ABD Device removes 99.99% of coronavirus from human skin – safely
New independent research proves that breakthrough technology from Galway company Aquila Bioscience safely removes the virus that causes COVID-19.
The medical technology company, a spin-out of the National University of Ireland Galway, is the developer of Pathogen Capturing Technology (PCT), now proven to safely remove 99.99% of SARS-CoV-2 – the cause of COVID-19 – from human skin.
The research was undertaken by NeoVirTech SAS, one of Europe’s leading virus imaging and antiviral discovery companies, at its facility in Toulouse, France, using donor human skin from cosmetic surgeries.
The results are a major milestone for Aquila Bioscience and the first time that a safe and non-toxic technology has been proven to remove the COVID-19 virus from human skin with such efficiency.
It couldn’t have come at a more opportune time, given the urgent need to protect society and control the spread of COVID-19 in the community in what has been called the pandemic’s ‘second wave’.
To this end Aquila Bioscience has launched a pilot product registered with US FDA as Class I medical device, the Anti Bioagent Decontamination Device, or ABD Device. It is a large wipe, soaked in proprietary PCT, sterilized and individually packaged, ready for use by front-line workers in healthcare centres, emergency workers, schools, offices and other facilities.
Because the ABD Device is free from alcohol or toxic chemicals it can be safely – and if necessary frequently – used on sensitive areas of the human body including the eyes, nose and mouth, without causing any adverse side effects. It can also be used on sensitive equipment.
Unlike other wipes on the market, the ABD Device is environmentally safe as it is made from natural materials, the gold standard for Covid-19 virus skin decontamination.
Its use will bring enormous benefits to individuals, communities and healthcare systems globally in the fight against the pandemic, without harming the environment.
The PCT technology was originally developed to protect first-responders and defence forces personnel from a potential biological attack from deadly agents such as anthrax, plague and ricin.
The technology works by using microscopic hooks to grab hold of bacteria and viruses, using a capturing mechanism similar to a nano-scale magnet.
The revolutionary technology was developed in collaboration with the Irish Defence Forces and the Czech University of Defence and supported by the European Defence Agency, the European Union Horizon 2020 and the European Innovation Council.
It is now being made available to governments and organisations as a superior decontamination solution in the fight against the spread of Covid-19.
“Aquila Bioscience’s innovative and groundbreaking technology is a major game-changer in the future of pathogen and infection control,” says Lokesh Joshi, Aquila Bioscience’s founder and Professor in Glycoscience and research VP at NUI Galway.
“We have been using chemicals that harm human health and the environment for over a century and while these methods kill the pathogens, they also harm and kill our own cells and lead to many health problems,” said Joshi.
The new results prove that this novel technology is equally if not more effective than the highest performing chemical-based methods currently on the market but, crucially, without any of the environmental or health problems.
“Nature is the greatest inspiration and greatest innovator and Aquila’s pathogen capture technology is based on how nature protects us every day from pathogens in a safe and effective manner. Our technology will pave the way for safer methods of decontamination that do not cause harm to humans or the natural world,” says Joshi.
The research and development of pathogen capture technology has been supported by European Defence Agency, EU H2020 and European Innovation Council and the technology was developed in collaboration with the Defence Forces Ireland and the Czech Republic’s University of Defence.
As the global battle against Covid-19 intensifies, Irish medtech and life sciences firms are ramping up production to meet soaring demand for nebulisers, ventilators and other badly-needed treatment and protection equipment.
Half of the existing ventilators in acute hospitals around the world were made in Ireland, which is ranked as one of the top five global medtech hubs.
Doubling production of critical devices
Medtronic, the world’s largest standalone medical device maker, produces ventilators in a large manufacturing plant in Galway, in the west of Ireland. It is doubling its capacity by more than doubling its workforce of 250 and moving to round-the-clock production.
Another firm increasing production to meet high global demand related to coronavirus treatment is Enterprise Ireland-backed client Aerogen. It’s the world’s leading supplier of aerosol drug delivery products through ventilators to patients in critical and intensive care.
Before the current crisis, Aerogen already provided hospitals in more than 75 countries with its products, benefitting 10 million patients.
Aerogen CEO John Power expects the company could ship 3m or 4m units in 2020, up from 2m in 2019. It is also investigating how to address the global ventilator shortage by adapting non-invasive ventilation systems.
Power and his team are striving to ensure they can meet the sudden and unprecedented growth in demand. “We are a global company and we are balancing demand from across the world,” he says.
Demand up by as much as 300%
Galway-based M&M Qualtech manufactures products for the medtech, aviation, ICT and other sectors. It produces ventilators, nebulisers and medical monitoring equipment for its medtech customers, including Aerogen and Medtronic. It says it’s seeing capacity demand three to five times higher than the usual pre-crisis level.
M&M Qualtech began to see this spike in manufacturing demand in early March and already expects to produce 4m nebulisers this year, up from 2m last year. It also anticipates a similar rate of increase in production of nebuliser controllers (likely to produce 45,000, up from 35,000) and ventilator AC modules (expecting to make 18,000, up from 5,000 in 2019).
It’s increasing capacity by focusing factory production on the most critically needed medical products, hiring up to 25% more Production Operators, engaging with suppliers daily to expedite materials into production, and redesigning its factory to meet social distancing requirements.
