Nordic Countries Offer Opportunities as Irish Fintech Grows

As a source of growth in both the Nordic and Irish markets, the fintech sector has become an important focus for innovation initiatives. Over the past five years, Stockholm attracted 18% of all European fintech investment, second only to London. When the organisers of Money 2020, the world’s largest financial services event, came to Europe, they chose to locate in Copenhagen.

Significant fintech growth predicted in Ireland

Ireland has become a fintech powerhouse with potential to grow significantly in the next decade. The government’s IFS2020 strategy aims to showcase fintech providers and increase market awareness of the domestic financial services offering. At the end of 2015, Enterprise Ireland counted 8,800 people specifically employed in fintech, up 40% from 2008, with over 100 client companies active in the area.

Showcasing fintech innovation

To capitalise on these growth prospects, Enterprise Ireland expanded the team that supports fintech and launched a sector-specific fintech Competitive Start Fund. The agency fosters fintech innovation through world-class acceleration programs organised with partners including the NDRC and Accenture. The Fintech Innovation Showcase held in Dublin gave ambitious Irish businesses, including Vistatec, Kyckr and Solgari, the chance to explore partnership opportunities with top players from Denmark including Nordea Bank, Danske Bank, Saxo Bank, Nets, SDC, Financial Services Union, Copenhagen Fintech, BEC and Festina Finance. Visitors learned about the capabilities of Enterprise Ireland clients in rapidly developing areas like artificial intelligence, data analytics, payments, cybersecurity, and regulation and compliance.

The opportunity for Irish companies in the Nordics is significant, an attendee explains, “We’re primarily interested in solutions that we can bring to our 10 million retail customers and 700,000 SME and corporate customers. We would like to partner with Irish start-ups that have banks as customers. Potential areas include open banking, solutions leveraging opportunities created by PSD2, like financial aggregators, and AI and machine learning. Inputs on the fintech initiatives of tech giants residing in Ireland are also of interest.”


Researching new markets

One challenge clients experience when expanding overseas is to understand the market’s business culture and customers. Attending events like the Fintech Showcase gives Irish companies an opportunity to learn about practical aspects of doing business in the target market. In the Nordics itself, the Copenhagen Fintech hub connects leading companies in the space in Denmark and can be a great starting point for Irish companies keen to see what Denmark can offer.

Before committing to expansion, Irish companies should be aware that the Nordic market is extremely advanced and has many indigenous global players, making competition fierce. Unless your company has a unique solution, it can be difficult to succeed. Fintech businesses in the region want a reliable, trusted, and secure supplier. An attendee describes their ideal Irish partner, “We like to collaborate with global fintech accelerators that provide a consistent pipeline, are highly verticalised within payments and adjacent services, and agnostic to geography. We are particularly interested in connecting with fintechs with IoT-knowledge, especially Internet of Payments. Value-added services connected to retail are of major interest if the technology can be exported to the Nordic context, for example start-ups that collaborate with a merchant to demonstrate a practical solution in the Irish market that can be easily exported overseas.”

In addition to attending events like the Fintech Innovation Showcase, there are a range of supports you can access to realise plans in the Nordics. Enterprise Ireland offers R&D, Innovation and Competitiveness funding to help companies identify and fill knowledge gaps. Local offices can connect you to specialist Market Advisors in the region. Taking time to learn about the realities of the Nordic market will give your plans for growth every chance of success.

Oman: the Ireland of the Middle East

Mike Hogan Manager for the Middle East & North Africa at Enterprise Ireland, describes surprising similarities that are creating opportunities for Irish exporters to Oman.

If someone described a neutral country with a rapidly growing population of 4.5m people, which is held in good standing by neighbours, whose people have a reputation for hospitality and being great talkers, with a distinctive style of traditional music, you might think they were referring to Ireland.

There is also, however, a country in the Middle East that matches that profile – the Sultanate of Oman. Oman has become a growing market for Irish companies and a gateway to additional markets in the wider Middle East, countries where Ireland currently has a weak export footprint, located along East Africa’s Indian Ocean coast.


Innovation creating opportunities for Irish businesses

A recent Trade Mission, composed of 32 Irish companies and led by the then Tánaiste, Frances Fitzgerald, testified to the growing importance of Oman as a regional commercial hub. Three Enterprise Ireland-backed companies, Ding, iheed and mAdme, announced deals and partnerships with Oman-based companies during the Trade Mission.

Talal Said Al Mamari, CEO of Omantel, affirmed the importance of Irish innovation, saying, “We are always looking for innovative ways to communicate and interact with customers to better understand their experiences and expectations. Using mAdme’s platform allows us to enhance that experience by engaging customers at the right moment with exactly the right content.”

Agreements were signed by Enterprise Ireland and Atlantic Bridge with the state-backed Oman Technology Fund (OTF). A major aim of these agreements is to further aid market entry for Enterprise Ireland clients to Oman and to position Ireland as a hub for Omani companies with plans to expand their presence in the EU. The OTF aims to learn from Ireland’s experience as a world-leading technology start-up centre to support the development of its own start-up ecosystem, tailored to the needs of the Gulf region. A related initiative has seen the OTF partner with Ireland’s National Digital Research Centre (NDRC) to run a pre-seed accelerator programme in the Omani capital of Muscat.

