Stanford University's Biodesign Fellowship is the inspiration for the BioInnovate Fellowship Programme in NUI Galway, writes JOHN HOLDEN

IRISH PEOPLE have never been opposed to taking on new and better business approaches from elsewhere. One area particularly ripe for increased commercialisation in this State is the medical devices industry. While our experience of commercialising academic research is still on a learning curve, US universities have been adept at the process for a long time.

When Ian Quinn of BioInnovate Ireland visited Stanford University a few years back, he hoped some of the American entrepreneurial spirit might rub off. It did.

Running in Stanford for 10 years now, the Biodesign Fellowship recruits eight people who, in two groups of four, look into the current needs of the medical device industry.

BioInnovate Ireland, based in NUI Galway, has the same objectives and has just completed its first programme since it began in 2011.

“It’s always a great idea to bridge the gap between academia, industry and innovation, says Quinn.

“In the medical device sector it’s worked at Stanford for years and doesn’t require huge resources.”

In a nutshell, the programme “hot houses” individuals from multidisciplinary backgrounds so they can discover and develop new opportunities for innovative medical devices. Doctors, engineers and business people are brought together to work intensively for one academic year. By the end, the expectation is that new spin-outs will emerge.

“We are a consortium which includes NUI Galway, Dublin City University, University of Limerick, Royal College of Surgeons Ireland and University College Cork,” explains programme director Dr Mark Bruzzi.

The programme is funded by Enterprise Ireland and also by the medical device industry.

“Our objectives are to train people in the process of innovation focused on medical devices, identify unmet clinical needs, invent solutions to meet those needs, implement them and bring the overall plan to market.”

Those recruited for the fellowship will have had some experience in the industry already but are now keen to start up their own business.

An interest and enthusiasm for the subject matter must already be there as the training gets intense. Fellows have access to six hospitals and 30 consultant doctors throughout their clinical exposure. “During this first year of the programme, the students identified over 300 medical device needs,” says Bruzzi.

“They then went on to list the top 40 problems where clinical needs were aligned. Two projects are currently under evaluation, one of which has received funding by Enterprise Ireland.”

This first year of the programme focused on cardiovascular disease, with the two based in Dublin and Galway respectively.

Colin Forde was the engineer on the Galway team. “I had been working in Creganna Tactx Medical Design and saw the fellowship advertised,” he says.

“Previously I had my own medical device business in the area of delivery systems and implants. My experience of being in business on my own meant I was already accustomed to working with doctors, start-ups and corporations. So I was delighted when this fellowship came up.

“The year was excellent. We achieved a lot along the way, and learnt a broad perspective of the medical device industry. Our main achievement though was identifying a problem worth solving and trying to start up a business to meet that need. We have started on that road.”

Wayne Allen was the business head of the Galway team and is as excited about their new venture as his colleague Forde.

“I already had 15 years experience in the medical devices industry, seven of which were spent in the US. So I had a good idea about successful commercialisation in medical devices,”he says.

“My main objective for getting involved with BioInnovate Ireland was to find a problem that would enable me to spin out a company, and we have done that.”

Their company is developing a new embolization device used in the area of interventional radiology.

“It shuts down blood vessels to prevent internal bleeding,” says Allen. “Very often it would be used as an adjunct therapy for cancer treatment. We just received Enterprise Ireland funding to develop the technology over the next 18 months.”

Technology transfer, university innovation and incubation centres are not new to Ireland. This type of activity has been going on here for decades. What makes BioInnovate and its inspiration, Biodesign, different is their needs-based approach.

“Many universities come together to work on programmes to support the medical device industry,” says Bruzzi. “But our unique selling point is that we work on real life problems by recruiting experienced professionals to work together in teams.”

Stanford has had great success since its BioDesign programme was set up in 2000. “My working definition of innovation is: ‘Inventiveness put to use’, meaning you

have an innovation and can actually get a product from idea to clinic,” explains Prof John Linehan of Bio Design in Stanford University.

“Historically in the medical device industry that was an exclusively entrepreneurial activity. Most disruptive technologies making their way into medicine are done by start-up companies.

“People often say successful entrepreneurs need to have had two or three failed companies before they’re successful. Mistakes are made and companies fail. But the process of innovation, ie putting invention to use, is an intellectual one – therefore you should be able to teach it.”

Medical device research and innovation is strong in Stanford where the co-ordination of activities between medicine, engineering and business has been very successful. Bio Design began in just over a decade ago and about 80 medical device innovation fellows have graduated. Of that number, about 20 firms have emerged, some still at an early stage, with others having already been acquired.

“It’s a complicated process,” adds Linehan. “You don’t just need to think about coming up with a device and putting it in a box. There are, for instance, regulatory processes that one has to attend to. You cannot legally market a device without approval of a regulatory agency.

“Early on, entrepreneurs in this area must also be careful they understand the freedom to operate, the intellectual property that may prevent them from carrying the product forward. Then one must also be clever about designing a manufacturing process, and be capable of making devices with a zero failure rate. There is no margin for error in the medical device industry.”

Linehan was also involved in the setting up of Bio Innovate Ireland and is impressed with what he’s seen thus far.

“It’s already serving as an effective connector between universities and industry as a neutral ground to meet and share ideas. BioInnovate is effectively tapping into the rich experience already in the manufacturing medical device space in Ireland and helping to foster new educational and training initiatives.”

My definition of innovation is: ‘Inventiveness put to use’, meaning you have an innovation and can get a product from idea to clinic