Jean-Charles Moczarski, a life sciences advisor based in Enterprise Ireland’s Paris office, describes how big data is shaping the future of medtech.

There are three important trends in medtech: data, data, and even more data. There is the data that is collected by individuals, which when collected generates data about populations. Then there are the many ways in which that data can be analysed, researched, and used to benefit people.

By 2030, we can expect things like smartphones, wearable tech, and the Internet of Things (IoT) to be fully integrated into our lives. Never before in the history of medical research will so much information be collected by individuals, generating an unprecedented volume of big data.

Predicting future health outcomes

Some of this data will be based on lifestyles, for example the amount of exercise we take, and the bars and restaurants we visit. And some of that data will be captured by devices, which monitor such things as heart rates and blood pressure.

Combined, that data will deliver an extraordinary snapshot of a person’s health and, with accurate interpretation, will help to predict future health outcomes. As data has little value if it cannot be interpreted, we will also have tools to help us analyse data in new ways.

A doctor, armed with this data, will be able to monitor a patient’s health, which will make things like annual health checkups unnecessary. If an issue arises, doctors can be automatically notified. If a doctor advises a patient to change their diet or exercise more and they don’t, that event can also be noted. Such features will help progress the preventative side of medicine and help improve the adoption of health regimes.

Predictive medicine is assisted by analysis of data collated from entire populations, as researchers will increasingly have access to data generated by millions of people spanning most of their lives, a vast increase in sample size.

Ireland’s role in the development of medtech

Ireland is uniquely positioned to benefit from these advances, for two main reasons. It is it the second largest exporter of medical devices, with a cluster of over 300 medical companies. Most of the world’s largest tech companies have a presence in Ireland too.

Here are some innovative Irish medtech companies that have established international reputations.

Irish company Aerogen has developed award-winning acute-care aerosol drug delivery products that are used in over 75 countries around the world.

The smartphone app ONCOassist gives oncology professionals access to adjuvant tools, formulas and prognostic calculators, among other features. Unlike many apps, it is classified as a medical device and can therefore be used to aid clinical decisions.

In the area of design, creative design and innovation consultancy, Dolmen work with a wide range of industries, from wearable tech to medical design. They have designed products for Cook Medical, Philips, and Soteira, collecting multiple awards along the way.

Collaborations across life sciences and tech

The fusion between big pharma and tech is hastening the next revolution in medtech, while the spark igniting that revolution is how big tech works with medical data and devices.

Companies such as Google and Amazon are already making inroads into the healthcare industry. In 2016, Google and the French pharma giant Sanofi, both of whom have bases in Ireland, announced a $500 million investment in a joint venture to develop treatments for people living with diabetes.

The partnership between Google’s experience in miniaturised electronics, analytics, and consumer software development and Sanofi’s clinical expertise is an example of how complementary companies from previously separate industries are joining forces.

On the artificial intelligence (AI) front, Alexa, Amazon’s voice recognition system, is being tested in US hospitals as an aid for surgeons in operating theaters.

Risks of medtech

While fusions across industries are full of potential, there are also risks which must be addressed. Products that rely heavily on software can be vulnerable to cyberattacks, hacking, and general IT downtime.

If we are to embrace and benefit from the age of big data, we will need to ensure that our data is safe, and that we can access necessary healthcare treatments when they are needed.

Nova Leah, an Irish cybersecurity start-up is only two years old, yet has established itself as an important player in this space.

Their innovative products ensure that individual devices connect safely and securely to hospital networks. In any large hospital at any one time, there are many devices which are gathering data and uploading it to a server.

All it takes is a vulnerability in one such device – and a timely piece of ransomware – to gain access, not only to the device, but potentially to the entire hospital or healthcare system.

The digital health market is expected to reach $379 billion in the next six years. It is a vast sum, and one which Ireland will benefit from.

While there will no doubt  be breakthroughs in many fields of medicine in the coming decades, it is the overarching influence of data – both big and small – that will see the greatest advancement.