Ripple effect of Covid-19 crisis
Also based in the west of Ireland, Vitalograph is the world leader in the analysis of cough drug trials. It specialises in cardiorespiratory and related devices that measure lung and cardiac function, diagnose lung disorders and also produces associated products and software.
Vitalograph is working to meet increased demand for spirometers and consumables such as bacterial-viral filters and test kits and seeing a significant increase in orders of remote monitors. Over the past 15 years, Vitalograph remote monitoring has mainly been used in clinical trials but is now rapidly being adopted by mainstream healthcare.
“Remote monitoring enables the most vulnerable patients with conditions such as COPD, cystic fibrosis and IPF to remain in their homes and not travel to hospitals or clinics and risk picking up infections,” said Frank Keane, the company’s CEO.
“As the patients we serve will be the most vulnerable to a respiratory disease of this nature, we are doubling our efforts to ensure we can fulfil our mission and serve them at this time.”
Vitalograph has also recruited more staff, and increased both capacity and orders from sub-suppliers, and activated their comprehensive business continuity plan.
Deirdre Glenn, Head of Lifesciences with Enterprise Ireland, Ireland’s trade and innovation said; “In the face of the Covid-19 pandemic, Irish medtech companies are rising to the challenge of meeting the increased global demand for essential equipment needed for the treatment and prevention of Covid-19. As the second largest exporter of medtech products in Europe, and with the highest number of people per capital employed in medtech in Europe, Ireland is primed to play its role in the global fight against Covid-19”
Irish companies are taking up the fight against Covid-19. New developments rapidly emerging from Ireland, one of the leading medtech hubs in the world, are being used to help stem the advance of the virus.
New rapid Covid-19 diagnostic test
Dublin based HiberGene Diagnostics develops and manufactures molecular diagnostics tests for human infectious diseases. It specialises in the manufacture of rapid and highly accurate testing solutions that are cost effective and simple to use.
Now it is developing a new and rapid test for the novel coronavirus, which it hopes to bring to market shortly after clinical evaluation at potential sites in China, Italy & Ireland.
HiberGene’s tests are based on non-invasive human samples such as swabs, and minimal sample processing.
Because the test for the new coronavirus is a “near patient test”, samples will be taken and tested on location, without needing to be sent offsite to a laboratory, it expects to diagnose a positive COVID 19 result in approx. 20 minutes, many times faster than the fastest existing molecular diagnostic tests.
New Protein to fight Covid-19 through diagnosis, vaccines and research
Fellow Irish biotech company Aalto Bio Reagents has launched a new protein with the power to fight the Covid-19 on three fronts – diagnosis, vaccines and research.
Its new recombinant SARS-CoV-2 nucleocapsid protein (code CK 6404) is available for diagnostic test manufacturers, vaccine developers and researchers globally, all of whom are working to stem the current pandemic.
“Patients are currently being screened for the virus by PCR”, explained Philip Noone, CEO of Aalto Bio Reagents, “however there is an important need for serological tests as well to detect all those mild or even asymptomatic cases that may otherwise be missed. Sero-epidemiologic investigations, such as those aimed to better understand transmission characteristics and severity of COVID-19, are also essential.”
The medical field and diagnostic industry have an unrelenting requirement for access to scientifically proven raw materials in outbreak situations like this, where fast diagnosis is required, he said. “With our new SARS-CoV-2 nucleocapsid protein we endeavour to meet this urgent demand.”
Irish company Aerogen has pioneered new ways to help people in respiratory distress. To date more than nine million patients worldwide have benefited from its innovative aerosol drug delivery technology.
Unlike conventional nebulisers, Aerogen has an in-line circuit design, which means the ventilation circuit does not need to be broken for drug delivery. Its management team believes it could therefore be a viable option to help deliver industry-leading care to patients infected with Covid-19.
Its products offer a lower risk of transmission of patient generated infectious aerosol for health care professionals in acute care settings than traditional nebulisers.
For patients requiring ventilation, its vibrating mesh technology, and closed circuit design, makes it a viable option to help deliver industry-leading care. Recent UK government guidelines state that when treating respiratory patients a closed suctioning system must be used, and that ventilator circuits should not be broken unless necessary.
Unlike conventional nebulisers, the Aerogen Solo device has an in-line circuit design and is designed so that the medication reservoir is isolated from the breathing circuit, minimising nebulisation of contaminated fluids.
Air Purification System to Kill Airborne Viruses
Pioneering plasma technology developed by Irish company Novaerus is already being deployed to purify air for patients and medical staff.
Novaerus helps control the spread of pathogens by closing the infection control loop made up of hands, surfaces, and now air. It uses a patented technology that kills airborne viruses by sucking air from a room and passing it through patented plasma coils which destroy them, reducing the risk of cross-infection.
Several of its medical-grade, clean air solutions have been donated to hospitals in Wuhan, China.
These include its latest model, Defend 1050, a mobile solution designed for rapid remediation in large spaces and situations with a high risk of infection.
Coronaviruses spread via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory pathogens spread. “The most difficult disease transmission-route to guard against is airborne because we have very little to protect us when we breathe,” explained Dr Kevin Devlin, CEO at WellAir, the Irish parent company of Novaerus.