Oman is focused on increasing diversification to drive economic growth, creating opportunities for Irish companies to assist in the process. David Shackleton, Ding’s Chief Executive, described the strengths that attracted his company to the region, “Oman is a significant and exciting growth opportunity for Ding given the flourishing economy and a proactive approach to world-leading technology. We are thrilled to partner with Asia Express Exchange across more than 30 branches.”

Irish companies already have strong positions in sectors such as ICT, healthcare, engineering and education, with almost 650 Omanis currently in higher education in Ireland. New opportunities are quickly emerging in sectors including aviation, agritech, aquaculture, food production and eLearning, in which Ireland has a strong export offering.


Doing business in Oman

Oman has developed a reputation as the ‘Switzerland of the Middle East’, maintaining strong political and commercial relations with both Saudi Arabia and Iran. Leveraging its network of friendly states, Oman is developing its status as a logistics hub, with the expansion and development of major ports at Salalah, Duqm and Sohar, and upgrades to international airports in Muscat and Salalah. The country is currently building out a railway network to connect its three port cities with Gulf neighbours. Boosting private sector participation in the economy is a key goal, as well as investment in indigenous food production, mining, shipbuilding and repair. Enhanced training of the Omani workforce is a priority, with 60% of the population under 30 years of age.

Perched on the Arabian Peninsula, with 1,700 km of coastline, Oman is an emerging tourist destination, with beautiful beaches and landscapes, coupled with outstanding nature and heritage tourism. Aiming to target up to 5 million foreign tourists by 2020, Oman expects to host 4 million foreign tourists in 2017 alone. There is a substantial opportunity for Ireland to assist Oman in developing its tourism capacity, in areas such as training, infrastructure, and ICT travel and tourism solutions. Clearly, whether for business or for pleasure, Oman will continue to be an attractive new market for Ireland.


This article was originally published in the Sunday Independent.

Africa Calling with Opportunity for Irish Exporters

The reality of the business opportunity in Africa is often different to what SMEs first assume. Beyond the ‘glass half-empty’ headlines lies an expanding market in the second-fastest growing region in the world. Rapid growth has created opportunities for Irish exporters in key sectors such as international education, healthcare, ICT, telco, fintech and aviation.

The scale of the opportunity is evident in the market size alone. Eastern Africa is home to 460 million people, 6% of the world’s population. Kenya acts as an ideal gateway into the region’s target market of 250 million people, covering Ethiopia, Uganda and Tanzania, in addition to Kenya itself.

The market in the region is developing quickly in ways that benefit Irish businesses. Ethiopia’s economy continues to experience exponential growth, and Kenya, with its rising African middle class clustered mainly in urban areas. 30% of its middle class live in Nairobi, offering a dense market for exporters to the region.

The growth of the Kenyan middle class is creating opportunities for Irish exporters in sectors including education and healthcare. 400,000 African students travel abroad to undertake undergraduate and postgraduate studies every year, creating an enormous market for Ireland’s education sector. Uncertainty generated by Brexit has created huge potential for Ireland to increase the number of African students that study here. A number of Irish universities are leveraging opportunities in the sector. During a trade visit to Kenya, Griffith College signed a partnership agreement with Nairobi’s Riara University, which sees it support the education of the country’s growing youth population. Minister Coveney also awarded International Computer Driving Licence certificates to students who are among the country’s rising skilled workforce.

Irish companies are using innovative technologies to help improve the quality of the region’s medical care. Enterprise Ireland facilitated a multimillion agreement between Novaerus Ireland and Quinton’s Pharmacy, a Kenyan based company, which is set to change the landscape of infections control and prevention in East Africa. Through its partnership with Quinton’s, Novaerus is adding value to Kenya’s healthcare system, reducing the number of infections in hospital environments and creating cost savings of approximately €12 million.

Dublin-based company Vitro Software announced a multi-million US dollar contract with The Nairobi Hospital, one of the most prestigious private hospitals in East Africa. Vitro’s electronic medical record software helps reduce change management challenges and deliver better patient outcomes. Mr. Odundo of The Nairobi Hospital affirmed the importance of innovation to the partnership, saying, “This initiative will bear great testimony to our ability to be innovative in all matters that ensure the highest standards are met.” For Declan Daly, CEO Vitro Software, the agreement is a gateway to the broader East African region, “We are now well placed to grow, not just in Kenya, but to other sub-Saharan countries.”

A number of strengths make Kenya a great gateway for Irish exporters considering expansion to Africa. The port of Mombasa is a key transit point, not just for imports and exports to and from Kenya, but also to and from Uganda, Rwanda, South Sudan, and the Democratic Republic of the Congo. The national air carrier Kenya Airways flies to more than 50 destinations in Africa and has direct connections to Asia and Europe.

