124 results

My tmixing HTA with regulation
Global Regulation

Posted on 17.08.2011

My thoughts on mixing HTA with regulation? The writing’s on my wall…

Not too long ago, I was invited to a friend’s 40th birthday party. As many other guests I came up with my best wishes and cheers stressing the benefits of getting “settled, mature, wise, stable, change-resistant and risk and-averse…” That was then, but it did make me think when today I was once again reading through the WHO report “Health Technology Assessment of Medical Devices” how ambiguous this whole age perception is.

By Victoria Malakhova Former Eucomed Director Economic Affairs

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


Posted on 18.07.2011

Hear, hear! We can really help current and future medical technology SMEs to innovate!

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.

By Sharon Higgins Chair, Eucomed SME Task Force


Posted on 01.07.2011

Standards: To infinity (well the next decade at least) and beyond

The European Commission published on 1 June its long-awaited regulation proposal on European standardization. The document consists of the proposed legislative measures which update and consolidate existing EU legislation as well as impact assessments and non-legislative measures such as a strategic vision for European Standards. There were also a number of recommendations aimed at other actors in the EU Standardization system. I am convinced that these proposals are a significant step forward in the development of standards as an essential tool in developing the EU single market.

By Andy Vaughan Eucomed Environment Consultant

Digital Regulation

Posted on 07.06.2011

eHealth applications and websites developed by clinicians: there are rules for that!

eHealth is booming, hospitals, doctors, clinics, SMEs, big companies, everybody seems to be developing an app nowadays. It is great to see how many people are throwing their weight behind eHealth initiatives in every possible way: remote monitoring of demented senior citizens by means of image interpreting software, decision support systems, …, you name it. […]

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

differentiate now

Posted on 30.05.2011

Changing environment for medical device companies? Differentiate now or fail later

Korn/Ferry International and Eucomed are co-organising the upcoming “How to differentiate in a changing environment?” conference taking place on 5 July 2011 in Brussels. We have worked closely together to design an exciting programme that will give participants a broad view on the future from a health economic point of view, but the various sessions will also discuss what hospitals are looking for from medical device companies. In addition, we have invited accomplished speakers representing other industries’ perspectives and experiences. In short, this meeting is designed to allow the exchange of experience and ideas, and see what is done in other industries to help medical device companies enhance their competitiveness and remain healthy businesses.

By Ulrika Hagle Managing Director Medical Devices EMEA Korn/Ferry International

Business Value

Posted on 14.04.2011

To the MedTech industry: don’t stick to old-fashioned business models when talking about the value of your technologies

Medicine became evidence-based a long time ago and rightfully so. So why is it that policy decisions are, still today, far from evidence-based in Europe? Why are healthcare managers and decision makers still relying upon short-term cost containment objectives when it comes to access, regulation and evaluation of new technologies?

By Rosanna Tarricone Director Master of International Health Care Management, Economics and Policy


Posted on 04.02.2011

Cheap trumps innovativeness… or not?

As I was commuting back to Brussels last week, a copy of The Economist laid out in front of me, my eye was immediately drawn to the title of that week’s Leader. Who wouldn’t be inclined to read on when an enticing header such as “Life should be cheap” is staring right at you. Intrigued […]

By John Wilkinson Former Chief Executive of Eucomed


Posted on 17.12.2010

You better watch out!

Yesterday, we, at Eucomed, had our Christmas party (Happy Christmas everybody and a big thank you to all the Eucomed members and staff for everything in 2010!!). And while thinking back at yesterday’s little get-together, it’s dawning on me that with 2011 just around the corner we will be just over two and half years since the original public consultation on the recast of the EU medical devices legislation.

By John Brennan Director Regulations and Industrial Policy