New Augmented Reality Hand Washing App
Leaders across the world have stressed that the primary tool we have at all our disposal in the fight against Covid-19 is the ability to wash our hands. Stemming the virus’ spread depends on how often, and how well, we do that.
If hand hygiene is done properly it can be over 90% effective in preventing the spread of harmful germs, yet a large number of people are unaware that they are not washing their hands correctly.
SureWash is an augmented reality hand washing app developed to provide proper hand hygiene training to healthcare workers, patients and visitors worldwide.
It ensures compliance in hand hygiene to World Health Organisation protocol by delivering training in an engaging manner that encourages participation. By providing real-time feedback, it helps users to improve their technique.
The software system also provides infection control personnel with the data necessary to monitor hand hygiene progress and to guarantee positive results.
In response to the Covid-19 pandemic it has launched its app to the general public, so that everyone can play their part.
New Covid-19 online portal allows GPs to treat patients remotely
Patient portal developer Wellola responded to a call from Ireland’s Health Services Executive (HSE), Ireland’s national health authority, to develop and launch a new secure communication portal for clinicians and primary care providers in response to the pandemic.
Called HSE Covid 19 Portal, it’s an easy to use digital tool designed to optimise doctor and patient safety. Patients access it via an app which is downloadable via the HSE Covid 19 website. The new online portal allows GPs and healthcare providers to treat people remotely so as to protect themselves from Covid-19. The portal allows GPs and primary-care providers to easily offer patients a range of services, including online bookings, a video consultation service, secure messaging and form completion to assist in triaging.
The Covid 19 app is based on existing technology already developed and tested by Wellola and so was ready to launch just four days after receiving the call from the HSE.
Finally, in the face of a worldwide shortage of life saving ventilators, an international initiative called the Open Ventilator Project quickly came together on Facebook to design and build a 3-D printed ventilator.
In Ireland the project was led by Colin Keogh of Sapien Innovation, a specialist in applied innovation, creativity and design thinking services. Within a week it had produced a prototype it hopes will be validated by Ireland’s health authorities for use in the fight against Covid-19.
Irish technology helps protect against the spread of airborne virus
The outbreak of a new coronavirus has confirmed a fact long understood by Irish company Novaerus: we are what we breathe.
The company manufactures and sells patented medical-grade, clean air solutions. Thanks to new partnerships with established distributors across China, its portable air dis-infection units are being made available to healthcare facilities in Hubei, Beijing, Shanghai, Zhejiang, Guangzhou City and the Chinese special administrative regions of Hong Kong and Macau.
It comes at a time of growing concern surrounding the recent infectious outbreak caused by a novel coronavirus first identified in Wuhan, Hubei Province, China.
Indeed this week, the Chinese Ambassador to Ireland, Mr He Xiangdong, visited Novaerus, who have donated several air dis-infection devices to two hospitals in Wuhan, the Chinese city at the centre of the COVID-19 outbreak; Wuhan Xincheng Hospital and Wuhan Third People’s Hospital. Among the donation of goods is a Defend 1050 for each facility, the company’s latest innovation in infection control. The Defend 1050 is a mobile solution designed for rapid remediation in large spaces and situations with a high risk of infection.
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
The current outbreak is a new strain that has not previously been identified in humans. It’s not yet clear how easily it spreads from person-to-person. However, both MERS and SARS are thought to have spread via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory pathogens spread.
“The most difficult disease transmission-route to guard against is airborne because we have very little to protect us when we breathe,” says Dr Kevin Devlin, CEO at WellAir, the parent company of Novaerus.
Currently very many people in affected regions – and further afield – have responded by wearing surgical masks.
Yet while masks may help guard against the kind of particulates seen in air pollution, they are ineffective against the much smaller size of viruses.
Cleaning the air is a fundamental component of managing infectious outbreaks. However standalone filtration systems are typically unable to trap tiny viral particles too.
Novaerus portable air dis-infection and purification units are unique in using a patented plasma technology that kills airborne viruses. Its devices pull air from a room and pass it through patented plasma coils to immediately eradicate viruses.
So destructive is Novaerus’ technology that he likens it to passing viruses through “a field of lightning – where particles get destroyed as they pass through.”
The company makes a range of devices, the biggest of which can take in 900 cubic metres of air per hour and is used in large spaces. The smallest takes in 80 cubic metres of air in an hour. All run 24 hours a day, using very low power, and provide healthy, contaminate-free indoor air.
The Novaerus units can be used to remediate rooms post-infection rapidly, which is why its primary market is medical facilities. These range from doctor surgeries and waiting rooms to hospital operating theatres and wards. “Anywhere there is a need to reduce the risk of cross-infection,” he says.
The efficacy of Novaerus products have been independently tested and verified across a range of pathogens including measles, influenza and C-diff, as well as fungal spores in buildings.
In fact, the biggest challenge the company faces are lower quality plasma products currently in the market, he says. These operate in a totally different way, typically by sending out ions into a room which are charged to attract pathogens. This technology does not kill pathogens on contact like the Novaerus technology. Rather the charged pathogens drop out of the breathing space onto surfaces where they can be disinfected or they are filtered out through an HVAC system.
Novaerus patented technology is entirely unique in killing virus, at speed.
