Medical devices are becoming increasingly complex, sophisticated and yet miniature.
The rise of nanotechnology, biologics and combination devices, among other innovations, is changing the shape and size – as well as the commercial and clinical potential – of the medical devices industry.

Moreover, in this deeply competitive commercial world – where it can take years and significant investment (not to mention regulatory clearance) to bring a device to market – there is a constant challenge to make development cycles shorter, often with very specific demands being put on components.

Pressures around cost, energy, design, materials and installation space, especially for devices being operated in confined labs or operating theatres, are intense. On top of this, of course, strict legal provisions and regulation of assemblies and materials have to be adhered to. This rapid evolution of devices is having a knock-on effect on positioning systems and drives, systems that are, of course, vital to the success of any device.

"Pressures around cost, energy, design, materials and installation space for medical devices are intense."

As Ulf Hottung, industry manager, medical technology at Cologne-based producer of injection-moulded polymer bearings and reinforced plastic cable carriers Igus, points out, systems are having to become ever more flexible, cost-effective and adaptable to respond to the competitive commercial climate.

"Positioning systems will, inevitably, be led by customer demand. Some will be looking for the highest accuracy; for example, if you need an ultrasonic device to destroy stones, then you, of course, need to be able to point at a very exact target," he explains.

"But for other customers, the priority will be around weight. For a mobile device, such as a syringe pump, it is the weight that is more important – and many are now not even as big as a mobile phone.

"As devices become more complex you do not want grease or oil between the device and the probe, so we are developing more positioning systems that do not need maintenance or lubrication," he says.

Plastic – medical devices’ flexible friend

A good example of this sort of innovation in action is Igus’s recently launched miniature linear axis SLN-27, where the priority was to create a system that was small, extremely lightweight and flat. It is lubrication-free, using plastic plain bearings in the spindle bearings and in the carriage. The focus, in terms of material and design, has been to make it as flexible as possible.

"Increasingly, what we are seeing in the medical devices arena are linear slides that are lubrication-free, light, quiet, modular and low cost," says Hottung.

Similarly, the use of polymer plain bearings has led to the development of systems at reduced cost and, again, eliminated the need for lubrication. Low-cost ‘e-chain’ (energy chain) systems and flexible cables are also driving innovation in this arena.

"The use of plastics, for example, means that systems are becoming more lightweight, which is very important because it saves on motion power and reduces energy, as well as increasing the life of the system," Hottung explains. "We have, for example, been working with plastics since the mid-1980s and do more than 9,000 trials a year.

"The use of polymer plain bearings has led to the development of systems at reduced cost."

"Devices are also becoming more portable. If you are in an operating room it’s no longer the case that devices will be fixed within the room; they will need to be much more portable, so it is about developing solutions that improve efficiency and save time as well as improve diagnosis."

The move in October by the Royal London Hospital to use an e-chain for a new X-ray machine is a good example of the imperative now being put on flexibility and portability.

"Smaller and cheaper – this is the mantra driving the market," says Hottung. "There will be a trend for medical technology to become smaller and more efficient. But there needs to be a balance – it needs to be solutions that are the most appropriate and the most adaptable.

"In terms of the market, I think we will see more collaborations between companies and more expansion into emerging economies, such as Brazil. There will be more collaboration around expertise and a continuing drive towards cheaper solutions."

New markets for plastic devices

Medical device manufacturers, and by default medical device positioning systems’ makers too, have been recognising the untapped potential of emerging economies and developing nations for some years now.

As Jim Furniss, senior vice-president at pharma market access consultancy GfK Bridgehead, pointed out in a recent online article, there is a growing recognition that the device market in developed countries, such as the US, Europe and Japan, has reached saturation point.

By comparison, markets such as Brazil, Russia, India and China are considered to offer real, sustainable potential for growth.

"The CAGR for medical devices was globally estimated to be 5.8% between 2009 and 2012."

The compound annual growth rate (CAGR) for medical devices was globally estimated to be 5.8% between 2009 and 2012, according to a Frost & Sullivan report published in 2010. By comparison, the CAGR for China alone between 2002 and 2006 (not even taking into account more recent years of strong growth) was 14.9%. In India, too, the medical device market is expected to reach $10.7bn by 2019.

"These regions are important, not only for the growth in sales related to increased adoption of medical devices owing to increased health awareness, but also as a desirable location to build capabilities," Furniss said.

"The key message is that medical technology has to look for the most appropriate solutions and applications, not necessarily the most high-tech," adds Hottung. "Medical technology is inevitably very expensive, so it is important to think about your human and material resources, too."