How eXpd8 followed the Thread to win new markets

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“We built the solution in 12 months and then wanted to validate our chosen market. That’s where market research support from Enterprise Ireland came in”

– Liam Mullaney, CEO

Key Takeouts:

  • Software specialists breaking into new markets with a new R&D led cloud-based offering.
  • Faced with challenges to future growth prospects, their Enterprise Ireland adviser helped them secure an R&D grant.
  • Today, enquiries are coming in from South Africa, Singapore, Germany and further afield.

Case Study: eXpd8

Enterprise Ireland market research support enabled Irish legal software specialist eXpd8 Limited to break into the US market with its new cloud-based offering – Thread. Since its launch in September 2017, the Thread legal case management solution has successfully been trialled by a number of law firms in California and North and South Carolina, with sales now following in the US and a number of other markets.

eXpd8 traces its origins to a first start as an office supplies company, founded in 1985 by Declan Branagan. In 2000, Declan recognised an opportunity to develop dedicated software for legal practices and the first eXpd8 software product was launched the following year. The solution has been hugely successful in the Irish market and has attracted interest from the US, Australia and South Africa.

Liam Mullaney, CEO, joined the company in 2015 and takes up the story from there, “As there are about 1,700 legal practices in Ireland, we had limited prospects for further growth. I spoke to Declan and we agreed that there was a huge opportunity to supply legal firms worldwide if we created a cloud-based product. That’s what led to the development of the Thread legal case management solution. That’s the product we are taking to the global market.”

It also led the company to its first contact with Enterprise Ireland. Mullaney continues, “We met with our Enterprise Ireland adviser, Eileen Bell, and she has been a great help. We received a feasibility study grant initially. After that, an R&D grant to help with the development of the product. Having the backing of Enterprise Ireland has been incredibly beneficial all the way along.

“We built the solution in 12 months and then wanted to validate our chosen market. That’s where market research support from Enterprise Ireland came in. We decided that the US was the place to be and we picked North and South Carolina as the two states to focus on initially. There are 7,000 legal firms in the two states, so that represented a good market for us.”

Under the market research grant, Head of Product Development Anne Marie Callaghan visited Charlotte, North Carolina in June 2017 to gather initial market intelligence. “It came through very clearly that using ‘the Irish card’ would work well for us”, she says. “People don’t realise how strong the support is for Ireland and Irish businesses internationally.”

The Thread solution was formally launched on September 18, 2017 in the Microsoft Campus in Charlotte. “The product is built on Microsoft Office 365”, explains Liam Mullaney. “This is very important, as it opens up a very big market for us and allows the product to be sold through the world-wide network of Microsoft resellers. Our close relationship with Microsoft has been invaluable throughout.”

Enterprise Ireland assistance has also been critically important, he adds.

“It is more than just financial support. Enterprise Ireland has a great network of contacts. They help you identify who you should talk to. Their encouragement and assistance also gives you confidence that you are doing the right thing. Enterprise Ireland has this web of connectivity and, when you get into it, doors open to all sorts of people who really want to help.”

Having enlisted their first customers in the US, the product is now going global. “Digital marketing begins to take over at this point. People hear about the product online and see the website. We now have interested law firms approaching us and already have users in South Africa and the UK. We’ve had enquiries from Singapore, Germany and further afield. I would definitely advise companies with export ambitions to talk to Enterprise Ireland about the supports they can offer.”

Cartoon Saloon draws audiences with creative magic

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“We have a creation and design part, but we also have a production and commercial part. Those things must marry and live side by side.”

– Gerry Shirren, Managing Director, Cartoon Saloon

Key Takeouts:

  • International recognition early on set the course for success.
  • Creative talent went hand-in-hand with strong business practice.
  • Feasibility funding from Enterprise Ireland facilitated the exploration of new platforms and market opportunities.
  • Joint venture with a Canadian company set to promote expansion.

Case Study: Cartoon Saloon

An animated fairy tale provided an unexpected twist in the story of Kilkenny-based animation studio Cartoon Saloon. The company’s 2009 film, The Secret of Kells, in which the unfinished Book of Kells is imperilled by Viking invaders and entrusted to the hands of a young hero, was nominated for an Academy Award – a remarkable achievement for the studio’s first production.