As word of its effectiveness has spread, the company has witnessed enormous interest across Asia Pacific, including countries such as South Korea, Vietnam and China, “We have always found it easier to get our message across in Asia, where people are very conscious of health risks from air pollution,” says Dr Devlin. “There are already a lot of solutions in this market, including ones which use HEPA (high-efficiency particulate air) type filters or masks, but these are effective only for particulates. Again, viruses are much smaller and can pass through them,” he says.
Novaerus machines are effective against hospital ‘super bugs’ and are an inexpensive solution for hospital systems, “particularly given the cost of post-operative infections,” he points out.
Today Novaerus sells into medical facilities in 40 countries, including South Korea. In October 2019 it signed a partnership in that country which will see its products sell into the high-end consumer market too. It’s a first for the company but a move likely to be replicated elsewhere.
“South Koreans are very aware of exterior air quality,” says Dr Devlin. “We launched in that country prior to the current coronavirus outbreak and know that products that are successful in South Korea transfer well around other countries in Asia Pacific.”
Already it has seen significant growth in demand throughout the region. “It helps that everything we say about our product is the result of independent tests. It’s not something we are pulling out of the air.”
Precision healthcare involves the use of data to provide customised care tailored to an individual patient based on real-time clinical, molecular/diagnostic and exogenous factors.
The emergence of such models demands that hospitals are no longer seen as places where healthcare is just delivered, and need to evolve into hubs that bring together clinical engagement and patient experience to provide customised care delivery with high outcomes.
Similarly, these outcomes won’t be limited to performance metrics such as quality of care, utilisation of resources and cost efficiency, but will extend to include non-tangible elements like patient comfort and satisfaction. It is therefore essential for hospital IT departments, clinicians and all stakeholders to embrace this change towards customised healthcare delivery that is no longer based on a one-size-fits-all solution.
Key Performance Indicators for Hospital CIOs to Support Precision Health
For several decades, hospital CIOs across Europe were focused on investing in healthcare IT infrastructure that mainly centred on electronic health records (EHR). Today, however, hospitals need to look beyond EHR and should have a robust data management strategy in place for precision health. For this shift, it’s important to not only invest in medical technology and devices that collect healthcare data, but also develop a roadmap that integrates all solutions so that clinicians can derive actionable insights from data.
There is also a need to invest in the latest technology that supports the vision for personalised care delivery such as data analytics, clinical decision-making and the overall development of a digital ecosystem that supports interoperability. Furthermore, it will be critical for hospitals to train physicians and clinical staff so that they can make use of the established infrastructure efficiently.
Hospitals should also increase awareness among patients to utilise technology for their self-management goals such that an integrated care delivery system comprising pre-, during and post-care follow up is achieved with active participation from patients. Hospitals will require integrated data including patient history, genomics and other social determinants of health, and data from post-discharge follow-up or home health, and use it in conjunction with the data that is generated in the hospital during care. This is especially important as hospitals increasingly engage in population health management and chronic disease management programmes.
Medical Technology: an Enabler for the Future of Hospitals in the Precision Health Era
According to Frost & Sullivan proprietary research, 90% of hospitals in Europe are digitally enabled yet less than 20% of them are fully digital, with capabilities to share data outside their own hospital network.
For personalised and precision healthcare delivery, two critical elements are healthcare data continuity across care settings within and outside the hospital, and high levels of patient engagement.
To enable digitisation of personalised care, medical technology vendors have to design data-enabled solutions and devices that will help hospitals achieve synergy between core-precision health technology including -omics Rx/Dx, remote patient monitoring and exogenous and lifestyle monitoring. In addition, they have to develop enabling technology for healthcare data management, interoperability and security.
There will be an emergence of business models that encourage collaboration between hospitals and medical technology vendors through risk-sharing agreements to drive patient engagement, especially in the light of increasing healthcare consumerism.
To summarise, hospitals, medical technology vendors and healthcare organisations that are able to digitise and democratise healthcare information to derive value from both institutional and individualised data will stand to generate high outcomes in a value-based care environment.
Medical technology companies devote about 7-8% of their annual sales turnover to research and development and it can take up to three years to bring a new product to market.
It’s a complex and time-consuming process, given the effort and cost of R&D, the elaborate review and approval process, and overcoming the “valley of death” between innovation and commercialisation. Additional pressures include the regulatory landscape, healthcare reforms and medical device tax, all of which restrict innovation.
Medical technology companies want to bring the latest products to market quickly and at cheaper rates. As such, collaboration between industry, academia and the clinical community will be highly beneficial to leverage the cumulative benefits of ideation, scientific skillsets, test beds for trials and manufacturing prowess to bring next-generation medical devices to market.
Key Benefits Offered by an Integrated Ecosystem to Medical Technology Companies
Academia provides a strong research engine for medical technology companies to tap into and in turn offers support for commercialisation through financial assistance, as well as development and manufacturing capabilities.
On the other hand, the clinical community can contribute to such collaboration by providing key inputs and professional opinion regarding use cases, thus furthering the pace of research and innovation.
Furthermore, government and regional healthcare authorities can provide assistance to these collaborative partnerships through policies and frameworks that support infrastructure development such as defined bio-medical clusters and life sciences enterprise zones. Other benefits include accessibility to experts in a variety of medical fields, often enabling them to expand to areas outside their current focus.
More importantly, it also provides additional opportunities for collaboration such as infrastructure sharing, collective buying and group purchasing, as well as the opportunity to be part of a coveted community of high technology, venture capital and innovation.
