TECHNOLOGY


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, while awaiting results, are immediately given intravenous antibiotics in case they have NS.


The device


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, while 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. These patients did not need to attend hospital and did not need to receive antibiotics. In fact, in 2018, over 50,000 unnecessary NS-related admissions took place while propagating antibiotic resistance. Health economic analyses show that incorporating NeutroCheck into the treatment pathway could save over £70million 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


finger prick blood test and decide whether or not a hospital visit is required.


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 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 challenges


The NHS is currently battling to keep the number of patients within hospitals low while 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


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NeutroCheck has continued to develop its technology throughout the lockdown. 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. 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. However, 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, while 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.


CSJ


About the author


Dr. Alice Greenhalgh is innovation manager at Health Enterprise East (HEE), where she supports a diverse range of innovators to turn ideas into products and services that will benefit patients, the NHS and the wider economy. Alice has experienced how innovation can impact healthcare and ultimately benefit patients within the NHS, and with HEE having the largest network of NHS organisations in its field, there is ample opportunity to connect healthcare experts and establish successful partnerships.


Alice has a BSc in Biochemistry from the University of York and a PhD in Breast Cancer Research from the University of Manchester. She previously worked at UMIP – The University of Manchester’s agent for Intellectual Property commercialisation, as well at start-up biotech companies in both the UK and US.


NOVEMBER 2020


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