“The nomination was a surprise to everyone and it broke completely new ground,” says managing director, Gerry Shirren. He attributes success to the studio’s uniquely strong visual style. Since then, Cartoon Saloon has garnered another Academy Award nomination for its feature Song of the Sea and enjoyed commercial success with productions such as Puffin Rock. Two seasons, totalling 39 episodes, of the seven-minute cartoon were first screened on pre-school channels RTÉjr and Nick Jr in May 2015, and subsequently picked up by Netflix for worldwide streaming the following September.

The studio clearly has outstanding creative talent but it’s also a for-profit business. “We call it a creative enterprise,” says Shirren.

“We have a creation and design part, but we also have a production and commercial part. Those things must marry and live side by side.”

It’s been a successful pairing. Puffin Rock was launched in China by a leading streaming service in August 2017 and has since had a streaming rate of more than one million views per day.

Cartoon Saloon has always innovated, creatively and technically. “We moved really quickly to digital delivery about five years ago when broadcasters were still looking for physical delivery. Now digital is the norm,” explains Shirren.

Early on, the company received RD&I grant assistance from Enterprise Ireland to evaluate and implement a digital management pipeline. This proved essential for efficient production. “We were looking at customisable software which needed to be heavily modified for our own processes,” says Shirren.

“The funding brought us into the realm of digital management systems which we hadn’t used before.”

It was another step on the path to a more professional, streamlined production process. “When funds are in short supply, that sort of support makes a difference. I don’t think we would have got through the implementation of the visual system without it,” adds Shirren.

More recently, the studio received a grant from Enterprise Ireland to embark on a small feasibility study, a sort of voyage into the unknown. “We wanted to find out whether we could port over to a virtual reality environment,” explains Shirren. A showcase piece was created, based on a virtual reality world inspired by Song of the Sea, and is now available for VR and Gear VR mobile platform, both free to download from the Oculus Store.

“It was a speculative project and we couldn’t have done it without support,” Shirren continues. “We learnt an awful lot from the process.” Anyone who has an Oculus Rift headset can now experience the studio’s creation.

Cartoon Saloon’s latest film, The Breadwinner, was launched at the Toronto International Film Festival in September 2017, and a new film, Wolfwalkers, is currently in production. The studio has also formed a joint venture, Lighthouse Studios, with Canada’s Mercury Filmworks to do third-party service work which may involve animations for big hitters such as Amazon and Disney. “In about twelve months, Lighthouse could be as big as Cartoon Saloon,” says Shirren. “That means Kilkenny could have two animation studios with perhaps 100 employees each, making the city a magnet for talent.”

 

Learn how Enterprise Ireland can support your R&I ambition with dedicated innovation funding.

Asavie

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“Enterprise Ireland have enabled us to take bigger bets and scale the company faster. And we’re really seeing the benefit of that today.”

Keith O’Byrne – Director

Who

Asavie are a technology company developing and scaling Internet of Things applications from prototype to production.

How

Funding from Enterprise Ireland has allowed Asavie to hire a team of developers instead of hiring one by one.

Result

Working with Enterprise Ireland allowed Asavie to accelerate their work, scaling far quicker than they would have without help.

See How We Helped Asavie

Dawn Farms Meeting Customer Expectations Through Innovation

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“We have had a long-standing positive and proactive relationship with Enterprise Ireland and currently avail of its R&D support programme”

– John McGrath, Head of Business Development

 

Case Study: Dawn Farms

Established in 1985, Dawn Farms is a family-owned company and the largest specialist supplier of cooked and fermented meat protein ingredients outside of the USA. The company currently supplies world-leading food brands across more than 40 markets, including the UK, the wider EU, the Middle East and Africa, offering a “one-stop shop” to customers in the pizza, sandwich, snacking and ready meal categories.

Named Irish Food and Drink Exporter of the Year in 2016, the company employs over 1,000 staff based in state-of-the-art facilities in Naas, County Kildare, and Northampton, England.

According to Head of Business Development John McGrath, a holistic relationship-based service that puts the customer’s brand first – with product, process and service innovation playing a central role in its total value proposition – is at the heart of the company’s success.