Emerging Models: Medical Device Innovation Clusters and Infrastructure Sharing Models
Access to the best healthcare facilities, universities and research organisations and the presence of several technology start-ups, manufacturers, suppliers and venture capitalists are the hallmarks of a hotbed of innovation.
There are 27,000 medical technology companies scattered across Europe, mainly in medical innovation clusters in France, Germany, Ireland, the UK, Spain, Switzerland and Italy and employing more than 600,000 people.
These companies are focused across the value chain, including R&D intensive technologies, proprietary products, contract development and manufacturing, packaging and sterilisation. From medical instruments for diagnostics, drug delivery and surgical intervention to highly specialised areas such as medical imaging, robotics, implantable medical devices, prosthetics, regenerative medicine, healthcare IT and telemedicine, these clusters play a big role in taking medical technology to the next level.
Apart from cost savings and research collaboration, these clusters offer other critical advantages. For instance, Ireland provides proactive support to medical technology companies through several initiatives that enhance the ease of doing business such as CÚRAM, a medical device research centre at NUI Galway. This culture of innovation has led eight of the world’s top 10 medtech companies to put down roots in Ireland. They also benefit from the export potential as medical devices account for 10% of all exports from Ireland. Similarly, 80% of the global production of stents and 50% of the ventilators for acute hospitals are manufactured in Ireland, which indicates the success of the medical device hotspot in furthering innovation.
To summarise, an integrated ecosystem of academia-industry-clinical community supported by government and regulatory authorities can collectively address major challenges by putting together the strategic competencies necessary to achieve a common goal.
Frost & Sullivan research has shown that healthcare providers across the globe could face a decline in operating margins of up to 30%, due to costs associated with regulatory reforms as well as general reimbursement.
As a result, they are often forced to cut back on the procurement prices of products offered by medical technology companies. This means that on the original equipment manufacturer (OEM) side of business, medical technology companies have to look internally for savings as research-led innovation or manufacturing cost management alone cannot bridge the gap.
Supply chain and logistics are major areas where costs savings can be achieved for a medical technology company: According to McKinsey, supply chain transformation not only results in a 10-20% improvement on profit margins and inventory days of supply (DoS), but also allows them to offer additional service solutions to their hospital customers.
Strategic Advantage Offered by Supply Chain Management
The time has come for medical technology companies to move away from a one-size-fits-all approach for supply chain management (SCM) and begin to develop differentiated strategies based on product line, target market and customer type.
An effective SCM strategy for medical technology companies should focus on overcoming the fragmentation in inventory management by giving an OEM the ability to base consignment stock on market demand. This will enable companies to have high product visibility across the supply chain, which results in optimised stock-keeping while reducing the cost of inventory holding and improving logistics as more products will be in circulation in the market.
To improve operational aspects of supply chain, most medical technology companies are investing in technologies that enable real-time tracking of assets to forecast demand and improve workflows. However, there is also a need to recognise the variations in the procurement of medical technology by healthcare providers to fine-tune the supply chain strategy based on customer type.
To achieve this, medical device OEMs will have to increasingly look into collaborative and risk-sharing agreements involving multiple stakeholders, including group purchasing organisations, hospital collectives, procurement departments of hospitals, and third-party distributors or logistics providers.
Integration and Collaboration will be Key to Effective SCM
Supply chain integration will be critical to overcome fragmentation and bring in more transparency and communication across the healthcare supply chain. This will require standardisation of transactions between medical device OEMs, distributors and healthcare providers.
Medical technology companies are working with distributors as well as directly engaging with healthcare providers to sell their products. In both cases, the focus should be on identifying and addressing the structural changes faced by healthcare providers, such as cost pressures due to regulatory reforms and reimbursement, and use that as the base for pricing and consignment stock management.
Medical technology companies that are revitalising their supply chains by removing redundancies and improving workflows to enhance operational efficiency should ensure that the transformation process is holistic and rolled out across the entire organisation simultaneously. A piecemeal approach will only add to the complexity and result in inefficiencies. An all-inclusive plan will lead to better cross-functional efficiency in the long term, as medical technology companies will be able to identify key performance areas within the supply chain and proactively address the challenges in real time.
Over 13,000 medical technology patents were filed through the European Patent Office (EPO) in 2017, an increase of 6.2% over 2016, underscoring that Europe is fast becoming a major hub for medtech development.
Medical technology is no longer product-oriented but is positioned more and more as a solution with an integral role to play in delivering value across the care continuum. That’s why medical device original equipment manufacturers (OEMs) have a constant need to innovate to stay relevant in a highly competitive market.
This is particularly the case in Europe, where roughly 27,000 suppliers face an average technology lifecycle of 18-24 months before enhanced features are made available in the revised version of a given product, according to figures from MedTech Europe.
As a result, medical device OEMs have to find ways to generate value over and above the typical R&D-based innovation that requires higher lead times to bring a product to market. In this scenario, product value engineering (PVE) gives OEMs a cost-effective and efficient route to bring incremental innovation to its solutions and provide ways of offering value to customers in terms of product improvement, efficient manufacturing and customer satisfaction.
The Rise of Product Value Engineering
Most of the healthcare challenges for which medical OEMs provide solutions are complex and systemic, often traversing clinical, economic, workflow and supply chain issues faced by hospitals.