Recognising the potential of the market, Enterprise Ireland appointed a dedicated trade representative for Kenya, based in Nairobi. Furthermore, there are a number of planned conferences and trade missions, upcoming. Enterprise Ireland’s advisors can help companies to identify opportunities in East Africa, get introductions to Kenyan buyers and potential partners, and get informed about important procedures, market entry barriers and license requirements.

A view from the Ireland-Estonia tech bridge

If your company is interested in expanding to eastern Europe, there are good reasons to consider Estonia. Business people in Ireland and Estonia share a positive attitude, making both tech scenes fun and collaborative. At home, Techireland gathers the community. Estonia has a similar catch-up with the cheeky hashtag #estonianmafia. While Irish companies are particularly strong at sales and networking, Estonians rank very well in mathematical and engineering skills.

Enterprise Ireland organised the Ireland-Estonia Tech Bridge event to encourage collaboration between businesses in both markets. Estonian companies, including Cybernetica, Paytailor, Estate Guru and Guardtime, travelled to the two-day event in Dublin to explore joint opportunities in fintech, e-government and cybersecurity – areas of strength in both economies.

Tech Bridge arrived at an opportune moment, with business between Ireland and Estonia already on the rise. In 2016, Irish CSO data showed a 65% increase in exports to Estonia, when compared with 2015. Enterprise Ireland clients generated over €8 million of exports to Estonia in 2016, with food representing 48%. It’s encouraging that companies like MalwareBytes, Arvato Financial Services and TransferWise are already active in both countries. It’s also great to see the first example of a UK/Estonian startup, Travatar, establishing its head office in Galway. One of the goals of the Tech Bridge visit was to encourage more Estonian companies to consider Ireland as a leading alternative to other European locations.

The economic profile of Ireland and Estonia is also similar in ways. Both are small markets, making it essential for home-grown businesses to be export-focused. Tech Bridge is one example of Enterprise Ireland’s Eurozone strategy in action. The plan offers clients multiple supports with the goal of increasing exports to the Eurozone by 50%, to €6.15bn, by 2020. Many companies in eastern Europe look at the supports clients receive from Enterprise Ireland with envy. From both a Polish and Estonian perspective, it is very impressive that a government agency is so active as an investor and that its processes are so efficient and client-friendly. Companies like Combilift and Novareus are examples of companies Enterprise Ireland successfully supported to grow internationally, particularly in EMEA. Combined with a record of attracting overseas start-ups and entrepreneurs, Ireland is in the top league in the competition for tech talent. I see a hunger to emulate that success in many eastern European countries.

There are also great reasons for Irish companies to look eastwards to Estonia. Most obviously, there are opportunities in cybersecurity – NATO has its Cooperative Cyber Defence Centre of Excellence in Tallin. Estonia’s state of the art eGovernment infrastructure is a clear example of strategic, long-term planning combined with tech-savvy spirit and a capable talent pool. Estonia also makes a great base for Baltic and Nordic export activity in general. At Tech Bridge, we connected clients with Estonian counterparts and pointed them towards business opportunities in the Baltics. The outcome of those collaborations will be seen in time.

If your business has an eye on Estonia, there are some practical challenges you should consider. Think about how key staff will travel, for example. Right now, there are only two direct flights weekly between Tallin and Dublin. That’s not very convenient for business travellers. While details like this might seem minor, it’s crucial to make sure they’re built into export plans. There is help available for these challenges big and small. The Irish Estonian Business Network will support any company thinking of moving from one market to the other. Together with Enterprise Ireland and The Embassy of Ireland, IEBN is forging new business relationships at a local level. Overcome the hurdles, and these supports could help your business to thrive in the east.

Supporting Female Entrepreneurship Benefits Everyone

When women play a smaller role in growing the economy, we all lose out. Women make up 50% of the population and the female employment rate is over 55%. Yet until a few years ago, female-led companies comprised 7% of Enterprise Ireland’s High-Potential Start-Ups group, just like the international average. Fewer female entrepreneurs meant fewer ideas, less innovation and export potential. Over the last number of years, Enterprise Ireland developed a range of supports specifically designed to encourage female entrepreneurs, including a dedicated Female Competitive Start Fund, offering women entrepreneurs €50,000 in start-up funding. The inaugural initiative drove the highest ever number of female-led companies backed by Enterprise Ireland. In addition to accessing those supports, here are six areas you can focus on to develop as a female entrepreneur.

Fuel your ambition  Women have high levels of ambition for their businesses, setting clear targets and goals. But women can also lack confidence, particularly in financial areas. Aversion to debt and a conservative approach to risk-taking can hamper ambition. Men often apply for the maximum amount awarded in Competitive Start Funds run by Enterprise Ireland. When the first dedicated Female Competitive Start fund was launched to help address known barriers, no one applied for the full amount. The fact that the latest competitive call had over 220 applicants for ten places shows that the strategy is working, with more female entrepreneurs taking the first step to building their own businesses.

Build your skills Accelerator programmes, like DCU Ryan Academy Female High Fliers, supported by Enterprise Ireland, target challenges facing female entrepreneurs and help women to fast track business development and leadership skills. By joining a programme, you become part of a supportive group of like-minded female founders. The long-lasting relationships these programmes foster in the female start-up community have helped achieve big improvements in just a few years.

