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The year is nearing its end and as I look at the christmas tree being put up, the smell of pinewood slowly filling our office’s reception area, I cannot help but think that 2013 was a crucial year for patients, healthcare systems and Europe as a whole. This past year was dominated by one topic of mastodont proportions, but other actions, activities and achievements have been just as important to us.

While enjoying my holidays I was reminiscing a bit about my time in Brussels and thought I‘d share my reflections with you. A little over a year ago, on 16 July 2012 to be precise, I joined EDMA and Eucomed. As such, this “fait divers” is not that important, but since then a lot has changed that will impact our industries and associations.

In the past few weeks, the Swiss newspapers have been littered with an uncomfortable and poisonous prospect: the U.S. A financial force banging its chest from its modest economic recovery is demanding tax justice from Switzerland. The stable currency, neutrality and talented investment acumen that the Swiss have quietly touted to global investors has allowed them to amass some 30-40% of foreign investments. Now the tables are turning. With increasing pressure from the U.S., Switzerland is about to be forced into giving up one of its oldest and most sacred treasures – the hidden, numbered, off-shore Swiss bank accounts. So far this only seems to be relevant to U.S. account holders, but the vultures are already beginning to circle. France, Germany and the U.K. will almost certainly follow suit once the dust clears and the stage opens up for more opportunistic assaults on secret Swiss accounts.

Until recently economic and regional integration in the post-Soviet countries to a large extent was only declarative. However, the initiative of going beyond the Customs Union (CU) to create Common Economic Space (CES) between Russia, Belarus and Kazakhstan draws attention to potential market opportunities and at the same time regulatory challenges for the MedTech industry.

The tool most commonly used to demonstrate the value of a new medical technology is the business case. Typical business cases can be thought of as falling into one of four categories. Compared with current care, the technology:

– costs less in the current year and you get what you get from current care (‘save money now’).
– costs the same and you get more than you get from current care (‘more value for current spend’).
– costs more in the current year but cost less when future savings are taken into account and you get what you get from current care (‘spend now to save later’).
– costs more but you get more (‘spend more for better quality’).

Medical device manufacturers routinely design products that, even a few short years ago, were the stuff of science fiction. And let’s not even mention the amazing research underway today that will animate tomorrow’s medical products, from Tricorder-like devices performing on-the-spot diagnostics to 3-D printers producing replacement body parts. But there’s a problem: money. To succeed in today’s marketplace, medical device original equipment manufacturers (OEMs) must take into account funding and reimbursement pathways, the critical role that health technology assessment (HTA) can play, and other factors that may have little to nothing to do with how well or how safely a device performs its intended task.

My wife and I are part of the problem. Last weekend we ran respectable 10 kilometre times although we are both in the latter half of our fifties and we will play energetic tennis twice in the week ahead. Both had life expectancies in the early seventies at birth and now our risk adjusted life expectancies are straddle ninety years. We are a triumph for modern lifestyles and medicine (both having had interventions for conditions which may well have been fatal one hundred years ago) yet healthcare is the political scourge of our times. The success of society in increasing healthy productive years is matched by the failure of that same society to plan for such success in the provision of pension, health and social care. Yes, we have a financial crisis which has followed the profligacy of a generation but this is a minor issue compared to the need to rebuild our economic models to accommodate the demographic changes which us ‘baby boomers’ are so central to.

Small and medium sized enterprises (SMEs) are the lifeblood of the medical technology industry. Research in the medical technology industry, which typically occurs at the bedside not at the bench, is usually a result of small or micro collaborations between health professionals, academia and SMEs. This research model brings rapid innovation, which quickly tackles current and emerging medical needs. This innovation can only be good news for under-pressure European healthcare systems as there is clear evidence that more effective treatments are capable of delivering clear benefits; reduced hospital stays (with an associated reduction in cost of treatment); better outcomes, and faster rehabilitation and return to society.

At 95 billion Euros the European medical technology market and industry is far from insignificant. Its impact on the lives of patients combined with the ability of health systems to operate efficiently dwarfs the value of the market while the industry has spawned hundreds of early stage companies year on year. Despite its size the medical technology market is less than 5% of total health spend and that figure appears to be declining.