In spite of all the benefits that these solutions bring to customers today, OEMs continuously face pressures to reduce product pricing while protecting business margins. In this context, specialised engineering solution providers offer competitive differentiation and cost savings to OEMs, especially when such innovation leads to better and improved versions of the solution, where enhanced features help to generate superior value for the customer.
It is all the more important with healthcare reform and reimbursement cuts affecting the profitability of medical technology companies. Not to mention, the added pressure from healthcare providers, payers and regulators demanding that OEMs demonstrate proven outcomes for their products.
To that end, PVE offers medtech OEMs a new lease of life as its activities revolve around providing more with less — more features, more benefits, and higher quality— for the same cost or lower. PVE ensures that solutions are optimised continuously during their lifecycle with respect to the needs of customers and market demand. The focus on PVE has led to the emergence of flexible business models in medical technology development and manufacturing, where the emphasis is on designing for value.
Outsourcing Medical Device Development and Manufacturing for Long-term Sustainability
The major customer segments of medical device OEMs — namely hospitals, imaging centres, laboratory groups, private medical centres and general practices — are facing the brunt of budget cuts and increasingly moving away from a capital expenditure model to one that’s focused on operational expenditure where possible.
Large-scale one-time procurement processes will eventually move to pay-per-procedure models. This situation is coupled with the reality that these customers have less money at their disposal to invest in cutting-edge medical technologies and have to make some quick and rational decisions when it comes to picking the appropriate technology, given the rate of change in terms of specs and features.
The eventuality is that medical device OEMs have to provide more for less in terms of features and ultimate value, and often do not have the in-house capabilities to transform their design, R&D and manufacturing capabilities. Medical device outsourcing (MDO) offers several advantages to OEMs looking to expand their capabilities, whether it is in terms of new technology development or market expansion. This helps OEMs to focus on their core competences, while adding new revenue streams and achieving cost efficiencies during product development. MDO enables OEMs to bring newer products to market in 30-50% less time compared to in-house development efforts, and at 10-30% savings levels when it comes to product development costs.
To conclude, medical technology companies recognise that delivering maximum value is a strategic sweet spot between superior functional performance and outcomes as provided by the solution and optimised costs in achieving it. To translate this value to its customers, OEMs will have to invest in sustainable and scalable models, with partnership and stakeholder collaboration playing an increasing large role to drive the engineering of solutions for the end customer.
Challenges in healthcare create opportunities for innovators.
How to drive change in an industry that is traditionally averse to change? How to fix a broken care and delivery model that does not manage people well in the continuum of care? How to cope with razor thins margins at a time when the expense of delivering care is outpacing reimbursement?
These are just some of the challenges identified at the North American Healthcare Forum, a major international event hosted by Enterprise Ireland, and attended by senior leaders from US and Canadian healthcare systems, as well as some of Ireland’s most successful and innovative healthcare solutions providers.
One of the biggest areas of opportunity for the latter was identified as the ongoing shift in focus from the acute setting to the social care setting, with a growing emphasis on the social determinants of health, such as lifestyles and behaviours.
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Budget is a major healthcare challenge
But working within constrained budgets was a recurring theme. For Arden Krystal, CEO of Southlake Regional Health Centre in Canada, where a socialised, single-payer care model exists, one of the biggest challenges is capital.
“We depend very heavily on foundations to fund our capital. Governments take a very limited role in that and it creates a lot of challenges for us in terms of keeping up with things like information technology and newer technologies. We’re always behind (the curve) just replacing things that are literally broken,” she said.
Hospitals in growing communities fare better than those whose communities are performing less well.
Michelle Conger is Chief Strategy Officer at OSF Healthcare in Illinois. Aside from Chicago, the region is not a growing market, she said. Much of its focus, as a result, is on the integration of social services agencies, through a digital platform. One current initiative involves a community of 22,000 people, whose local hospital has closed, leaving residents without access to acute care facilities.
The aim is to improve health outcomes by providing access to OSF hospitals using technology and making better use of community-based programmes.
“In the US, social service agencies and healthcare operate in silos. A lot of times we are all working with the same people but not able to improve their health outcomes because we don’t realise it. Just creating that kind of transparency has had a big effect,” said Conger.
Opportunities for innovation in healthcare
Another challenge is transitions of care, said Brian Donley, CEO of the Cleveland Clinic UK. “Whether it is transitions from hospital to home, from one hospital to another, or from the operating room up to the floor, we see that as a big cost opportunity. Transitions of care costs a lot of money,” he said, pointing out they also lead to concerns about quality and safety. “How we achieve transitions of care better represents an opportunity for innovation,” he said.
Advances in electronic medical records software is a complicated topic, said Michelle Conger. “It gave us access to the data we need – and we built a separate data warehouse that helped us – but I think work has to be done to really help providers work differently because I’m not sure the system has made it more efficient.”
The challenge of highly constrained funding over the past seven years was highlighted by Rob MacIsaac, CEO and President of Hamilton Health Sciences in Canada. “Our strategy is to constrain funding in healthcare and expand capacity in communities,” he said.
“What that has meant for many providers is that we are being challenged to transform the system without having the resources to do that transformation. Innovation is very challenging if you can’t invest in it.”
