For a small country, Ireland's medical devices sector is huge. Proportionally, we have more people working in the industry than anywhere else in Europe. With 250 medical technology companies in the country, a large proportion of Ireland’s engineering talent is being employed in the R&D of new devices, often for multinational rather than indigenous companies.
When Galway entrepreneur Ian Quinn of med-tech firm Creganna-Tactx Medical witnessed the Irish engineering talent that was contributing to R&D in multinational companies, he believed there was an opportunity to encourage and support these people to develop their own ideas and set up indigenous Irish R&D med-tech companies. Quinn had observed a programme in Stanford University, California, called Stanford Biodesign. This encouraged invention and entrepreneurship among professionals. He was convinced that something similar could be set up in his home town of Galway and he mentioned it to Dr Jim Browne, the president of NUI Galway.
The result, the BioInnovate Ireland Fellowship, a medical technology innovation programme focused on developing the next generation of medtech entrepreneurs, has become one of the most exciting opportunities for engineers, doctors and business people who want to make a splash in the potentially highly lucrative med-tech sector.
“When engineers and doctors put their heads together to solve problems, a certain magic happens,” according to Paul Anglim, programme manager of the BioInnovate Ireland Fellowship.
BioInnovate Ireland brings teams of professionals together – engineers, doctors, product designers and business people – and sends them into hospitals where they observe and gather information in order to identify areas for improvement known as clinical needs.
The multidisciplinary nature of the teams is key to the programme. These are all serious people, with serious careers who bring a unique perspective to the problems doctors encounter when treating patients.
“Engineers think differently and bring a very useful set of skills when it comes to solving the problems that doctors and patients face,” Anglim said. Indeed, everyone who is on the ten-month BioInnovate programme is sponsored by Enterprise Ireland to the tune of €30,000. It is a credible investment and the results so far are very promising.
After identifying their lists of clinical needs, the participants then go through a process of whittling down the list of needs they have identified to just one or two. In the process of narrowing the list, the teams are also identifying the market opportunity behind the needs and they then set about and developing a medical device or indeed an ICT solution to address the need. The beauty of this process is that in order for there to be a market for a new medical device or solution, the new product has to be significantly better, more efficient or cheaper than what is already in place. If it’s not, there will not be a demand for it.
BioInnovate fellows have the potential to both improve patient outcomes and develop a potential future medtech company. The fellowship so far has been very successful. In just four years, BioInnovate Ireland can claim ten technologies, one spinout company, one licence and three other companies in development. It has the Stanford seal of approval – it is the only affiliate of Stanford Biodesign worldwide – and it collaborates with the Mayo Clinic.
Engineers are a crucial element of the team. Anglim says, “The engineering background is critical in the creative thinking, problem solving and technical expertise aspects of the process. Without the engineers, there would be no working solutions much of the time.”
BioInnovate fellowship profiles
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Kevin Kelleher[/caption]
Kevin Kelleher has a PhD in biomedical engineering and a master’s degree in technology entrepreneurship. He and his colleague Rhona Hunt have just completed year one of the commercialisation process for their device Ostoform.
"Before I did the BioInnovate fellowship, I was working for a Dublin-based medical devices company called Trulife, initially as a materials engineer and then as the group research and innovation manager. I saw the chance in BioInnovate to identify and commercialise opportunities myself. The idea of being involved in a start-up appealed to me.
"I was also curious about the BioInnovate process as a way to innovate. The approach I was familiar with was very technology driven. BioInnovate takes a different approach, using the clinical need as the starting point. It was also a great opportunity to work with a team with diverse backgrounds.
"The first month was a big learning curve. There were so many things laid out for us to consider. We had to look at regulation, evaluating market size, figuring out whether a device could be commercially viable. In addition to that, we were studying up on anatomy – my team was going to be looking at the area of gastroenterology so we were learning about that too. After the first month, we went straight into hospitals which was another huge learning opportunity. It was very foreign to me as an engineer – everything, from the hygiene rules to communicating with doctors and access to patients. It took a lot of time to get the hang of everything.
"By the end of that experience we had identified hundreds of clinical needs, all of which we needed to research and filter through. That was a time-consuming job, but when it came to the final group of needs, we settled on trying to come up with a better solution for peristomal skin complications. Patients with colostomies or ileostomies can develop a lot of skin problems and we decided to try to develop a solution for that. Having a background both in engineering and in business was really useful, especially in the second half of the year. I found that as the concept developed, having the skills to design and mock-up prototypes was very useful.
"Our device, Ostoform, is now a year into the commercialisation process, funded by Enterprise Ireland. We're based in the University of Limerick and at this point we've collected some really encouraging patient data. We're now working towards a bigger patient study and so far things look promising."
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David Townley[/caption]
David Townley is co-founder of Neurent Medical Ltd, an early stage, medical device start-up company, developing a novel solution for rhinitis, a condition that affects millions of people worldwide. He has 14 years’ experience in medical devices companies in the life science sector. Townley holds a Bachelor of Engineering Degree (Mechanical) from the National University of Ireland Galway, a Masters of Science (Technology Management) from the University of Limerick and a Masters of Science (Bioinnovation) from the National University of Ireland Galway.
"I was working in industry as an R&D manager in Australia, but I really wanted to engage with an entrepreneurial and innovative environment back in Ireland. BioInnovate was it for me. You need to understand, while the BioInnovate fellowship may be based in NUI Galway, for me this wasn't an academic undertaking. This was an intentional career move.
"A lot of aspects appealed to me. The access you have in the programme to the people who are at the forefront of the med-tech industry is incredible. Their mentoring greatly enriches everything that happens, its and active partnership between academia, industry and clinicians. The multidisciplinary team structure also fosters a very creative environment. I've worked in a lot of different fields in the medical devices sector – vascular, orthopaedic, ophthalmology – but I was allocated the ENT (ear, nose and throat) discipline as a focus area in the fellowship. I had no preconceptions about the areas of opportunity or the clinical needs, which was a great advantage.
"The clinical immersion aspect was extraordinary. The access we had and the time we spent observing and communicating with clinicians, healthcare workers and patients was – we made thousands of observations which we then had to investigate and filter through.
"BioInnovate is a great vehicle for innovation and entrepreneurship because you are forced to really interrogate the opportunities and look at it from all angles. You have to gauge the appetite for the product from a technical, clinical and investible perspective; you have to look at market analytics, competitive landscaping, healthcare economics, financing and user acceptance. It all serves to lessen the risk when you examine an idea that closely. If you manage to convince yourself that it's worth working on, you're on firmer ground when you're trying to convince others to do the same.
"Right now, we're still at an early stage of developing our idea but it's incredibly exciting. We've had really positive feedback and rhinitis is a massive unmet clinical need so we think we're on to something meaningful.
"My engineering qualification has been vital to the whole BioInnovate experience. We have such a huge cohort of people working in the medical devices sector in Ireland, they can bring so much to a programme like this. The level of talent that BioInnovate is recruiting is second to none. When you have a room full of people who have made personal and career sacrifices to have the chance to innovate and become entrepreneurs, you know you're in the middle of something very special indeed."