“We have identified a number of key trends, based on consumer insights, that drive our product development pipeline”, he explains. These include the “quest for health and wellness” and “sustainable lives”.

In line with these trends, all Dawn Farms products are free from artificial colours, hydrogenated fats and MSG, while also meeting the latest standards on salt.

The company’s new Streetfood Collection, born out of its extensive investment in consumer insights, combines a bespoke cook and sear process to produce a range of Mexican, American and Korean-inspired street food cooked meat products to allow their customers meet growing demand in the hand-held snack and food to go markets across Europe. Cooked “low and slow”, this new range brings all the flavours of street food alive and comes in vacuum-sealed pouches for better and more consistent recipe and flavour delivery in store.

“Today’s consumers are seeking out authentic and better tasting food experiences”, says McGrath. “The Street Food Collection delivers on that need for Dawn Farms customers.”

 

     

    The company’s Texan BBQ Beef Burnt Ends sandwich filling is another example of this consumer-led innovation in action. “Consumers today are becoming more discerning about barbecue food and this is evident in the different types of regional barbecue sauces offered in burger chains as well as the broad choice of restaurants seeking to deliver authentic American barbecue experience and tastes”, McGrath points out. “It also taps into the ‘back to basics’ food trend – a return to primeval cooking methods such as grilling, barbecuing and fermentation. The burnt ends’ concept also fits the sensorial trend towards charring, blackened and burnt textures in ingredients from meat to ice cream.”

    Similarly, the company’s Italian-Style Porchetta product was inspired by traditional Italian street food. “The rationale behind this ingredient is to give food-to-go consumers an authentic Italian food experience. This fits in with the Borrowed Nostalgia food trend, where people are looking for traditional food experiences from other countries. Porchetta is a traditional Italian roasted pork delicacy, typically sold from a cart or a truck, sliced to order and served in a sandwich as a quick treat at the market or at a fair.”

    “We have had a long-standing positive and proactive relationship with Enterprise Ireland and currently avail of its R&D support programme”, he adds. “This has allowed us develop a range of product and process improvements across the business that underpin our commercial strategy and foster new growth opportunities in a very demanding marketplace.”

    APC

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    “Enterprise Ireland has the knowledge and understanding of the various industries and markets and is very willing and supportive in passing on the information and advice.” – Sharon Davin – R&D Grants Manager

    Who

    APC are a pharmaceutical and biotech process research company based in Dublin.

    How

    Development Advisers from Enterprise Ireland were able to help APC rapidly access global pharma and biotech markets.

    Result

    Support from Enterprise Ireland allowed APC to create processes that are robust and portable. This allows their partners to have flexible supply chains, speeding up delivery to end users.

    See How We Helped APC

     

    Oman: the Ireland of the Middle East

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    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

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    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.

    Irish Dog Foods brings export market to heel

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    “Initially, we set up as a standard dog food business. But we found that we were just a ‘me too’ brand, so we needed something to set us apart. As a business in a small island nation, with all the logistical and transport challenges that poses, our business had to find a niche to allow us to sell globally.”

    – Liam Queally, Managing Director, Irish Dog Foods

     

    Case Study: Irish Dog Foods

    “We have grown at an exponential rate and Enterprise Ireland’s support has been key to that growth,” says Liam Queally.

    “We’re currently in our second phase of Enterprise Ireland-supported R&D projects with a range of new products focused on export markets in North America.” Queally is managing director of Irish Dog Foods, a pet food manufacturer headquartered in Naas.

    The company, a recipient of Enterprise Ireland’s RD&I funding, produces a range of dry pet foods and meat-based treats. It found that ‘humanisation’ – creating dog snacks inspired by appealing and healthy human foods – was the key to opening new markets and increasing sales.

    “Initially, we set up as a standard dog food business. But we found that we were just a ‘me too’ brand, so we needed something to set us apart,” explains Queally. “As a business in a small island nation, with all the logistical and transport challenges that poses, our business had to find a niche to allow us to sell globally.”

    Key Takeouts

    • Developing niche products defined brand and opened new markets such as the US.
    • Applying for Enterprise Ireland’s RD&I funding was straightforward and encouraged strategic thinking about research and development.
    • Open discussions and idea generation were a major part of the R&D process.