There are however great sparks of innovation happening, he said, including R&D work around remote monitoring, to try and help patients into their home more quickly after treatment and surgery.
“We’ve also done early work in stratification of patient populations, trying to gain insights so we can start to better predict people before they crash, in a way that helps to prevent that. We are starting to do work around understanding what the potential is for us as a learning health system, and the role metrics and analytics can play in that,” he said.
Southlake Regional Health Centre is in a growing region, and so is the recipient of more funding. This has enabled it to invest in its own innovation centre. It has successfully partnered with a number of tech companies and entrepreneurs to develop products and services, which it has gone on to procure.
The aim is to have innovators come in at an earlier stage, “rather than with a fully baked product that may or may not work in a healthcare environment,” said CEO Arden Krystal. “We hope to do our call outs sooner, saying, here’s a couple of big chunky problems we have – companies, come to us and tell us how you think you can work with us and co-design a product that can help us.”
As with many healthcare systems, particularly those with ageing populations, “a lot of our big problems are around the fact that we have way too many patients and not enough space, so we have to find a way to continue to reduce stays, to help people back into the community. So remote monitors are big, but also some process tools to help us communicate faster and move people through our system hospitals. It’s all those kind of non-sexy processes that we sometimes don’t do very well in healthcare. We’re open to all of those as well.”
Any innovation that enables medical professionals to work “at top of licence” will be welcomed, said David Longworth, interim CEO of Lahey Hospital and Medical Centre in Massachusetts.
Ensuring doctors and nurses are not bogged down in routine tasks or paperwork, for example, will ease problems of burn out.
“If I had a blank canvas in relation to solutions in healthcare I would look at the way patients move through the system and at who is delivering the care, having people operate at the top of their licence,” said Lahey’s Longworth.
“I would also invest in transitions of care, leveraging technologies and applications to help foster seamless transitions of care, care giver engagement and patient engagement. I think we have just scratched the surface in how we can apply technology to not just individual patients, but populations of patients.”
As a global top five medical technology hub, Ireland boasts some of the most innovative medtech start-ups in the world.
While much of the sector focuses on sales to other life sciences organisations – from clinics to physical performance centres – a significant number sell to consumers.
In a world where the knowledge gap is constantly shrinking and consumers are taking ever-greater responsibility for their wellbeing, the size of the B2C medtech market is likely to increase. Among those blazing the trail will be these four Irish medtech companies.
TippyTalk is an app that helps non-verbal children to communicate with caregivers.
Created by Rob Laffan, whose daughter has non-verbal autism, the TippyTalk app allows its user to select a customised picture which corresponds to their desire, want, need or feeling. The app then translates that picture into a text message, which is sent to the phone of a family member or caregiver.
Moving beyond traditional face-to-face solutions, TippyTalk is the only platform that allows users to instantly communicate with anyone, anywhere, at any time.
“At TippyTalk, to date, we’re the only ones who are focusing on an ‘out-of-room’ approach to non-verbal communications,” Rob explained, in a recent interview with The Irish Advantage.
“All the other solutions out there mean you’ve got to be in the same room as the person you’re communicating with, which is very limiting – not to mention out of step with today’s connected world.”
A version of the product is available for the educational and professional care markets, TippyTalk EDU. Boasting two-way communication, it can also provide data-driven insights for students and clients.
According to founder Dr Johnny Walker, Jinga Life gets its unique name from the name of an African warrior queen – a defender and protector of the people.
The cloud-based platform allows a user to store whole-of-life health records for their entire family, which is essential not only for record-keeping, but also for medical professionals who increasingly use big data to inform their decisions.
The ‘Jinga’, the primary caregiver in the home, can store important health information and documentation like prescriptions, vaccination records, or test results and digital images such as scans and X-rays. They can also keep track of doctor’s appointments and even connect their wearables, all on a secure, mobile and easily accessible platform.
Technology has often been blamed for declining attention spans in younger generations – or at the very least, creating additional problems for those with pre-existing neurological conditions – with gaming in particular singled out for criticism.
However, the problem may also hold the key to the solution. Driven by a desire to improve the lives of children with attention deficits, Áine Behan and the Cortechs team combined neuroscience and brainwave technologies to develop brain-powered play that can permanently improve attention regulation skills.
Zip and the Misty Mountain is a hands-free computer game for six- to 12-year-olds where the player uses their brainwaves, with the help of a ‘Neurosky’ headset, to play the game. The more they stay in the attentive zone, the further they progress.
“What we do challenges the traditional health delivery models by using gaming and brainwaves as a ‘digital medicine’ based means of prescribing better behaviors,” Áine explains.
“We are creating consumer facing solutions to treat the symptoms of ADHD in a digital cost-effective manner.”
Neurofeedback such as this is proven to alleviate the core symptoms of ADHD and is recommended by the American Academy of Paediatrics as the ‘best support’ non-pharmacological treatment option for children with ADHD.
When you don’t feel up to a trip to the GP’s surgery, Webdoctor provides a safe and affordable online GP service available anytime, anywhere. Patients can book an appointment using the iOS app or website to consult with a doctor, face-to-face, using state of the art secure video.
They also offer a home testing service for common health issues, and can fax prescriptions straight to your pharmacy when time is of the essence.
Webdoctor launched in 2014 and was an Enterprise Ireland High Potential Start-up. They have partnered with health insurance company Laya Healthcare to provide their CareOnCall service, and have plans to expand into Europe and the US.
