Pharmaceutical drugs and medical devices help millions of people worldwide to live longer, and better lives. It is crucial, however, that existing products remain safe for consumers, despite ongoing changes in the materials or equipment used to produce them. It is also vital that everything possible has been done to ensure the safety of new medical devices and drugs. The front-line in the fight to ensure all these products are safe, time after time, are validation engineers like Emmet Tobin, based at Millipore Ireland, in Cork.

 The size of the medical device market is staggering, with approximately 160,000 hip and knee joints replaced with implanted devices each year in England and Wales alone. The prescription drug market too is massive too, with an estimated one sixth of the UK adult population, or just under 8 million people, taking anti-depressant drugs on a regular basis. Given these figures, from just one country, our nearest neighbour, it is remarkable that industry has managed to produce medical products so safely for so long.

 That they have done so is due in large part to the work of engineers like Emmet that work feverishly to ensure that processes and manufacturing standards comply with those of the world’s leading regulatory agencies, such as the US Federal Drug Administration or the European Medicines Agency. We all take the safety of medical products for granted, and there is outrage when safety has been breached. This is the context in which Emmet works. His work is difficult – success is expected, and failure is unthinkable.

Education

Waterford native Emmet had an uneventful primary school education before attending Mount Sion where he started to show an aptitude for technical subjects. He studied engineering and physics for his leaving certificate and had an ambition to go into teaching. However, the points for teaching training courses were high, Emmet recalls, so he decided to apply for a manufacturing technology course in Waterford Institute of Technology. He was accepted for that, and got this Higher Certificate in 2001. However, rather than seek work immediately he decided that he would apply for another third-level course in Medical Engineering and Medical Bioengineering at the University of Bradford in the UK.

The interest in medicine and biology had been stimulated by his volunteering work with the Order of Malta in his youth. He was trained as an early responder to medical emergencies and attended public events such as gymkanas, horse shows and rallies in that capacity. He did his research and discovered that the University of Bradford had a long history of achievement in the bioengineering field. The lecturers were well known, and some had been at the university since the start of hip and knee replacement surgery in the UK several decades before. He decided this course was for him, and he made the brave decision to move to England to further his education. Emmet had a friend in Bradford, but he recalls that the initially six months were difficult as he tried to settle in, and make some friends. The course lived up to expectations: the lecturers were passionate and knowledgeable, and the they covered key areas such as biomechanics, biodynamics, tissue engineering, medical ethics, and electronics.

There was an opportunity mid-way through his time at Bradford to come back to Ireland for a summer and work at the National Centre for Biomedical and Engineering Science at Galway. This helped him learn more about biology, and how to grow cells in the laboratory. In his final year at Bradford he worked on a tissue engineering project focused on growing cells to replace damaged or burned skin tissue. By the time he graduated, he was ideally placed to find work in the pharmaceutical or drug device industry.

Work

After graduating in 2005, he returned to Waterford where he got his first job working with the manufacuring division of Teva Pharmaceuticals in Ireland. This operation was involved in the manufacturing of tablets and inhalers. Emmet worked there as a research and development engineer for two years. However, he started to become restless after a few years, as he was still living at home with his parents, and was keen to strike out on his own. Antoher factor in his getting itchy feet was that he felt that the wheels of the pharmaceutical industry turned very slowly, and it took a long time to get things done. He was getting bored. Then in 2007 his mother passed away, and he decided he would give up his secure, permanent job and go travelling the world. His career was effectively put on pause, and leaving his job was something of a risk, but he was betting that he would be still well placed to get job when he returned to Ireland. The travelling brought him to South Korea where he taught English as a foreign language. It was hard work, but he gained very valuable experience working in a an Asian country.

Emmet returned to Ireland in 2008, and suddenly the country was in the middle of a huge economic crisis. He found himself out of work for several months, but finally got a new job in his native Waterford with the giant contact lens manufacturer Bausch and Lomb. The fact that he had been educated in the UK, and had travelled and experienced life abroad helped to ‘put some colour on his CV’ and make it stand out from the crowd, Emmet said. At Bausch he had the responsible job of ensuring the safety of new products coming onto the market and meeting the stringent regulatory requirements of the US Federal Drug Administration and the European Medicines Board. He became familiar with what it takes to deliver safe and effective product onto the market time after time. This was a responsible and important position.

His first job in Ireland outside of Cork came next with Stryker Orthopaedics at Carrigtwohill. The products here were a long way removed from disposable contact lens. Instead they produced hip and knee implants and other medical devices that were designed to last for 15 to 20 years or more inside the body. Again he worked as a validation engineering making sure that new Stryker products, or the industrial processes in place to develop these products complied with safety regulations. It was a hard-driving culture at Stryker, with people regularly working long hours, and pressure to get the job done. It was differnt to other working environments he had been in, but it was another new, valuable experience.

Emmet spends a good deal of his time on the computer writing safety protocols, or plans for how the safety of products and processes can be continually ensured. He also runs tests of various kinds, liases with people on-site and off -site as required. These people include other engineers, operators, chemists and vendors, for example. Millipore produces a lot of differnt products, so Emmet is kept extremely busy with ensuring the safety of existing products and processes, as well as new products. He has been ‘ up the walls’ with work at Millipore since his arrival there, and has no time to get bored. The job is challenging and rewarding, with a great deal of variety, and that’s the way he likes to have things.

Advice

In terms of advising the current crop of school leavers, Emmet says that engineering is an excellent choice for those that are technically minded. Engineering offers many options to change career path and people can end up doing things that they like that they had never envisioned starting out. For example, Emmet says that he would never have thought that he would have ended up being involved with making hip implants when he started his course at WIT. Engineering offers multiple career choices, and unlike some other careers, people don’t tend to easily get ‘boxed in’ career wise. It also offers the opportunity to travel, gain experience, and work with many different companies. The only downside, he offers is that the work can be very responsible and serious and there can be a lot of pressure at times to get the job done.

There is also the fact. that bio-engineers are highly sought after in Ireland. Emmet says that at any time he has a choice of potential jobs available to him, given his specialised education and the high level of his work experience. If I updated my CV on Monster one day I might get 20 calls about jobs the next day, said Emmet. These days in Ireland, he acknowledges that this is a very privileged position to be in.

This article was first published in Science Spin, September 2013 Issue