1. 3D-printed swabs designed with AI
Belfast-based Axial3D, an artificial intelligence software company specialising in medical 3D printing to create anatomical models, has deployed its 3D capability in new ways to print face shields, ventilator parts and nasopharyngeal swabs for testing.
Following clinical trials in New York and Florida, it has sent hundreds of thousands of specially designed swabs to capture COVID-19 samples across the United States, Europe and Asia. Measuring around 15cm, these are produced on Formlabs printers on surgical guide resin and keep samples more intact than traditional swabs; they can also be condensed into tubes. Each printer produces 1,000 a day.
“3D is sometimes seen as a [slow] last resort, but the function of a printed swab can be better than the traditional swab,” says Axial3D’s chief executive Roger Johnston. His firm employs just 30 people, but local partnerships helped expedite regulatory approval and scale up this healthcare innovation.
“Our primary market has been the US, where demand is huge,” says Johnston. Acceptance of 3D printing for personal protective equipment and clinical applications is accelerating. “There won’t be a turning point backwards,” he says.
2. Over-the-counter COVID-19 tests
CRISPR, the new class of molecular tools, is being used in multiple ways as a prophylactic strategy and to increase vaccine yields, for example. CRISPR-based platforms are also being employed to develop diagnostic tests as a scalable means to address disease detection, since the standard technique, RT-PCR, is too limited to offer the mass testing epidemiologists say is needed.
US-based Mammoth Biosciences, co-founded by CRISPR pioneer Dr Jennifer Doudna, is now collaborating with GSK with the aim to deliver “extremely accurate and robust tests in a rapid format” by early next year. “People think of CRISPR as an editing tool, but we think of it as a search engine for biology,” says Mammoth co-founder and chief executive Dr Trevor Martin.
The test, which could provide results in 20 minutes from a nasal swab, uses guide RNA and a programmed sequence specific to SARS-CoV-2, the current strain of coronavirus, with viral evidence triggering a “molecular shredder” that creates a release of colour to display a read-out. “CRISPR diagnostics can have a large impact in this space,” says Martin, “particularly in a pandemic.”
3. Applying AI to real-time patient data
The Patient Status Engine (PSE) automates the collection of raw patient data and decision-support tools for clinicians, combining wearable sensors with wireless networks and big data to provide high-resolution patient monitoring. Currently used in two NHS trusts and globally, it’s a class-2 medical device that’s FDA-approved in America and, says maker Isansys Lifecare, the only medically certified end-to-end digital solution of its kind.
“Bedside equipment in hospitals gives clinically accurate data, but isn’t portable, while wearable products generally don’t provide information accurate enough to make clinical decisions,” says chief executive Keith Errey. He likens the PSE to an app store for healthcare. “People are developing their own artificial intelligence to run within our platform,” he says.
Installed behind hospital firewalls, this healthcare innovation includes wireless connections as part of its design, with patients connected through an Android “gateway” running Isansys applications that receive incoming data from sensors via doubly encrypted Bluetooth. High-dependency isolation wards can be created rapidly, says Errey.
“With COVID-19, the needs we’ve been talking about for years have become very apparent. This is smart tech, but the key is usability and meeting customer needs,” he says.
4. Monitoring social distancing
Chris Stretton and Adam Bykowski met while studying telecoms engineering and founded Locilabs last November to develop a precision tracking product based on ultra wide band (UWB) technology.
As the COVID-19 pandemic began, they pivoted to an application for social distancing, launching their SafeSpace system. Via badges and watches, this measures how closely and for how long individuals come into contact, by monitoring the time of flight of radio signals between units. It also triggers alerts and real-time feedback via a cloud platform to identify those at risk of COVID-19.
“With UWB, we can define a distance with a 10cm margin of error, which is more accurate than Bluetooth or radio-frequency identification,” says Stretton, who previously worked on big telecoms and major infrastructure projects. “We can say definitively when contact occurred and give total exposure time. Tangible data could help to avoid use of quarantine.”
Its (ingress protection) IP67-rated hardware, European CE and FCC (US Federal Communications Commission) approval mean major organisations are already trialling the innovation. Stretton believes their system offers potential to track COVID-19 cases in healthcare systems.
5. Detecting COVID-19 via smartphone
Docdot is a mobile app that uses artificial intelligence to enable clinicians to monitor vital signs remotely. Developed by Italy-based SDG Group, it has undergone clinical trials in Canada, India and Japan, and is now used in US hospitals.
The app works using light signal processing technology known as remote photoplethysmography, or rPPG, through which a smartphone camera records light reflected by blood vessels beneath the skin. Blood volume in micro-vascular tissue varies in response to respiration, blood pressure and other changes; the app converts this into measurements reportedly 90 per cent as accurate as hospital-grade monitors.
Docdot enables people to look into their smartphone’s screen and share early indicators of infection. It records heart rate, oxygen saturation and stress, collects data in real time, geo-references it and collates this to show COVID-19 cases and hotspots.
“Use of this technology for virus monitoring and detection is new,” says Heather Beardmore, SDG Group UK chief executive. “This healthcare innovation is the first remote-monitoring and triage tool with potential to transform diagnosis and management.”