When tuberculosis wiped out a herd of cattle on Martin O’Connell’s family farm in Ireland’s County Kerry, he had the idea of developing a preventative filter to block bacteria before they reach cows’ lungs. Realising the potential for a similar device for human use, O’Connell founded Nasal Medical in 2014 with Keith Yager.
The team’s focus on strong product design resulted in patented, novel and effective medical devices, such as the Discreet Snoring Aid, which has been shown to significantly reduce snoring in 9 out of 10 patients, and the recently launched Allergy Nasal Filter, which offers a drug-free solution for allergy sufferers.
Innovation and a customer-centred approach have turned Nasal Medical’s unlikely beginnings on a family farm into an Irish medtech success story.
Digitisation of medical technology is critical for connectivity and integration of healthcare data across the continuum of care. However, digitally enabled medical technology is only part of the solution. The use of patient engagement to motivate patients to access, use and adhere to digital services and tools to manage their health and wellbeing is critical for 100% utilisation of the digital healthcare ecosystem.
Increasing role of patient engagement
Investment in advanced medical technology gives healthcare professionals and patients access to digital services and tools that support the patient journey across the care continuum, as well as fulfilling treatment goals. Healthcare professionals are making clinical decisions based on insights from healthcare data, leading to improved outcomes for patients. Patients are also playing an active role in their own care delivery by investing in their own care and setting their self-care management goals.
At this juncture, where healthcare delivery is undergoing a major digital transformation, there is an urgent need to make medical technology more patient-centric. To achieve this, there is a need to design a successful engagement strategy.
Channels of patient engagement for healthcare organisations
Patient engagement in a value-based care ecosystem revolves around a need to communicate with patients at every stage of their healthcare journey. To achieve this, healthcare providers are investing in key patient engagement services and tools such as remote health monitoring, chronic disease management, compliance programmes, patient education programmes and wellness support. Furthermore, they are involved in the effective use of traditional as well as digital channels to allow incoming, chronic and transitioning patients to seek preventive and reactive intervention. The focus is on delivery of personalised and dynamic care recommendations to every patient irrespective of care settings. In addition, they are introducing initiatives to optimise population health management efforts through member specific guidance and value-based healthcare relationships. Healthcare providers are also looking to foster behavioural trends that encourages proactive self-care among patients.
The ultimate aim of patient engagement is the attainment of high patient satisfaction and healthcare providers are increasingly looking at non-clinical factors to drive patient experience. With the rise of smart hospitals there is a focus to enhance patient wellbeing during their hospital stay and drive outcomes in three major areas–operational efficiency, clinical excellence, and patient-centricity. We see hospitals investing in business process automation of workflows as well as improving overall hospital design to drive patient satisfaction through areas such as smart patient rooms and services.
A healthcare provider ecosystem that uses smart technology to facilitate seamless communication between clinical and non-clinical systems, and that uses digitally enabled medical technology to generate actionable insights will drive patient engagement, in turn creating endless possibilities for outcomes-based care.
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Role of medical technology in supporting healthcare providers to achieve high outcomes.
Healthcare systems across the globe face several challenges in delivering high quality care, due to reductions in reimbursement, budget shortfalls, and a restrictive regulatory environment. The pressure to deliver high quality care against financial constraints forces healthcare providers to pass on this cost deficit to medical technology solution providers. Medical technology vendors are themselves grappling with the need to bring the latest technology to market quickly, while maintaining their profit margins. In such a context, there is a need to balance both qualitative as well as quantitative outcomes; and a value-based care model offers healthcare providers and medical technology new possibilities.
Impact of value-based care on efficacy and efficiency of healthcare delivery
Value-based care model is a process based approach used by healthcare providers to deliver accurate diagnosis and treatment algorithms to improve patient outcomes and thereby reduce disparities in treatment of diseases and conditions. From a reimbursement and pricing point of view, this means that payment is based on efficacy and efficiency of care delivered. For hospital CIOs, value-based care provides additional metrics to evaluate their performance including specific measures such as reducing hospital readmissions, improving emergency care and operating room utilisation, and a focus on preventative care. This not only allows hospitals to improve their financial performance but also provides additional advantages such as increased level of patient satisfaction.
Collaboration of medical technology OEMs and healthcare providers to drive VBC
Healthcare data supported by a digital health ecosystem will be the backbone to driving VBC. Medical technology vendors can provide digitally enabled solutions to support digitisation; they will increasingly need to demonstrate economic value offered by their solution in addition to clinical outcomes. With rise of integrated care, healthcare providers and medical technology vendors will need to increasingly collaborate to deliver value across the care continuum and improve overall quality of life.
Healthcare providers are at varying stages of digital maturity and medical technology vendors have an influential role to play in overcoming this gap. Vendors can work with hospitals to optimise the performance of existing infrastructure in areas such as inventory management, resource utilisation, etc. through incremental innovation.
A joint endeavour between healthcare vendors and medical technology OEMs will ensure that clinicians have access to healthcare data that will assist them in clinical decision making. At the same time, it will enable optimisation of key clinical workflows and business processes that drive overall operational efficiency. This two-pronged approach will result in achieving both clinical outcomes and business goals, leading to value-based care in its truest sense.