The medical devices industry: forgotten by governments?

The medical devices industry is often overlooked in terms of economic and technological importance, particularly when compared with the pharmaceuticals sector. Determined to raise awareness among national healthcare systems that are reluctant to fork out for supplies, however, the industry is on something of a public relations drive.

Bleeping scanners, wheelchairs and syringes are perhaps less exciting than genetics and pioneering stem-cell treatment. Much of the medical device sector produces the mundane paraphernalia to be found in any local hospital, the clunky objects that have come to be taken totally for granted. Given the sheer cost of some items, many governments are reluctant to invest in stocks of say, orthopaedic shoes and artificial hips, preferring to pump out painkillers and penicillin instead.

"We have a serious challenge in terms of funding and reimbursement," says Maurice Wagner, director-general of the European Medical Technology Industry Association.

"A lot of governments consider a lot of devices to be too expensive. But, we want to show that efficient use of devices can reduce the cost of treatment. What we are really trying to do is to demonstrate the real value of this technology."

In terms of legislation, items such as bandages, bone filling and scanners are covered by the medical devices directive, adopted by member states in 1993. ‘Active’ devices like pacemakers, which regulate internal functions of the human body, are covered by the active implantable medical devices directive, adopted in 1990. These two pieces of legislation are currently under review - both should be approved by the European Parliament and member states by the end of the year. Finally, devices used to conduct tests on samples - for example, blood, tissues or urine - are covered by a third piece of legislation, the in-vitro diagnostic medical devices directive.

"The EU institutions have recognised the efficiency of the current system," says Wagner, referring to the review of the first two directives, which together form the core of legislation governing the sector. "That’s what we think is important." But, he points out, new technological developments straddling the fields of mechanical medical devices and pharmaceuticals may not be covered as effectively by existing legislation.

Devices used in cases of arterial collapse are one such example. ‘Stents’ are the metal mesh tubes used to prop up arteries. The devices, which have a clear mechanical function, also have pharmaceutical properties. To prevent the artery from dilating, a common negative reaction after treatment, the stent releases a drug called paclitaxel. Currently, ‘stents’ are not catered for fully by EU legislation.

"Applying the rules of the directive, the principal function [of a ‘stent’] is that of a medical device," says Wagner. "This is a very research-intensive industry. I’m sure there will be many changes in the future. There will be a need for all stakeholders, industry, regulators and scientists to rethink how new breeds of product which possess mechanical and pharmaceutical properties are addressed."

Other changes in sight are communications-related. The advent of e-labelling, for example, will mean greater use of the internet, CD-ROMs and so-called integrated support systems that will allow consumers to programme medical devices. Using this innovation, consumers will be able to set implanted electronic devices such as pacemakers in accordance with development of their condition. Revisions to the medical device directive will open the way to increased use of information technology in the sector later this year.

All in all, it is thought that the potential value of the sector has been underestimated. Currently, devices represent less than 10% of total healthcare expenditure in the EU, a meagre proportion of the market. "We feel the industry has an important role to play in supporting the Lisbon Agenda," says Wagner. "We are employing 400,000 highly qualified people in Europe."

The sector, with its 10,000 or so different products is certainly diverse. In recent years, the EU market has fallen behind economies such as the US and Japan in terms of growth, a result of falling European expenditure on healthcare. Yet, in many ways, the innovative industry is as important a part of the healthcare landscape as pharmaceuticals.

The medical devices industry is often overlooked in terms of economic and technological importance, particularly when compared with the pharmaceuticals sector. Determined to raise awareness among national healthcare systems that are reluctant to fork out for supplies, however, the industry is on something of a public relations drive.

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