Ask No business owner knows all the answers or has all the skills it takes to succeed. It can be difficult to work alone or as part of a small team when starting a company. Women can be especially reluctant to seek support. Don’t be afraid to ask for help or advice when you need it. It is important to step outside your comfort zone and remember the adage – if you don’t ask, you don’t get.

Perfect your value proposition Be completely clear about your value proposition and the problem you are solving. Be clear on your differentiator. You don’t have to use highly technical or scientific language; you need to be understood. Clodagh Cavanagh from Abbey Machinery says that your product or service must have value for the end user. Know their needs, not what you think they need.

Perspective changes attitude The way you look at something alters your approach and attitude. Thinking about perspective allows you to understand investors and customers better. When meeting an investor, imagine what your business looks like from their perspective. Alison Cowzer from East Coast Bakehouse advises asking: How much do I want? How will I use it? How much will I return? Thinking about answers from an investor’s perspective helps you to understand the value of your business to them.

Above all, persevere Perseverance doesn’t mean sticking with your idea at all costs or doggedly pursuing a start-up that doesn’t meet the needs of the market. Perseverance means recognising that you are on an entrepreneurial journey. The start-up space can be tough but also rewarding. Aim high and keep going.

While there is still a lot to do, supporting female entrepreneurship is paying off with continued growth of female-led start-ups. Enterprise Ireland will continue to support ambitious business women because diversity drives performance, and that benefits everyone.

Sweet seduction of Switzerland should whet Irish firms’ appetites

Jane Greene, Enterprise Ireland Market Adviser for Germany, Switzerland and Austria explains the allure of Switzerland for Irish companies looking to export.

Switzerland is on top of the world – almost literally, because from the dizzy vantage point of those Toblerone-shaped peaks in the Alps – it is number one for competitiveness, according to the World Economic Forum Global Competitiveness Report 2016/17.

Retaining this position for the eighth year in a row, despite the Swiss franc remaining sky-high since it was unpegged from the euro in January 2014, is a testament to the sophistication of its economy.

Innovation is key to this. Switzerland was ranked first in the world for innovation by the European Union in 2016. The Swiss Federal Institute of Technology Zurich and the University of Zurich are listed 20th and 54th respectively on the 2015 Academic Ranking of World Universities, while the International Institute for Management Development in Lausanne is among the world’s top business schools.

History and geography play a part too. For centuries, the Swiss have controlled access through one of Europe’s major physical frontiers – the Alps. Swiss engineering ingenuity has been honed by the need to tunnel and build a network of cable cars, rail tracks and motorway against gravity-defying odds, giving them one of highest road and rail densities in Europe.

Their precision engineering prowess in watchmaking has made them leaders not only in luxury goods, but also in the medical-devices industry. And, of course, those Heidi-inspiring landscapes give us Swiss chocolate, Emmental, Gruyère and an international dairy and food ingredients industry. Switzerland is an attractive market for Irish companies because it is strong in areas where Ireland also has world-leading capability and expertise. This includes pharmaceutical manufacturing, medical devices, dairy and food ingredients, financial services and engineering.

Along with the Brown Swiss cattle breed, chocolate and the Alps, neutrality is badge of Swiss identity – a shared value in a country with a historic Catholic-Protestant divide. It also has four official languages – German, Italian, French and Romansh, each with its attendant culture leanings – and 26 cantons, with the power to determine local regulations and taxes. Neutrality has made Switzerland a unique player in international relations and a major base for international agencies like the United Nations and the Red Cross, as well as sports governing bodies, including the International Olympic Committee and Fifa.

It has also contributed to Switzerland’s historic standing as a safe financial haven. Switzerland’s financial sector, including its banks and insurance industry, remains in rude health, providing some 6pc of all employment in Switzerland and accounting for a tenth of value-added.

Alongside major financial players – UBS, Credit Suisse and Zurich FS – Switzerland is home to global giants in pharmaceuticals and the food industry; for instance, Nestlé, Novartis and Roche. With 15 home-grown Fortune 500 players, it punches above its weight compared to larger neighbours, Germany, France and Italy. Now is a good time for Irish business to consider this market. Swiss companies are feeling the pain of the strong franc and are looking to retain competitiveness by sourcing outside the country.

Currently, Switzerland is the 11th-largest export market for Enterprise Ireland clients. Total sales rose from €295m in 2014 to €306m in 2015. This is higher than larger markets such as Canada, Australia and South Africa.

Switzerland’s appeal is manifold. A prosperous market, political stability, a competitive tax rate and good rankings for ease of doing business. Being outside the European Union presents few difficulties for Irish exporters because it is a member of the single market.

For sure, it’s an expensive place. But Swiss companies have massive purchasing power and a desire to do business externally. With direct flights to Basel, Zurich and Geneva taking just two hours, and plenty to occupy business travellers’ down time, Irish supplier could find Switzerland a sweet seduction.