 

With innovation driving yet another Irish start-up to succeed in Europe, the factors shaping Ireland’s thriving medtech sector are increasingly in international demand.

Irish start-up Bluedrop Medical has won the prestigious URGO Mentorship Program in France. Urgo Group, which specialises in wound treatment, announced the winner in March 2018.

CEO of France’s URGO Group, Pierre Moustial, commented, “Bluedrop Medical’s positioning regarding diabetic foot ulcers is in perfect synergy with URGO, and in alignment with the recent positive results of our own clinical trials.”

Moustial was also impressed by Bluedrop Medical’s approach to innovation and partnership, strengths for which Irish medtech companies are in growing demand.

The innovative solution developed by Bluedrop Medical will help to prevent amputations caused by diabetic foot ulcers.

Ireland’s medtech cluster

Ireland’s successful collaborations with international partners are supported by its cluster of 300 medtech companies, 60% of which are actively involved in research, development and innovation.

The ecosystem is further strengthened by the presence of 18 of the world’s 25 largest medtech multinationals. Years of supplying to, and servicing the needs of, major multinationals have enabled Irish medtech companies to develop expertise that operates on a global scale.

Ranking first in the world for attracting and retaining talent in IMD’s 2017 Global Competitiveness Yearbook, Ireland is the biggest employer of medtech professionals per capita in Europe.

Jean-Charles Moczarski, Enterprise Ireland market advisor with a focus on medtech and located in Paris, has assisted many international companies like URGO Group in sourcing innovative Irish partners. He comments, “Ireland is a key partner for global health leaders and Ireland’s medical technology ecosystem is among one of most innovative in Europe.”

Buyers in search of pioneering innovations, access to the world’s best medtech companies, and an ecosystem of research expertise are increasingly turning to Ireland to source their competitive advantage.

Medgadget, the medical technology news website, visited Ireland as one of the most exciting locations for medical technology companies to do business. Read the highlights of their reports.

Medgadget visits Med in Ireland to check out Europe’s Medtech hub

Ireland is the fastest growing economy in Europe and one of the hottest places for medical technology companies to do business. As anyone in the Medtech industry knows, Ireland is one of the world’s main hubs for designing and building advanced medical devices. On the invitation of Enterprise Ireland, the government agency responsible for the growth of Irish business abroad, Medgadget visited Med in Ireland, an event held at the Royal Dublin Society.
Read the full story on Medgadget.

Kastus glass and ceramics coating kills pathogens with light

While checking out the dozens of Medtech companies showing off their stuff at Med in Ireland, Medgadget were intrigued to discover Kastus, the inventors of a pretty amazing surface coating technology. Kastus’ Log4+ superhydrophilic coating can be applied to glass and ceramics, remaining completely transparent and not inhibiting the functionality of touchscreen technologies. This is a pretty big deal, as smartphones, tablets, and touchscreen monitors are a major vector in helping pathogens jump from person to person in clinical environments and in the general population. Moreover, the coating is touch and scratch resistant, seemingly perfect for modern electronics and portable devices.

Read the full story on Medgadget.

Body monitoring sensors from Shimmer help researchers get science done

The Med in Ireland conference that we recently had a chance to visit, featured Shimmer, a successful body-sensing firm out of Dublin. The company also has offices in Cambridge, MA and Kuala Lumpur, Malaysia. They build a variety of modular sensing devices for clinical studies, product development, and anything else that would require to record electrocardiograms (ECG), electromyograms (EMG), respiration, and the like, particularly in large numbers of people.

Read the full story on Medgadget.

Sign up to our newsletter for more insights into the global Medtech industry.

Sheila O’Loughlin, a Senior Market Advisor at Enterprise Ireland, describes how Ireland has emerged as one of the world’s leading Medtech hubs.

