Cardiovascular implant pioneer finds that getting the 'right people in the room' is crucial, reports Dominic Ryan

Every year, patients are invited to visit the Vascutek manufacturing facility in Glasgow. For the 700-plus employees who work there, it is a day to experience the ultimate feeling of job satisfaction.

This is because their guests, who are often accompanied by equally grateful family members, are the recipients of devices Vascutek has pioneered and manufactured to help combat life-threatening cardiovascular diseases.

These devices are highly engineered woven or knitted tubes made from polyester yarn impregnated with a unique gelatin sealant, that act as replacement blood vessels.

Often they are used for someone who has suffered an aneurysm - a bulge in the aorta, which is the main artery leading from the heart.

The visitors are here to observe the graft manufacturing process, meet the production operators whose skill and work have helped save their lives and share their own story with employees, recounting what life was like before, during and after surgery.

For the company's President and CEO Paul Holbrook, the visit is living proof of a job well done.

That job is a team effort with input from surgeons, technicians, biomedical engineers, production operators, patent lawyers and marketing teams.

This belief in the power of teamwork is, in fact, what gave birth to Vascutek in the first place.

Holbrook traces the roots of the company back to 1979, adding: "That's when three groups - Coats Paton, who are renowned experts in textile technology, surgeons from Glasgow Royal Infirmary and biomedical engineers from the University of Strathclyde - joined together to develop a new vascular graft.

"It's actually a really nice story of innovation, with three very well established and respected organisations in the West of Scotland combining to produce a global product that in many ways represents the gold standard in the treatment of vascular disease."

What began life as a team project very quickly evolved and then, just three years later, Vascutek as a limited company was founded.

It is a remarkable beginning but, as Holbrook points out, finding new and innovative ways of doing things is at the heart of the business.

"Innovation isn't simply about product development or new products," he says, "it's also about manufacturing. Innovation can apply across a whole range of different functions within an organisation but what Vascutek was able to do from 1982 onwards was to take conventional knitting and weaving technology and adapt this to produce sophisticated structures that are the basis of vascular graft technology today.

"Our style of weaving loom, for example, was once used in the car industry to make seat belts and our style of knitting machine is still used to produce ladies' hosiery," he adds.

"So, you see, what Vascutek engineers were able to do is take traditional technology and adapt it for use in our medical industry.

"Right at the start of the company's development innovation was already at play in the manufacturing arena and it laid the foundations of our business. Innovation is intrinsic to the development of Vascutek, historically and going forward."

As Vascutek's VP Research and Development, Dr Mark Steckel also places great import on the continual evolution of its processes and products.

"Vascutek developed its own in-house technology," he says, "and because of this we've been industry leaders from day one. We're well positioned to continue that leadership with the next generation of medical device technology."

If technology has given Vascutek a head start on the competition, Dr Steckel is keen to emphasise that saving lives and improving health remains its primary motivation.

"Typically, our new product innovations are driven by what the clinical need is," he says. "We have a very focused vision: 'It's all about the patient!'

"We're always looking at how we can improve the clinical outcomes for patients. That can be a faster recovery time, a smaller incision, reduced time spent in the operating theatre, or the elimination of a secondary surgical procedure.

"These are the things we focus on: what are the unmet clinical needs and how can we meet them?."

Importantly, the notion of teamwork plays its part here too.

"It's a global collaborative process," says Dr Steckel. "We have a group of cardiovascular surgeons who share information and ideas from all corners of the world which helps us to identify patient needs and product opportunities.

"In-house we also have research and development, production and marketing, all working within, as you would expect, a highly regulated environment." Such teamwork has paid dividends for patients not just in Scotland but all over the world. The vast majority of the company's total output is now exported to around 100 countries.

Holbrook says: "In general we haven't experienced obstacles in developing our international business. The UK is an important marketplace for us but consistently 90 per cent of what we develop and manufacture is exported, so we have a tremendous history in providing products that not only meet the needs of patients and clinicians here in the UK but overseas as well.

