adoption trail
Sameer Kothari, chief executive of Manchester-based Zilico, admits to having experienced difficulty in navigating the NHS procurement process for ZedScan, the company’s groundbreaking testing process for pre-cancerous cervical cells.
Although its patented technology offers a quicker and more accurate way of identifying tissue problems after a positive smear test than does the traditional visualisation process, ZedScan has not had an easy ride to market.
Even though it came with impeccable credentials, having been the result of a successful collaboration between the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, was not enough to fully open the door to the NHS. The first breakthrough came when the Sheffield Trust accepted the product, but even this was not without a degree of difficulty as the board went to great lengths to show there was no conflict of interest.
It was with the arrival of the Greater Manchester Academic Health Science Network (AHSN) that things started to gain a degree of traction, thanks to assistance provided by the procurement advisors on the AHSN team, all of whom had worked for the NHS. Eventually this led to two breakthrough presentation meetings being set up by the AHSN – one with the chair of the Greater Manchester NHS Trusts, the other with the heads of procurement in the City Region.
Now, having had ZedScan adopted by two Trusts and with more in the pipeline, Sameer Kothari thinks that things are changing. “I believe the AHSN’s work is starting to have impact,” he says.
“Procurement advice is a very common form of support requested by SMEs [small and medium-sized enterprises],” says Dr Linda Magee, executive director of industry and wealth at the Greater Manchester AHSN, “but it is just part of an integrated provision to support industry-NHS engagement across our innovation pathway delivered via the AHSN’s Innovation Nexus.”
Glovemakers win approval
A North West firm has been successful in breaking into the multi-million-pound NHS surgical glove market, with help from the Innovation Agency (formerly the Academic Health Science Network for the North West Coast).
Launched in 2014, Leanvation, of St Helens, has pioneered an innovative approach to surgical gloves. By employing the latest advances in material technology, it has developed gloves suitable for use across most surgical procedures, so removing the need to stock a wide product range.
Last year saw Leanvation ship large quantities of gloves to West Africa for health staff treating Ebola sufferers. Building on this and other commercial successes, the company has now completed the rigorous processes involved in securing framework award contracts with NHS Supply Chain.
As the largest supplier of surgical gloves to the NHS, the Supply Chain framework means that Leanvation gloves will, for the first time, be available to NHS Trusts throughout the UK. Leanvation was established in 2013 by former healthcare executives Dr Jonathan Day, Tony Downes and Steve King, and has received financial backing from both Finance Wales and the North West Fund for Venture Capital.
“This is the breakthrough we have been waiting for,” says managing director Jonathan Day. “There is strict governance in the health service which means that only a limited number of approved companies are allowed to provide supplies.
“It is only as a result of the intervention of the Innovation Agency’s commercial team that we have been able to break through barriers to joining NHS frameworks for suppliers, such as a requirement for a £1 million turnover in the previous year.”
One Day to get Creative
A national creative education company from Wetherby is working with Little London Primary, a school that has excelled despite being in one of the most deprived areas in Leeds (one where 60 languages are spoken), to help develop a digital platform to promote positive mental health.
Having established itself with “mindfulness” workshops, the company – One Day Creative – came to the attention to the Yorkshire and Humber Academic Health Science Network (AHSN). This is providing funding for the workshops to be turned into a digital platform with the help of digital agency Mednet – also based in Leeds – for the benefit not only of the children but also of their parents and teachers.
One Day Creative was one of four successful companies in the region to receive a support package worth £23,000 from the Yorkshire and Humber AHSN, comprising £18,000 for tailored consultancy advice from the delivery partners and £5,000 cash to spend on product development to help the company advance its concepts.
Business owners Rebecca Zimmerman, aged 30, and Stephanie Noble, 29, both from Boston Spa, set up One Day Creative in 2013 after meeting on a performing arts course at Northumbria University. Since those initial days working from a back bedroom, it has grown into a national company employing more than 60 people.
One Day Creative addresses a range of topics in schools, but issue-based learning, which aims to keep children and young people healthy, happy and safe, is one of its main goals.
“Young people today live in a harsh world,” Rebecca Zimmerman says. “They are continuously faced with e-safety and cyberbullying issues, leading on to mental health issues and self-harm and ultimately a lack of employability skills.
“If we can do something to help some children somewhere, then all our hard work is worthwhile. The support of the Yorkshire and Humber AHSN, in terms of funding, expertise and experience, has been invaluable to our cause.”