Over the last twenty years, Ireland’s Medtech industry has seen major success, attracting the interest of international investors and start-ups alike. Home to a closely-knit cluster of Medtech companies, supported by industry, academic, clinical and government agencies, Ireland has a deep pool of experience and highly trained talent.

While maintaining leadership in manufacturing excellence, Ireland has quickly become the second largest exporter of medical technology in Europe. In fact, medical device exports exceed a phenomenal €12bn per year.

The global mindset of Irish companies has been a key driver of rapid growth to date. Recognised internationally as one of the world’s top five emerging Medtech hubs, Ireland’s ecosystem of innovative companies presents various areas of expertise, ranging from orthopaedics, cardiovascular and diagnostics, to Medtech services, contract research and manufacturing.

Current drivers of the sector include an aptitude for innovation, a supportive environment for R&D, world-class talent and product development expertise.

13 of the top 15 global medtech companies are headquartered in Ireland, including Boston Scientific, Medtronic and Stryker. Indigenous leaders have emerged, including Aerogen, Vitalograph and IMS Maxims.

At the same time, global leaders are increasingly turning to Ireland for a number of reasons. One of the top advantages of collaboration with Irish companies is their partnership approach, reliability and strong B2B capability. Irish companies are also highly focused on using innovation to help customers to achieve their goals.

And given Ireland’s success in technology, supporting the likes of Google, Microsoft and Facebook, paired with its medical devices expertise, Ireland’s digital health expertise is growing rapidly.

In the face of emerging trends such as increasing regulation, technological advancements and rising health costs, developing conditions where innovation and entrepreneurship can thrive is crucial.

Some initiatives to encourage collaboration are already in place, for example BioInnovate, which enables participants to spend time with clinical teams to identify needs and develop solutions, driving high growth start-ups. Similarly, through a collaboration with the Mayo Clinic, Enterprise Ireland aims to create 10 spin-out companies in Ireland based on up to 20 successful US medical technologies.

Sign up to the newsletter for more insights into the global Medtech industry.

3D4Medical’s pioneering videos are almost literally mind blowing, thanks to an “Explode” feature that moves the segments of an organ apart, allowing each to be studied in isolation. The Irish Medtech company is ahead of its time, leading the pack in the use of mixed and Augmented Reality (AR) in medical education, over the past three years.

Timely Research & Development and Innovation investments helped Medtech visionary, CEO John Moore, to push towards the bleeding edge of digital health technologies. The journey into Augmented Reality began with “Project Esper: Mixed Reality Anatomy Learning”, a video 3D4Medical made three years ago, that showcased capabilities the company had then developed, as well as where it aimed to go.

Watch Project Esper to see this remarkable technology for yourself.

The video’s YouTube comments speak for themselves.

“Project Esper: Mixed Reality Anatomy Learning” video by 3D4Medical

Irish Medtech Innovators

3D4Medical’s pioneering Medtech videos

Irish Medtech Innovators

So how does this apparent magic actually work? John explains,

Our application of augmented and mixed reality is based on 3D models that we invested heavily in to ensure that they’re medically accurate to the point of photorealism.

John describes the combined sense of reality and unreality that is a hallmark of the 3D4Medical experience and has wowed such reputable international partners as the Mayo Clinic.

A user can take a heart, for example, and place it on an everyday surface like a kitchen table and see it through an iPad. Of course, the heart isn’t actually there, but the room is. So you can view a photorealistic beating organ in your own home or office.

When you watch a 3D4Medical video, that attention to detail stuns just as much as the potential of the technology. It feels futuristic to examine the body’s hidden vital pieces with such precision. The organ you see in their latest video, the Complete Heart, is the most advanced 3D realistic heart which has ever been developed. It took the company several years with an extensive team and resources to develop the technology necessary. The heart model alone took almost a year to develop with 100 moving parts that allow it to look completely photorealistic and in such a natural manner.

3D4Medical operate within an ecosystem of Irish Medtech pioneers whose innovation have taken them global. As John describes,

Irish Medtech companies are now seen as among the best in the world. People know we can compete with anyone in Silicon Valley. We work closely with all the US tech giants in the States and have a particularly close relationship with Apple. We work in their lab, with expertise passing both ways.

