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Professor Steve Morgan from the University of Nottingham writes about the benefits of smart invasive devices after it secured over £800,000 in funding for a smart breathing tube last year.

Invasive devices such as urinary catheters and central venous lines are commonly used in healthcare. They serve a useful purpose but are essentially ‘dumb’ devices used to transfer fluids or gases to or from the body. The global catheters market was valued at $45.26 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.4% from 2021 to 2028, according to Grand View Research. A high prevalence of chronic disorders leading to hospitalisation has driven the growth of this market. There is considerable interest in incorporating new sensing technology within these catheters to facilitate ‘smart’ catheters that can monitor key physical and physiological parameters, contributing to the Internet of Medical Things.

The large datasets obtained from such devices can be used to train deep or machine learning algorithms to recognise changes in a patient’s condition. For example, Silicon Valley based company Potrero Medical has developed a smart foley catheter that measures urine output, intra-abdominal pressure and core body temperature. Algorithms are then used to help to predict acute kidney injury earlier.

Different sensing approaches can be used. Commercially available miniature microelectromechanical systems (MEMS) technology, which integrates sensors or actuators, can be embedded within a catheter. Swedish start-up CathPrint AB is developing a process for printing flexible electronics directly onto catheters. Our interest is in the integration of optical fibre sensors into invasive devices. Optical fibre sensors are a highly versatile platform technology that can make a range of physical and biochemical measurements. This sensing capability, coupled with their small diameter, flexibility and immunity to electromagnetic radiation means that they can add greater functionality to existing medical devices.

In collaboration with Nottingham University Hospitals NHS Trust and P3 Medical, we are developing a smart endotracheal tube known as iTraXS (intra-tracheal multiplexed sensing) which utilises optical fibre pressure and perfusion sensors to monitor the cuff-trachea interface. Incorrect cuff inflation pressure causes significant problems for intubated patients. Around 3% of intensive care patients intubated for over 48 hours suffer tracheal stenosis due to high contact pressure impairing mucosal perfusion, and 1,900 patients per year require tracheal resection in the UK alone. 50% of surgical patients in the UK complain of sore throat related to high pressure. If cuff pressure is too low, this also causes harm through increased pulmonary micro-aspiration of fluid materials, a major contributing factor in ventilator associated pneumonia (VAP). VAP occurs in 10-20% of ventilated intensive care patients and on average increases length of stay by six days, and mortality by up to 50%. Each episode costs approximately £12,000 in the UK and $25-40,000 in the U.S. While adequate contact pressure is required to reduce microaspiration and to enable positive pressure ventilation of the lungs, high pressures cause ischemic injury. These competing requirements create a narrow target for the optimal contact pressure. It is essential to develop a sound value proposition to support adoption of the technology. Conventional ‘dumb’ devices are low-cost disposables, for example, an endotracheal tube typically cost £3-5 and purchasers may be reluctant to invest in a smart tube priced at £100-£200. These sums are a tiny fraction of the cost of surgery, or stay in the intensive care unit, but a business case still needs to be developed based on clinical evidence of the reduction in VAP or prevention of tracheal injury.

Nonetheless, the future is highly promising for smart invasive devices. The range of sensing technology; connectivity within the Internet of Medical Things; and the prevalence of artificial intelligence will lead to better treatment and diagnosis, improved patient outcomes and more efficient healthcare.

Lucy Mackillop, chief medical officer, Sensyne Health, considers the increase in digital health use during the pandemic, and remote patient monitoring as a lasting legacy.

In the last 12 months, the healthcare industry has faced huge challenges due to the pandemic and has made significant, rapid changes to its ways of working. One of the biggest shifts has been the greater adoption and use of technology by hospitals and doctors’ surgeries. In March 2020, 10% of patient appointments were made remotely compared to 3.5% in March 2019 and registrations to the NHS app increased by 111%. Investment in digital healthcare has meant that many patients can now monitor their symptoms or illnesses from home and share their health status with clinicians without having to visit a hospital or GP practice. It has also enabled virtual appointments, reducing face-to-face consultations which has been particularly important for the maintenance of quality care during times of social distancing.

This model has had success, with many people keen to embrace virtual care. Recent research conducted by YouGov revealed 49% of people believe that being able to track symptoms or use monitoring devices to assess health concerns, has been important and helpful during the pandemic, and 52% of people keen to have the option of remote consultations with healthcare professionals when the pandemic ends.

Clearly, there is a real imperative for remote patient monitoring (RPM) and management to continue to support patients and drive efficiencies across healthcare systems, especially after the pandemic. As we move beyond the initial uptake of digital healthcare, we must consider how tools like RPM can be implemented in new care pathways and assist healthcare professionals to manage increasing demand without over-stretching already strained resources.