To learn more about Enterprise Ireland supports and for further information on exporting click here

Two Irish Medtech Companies with Global Ambition partner with Northwell Healthcare

The largest healthcare provider in New York State, Northwell Health, signed and sealed two new partnerships with Irish Medtech businesses. Northwell Health is using solutions from Irish companies to enhance customer experience and improve efficiency and productivity, thanks to a partnership signed with Enterprise Ireland.

Northwell Health has 22 hospitals and 600 outpatient facilities, and cares for more than 1.8 million people a year in the New York area, and beyond. President and Chief Executive Michael Dowling is highly focused on continuous innovation in what he views as a fast-changing and increasingly more competitive market.

Northwell Health reviewed over 50 Irish companies and agreed deals with two – Technopath Clinical Diagnostics and Salaso Health Solutions.

Technopath developed a first-of-its-kind, consolidated immunochemistry testing product. Consolidation is attractive to companies like Northwell Health because it enables clinical labs to significantly reduce handling requirements, reclaim storage and minimise waste, leading to a more efficient quality control process.

“The solutions Technopath has developed have dramatically helped us to improve the quality, efficiency and cost-effectiveness of our laboratory quality control processes.”

Northwell Health has signed a 50-50 joint venture agreement with Technopath, with a view to promoting the Irish companies’ offering to labs all over the US. It owns one of the biggest labs run by a health system in the US – performing more than 30 million tests and analysing 200,000 surgical specimens a year.

Salaso Health Solutions is based in Kerry. The company has developed a platform which allows patients to use their smartphones or tablets to access and interact with high-definition video exercises prescribed by their clinicians.

The deal expands on the company’s existing contract with Northwell Health to provide online care management services to stroke survivors and patients with movement disorders and other neurological conditions.

Under the agreement, Northwell Health will invest in Salaso Health Solutions to enable the company to further develop the solution, expanding the scope of online rehabilitation care to patients with cancer, COPD [Chronic Obstructive Pulmonary Disorder] and other medical conditions.

“We are always interested in solutions that can improve clinical outcomes. Salaso’s app can improve what a patient does at home after they have been treated by a doctor so they don’t have to come back to the hospital and are more knowledgeable,” said Dowling.

Until two years ago, Dowling didn’t appreciate the scale of the entrepreneurial developments that have been built in Ireland. “I spent a couple of days going around to a lot of companies with Enterprise Ireland and I was completely blown away,” he says. “The capabilities and competencies that exist in Ireland, especially in areas such as Medtech, are phenomenal. In my view, this is down to the education system and the innovative spirit, personality and knowledge of the people.”

One of the areas where Irish Medtech companies are particularly strong in is digital health, according to Dowling.

“Everything is becoming more democratised because of the access consumers have to mobile phones. We do business with other countries, but there is nothing as expansive as what Irish companies are doing in the whole digital health and customer experience space. The consumer is the biggest change agent in healthcare. We have to deliver what the consumer wants. The innovations coming out of Ireland fit right in with that.”


Learn more about the Irish companies adding value to the North American health systems and key information on doing business in the USA.



Irish companies focussed on export growth

John Beckett from Channelsight, Drewry Pearson from Marco Beverages and Seamus Lawlor from Keltech Engineering are some of the Enterprise Ireland clients aiming for export growth in 2017

To learn more about Enterprise Ireland supports and for further information on exporting click here.

3 Steps to Successfully Launching a Medical Device in Europe

When launching a medtech device in any new market, there are typically challenges to overcome. However, the European Union is widely accepted as being an easier market to overcome compared to the USA. Essentially, there are three steps to follow to ensure it is a more efficient process:



Route to Market


Authorisation – A Key Factor to Medtech Green Light

In Europe, every marketed medical device must carry a Conformité Européenne (CE) mark indicating that it conforms to relevant directives set forth in the EC Medical Device Directives. “Once your product is classified as a medical device and gets CE accreditation, it can be commercialised in any EU market,” advises Jean Charles Moczarski at Enterprise Ireland’s Paris office.

Non-implantable medical devices are considered low risk meaning manufacturers themselves can certify compliance and apply a CE mark. Higher risk devices must undergo an external review and may require clinical and/or non-clinical evidence to support approval.

The application can be filed in any member state and is reviewed by a ‘notified body’ authorised by that state’s competent authority. Currently, there are over 70 notified bodies operating in the EU; typically, these are for-profit, private companies.

The European regulatory process is an easier place to start, agrees Atlantic Therapeutics CEO Steve Atkinson. Atlantic Therapeutics has offices in Galway, London, and Salem in Germany. It attracted €15 million in venture capital to expand market reach for Innovo, a non-intrusive device to treat urinary incontinence by strengthening pelvic floor muscles. Moreover, European Union authorisation has helped open doors for Innovo in the Middle East due to the similarities between the EU and local regulatory regimes.

In contrast, medical device approval is overseen by a single authority in the USA – the Federal Drugs Administration (FDA).

In a comparison of the two systems published in 2016, Gail Van Norman noted, “Before approval of a medical device in the United States, a device must not only be shown to be safe, but efficacious. Medical devices approved in Europe need only to demonstrate safety and performance – they are not required to demonstrate clinical efficacy.”

