By Alice Greenhalgh, Innovations Manager, Health Enterprise East (HEE)
Originally published by Clinical Service Journal
The innovation landscape pre-COVID-19
Innovation is pivotal in many industries such as healthcare, defence, and agriculture. Innovators from such industries, that have not worked with the NHS before, often assume that being one of the largest, unified healthcare systems in the world, innovation is not only embedded into the NHS ecosystem, but actively encouraged. However, if there is a place in healthcare to innovate and improve at scale, the NHS should surely be the poster child. Over the past decade, the NHS ecosystem has improved greatly, with dedicated staff and funding now set aside for innovation.
Some would argue however, that the pace and scale at which innovative new medical technologies have been adopted within the NHS has been too slow and cumbersome in the past. The speed and consistency of the NHS switching to electronic patient records for instance, along with the outdated use of pagers, has often been cited as evidence of the slow pace of change.
This has, in part, been addressed by the creation of the 15 Academic Health Science Networks (AHSNs) across England, which work by connecting the NHS with academic organisations, local authorities, the third sector and industry to drive new innovation into the system. Additionally, the creation of the NHS Innovation Accelerator (NIA), launched in July 2015, is also indicative of the NHS embedding innovation into its ethos in the past decade. Designed to aid in the delivery of the Five-Year Forward View and, as a national accelerator, the NIA helpfully offers real-time workable insights to inform the national strategy.
Although this gentle approach to innovation has proved to be effective, with the NIA’s first year saving England’s health and care system an estimated £12 million, there is yet to be a single, over-arching strategy to address barriers to innovation in the NHS. In fact, in many ways, the UK still lags behind other developed countries in providing technologically advanced solutions.
Innovation and COVID-19
The emergence of COVID-19 has forced rapid change upon global healthcare delivery and the NHS has proven that it can rapidly adapt and innovate whilst continuing to deliver world class care. Innovation is at the forefront of this push, with the main goal of streamlining clinicians’ work, optimising systems, improving patient outcomes, reducing human error, and lowering costs through digital solutions. Their unique and valuable viewpoint has seen NHS clinicians and care providers continuously thinking up new ideas every day to solve the frontline problems.
We’ve seen the calls for PPE to be delivered to protect staff and we’ve seen consortiums set up to co-develop ventilators and other lifesaving equipment. There are two clear streams on innovations - those that were (and still are) needed during the immediate pandemic, and those that will only start to be required now as a transition is being made towards a more normal way of life. On this second point, waiting lists are at the highest point since records began, and we urgently need innovative solutions to address the current treatment backlog.
The NHS is already in phase 3 of re-starting routine clinical care, but much more needs to be done to protect the health of staff and patients alike. At Health Enterprise East (HEE) we have seen multiple ideas all centred around this point of providing the same capacity of care as was delivered pre-covid, but in a safer manner. Some of these ideas relate to physical devices required to make high-risk procedures safer and thus increase throughput. Other ideas relate to getting information to patients faster in a socially distant manner. While many clinicians are anxious as to what the future may hold and how this might affect their daily duties, all are still as committed to providing the best possible care for their patients as ever.
The challenges and opportunities for innovation
There are several challenges to innovating in general and not least in response to a global pandemic, yet perhaps of the upmost importance is speed. This has caused confusion amongst innovators; if they are to develop a new tool or medical device to protect, diagnose or treat, how do they undertake the usual well-trodden product development pathway, when this can take five to six years to complete? Put simply, the answer is that they cannot, and COVID-19 innovations need an accelerated development route. This will require streamlined access to funding as well as exemptions or fast-tracked regulatory approvals.
In the UK, concessions have already been made for medical devices that address an immediate COVID-19 clinical need. Some of these are simple solutions such as an expedited advice service for all COVID-19 related enquiries by the Medicines and Healthcare Products Regulatory Agency (MHRA). Others are a little more complicated, such as certain exemptions from device regulations during the COVID-19 outbreak.
Exemptions have been made, for example, for ventilators, PPE and COVID-19 testing kits; however, this is not a free pass at a CE mark. Applicants must explain why they have not yet gained CE marking and state when they expect to gain this, as well as other criteria that must also be met such as providing evidence that the work has been undertaken according to the appropriate ISO standard. In addition to these examples, there are many other flexible policies that the MHRA and other regulatory bodies outside of the UK, such as the FDA, have put in place to ensure medtech innovations are not unduly held up by the normally lengthy regulatory process.