When the pandemic first hit, RPM gave healthcare providers the option to deliver care to patients in their homes, reducing the risk of infection. It also allowed patients whose follow up care could be delivered remotely to be discharged from hospital earlier, alleviating pressure on hospital resources. In such cases, if a patient’s condition deteriorates while at home, RPM software can convey information to healthcare professionals in near realtime.

While RPM technology has played a crucial part in care delivery during COVID-19, its use doesn’t start and end with the pandemic. It has the potential to enhance or radically change existing healthcare pathways, improve operational efficiency and help deliver better patient outcomes.

For example, Sensyne Health’s GDm-Health digital therapeutic app, helps pregnant women and their care teams proactively monitor and manage diabetes remotely. The risks to mother and child associated with this condition are significant if not treated, and include an increased rate of caesarean section, pre-eclampsia and premature birth. Clinicians use the system to monitor blood glucose levels remotely, and prioritise care to women needing it most whilst still providing efficient and effective care to all patient cohorts. Mums-to-be upload their blood glucose readings from home, and communicate with their care teams through the app. The need for face-to-face appointments is reduced, administrative time is saved, and quality of care is enhanced.

The fundamental role of RPM is to improve the quality of data to deliver timely, effective and safe care. Data from RPM applications can be uploaded to Electronic Patient Records (EPR) and combined to form a rich dataset from which machine learning algorithms can be developed for, for example, prediction of certain outcomes that are important to patients, clinicians and hospital managers to aid better decision making, resource utilisation and ultimately patient outcomes. Furthermore, this data can be anonymised, aggregated and used to analyse patterns within a disease and inform clinical research aimed at drug discovery and disease prevention. Gaining insights from anonymised patient data may allow for faster development of new treatments.

Attitudes towards using patient data have changed since the pandemic. The YouGov research found that now, 64% of people are happy to share personal health data to support the development of treatments and vaccines for conditions including COVID-19. Before the pandemic, just 13% trusted technology companies to handle anonymised NHS patient data confidentially.

COVID-19 has provided the motivation for both patients and clinicians to embrace new technologies including RPM. This change is likely to be a common feature of routine clinical practice going forward. Demand on our healthcare systems will continue to rise, but it can be better managed with technology that supports earlier detection and intervention.

In October 2020, the European Commission issued a Recommendation on COVID-19 testing strategies, in which the use of rapid antigen tests was encouraged continuously as a way of strengthening testing capacity. The extent and intensity of these efforts vary from country to country and are constantly changing as the infection rates change and new technologies come into play.

The conventional COVID-19 testing deploys the PCR test, and the access to PCR tests is primarily limited to healthcare facilities and private medical labs. Its prolonged turnaround times, which take one to three days for reporting test results, can hinder the swift detection of infected cases.

iXensor, a mobile health start-up, that was fostered in Silicon Valley and incorporated in Taiwan, developed a fully digitalised rapid antigen testing and digital platform for COVID-19 management. PixoTest provides computer analysed COVID-19 test results, lowering the risks caused by misinterpretation of human eyes. The palm sized PixoTest Analyser transmits digitalised test results to PixoHealth Pass App users in as short as five minutes for people with high viral loads.

The PixoHealth Pass App serves as a free digital health pass for app users to access the controlled places which demand a negative PixoTest COVID-19 antigen test result. The app retrieves test results via an encrypted QR code format simultaneously as soon as the PixoTest Analyser finishes the analysis of the rapid test. The testing-toreporting processes are entirely integrated without the need for manual record and interpretation of test results, demonstrating rapid, cheatproof, and connected testing experience to organisations and test recipients.

To meet the public health and social interests of getting back to post-pandemic normal, iXensor offers the additional PixoHealth Pass Admin App and Web Portal, complementary with PixoTest, as an enterprise solution for COVID-19 screening and access control.

It supports organisations such as schools, manufacturers, multinational logistics companies, event organisers, and health authorities to easily maintain safety and sustain operations.

PixoHealth Pass Admin App verifies the authenticity of PixoTest displayed by PixoHealth Pass App users with one scan on a smartphone.

One QR code scan takes a few seconds to complete, and the scan can bring benefits to an entire organisation. As it further empowers organisations using PixoHealth Pass Admin Web Portal to keep digital records of people’s COVID-19 test results and trace COVID-19 related symptoms. The digital tool allows for prevention to becoming an outbreak cluster, swift contact tracing, and the implementation of prompt and targeted isolation and quarantine actions.

GDPR imposes challenges on how healthtech companies bring forth innovative products. iXensor has taken the principle of GDPR compliance into account in the early stage of solution design.

The PixoTest and PixoHealth Pass products work together with a fine balance of offering convenience while complying with privacy policy to users.

Up until now, iXensor has rolled out multiple clinical studies in Europe, Asia, Africa and Latin America. As of 25th March, the IXensor’s PixoTest is undergoing the submission process for CE marking and WHO EUA.

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