    The company responded to this challenge by developing new product ranges, with support from Enterprise Ireland.

    “New products are key to our growth in new markets. Enterprise Ireland’s RD&I grants have enabled us to get new products to market in a shorter time,” Queally explains.

    In 2012, Irish Dog Foods successfully applied for Enterprise Ireland’s RD&I funding to develop a humanised pet treat range, with the aim of launching these products in North America. The range included a healthy granola-style bar and a chicken fillet-based snack with superfood ingredients such as kale, spinach, cranberries and blueberries, and ingredients to promote good joint and skin health.

    This innovation paid off, and the new products opened doors in the US market. Between 2013 and 2015, export sales increased from €29 million to €43 million and 30 new staff members were hired in Ireland. The company is now heavily export-focused, with many well-known retailers stocking its products. These include Petco, Petsmart, Walmart and Costco in the US, and Aldi and Lidl in Europe. Irish Dog Foods also has distributors further afield in countries such as South Africa, Korea and Japan. “Our American customers operate in what is widely agreed to be the most impenetrable and competitive market worldwide. In a number of these, we are the only Irish manufacturer listed,” points out Queally.

    The company carries out all its R&D in dedicated facilities on-site. Initially, it had only one employee working on new product development. Now, the team has grown to fourteen people, including food technologists and innovation experts. R&D doesn’t have to be hugely technical, much of the work involves coming up with new ideas. “A key R&D facility is our innovation suite, a stand-alone room for thinking and brainstorming,” says Queally. “This is an environment designed for open discussions and idea generation, where we use idea boards to develop new concepts.”

    Queally would advise other Irish companies to follow his lead and apply for Enterprise Ireland’s RD&I funding. “Applying is fairly straightforward, and we learnt a lot about R&D throughout the whole process, even the application stage,” he explains. “It got us thinking strategically about our R&D and what it could bring to the business. Any hurdles were worthwhile and we had excellent support.”

    Click here to learn more about Enterprise Ireland’s Innovation supports.

    Chanelle

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    Tenacity and R&D Drive Chanelle Group Growth in the EU

    “The EU accounts for a much larger percentage of the total global veterinary pharmaceutical market – making up around 36% of the €23bn total, compared to 14-16% in South America.”– Michael Burke, Managing Director

     

    Key Takeouts

    • Higher prices and stable markets made EU the priority export market.
    • Concerted and strategic R&D investment has been a key driver of growth.
    • Enterprise Ireland supports have helped develop innovation and production capacity.

    Case Study: Chanelle

    Chanelle Group’s success in Europe has been largely based on founder Michael Burke’s long-term vision and awareness of the need to take time to develop markets which he believed held potential for the company.

    A qualified veterinary surgeon, he decided to give up his practice in the mid-1980s as he had spotted an opportunity to manufacture generic pharmaceutical products for animal health.

    In 1985 he bought a seven-acre site in Loughrea, Co Galway and started out with just two staff manufacturing products in a 40,000 sq ft warehouse for the Irish and export markets. “It was a small beginning, but we grew organically every year since as we learned,” he says.

    Nowadays, Chanelle is the largest Irish-owned manufacturer of pharmaceuticals in Ireland, employing 395 people and exporting to 80 countries worldwide, with key markets in the EU, Australia, New Zealand, Japan, South Africa and the Middle East.

    The group supplies ten of the top 12 multinationals in the world in both the human and veterinary pharmaceuticals sectors, with a product range including anthelmintics, anaesthetics and antibiotics that have come off patent. Sales growth in the past three years has been 30%, reaching around €100m in 2016.

    Burke was named Visionary CEO of the Year in the 2016 Animal Pharm Awards in January. Animal Pharm is a worldwide animal health publication in existence for over 30 years. Chanelle also won the Exporter of the Year 2016 award at the Irish Exporters Association’s annual awards.

    Top Tips for Exporting to Europe:

    • Perseverance and persistence are the keys to successful product registration.
    • Clear and simple strategy and goals enable organic growth.
    • Strong sales depend on continuous innovation.