Support for medtech development
Another area where medtech innovators may need a helping hand to develop COVID-19 Innovations is through funding. While conventional funding programmes are not set up to deal with innovation at such a pace, we are seeing more opportunities becoming available that recognise this.
Unfortunately, there is a lack of funding available for proof of concept work in healthcare generally, but more specifically within the NHS. There are funding streams such as the National Institute of Health Research (NIHR) Invention for Innovation (i4i) scheme which has three funding streams: Product Development Awards (PDA), Connect and Challenge Awards. However, there is a need to have some form of proof of concept work done, whether this is a health economic assessment, IP and freedom-to-operate searches or a prototype made. This sets a very high bar as this is a large portion of work to be undertaken by anyone - let alone an NHS staff member who is likely also working a highly stressful, full-time job.
Medtech Accelerator Support
With this in mind, HEE identified a need for a new venture to provide necessary support and financing for NHS-led innovation projects in order to maximise the potential for success in bringing new life-enhancing technologies to patients. In essence, a fund was necessary to help cross the infamous ‘valley of death’ in early-stage technology development projects. The Medtech Accelerator, led by HEE as a joint venture with New Anglia Local Enterprise Partnerships (LEP), Cambridgeshire & Peterborough Combined Authority, Essex County Council and the Eastern AHSN, was therefore set up to support and finance the early stage development of innovations in the broad area of medical technology (devices, diagnostics, software and eHealth) that meet unmet clinical needs within the NHS.
Through this venture, a total of £2 million was made available, granting individual awards of between £15,000 to £125,000. These awards are given to innovation projects that show the potential to create future spin-out companies primarily out of NHS organisations, and are aimed at supporting proof of concept work, which might include IP protection, market analysis, prototype development and testing, clinical evaluation, regulatory support and pilot product production.
Since inception in 2016, the Medtech Accelerator has committed £1.4 million to 13 projects. This track record means that 13 pioneering technologies, originating from within the NHS, in various stages of development, can attribute their success to early support from the scheme. These technologies all have the potential to make a dramatic impact in a wide range of medical fields, including cancer surgery, endoscopy and anaesthesia. The first product, SAFIRA, a regional anaesthesia solution, reached market earlier this year.
COVID-19 Specific Medtech Funding and Support
The COVID-19 pandemic is like nothing else to hit the NHS since its formation more than 70 years ago. Who better to understand the urgent unmet clinical needs of the NHS than the frontline NHS staff? HEE is partnered with over 20 NHS trusts, meaning we receive details of new innovations throughout the year from clinicians and care providers. Since the UK lockdown in March, over 50% of innovation disclosures made to HEE have been COVID-19 related, ranging from mobile applications to help disseminate information, modifications to existing products such as ventilators, to entirely new devices to address the new clinical needs posed by COVID-19.
What has been made evident is that there is a clear drive to get new innovations to those who need them on the frontline, which requires specific funding for COVID-19 innovations and an accelerated development pathway. Sometimes taking up to a year from initial application submission before funding is awarded, funding schemes with lengthy and robust application procedures simply do not work for COVID-19 innovations. In response, Innovate UK launched a business-led ‘innovation in response to global disruption’ competition in April. This one-off competition to help UK businesses focus on emerging or increasing needs of society and industries, during and following the COVID-19 pandemic, led to fast-tracked decisions. Through fast-tracking the innovation process like this, it is hoped that the UK will be better placed to maintain employment levels, a competitive position in global markets and make the country more resilient to similar future disruption.
In addition to this Government support, new initiatives are being set up to help clinicians and innovators develop new medtech products, which will help them deliver care in the ‘new normal’. A new fundraising initiative, Innovate Now, has just been launched by HEE, which aims to help pave the way for a safe and swift return to routine services as the acute phase of the COVID-19 crisis subsides.
NHS partners have already highlighted the need for urgent support in areas such as managing outpatients remotely, reducing risk of contamination during surgery, patient self-monitoring and mental health support for those with long-term symptoms. This needs-based approach means that solutions can be delivered with relatively modest funds and in incredibly short timeframes.
