The pandemic has had unintended consequences, acting like a wrecking ball that has helped reimagine Diagnostics and Healthcare delivery services, accelerate research and development and, critically, regulatory approvals. Solutions had to be found swiftly during the past 19 extraordinary months and disruption has become the sector’s best friend. The need to do things differently has had a profound impact, further supported by emerging enabling technology that has allowed the Health Tech sector to recontextualise how to improve patient outcomes.
Innovation in fields such as AI, Machine Learning, Internet of Things (“IoT”), Digitalisation, Materials and Mobility move across core segments such as Diagnostics, Devices, and Digital Health to drive remarkable synergies and improvements in quality of life.
Faster routes to market
Without doubt, COVID-19 has impacted Health Tech’s ability to bring products to market, but in other ways it has injected pace into the regulatory process. A precedent has been set with the US’s Food and Drug Administration (“FDA”) approving a large number of emergency authorisations during the pandemic.
Overcoming clinical and regulatory challenges is fundamental to the success of innovative start-ups in the Healthcare space. Certainly for Locate Bio, an orthobiologics-focused regenerative medicine company, receiving two breakthrough device designations from the FDA was a contributing factor in the recent oversubscribed funding round that raised £10.0million. The products in question are Chondor3, a biomimetic graft for osteochondral lesions and CognitOss, a single-stage therapy that combines the local delivery of therapeutically appropriate levels of antibiotics from a ‘smart material’ that is designed to be responsive to the presence of infection and promote the regeneration of bone. These two products are key proof points that Locate Bio is building best-in-class technologies that are not only reinventing the wheel, but also addressing performance limitations, enabling orthopaedic surgeons to improve the lives of people suffering from debilitating conditions.
Cooperation at the highest level is not new however and can already be seen in some business models where Health Tech and clinicians are coming together to meet the demand for solutions to continually improve patient outcomes.
This type of effective partnership is seen in companies such as Medovate, that works closely with clinicians and professionals to take Healthcare technologies from the NHS innovation pipeline to the commercial market. Its first commercialised product, SAFIRA®, offers a more accurate regional anaesthesia process that helps prevent nerve damage and can be administered by one person. Giving the anaesthetist total control, SAFIRA® makes the procedure safer by preventing the chances of severe nerve damage. Administered in the field, regional techniques may optimise acute pain control to allow for early ambulation and shorter hospital stays, resulting in a significant favourable financial impact on Healthcare system resources.
A smart move
New use cases for smart sensors and devices continue to play out across Healthcare capturing data into pathways that improve both existing, and often disruptive, technologies for improved end-to-end efficiencies. Smart sensors are a prime example of the role of enabling technology, seen in Adapttech and its INSIGHT system, which makes it faster and easier to fit lower-limb prostheses and monitor a patient’s rehabilitation.
Severe peripheral artery disease is the leading cause of lower extremity amputation, with or without diabetes, and the number of limb amputations is increasing. As much as prosthetics are becoming more sophisticated in terms of material and design, a key ‘pain point’, literally, is the pain of badly fitting prosthesis. INSIGHT combines a 3D scanner, sensors, wearable technology and a mobile app to make it faster and easier to reach a comfortably fitting prostheses socket and monitor a patient’s rehabilitation process. This reduces the number and duration of appointments, which have both commercial and waiting list benefits.
Extending telemedicine to including remote monitoring through at-home testing, especially at scale, is now seen as much as a political agenda as a medical one. The pandemic has accelerated the shift towards remote models of Healthcare – to protect both Healthcare workers and the vulnerable patients whom they treat.
With operations in the UK and the US, Sense Biodetection is focused on the development of instrument-free molecular diagnostics, delivering true point-of-care molecular testing in just 10 minutes. Able to address the unique challenges of remote testing at scale, Sense’s Veros® platform has the potential to transform the way medical providers and patients approach Healthcare, making it possible to take monitoring outside of the traditional clinical frameworks of hospitals and GP surgeries and into any context where it is required.
Rinicare has further evidenced both the need and the success of in-field monitoring. PRIME™, its continuous vital signs monitoring system, is designed to allow clinicians to monitor patients’ vital signs wirelessly and remotely. The portable system provides a complete range of real-time, hospital-grade data that is accurate and consistent. Rinicare’s technology also integrates with existing IT infrastructure to interface with any data stream, so when used across a variety of healthcare systems provides an early warning system for patient deterioration. Current early warning score models utilise generic thresholds, whereas Rinicare’s technology, STABILITY™, can anticipate deterioration before it occurs and, combined with the patient’s physiological data, can personalise each risk predication.
The convergence of precision engineering and Healthcare has delivered exceptional technology and there have been many examples of alliances between device manufacturers and component part manufacturers. Advanced manufacturing is also starting to feature more in the context of product, as opposed to just prototyping, and the use of novel materials is helping to navigate the issues and inefficiencies in the supply chain, inflicted by both the pandemic and geopolitical changes.
Axis Spine is already exploring the further application of 3D printing in the continued development of its technology. Its next generation of Anterior Spinal Implant technology, which provides surgeons with increased correction and alignment options, has attracted significant commercial interest. The Axis-ALIF, Axis Spine’s first implant system, will soon be demonstrating its clinical benefits in the US’s £7.0billion spinal implant market, with several top US spine surgeons ready to start using the device. More than 300,000 procedures involving anterior spinal implants take place each year in the US.
The Health Tech industry is the most innovative in its category of Healthcare and Life Sciences and is expected to grow to reach nearly $660.0billion by 2025, buoyed by emerging markets, the aging global population and the steady rise in long-term conditions such as cardiovascular and those associated with obesity. This will be further fuelled by the huge growth of data and the sharing of information through IoT-enabled devices and patients’ expectations for better outcomes and increased information and control. This in turn will drive product level innovations such as the continued evolution and use of digital devices, AI services including mobile apps, remote monitoring and cloud-based applications to store, process and analyse patient data to improve the outcomes.
Mercia will continue to seek and invest in thriving regional businesses that can deliver strong outcomes by leveraging innovation, improving efficiencies to bring down the cost of healthcare, the burden placed on health systems and, critically, improve patient outcomes