Cork-based start-up PMD Solutions has developed RespiraSense as a continuous and accurate, discrete sensor that measures the mechanics of respiration in general ward patients who are at risk of adverse events until discharged from hospitals. The device has been trialled in hospitals in Ireland, Europe and Asia.

Having selected Europe as an initial target market, CEO Myles Murray says,

“It’s all about resources. SMEs need to be strategic about the territory they enter. The European CE pathway, although still rigorous, can be easier.”

If European industry and patient lobby groups have their way, this advantage will remain. However, it could be a case of watch this space. Proposed amendments to Europe’s medical device regulations, which would bring it closer to the US system, include involving the European Medical Agency in device regulation, tightening controls over notified bodies and requiring more rigorous clinical evidence.

Reimbursement: What you need to know to help green light your Medtech Device

Step two involves getting on the ‘approved list’ for reimbursement, so that customers – whether a hospital or patient – will be reimbursed by the relevant health insurer, if they purchase the device.

SMEs often make the mistake of assuming the data they have used to file for the CE mark will be sufficient to include them on a territory’s qualified list of products and services for reimbursement. In the era of value-based healthcare, companies need to prove that their product will deliver clinical, economic and, for patients, quality-of-life benefits.

Additionally, success in one European market does not offer a free pass to the next one. Companies should understand the various reimbursement schemes operating in intended target markets and consider what additional evidence might be required when setting up a clinical study. Specifically, they should analyse existing reimbursement arrangements for their product type or alternatively, work on getting a new procedural coding.

The Haute Autorité de Santé assesses whether a product should be made eligible for reimbursement by France’s national health insurance, based on clinical trial evidence and added clinical value. If the benefits are determined to be sufficient, the medical device is registered on a list qualifying it for reimbursement. The manufacturer then negotiates a reimbursement with the public pricing committee, or CEPS as it’s known, based on the clinical value and how it compares to existing products or therapies.

Atlantic Therapeutics found the French market relatively easy to navigate since a product code already existed for devices of Innovo’s type, allowing for reimbursement for homecare use. If Innovo is prescribed by a French doctor, the patient can simply call into a pharmacy with the reimbursement code to collect it.

The French medical device market is the second largest in Western Europe and the fifth largest in the world. Its formidable healthcare system has one of the highest spends in Europe representing 11.6% of GDP. Public health chalks up 78% of the total spend and the country is in the midst of a hospital investment programme. In Germany, healthcare expenditure represents around 11% GDP.

“The German healthcare market is unique because 90% of it is public, dominated by statutory health insurance,” says Marco Kalms, CEO of Palms & Partner, a consultancy firm based in Berlin.

Kalms says entry into the hospital (inpatient) side of the market is easy, and even off-label use of devices is permitted. On the ambulatory (outpatient) side, everything is forbidden unless approved. The Federal Joint Committee (G-BA) ratifies new procedures for coverage by the statutory health insurers.

“For the ambulatory market, you need to approach the Federal Joint Committee (G-BA), the highest decision-making body, to see if there is potential. They assess the clinical evidence and decide on how much to pay for it,” he explains.

“Once you have a CE mark, you can sell into the hospital market using an existing code or apply for a new code to one of the healthcare technology assessment bodies of the Federal Ministry of Health (BMG),” Kalms explains.

Billing is based on the German Diagnosis Related Groups (G-DRG). The compensation amount is based on data continuously gathered from German clinics. On the hospital side, the InEK Institute determines price.

“The German public healthcare market is running a surplus, something in the order of €28 billion to €30 billion, which is very different from the UK, the US, or France,” says Kalms.

“There is a reason for that. They are always looking for opportunities to save money, so with a reasonable price, a product can do well.”

“A misconception we see with a lot of clients is that having economic data will get you into the German market. The first data the health assessment technology bodies look at is clinical evidence, patient benefits and if there are proven sophisticated clinical studies.”

“A common mistake is for companies to put their workload into getting FDA and CE approval. Once they have it, they say now for reimbursement. They should have already started on this.”

Atlantic Therapeutics’ Steve Atkinson agrees and explains, “The reimbursement system in Germany depends on a network of insurers. Which insurer you are with determines how much you will get reimbursed. As a seller, you need to make sure your product is covered by each insurer, and you should get that done ahead of your launch in Germany. Otherwise, you are not going to get paid. Culturally, Germans are not used to paying for healthcare out of their own pockets.”

Route to Market: Medtech to Market

Having surmounted two major obstacles, companies have to address the final issue that faces almost any exporter – route to market.

Small medtech companies are usually best advised to sign up distributors. Additionally, they also need to be aware of the role of group purchasing organisations or GPOs. These are entities intended to help healthcare providers realise savings and efficiencies by aggregating purchasing volume and using that to negotiate discounts with manufacturers and distributors.

In France’s public hospital system, for example, the Parisian Hospital Board is a central buying group, comprising 37 hospitals organised into 12 hospital groups with 23,000 treatment beds. Its annual budget is around €7 billion.

