205 results

Commission
Access Value

Posted on 24.05.2012

The safety of patients: what role for the EU?

The current situation for patient safety is alarming in Member States. It is estimated that 37,000 deaths occur in Europe each year from preventable infections acquired while receiving treatment. Yet, this figure published by the European Centre for Disease Control (ECDC), could very well be a low estimate as Member States differ in their measurements of healthcare associated infections (HCAIs), often in how frequently data is collected, for which infections data is collected and how data on infections is reported. This is of particular importance because when we talk about patient safety, we often do not have comparable information to really understand what the state of patient safety in Europe truly is. That is to say, we do not always know which healthcare settings are safe when we seek care.

By David Byrne Former EU Health Commissioner and Patron of Health First Europe

Fotolia_56508307_Subscription_Monthly_M
Digital

Posted on 23.05.2012

It’s not the technology stupid! (Or what eHealth should do to go from promise to reality)

Two weeks ago I attended the eHealth 2012 conference in Copenhagen, along with 2 500 other delegates, policy makers, providers, industry and many others. Coming out of there, my strongest take-away is the amazing opportunities innovation in technology can bring -for patient empowerment, improved health and more efficient provision of care – and the frustratingly slow pace at which it is being adopted in the health care system.

By Anna Sohlberg Eucomed eHealth taskforce and CRM Telemonitoring working group member Health economics and reimbursement manager Cardiac Rhythm Disease Management Medtronic Europe

regulatorymirror
Regulation

Posted on 12.04.2012

Standalone software: objects in the regulatory mirror may appear simpler than they are

January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.

By Erik Vollebregt Life Sciences and IP Lawyer, and Founding Partner Axon Lawyers

Value
Value

Posted on 28.02.2012

Assessing the value of medical devices – it’s about more than just clinical effectiveness

Ever since the end of WWII, the reigning clinical philosophy was one whereby there was no limit on medical treatment. From the 80s onwards, this philosophy shifted towards a more balanced approach whereby the benefit of the treatment had to outweigh the potential risks associated with it, with evidence-based medicine being the concept used to assess a new treatment.

By Yves Verboven Director Market Access and Economic Policies, MedTech Europe

Silver linings
Business

Posted on 17.01.2012

On clouds and silver linings: Leadership transition at Eucomed

Most of you know that John Wilkinson has left the position of Eucomed Chief Executive at the end of last year. And even though John’s decision was announced already in June of 2011, as I write this now, more than six months later, it still feels as if he informed me of his intentions only yesterday. Fond of the Brussels bubble while at the same time being excited about the European and global perspective of the job, I am sure it was by no means an easy decision.

By Guy Lebeau Chairman of the Eucomed Board

Access
Access

Posted on 07.01.2012

A MedTech map for bypassing market-access roadblocks

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.

By Norbert Sparrow Editor in Chief, EMDT, medtechinsider

EU Medical technology
Business

Posted on 06.09.2011

Medtech industry must change its way of doing business to remain successful in the EU

Europe is an important and continuously growing market for medical technology products. Driven by budgetary pressure on the payer and provider levels as well as by strong competitive dynamics, the commercial climate for established medical technology companies is, however, deteriorating. The recent industry survey MedTech Barometer 2011 conducted by us (and with ‘us’, I mean global strategy and marketing consultancy Simon-Kucher & Partners) confirms the presence of increasing commercial challenges but still provides an overall positive short-term business outlook. Yet the longer-term outlook is less positive and suggests that in order to remain successful in the European market place, established players will have to adapt their way of doing business in the future.

By Joerg Kruetten Executive Vice-President at Simon-Kucher & Partners and head of the Medtech competence center

facingsocialmedia
Value

Posted on 09.08.2011

Facing up to the Social Media Challenge – How Should the Industry Engage with Consumers?

Next week, pharmaceutical, biotechnology and medical device companies will change the way they interact with consumers on Facebook. These changes are occurring, not based on new communications strategies or industry regulations, but because Facebook itself is changing its policies.

By Sam Barnes Director, Head of PR at AXON

Industry dialogue
Access Business

Posted on 03.08.2011

HTA in Medical Technology – The Displacement of Concepts

I’m fascinated by organisations. In particular, I’m in intrigued by the way some organisations succeed at their chosen task whilst others fail. There are, of course, lots of explanations for what separates “the wheat from the chaff”, as we English say. Some academics say it is the firms’ capabilities and resources, others their culture, still others put it down to leadership. But all of these are what one might call “static” explanations.

By Brian Smith Adjunct Professor at SDA Bocconi