    For more detail, click here

    Exporting strategy

    When Chanelle started out as an exporter it concentrated on South America and the Far East as it was easier to get product licences in those regions, according to Burke. “Europe, and the UK, was exceptionally difficult in terms of registering products. These markets were protectionist at the time, only wanting to grant licences to local companies operating in our sector,” he notes.

    However, in 1996 Burke took the strategic decision to pull out of South America and redirect his focus onto the EU as he felt there were better long-term opportunities there and it was a higher price market.

    “The EU accounts for a much larger percentage of the total global veterinary pharmaceutical market – making up around 36% of the €23bn total, compared to 14-16% in South America,” says Burke.

    “The first few years in Europe were very difficult but we just had to live with it. You could have a product registration application submitted for two or three years in any one market before you would even get a reply from the authorities – they just weren’t interested in registering foreign products.”

    Burke was undeterred and believed that patience would pay off in the EU after his experience of cracking the Japanese market. “We were the first company to introduce generic veterinary pharmaceutical products in Japan and it took us six years to gain a foothold there, with the help of the Irish ambassador at the time,” he recalls.

    “It’s a different ball game in Europe now. Everything is much easier from a regulatory perspective. Things changed in 2003/4 – now as a pharmaceutical manufacturer you just have to meet the necessary requirements and will get a product registered in about a year and a half.”

    Chanelle was required to register its products in each country in Europe individually. Once it had managed to get product licences the markets were open to dealing with the company and it was easy to get distributors, according to Burke – who makes a point of visiting all the company’s international customers personally at least once a year.

    Now, Chanelle Group has over 1,700 animal health licences registered in the EU and 500 in the rest of the world – the largest number of registered veterinary licences of any company in Europe. It holds over 800 product licences for human health products worldwide.

    About 83% of Chanelle’s business is in the EU at the moment. The veterinary side of the group has grown by 326% in the past ten years and by 236% in the past five years. Growth rates on the human side have been similar, having come from nothing in 2000.

    Chanelle’s approach in Europe was to start with the UK, followed by Spain and Germany. It set up a dedicated UK subsidiary, Chanelle Animal Health UK, in 1992 and in 2000 established Chanelle Medical, which focused on human generic pharmaceutical manufacturing.

    “The building of a new facility in the mid-1990s in Loughrea gave us the impetus to diversify,” says Burke. “We have totally different distributors, sales staff, regulatory staff and research and development [R&D] departments for the two sides of the business.”

    Focus on R&D

    The group as a whole is very focused on R&D as a way of differentiating its offering and dealing with competition. This has been a key driver of its growth. It has over 70 people working in R&D now, including 40 people at its R&D laboratory in Amman, Jordan. Chanelle Group also has sales offices in the UK and India.

    “We invest over €8m annually in R&D and this investment will continue as we launch 75 new products over the next five years in both human and veterinary pharmaceuticals,” says Burke.

    “We try to pick products for our pipeline that other companies may not be picking. This is an art in itself. For example, on the veterinary side we are developing ten ‘super generic’ products, one of which we have launched. There is nothing similar to these products on the market – other products may have the same active ingredients, but not the same formulation.” The super generic product launched was Rheumocam Granules, which treat musculoskeletal disorders such as arthritis in horses.

    Chanelle is in the process of completing a 30,000 sq ft expansion of its 300,000 sq ft facility in Loughrea as part of a €70m investment programme supported by Enterprise Ireland. This will double production capacity at the site and lead to the creation of 175 new jobs over the next five years.

    “One of the keys to our success has been our people, 60% of whom are third-level graduates,” notes Burke. “This will continue to be the case as we look ahead to expansion into new markets including the US. We expect revenues to increase by 65% over the next five years.”

    Chanelle’s Partnership with Enterprise Ireland:

    • Availed of various supports including overseas advice and R&D supports.
    • Enterprise Ireland Lean programmes have helped drive operational excellence.
    • Completing a major expansion of its Loughrea facility as part of a €70m investment programme supported by Enterprise Ireland.

    To see how Enterprise Ireland has supported Chanelle from day one, click here.

    Irish companies focussed on export growth

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    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

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    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:

    • Authorisation

    • Reimbursement

    • 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

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    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.