In Germany, the leading group purchasing organisation is Prospitalia, with over 700 medical institutions and 135,000 hospital beds; 350 contracted suppliers; 500,000 listed items; and over €1 billion in purchasing volume.

Internationally, the dominance of GPOs has been blamed for narrowing channels to market to the extent that developing an effective medtech product is, in itself, not enough for a company to reach its ultimate customer.

“Public buying groups are large, powerful players when it comes to negotiating procurement contracts. This can be a hindrance for smaller companies,” says Moczarski.

Therefore, Irish companies must also work hard to create market pull, targeting influential surgeons, clinicians and patient groups to champion their products.

How to Thrive in The Age of Disruption

Unless you’ve had your head in the sand, you’ll know that we’re entrenched in the chaos of a post-industrial world, an age of disruption where established businesses are being superseded by technology-driven companies that are smarter, faster and unencumbered by outdated business models.

There’s a general understanding that the web, Big Data, analytics and automation are facilitating major change, variously described as somewhere between the third and fourth industrial revolutions.

Specifically, it’s running businesses in public and private clouds with huge computing power and the ability to analyse data on an industrial scale, something that was impossible a decade ago. The cumulative effect is a digital revolution, where the ripples are creating a domino effect that’s toppling established players in one sector after another.

Identifying opportunities

Damian Costello, who runs a consultancy called Decode Innovation, cuts to the chase on what it all means for new businesses. “If you’re small and trying to get into a bigger market, you’ve got two options: position yourself to pick up the scraps from somebody else’s table or disrupt,” he said.

His day job is advising established businesses on strategies to sustain growth and avoid disruption, which means recognising where they are vulnerable and doing something about it. Often it’s a fear of cannibalising their own business that leaves a gap for disruptive new entrants – he cites the example of IBM hesitating to move on mini computers because it threatened its mainframe business, thereby leaving the door open for Intel and Microsoft.

Costello makes the strategy for disruptors sound wonderfully simple.

“Whatever the incumbents love most, reverse it. Whatever they’re most proud of, reverse it,” he said. “After that, you have to have insights that show you something about your customers that large scale competitors can’t do well; you have to highlight an opportunity that they’ve missed, something that for them is negative, awkward, uncomfortable, and undermining.”

He takes it further. The aspect of their business that they are most proud of is likely to be their Achilles heel and something you can do without if it’s trucks on the road brandished with fancy logos, outsource your supply chain. If it’s a huge inventory, keep yours just-in-time. Running a business without components that were once considered fundamental is what digital technology is enabling. “If you’re starting from scratch, you can build a global infrastructure purely in the cloud. Digital allows you to do everything – it’s like building a business with Lego blocks,” he said.

There is a perception that digital transformation is mainly about cost saving through automation, but Costello argues that it’s much more than that; it moves businesses beyond silos that slow them down. “Operations, sales, marketing, and quality are all entirely different domains in the real world but in the cloud they’re just ones and zeroes. And no matter how different and incompatible they are in the real world, an algorithm, translator or API can bring them together in the digital world in ways that were never possible before. It changes everything,” he said.

Mashing up data

For a start-up or nascent business, digital also provides a platform for assessing market opportunities in ways that were impossible before the advent of Big Data. Now that infrastructure is taken care of by digital technology, new entrants can concentrate on testing market opportunities, quickly and affordably, with predictive analytics and modelling. “All the entrepreneur has to do is work out who their customers are and use data insights to decide on the value proposition,” he said. “It’s about identifying mash-ups and interconnects when you take data from entirely different fields.”

Cronan McNamara does this for a living. His company, Creme Global, has developed a cloud platform where clients in the food and nutrition sectors combine unique and disparate data sets for predictive intake modelling that informs strategic decision-making. He argues that similar processes should be fundamental to any business strategy. “Finding a market fit for a product or service is a critical step for any new business, and data is key. You have to become a data-driven organisation.”

Cost of entry can be low. He talks about “growth hacking”, a suck-it-and-see approach to market experimentation where the investment can be as little as a webpage and some Google AdWords to ascertain if there’s any interest in an idea. “It takes a lot of creativity and experimenting, but it’s a good starting point for any business,” he said.

Open source languages like Python and frameworks like Hadoop make it possible to crunch huge volumes of data at scale for a fraction of what it used to cost. “You could do something for €10,000 today that would have cost closer to a couple of million ten years ago,” he said, “but you have to be scientific in your approach, testing your hypothesis and rigorously carrying out experiments.”

Without scientific analysis, he warned, you may have trouble distinguishing between real trends and random noise. It takes scientific training to understand the difference and to set up experiments where you can rely on the results. McNamara believes every business should have a technical co-founder capable of creating programmes that connect up data sources.

Analytics as service

Data sets, including free open data, are now readily available, giving firms competitive advantage if they have the skills to mine it. “Only a small number of organisations are at this point,” he said.