Demonstrating the value of innovation: NeutroCheck
The latest award from the Medtech Accelerator of £125,000 was made to Cambridge-based company NeutroCheck Ltd, to progress development of an at-home safety monitoring test for chemotherapy patients. Neutropenic sepsis (NS) is a life-threatening medical emergency that occurs in patients having chemotherapy whose immune system has been suppressed by their treatment. The key blood cell that is suppressed in NS is the neutrophil, making even a mild infection potentially fatal. If a chemotherapy patient feels unwell, they must immediately go to hospital to have a blood test to check their neutrophil count and whilst awaiting results are immediately given intravenous antibiotics in case they have NS.
NeutroCheck is developing a transformative new medical device that allows patients to quickly and accurately check their neutrophil count in their own home from a finger prick of blood. The focus is to produce a fast, reliable and low-cost device, which will improve safety and quality of life for cancer patients worldwide, whilst saving healthcare institutions resources by reducing unnecessary hospital admissions.
Impact on patients and the NHS
The hope is that NeutroCheck will enable patients to test the levels and potential activity of a key blood cell at home, therefore gauging their vulnerability to infection. As a result, the early signs of NS could be spotted much quicker than before, enabling patients to get to hospital as quickly as possible and get the treatment they need. This will give patients reassurance about when to go to hospital and therefore may help avoid to unnecessary hospital visits. Currently, approximately 50% of patients who present at hospital do not have reduced neutrophils on their hospital blood test, therefore did not need to present at hospital or receive any antibiotics, and in 2018, over 50,000 unnecessary NS-related admissions took place whilst propagating antibiotic resistance. Health economic analyses show that incorporating NeutroCheck into the treatment pathway could save over £70,000 and, by identifying patients at risk of NS sooner and reducing delays to antibiotic delivery, NeutroCheck could save hundreds of lives in the UK each year.
The development process
The development process for NeutroCheck will follow the broad process for a medical device; initial proof of concept work will be undertaken, which may include various iterations of a prototype and in the cases of diagnostics, multiple reactions, timings and reagents will be trialled alongside the rest of the product development. Other activities may include intellectual property (IP) searches as well as establishing freedom-to-operate. This will then allow for IP protection to be filed, which is something investors often look for in order to de-risk projects. Along similar lines, a health economic assessment may be undertaken, which will demonstrate potential costs benefits and could include time and efficiency savings, as well as savings in antibiotic use.
Activities such as these can be covered by funding streams such as the Medtech Accelerator, helping projects get off the ground. Alongside financial assistance, the Medtech Accelerator also gives innovators access to technical expertise, helping them scope out the market opportunity and confirm the commercial viability of their devices. The collaborative structure of the project means that unmet clinical needs within the NHS can be accurately pinpointed and that medtech innovations that offer solutions to these problems can be fast-tracked to market.
Once this initial proof of concept work has been undertaken, technical information will also need to be collated and, in most cases, compiled into the technical file for submission during the CE marking process. The documents and procedures which are undertaken and collated will differ according to the medical device classification, which is based on risk. Getting a medtech device to market can often take between 3-5 years but this can vary hugely with the device classification and regulatory framework under which the work is being carried out.
The NHS is currently battling to keep the number of patients within hospitals low whilst delivering the same standard of care as pre-lockdown. For many healthcare establishments, this has meant reducing face to face visits in favour of video and phone consultations, as well as not permitting visitors. Therefore, the benefits of a device which provides peace of mind to the most vulnerable and immunocompromised patients over whether to stay at home or to seek medical attention have been vastly increased due to the coronavirus crisis. Keeping cancer patients safely at home is just the beginning of the advantages Neutrocheck can offer patients. Moreover, once restrictions have eased patients will be able to place the device into a handbag or pocket and continue their daily lives with the security of knowing that if they feel unwell, they can quickly do a finger prick blood test and decide whether or not a hospital visit is required.
Whilst NeutroCheck has continued to develop their technology throughout the lockdown, the pandemic has expectedly affected operations. Social distancing measures have been instituted across NeutroCheck, and other partners helping to develop the device prototype, to ensure a safe working environment. Where possible, individuals have worked from home and most meetings have taken place over videoconferencing platforms. Additionally, NeutroCheck have also faced slight delays in acquiring patient blood samples from Cambridge University Hospitals (CUH), as CUH have had to focus on the most pressing issues regarding the pandemic.
The COVID-19 pandemic has taught us many things, most notably, the need for innovation. Innovations such as NeutroCheck can help ease the pressure on the NHS, whilst also providing patients with the peace of mind to know when is best to seek medical attention, greatly improving quality of life and overall patient outcomes.