For Medtech pioneers like 3D4Medical, investment in innovation is essential:

The funding for Research & Development that we received from Enterprise Ireland allowed us to reach another level that we may not have attained otherwise. Innovation pushed us onto the world stage, where we became recognised as international leaders in medical applications.

John Moore CEO of Irish Medtech company 3d4MedicalSaving costs and creating efficiencies in Medtech

For medical professionals and students, the technology’s immediate applications are highly practical. Innovations in augmented and mixed reality create efficiencies that revolutionise medical learning. The technology extends the lifespan of events that occur in the real world, while fundamental parts of a medical education may no longer need to occur physically at all. John explains,

With the technology we have today, users can already virtually cut and dissect organs and walk around them. Professors can record a virtual or a physical dissection and push it out to students, who can view the recordings in augmented reality.

In pedagogical terms, these applications give students huge control over how they absorb and learn from dissections.

Students aren’t just sitting passively in a theatre or lecture room. They can walk around at the same time and see exactly what is happening from every angle they want to.

But the use of Augmented Reality in medical learning doesn’t just benefit students and professors. There are huge potential cost savings for institutions and professional bodies.

Augmented reality potentially displaces cadaveric dissection, which can be expensive. In Ireland, dissection is not as expensive as it is in some countries because many people donate their bodies to science after death. In countries with lower levels of donation, managing dissection can be expensive. Augmented reality offers a clean way to learn and economies and efficiencies when compared with traditional methods.

The question of realism intrudes here also. How ‘realistic’ is cadaveric dissection? How ‘realistic’ is the virtual version offered by Medtech?

When you examine a cadaver, the body is, of course, dead. Students and doctors dissect something that is already dead. With a technology like our Complete Heart, dissection occurs while the organ is actually beating. Our patented technology allows users to cut the organ while it is beating. They can examine something like endocarditis, growths on the heart’s valves, and see how they affect it in real time. They can slow down the body’s processes to examine the impact a problem with a valve has on blood flow. Everything can be performed in real time, as if the model was alive, compared to dissecting something dead, in which case there is no blood flow or movement.

Waiting for the hardware

When you think about medical learning, one of the first things to spring to mind are heavy, expensive books. The technology that 3D4Medical pioneers has been embraced by publishers who recognise collaboration may spare their obsolescence. The future of augmented and mixed reality also departs from the iPad as viewer. Realising the full potential of 3D4Medical’s innovations is reliant on hardware keeping pace. John explains,

People like us software developers depend on innovations in hardware. Right now, we are close partners with Apple. The technology they deliver with the iPhone and iPad is fantastic. But we won’t have surgeons doing operations while looking through an iPad either. The next big stage in development lies in the use of mixed reality glasses with cameras. Users will wear what look like normal shades but when they look through them artificial intelligence explains what they are seeing.

3D4Medical’s applications will soon be integrated with Microsoft’s mixed reality smartglasses, HoloLens:

When professors record a dissection or an operation and push it out, students use a HoloLens headset to view it there and then. There could be several students wearing headsets at the same time, in the same room, walking around the dissection or operation, viewing it from whatever angle they want, and understanding it better. When students play back recordings, HoloLens allows them to hear the professor’s voice as they describe what they are doing on the model at the same time. We will be releasing an app which works like that in early 2018.

Combining Augmented Reality and Artificial Reality is the future of Medtech

John may be a visionary but his feet are firmly on the ground. He has an aversion to unsubstantiated hype about the technology’s future. His focus circles back to end users, the practical wins for students, professionals and the ultimate end users, patients. The question he returns to repeatedly is:

What does augmented reality really offer over alternatives? There has been a lot of hype. Too many applications look cool but don’t offer much. There are a lot of gimmicks. Innovation must offer value and improve on what it displaces.

