Featured Article 30 Aug 2019
Image: © Monkey Business/Stock.adobe.com
Image: © Monkey Business/Stock.adobe.com

The decision by German medical device company Phenox to establish an Irish manufacturing and development facility in Galway in 2015 was a direct result of the city’s status as a global hub for the medtech sector. Indeed, before moving into lean consultancy, Phenox Ireland’s managing director, Ken Beatty, had worked for many years in the sector in Galway.

Founded in 2005, Phenox is a privately held company headquartered in Bochum. The company is focused on neurovascular devices, developing and manufacturing innovative, cutting-edge products for the interventional treatment of ischemic and haemorrhagic stroke. It is an acknowledged leader in the development of technologically advanced interventional neurovascular devices. Its products are sold directly into the most active hospitals in the field throughout Europe and in a number of countries in Asia, Africa and Latin America.

“Our role in the Galway facility is two-fold”, said Beatty. “Initially we transfer products designed by our German parent and make them ready for sale in the US market while, also in parallel, design and manufacture a range of industry leading microcatheters for the worldwide markets that work in tandem with those products.”

The engineering involved in the design, development and manufacture of these products is highly sophisticated and enormously complex. The products themselves have to be small and delicate enough to travel through the circulatory system into some of the smallest blood vessels in the human brain and perform a range of functions. These include the removal of blood clots, reinforcement of blood vessel walls and the diversion of blood flows – all without doing any damage.

At present, the Galway facility is in the final stages of the development of a catheter portfolio which will be used to carry a number of thrombectomy, flow diverters and bifurcation aneurysm implants.
While the popular image of a catheter is of a very thin plastic tube inserted into the body either to facilitate the outward flow of substances or to carry in payloads such as cardiac stents, this view is overly simplistic.

Beatty explained that the catheters under development and tested in Galway involve intricate braiding and coiling technologies fused together under nine different polymers which gives the catheter the flexibility and capability to be tracked through the blood vessels all the way to the point of treatment in the brain. The profile of the catheter tapers almost imperceptibly as it narrows to a thickness of less than 0.5mm with the leading edge retaining its shape, yet soft enough to not damage the blood vessels it traverses. In addition, advanced hydrophilic coating is applied to reduce friction on its journey through the circulatory system.

The device has been designed completely in Galway. This is accomplishment enough, yet the manufacturing process is even more impressive in its own way. “We can manufacture in a day here what it would have taken anything up to 15 days to do 25 years ago”, said Beatty. That’s also testament to the level of medtech expertise which exists in the local workforce.

Galway-manufactured catheters could be in use by neurosurgeons in Europe as soon as the end of this year, a quite remarkable achievement in this industry sector. “You need to do many design iterations until you get a catheter that’s going to perform in the neuro area”, Beatty explained.

“We have taken less than three years to take a product from design to market, that’s extremely quick by the standards of this industry. The catheters will have to go through a number of design verification tests prior to its submission to get a CE Mark. Once that’s done, we should start generating revenue from sales in Europe. We hope to get there by December of this year.”
That will be followed by other Phenox products coming out of Galway for sale on the US market.  The future is bright for the Galway facility which currently employs 40 people and is set to grow to 55 by 2020.
“It’s a billion-dollar market and growing”, sayid Beatty. “The growth is being driven by multiple clinical studies demonstrating that the reduction in disability after stroke onset is directly linked to patients who are treated quickly with medical devices as opposed to those treated with drugs alone.”
This data has initiated the move to decentralised treatment of stroke, which in turn will see an increase in the use of devices. Patients often make it to centralised facilities too late for treatment. It’s about the FAST (facial drooping, arm weakness, speech difficulties and time to call emergency services) protocol. To achieve that you need more treatment centres.

“It’s a very stable industry”, he added. “It’s still quite labour intensive. You won’t make catheters of this type with robotics for some time as there are subtle skills that are required. You can programme some elements of the process into machines but not the whole lot of it. In addition, quality assurance will also stay manual, for example. Phenox will remain an out-and-out neuro company and there is not a lot of that in Ireland at the moment.”

Barry McCall

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