"The United States, for example, is one of our biggest international markets. We consistently grow year on year there and with a product range that is extremely important to clinicians and, in particular, cardiothoracic surgeons. We also cover markets in Japan, Latin America, Asia, throughout Europe and the Middle East, so we have a truly global portfolio."

One challenge in operating in so many different markets is that each country has its own unique regulatory hurdles to overcome.

"Essentially regulatory bodies are interested in the safety of the device and the efficacy of the device," says Holbrook. "Depending on what the product is it may require a clinical trial - different markets have unique interpretations of what's needed."

Economic priorities mean there are differences, too, in the emphasis that certain countries are able to place on using devices. However, as economies in developing countries, such as Latin America and Asia, are gradually able to increase their public healthcare expenditure, Holbrook expects more funds will be made available to target vascular disease.

Meantime, in more established marketplaces such as the USA, Germany and Japan, he is seeing an appetite for increasingly sophisticated technology - and the Vascutek team is already working hard to meet the demand.

"For example, we have a new product called ThoraflexTM Hybrid," says Holbrook. "This saves lives as it enables the treatment of patients who may have previously not survived the trauma of the second stage of a specific type of operation. These patients can now be treated, as the innovative design of our product enables the procedure to be completed in one operation.

"Our device significantly cuts down the operating time, which means patients who could have died of an aortic dissection or aneurysm can now be more safely and successfully treated."

Being able to treat such groups of patients means that Vascutek can deliver products to a whole new patient population within established economies.

"So there is business growth at a macro level," says Holbrook, "but when you get down to individual disease states and patient

populations there is growth within there too."

Such degrees of complexity in meeting the needs of a range of different medical diagnoses - as well as dealing with the various regulatory bodies, legal systems and potential patent issues all over the world - reflect the fact there is more to the business of creating ingenious medical products than a single Eureka moment.

Dr Steckel says: "It's still very much about having that great idea but the really hard part is pulling it all together into product technology that is of benefit to patients and is commercially viable.

"One key principle of the Research and Development team is to design and develop devices which meet the skills and requirements of all surgeons worldwide and not just the most highly experienced surgeons, thus treating the greatest number of patients."

And so is there a secret to success? What advice might he give to a Scottish business that wants to be more innovative?

"Whether it's entrepreneurs, start-ups or businesses at various stages of development, I think what it boils down to is having the right people in the room," says Dr Steckel. "As I mentioned, the idea is often the easy part and the really hard work is putting it into practice and commercialisation. So to build a successful business out of that requires every single one of the players to be working together."

Even with the team working together, however, not every great idea will find success. Holbrook estimates that - across industry - for every 100 new ideas 99 don't make it to fruition.

He points out: "Our experience is that there is no end of good ideas but what you really need to understand is what the clinical need actually is: will the end user's need be met and how do we develop and manufacture in a way that is meaningful to everyone.

"Just as much as looking at technology, that involves knowing how to launch and market the product rather than simply creating something that is a nice idea then finding out we haven't the commercial

elements that have to go hand in hand to make everything work."

Award-wnning technology

Vascutek has received a total of seven Queen's Awards, with recognition for its pioneering work in Innovation and International Trade.

In 2012 Vascutek was honoured for "Business Innovation of the Year" at the Scottish Business Awards.

In 2013 the award was again granted to Vascutek in recognition of the development of Fenestrated AnacondaTM and the "significant contribution made by the company towards saving the lives of patients worldwide with innovative medical technologies".

This year Vascutek was a finalist for the Innovation Award in the prestigious Scottish Enterprise Life Sciences Awards.

To date there are almost 1,000 previously "inoperable" patients all over the world whose lives have been saved by clinicians using Vascutek's new Fenestrated AnacondaTM device.

In 2005 Vascutek launched AnacondaTM - a unique stent graft that can be repositioned if the clinician can see on the X-Ray that the patient's renal arteries are being compromised.

Since the launch of ThoraflexTM Hybrid in 2012, over 800 patients and their families have been freed from the trauma of a second operation.