For John, much of the technology’s potential lies, not just in the use of augmented reality but in combining it with Artificial Intelligence (AI).

The future lies in the combination of augmented reality and AI. When a surgeon wearing mixed reality glasses cuts something or looks at an open wound, smartglasses will recognise what they are looking at – that’s an aorta, that’s a vein, that’s a nerve, don’t cut it, and guide the user through the operation, even as a novice. Intelligent glasses will superimpose labels and signposts over what the eye sees to tell the viewer what they are looking at.

While the phrase Artificial Intelligence can seem esoteric, the benefits are, again, immediate. The value for a 3D4medical partner like the Mayo Clinic lies in the elimination of the messiness and challenges of working with physical bodies. John explains,

Some operations release a lot of blood, or a lot of spinal fluid. That creates risk, if a surgeon can’t see the anatomy clearly. They still have to perform the operation, pretty much blinded. There you see the value of being able to superimpose labels or signposts on to the anatomy which is based on a 3D scan of the patient’s body made before the operation. Over the blood or spinal fluid clouding the surgeon’s view will be a photorealistic scan of the body part in question. The risk of cutting a vital nerve or the wrong tissue or leaving something behind is then greatly reduced.

The winners of those improvements are, of course, all of us. Our operations will be safer when surgeons have been trained and assisted to see the body at a level of depth and clarity the human eye alone could never hope to achieve.

Ryan Murphy, an Enterprise Ireland life sciences advisor, describes how Medtech companies can address the US market’s reimbursement challenge.

The US market often proves alluring for Medtech companies in Europe. Worth an estimated £115 annually, the US alone accounts for about 43% of the global medical device market.

Reimbursement is one significant challenge that faces European Medtech companies with plans to export to the US. Getting authorisation from the Food and Drugs Administration (FDA) can be a slow process. While most first-time Medtech developers are aware of what is required to achieve regulatory authorisation, some underestimate the extent of what is required to get reimbursement approval from health insurers.

Earlier this year, Enterprise Ireland, the national export agency, co-ordinated a client workshop across its US, German and French offices to share guidance on how European Medtech companies can overcome the reimbursement challenge.

Most workshop attendees agreed that the FDA is fair and transparent about the steps required to navigate the regulatory process. Reimbursement by health insurers can be less straightforward. The US has a complicated reimbursement system, involving multiple coding systems for using a device, and hundreds of payers with varying incentives and coverage decisions.

When targeting the US market, European Medtech companies are advised to do their homework early. With sufficient planning, a single clinical study can supply all of the data required for regulatory authorisation and reimbursement approval, saving the time and costs involved in conducting multiple studies. Even small design modifications implemented later can affect a product’s regulatory classification, the establishment of a predicate device, or your ability to use an existing reimbursement code.

An upfront analysis of realistic timelines and price points can provide a vital indicator of whether your product or solution is likely to achieve timely approval and worthwhile profit margins in the US.

European companies should take advantage of pre-submission meetings with the FDA to establish a good relationship, ensure proper classification, and develop well-designed submissions and studies.

Medtech developers also need to engage with stakeholders early in the process. Even if your new device is amazing, if it doesn’t fit a physician’s workflow, it will not be used. Equally, if a solution doesn’t address a significant pain point for payers, it won’t be reimbursed.

Finally, it’s important to know when to ask for professional help. Getting a complex device to market often requires assistance from a seasoned consultant.

Priorities in the Medtech industry are constantly changing. European companies should be aware of the evolving concerns of providers, payers and, increasingly, patients. US health system managers, for example, are now actively looking for value-based care solutions.

The European Union’s market authorisation system is perceived as easier and faster as it simply requires qualifying for the CE mark. There are, however, signals that the EU may move closer to the FDA model, which could impact the tendency of European Medtech developers to target European markets before the US.

Sign up to the newsletter for more insights into overcoming Medtech’s big challenges.

A version of this article originally appeared in the Sunday Independent