“More traditional companies don’t seem to understand the value of the data that’s out there on the web and on other platforms. But the companies that get it are starting to dominate. ”

Because of what he calls “the democratisation of data”, organisations need some expertise but not all the expertise – that’s what third parties like Creme Global can deliver as a service. All this will increase the invisibility of technology, which Damian Costello believes is another phenomenon of the age.

“Kids don’t see their smartphones as monitors or processors; they just see a screen into the virtual world. The same thing will happen with entrepreneurs. All the hype around data and the Internet of Things will disappear into the background because third-party companies will handle all of that for them.”

Costello believes the big challenge will be less about having access to the skills and technology and more about having the imagination to identify the opportunities. “Nothing’s impossible with digital, but a monumental amount of what will be done will be really stupid. About 10 per cent will have the capability to change the world.”

New model for growth

Digital technologies are helping transform fundamental business models, according to Damian Costello. The traditional approach is to forecast market share based on assumptions, and then make investments to help achieve those targets. Now, using predictive analytics and modelling, you can make a projection and identify the assumptions that have to be proved true if the projections are to occur. You only invest when the assumptions are proved accurate.

Russia’s Bearish Economy is Open to Under-Supply Solutions

Russia’s economy is grappling with trade sanctions, deflated oil prices and difficult international relations. But as a high-level, three-day conference in St Petersburg shows, this gateway to 250 million consumers is still up for doing business, and so too are powerful interests in the West.

European Commission president Jean-Claude Juncker, Italian PM Matteo Renzi, UN Secretary-General Ban Ki-moon and former French president Nicolas Sarkozy were among the 7,000 attendees at the St Petersburg International Economic Forum (SPIEF 2016), which was addressed by Vladimir Putin.

The Irish delegation included Ambassador to Russia Adrian McDaid, and Enterprise ­Ireland chairman Terence O’Rourke, who were among the business leaders, journalists and academics from around the world ­contributing to debate about the global economy and ­Russia’s place in it.

Entrepreneurship, medium-term macro-­economic strategy, Eurasian Economic Union and world energy markets were on the agenda, along with development of market infrastructure, high-tech industries and Russia’s regions.

As the guest list shows, this conference is more than Russian lip-service to economic openness. The country is actively seeking financial and expertise inputs.

Following steady growth averaging 3pc-5pc from 2009 to 2014, Russia hit a recession which reached its nadir in Q2 last year with a 4.5pc drop in GDP as the country hit a fiscal ‘perfect storm’ due to negative macro- and micro-economic events.

Predictably, this has had knock-on effects for Irish exports over the past 18 months. Figures for 2015 show a 55pc drop compared to 2014.

But things look like stabilising. The slowdown has been less pronounced over the past 12 months and Q1 figures this year show Irish exports up €4m year-on-year with the economy projected to flatline between now and 2020.

President Putin appears serious about further opening up Russia’s 143 million-strong market to imports which will also help access to the 100 million people in the rest of the Commonwealth of Independent States.

“We must react more swiftly to the shifting demands of the market and to the looming transformation of the global technological landscape,” the Russian President said in his welcome message at St Petersburg.

Irish exporters have lost ground in the ­Russian market recently – but opportunities still exist. Demand for high-quality niche goods and services is consistently increasing in the B2B and B2C sectors. Moreover, the relative clear-out of foreign competition due to the recent downswing means there is a more positive local response to companies making the gesture of visiting Russia to build partnerships in a highly relationship-focused society.

Irish companies exporting to Russia

There are plenty of Irish success stories. Companies such as Dublin Aerospace, Hi-Spec, Prodieco, Dairymaster and Hermitage Genetics are looking at stable or increased sales for 2016.

These companies are similar in that they have a market presence, or make regular ­visits, demonstrating a willingness to listen to Russian partners and consult on solutions as a pathway to sales.

Potential exporters to this market should ­follow their lead. They all offer reliable ­after-sales support and offer products and services that compete in quality and price.

Our assessment is that it will become more difficult to sell directly into Russia going forward. However, long-term partnerships creating joint R&D, IP and products relevant to Russia as it develops its manufacturing, food production, and telecoms infrastructure, will give Irish-based ‘hybrid’ companies access to a huge and under-supplied market.

The first stage of forming those partnerships is our recent campaign to attract Russian start-ups to Ireland, integrate them into our business ecosystem, develop their international export potential and prepare them to scale-up for entry into the Russian market.

With a third of all applications, and 40pc of investment winners, for Enterprise Ireland’s International Competitive Start Fund coming from Russia/CIS, this process has momentum, creating the opportunity to form partnerships from home and ultimately ­counterbalance the ­recent drop in Irish exports.

Gerard MacCarthy is Enterprise Ireland manager for Russia/CIS

This article originally appeared in the Sunday Independent

How to do business in the Middle East

Doing business in the Middle East has become more challenging in recent years – the process of getting a product or service on the market there is not as easy as it used to be. Enterprise Ireland Market Advisors, Eamon Sikafi and Rachel Kouyoumdjis, discuss the challenges and opportunities for key sectors, in particular, aviation and security.

To learn more about Enterprise Ireland supports and for further information on business in the Gulf States click here.