6. Ventilating through the cloud
The coronavirus pandemic led San Diego-based ResMed, a market leader in sleep and ventilation devices, to accelerate the release of AirView, its patient data management software.
With this cloud-based system, cellular chips in ventilation devices send data which is then sorted and made available to clinicians in an easy-to-read format, enabling “management by exception”, triaging patients and troubleshooting. Medical staff can also change settings remotely.
UK and Ireland country manager Antoine Valterio says: “With COVID-19, clinicians are short of time, so this enables them to ensure the right patient gets the right care.” Remote monitoring allows other patients to remain at home and avoid visiting the hospital unless necessary.
ResMed is now training healthcare providers virtually to use the software. “The NHS has adopted cloud-based technology at an incredibly fast pace,” says Valterio.
“An inflection point brought about by COVID-19 means digital health is being adopted at an accelerated rate, benefiting patients, clinicians and the healthcare system. Capability is there to drive a virtual care pathway and tools are available.”
7. F1 speeds innovation
In a project kicked off by a professor of intensive care medicine at University College London, engineers from Formula 1’s Mercedes-AMG collaborated with UCL colleagues to create a COVID-19-specific non-invasive ventilation device – continuous positive airway pressure – the UCL-Ventura.
Teams reverse-engineered an off-patent mechanical device, previously used in the NHS, to create a less oxygen-hungry version. This involved redesigning the entrainment port and improving flow and pressure. Mercedes set up a rig to do flow tests on filters, while simulation engineers, more used to designing inlet ports and compressors for F1 engines, improved fluid flow through the jet pump.
Applying motorsport characteristics of competitive ingenuity and adaptability helped to drive the success of this healthcare innovation; from idea to hospital testing took just 100 hours, with Medicines and Healthcare products Regulatory Agency approval gained in ten days.
“We delivered a 70 per cent improvement in oxygen requirement which could be measured clearly,” says Andy Cowell, managing director of Mercedes-AMG High Performance Powertrains. The Department of Health and Social Care ordered 10,000 devices and 100-plus countries are now using the UCL team’s designs.
8. Low-cost quality ventilation
Another COVID-19 healthcare innovation launched by a clinician is JAMVENT. The spark for a low-cost high-performing emergency ventilator model, which assembles quickly and simply using commonly available components, came when senior anaesthetic registrar Dr Jakob Mathiszig-Lee, also an honorary clinical research fellow at Imperial College London, began treating COVID-19 cases.
Crucially, JAMVENT doesn’t use proportional solenoid valves, but simpler on-off valves which are cheaper, maintenance friendly and available from numerous manufacturers. Importantly, too, it has a breath-sensing mode to help ventilated patients recover their ability to breathe.
“Our original plan was to produce the design and put it on the internet for everyone to pick up and run with,” says Dr Joseph Sherwood of Imperial’s bioengineering department, the project lead. The regulatory side was “the bottleneck in the process” but the team, now awaiting emergency FDA approval, points to JAMVENT’s significant performance improvements compared with other models, combined with a “basic-enough design to be nowhere near the costs of intensive care”.
9. Portable protection for the pandemic
Personal protective equipment (PPE) has been a major point of discussion throughout the outbreak. Aerosol-generating airway management procedures create particular risks for medical staff, so Dr Egidio da Silva, a consultant anaesthetist at the Royal Orthopaedic Hospital NHS Foundation Trust in Birmingham, sought help early on from Mat Campbell-Hill, a senior fellow in novel medical technologies at the University of Birmingham.
With input from his GP wife Lydia, Campbell-Hill and colleagues developed the AerosolShield, an inexpensive, disposable four-component pop-up tent that covers a patient’s head, neck and chest area to give workers portable, continuous protection.
“It can take up to seven minutes to correctly and safely apply full PPE,” explains Campbell-Hill, now scaling up production with Airquee, a specialist manufacturer of clinical isolation tents. While recent changes to resuscitation guidelines might delay early and urgent interventions, this healthcare innovation can, he says, enable staff to form a rapid but workable protective barrier before carrying out lifesaving procedures.
Already deployed in GP practices, care homes and major hospitals, AerosolShield could find uses in emergency services and under-resourced settings globally.
10. Providing comfort for clinicians at risk
A further healthcare innovation to protect workers involved in risky, aerosol-generating procedures is the PeRSo, a powered air-purifying respirator developed in just weeks.
Clinician Paul Elkington, professor of respiratory medicine at the University of Southampton, realised medical staff working long shifts needed more comfortable respiratory protection that was sufficiently robust.
A Southampton-based academic team, including bioelectronics professor Hywel Morgan, took forward the idea. It created a lightweight design which features a small portable unit delivering clean air through a high-efficiency particulate air filter, with a battery-powered fan mounted on a belt pack.
Dr Alex Dickinson, a mechanical engineer now helping develop PeRSo for low-resource settings, says: “We made careful decisions in specification and design relating to use for COVID-19 cases.” Preventing neck fatigue and promoting ease of cleaning were vital.
“We were constantly talking to users and to Paul Elkington, our clinician champion, to understand more.” The team has since published its prototype computer-aided design and open specification, with 4,000-plus PeRSo devices now being used in hospitals.