117 results

papers-standards
Regulation

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

differentiate now
Business

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

eHealth
Digital Global

Posted on 17.05.2011

Exciting prospects on the eHealth horizon!

When health and technology go hand in hand, safe, efficient and cost-effective solutions are often the result. Realising the immense potential that these two fields possess if they are well attuned to one another, the Commission is focussing a lot of its attention on eHealth and the benefits that these exciting technologies can bring. But not only the Commission is showing increased interest – people are talking about it, thinking about it or working with eHealth technologies.

By Anna Lefevre Skjöldebrand Chair Eucomed eHealth Working Group

USglobalcompliance
Ethics

Posted on 04.05.2011

How we in the U.S. see global compliance challenges for MedTech companies

AdvaMed and Eucomed are co-organizing the upcoming International Medical Device Industry Compliance Conference, taking place on 18-20 May in London. Both AdvaMed and Eucomed worked closely with our member companies to identify the hottest issues in medical device industry compliance today to shape a truly global, industry specific event. We also worked together to invite accomplished discussion leaders and moderators, and panel participants representing North American and European perspectives and experiences.

By Christopher White General Counsel, AdvaMed

bike-1882
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

payhighprice
Value

Posted on 06.04.2011

On e-health and medical technology: grasp the nettle or pay a high price?

Chairing a two day conference on e-health and presenting at a groundbreaking Innovation in Healthcare conference put on by DG Research has further fuelled my enthusiasm for telling the story about the power of technology to enable massive changes to the way that populations are cared for, whilst simultaneously improving outcomes, the patient experience and cost. If all this seems too good to be true just look at what the alternatives might be.

By John Wilkinson Former Chief Executive of Eucomed

letters-random
Business

Posted on 01.04.2011

UDI, GS1, GTIN, GHTF, ETF, EHR, ISMP… What does it mean to me and to you?

Having been involved with the medical devices industry for many years, I’ve seen how the industry has evolved using innovative solutions and has constantly embraced technological developments. Recently however I had a friend on the receiving end of this technology and I hope you find his ‘patient case report’ below of interest – do note he also works in the medtech industry hence his knowledge on this subject…

By Mike Kreuzer Chairman of the Eucomed Taskforce on E-Business and Supply Chain Management (ETF)

Leaf
Regulation Value

Posted on 03.03.2011

WEEE & RoHS: the dynamic duo that wants to keep people healthy

Everybody who has anything to do with electrical medical devices has been watching with interest the progress of the WEEE (Waste Electrical and Electronic Equipment Directive) and RoHS (Restriction of Hazardous Substances Directive) Directives through the European political process. RoHS, which should soon be published in the Official Journal of the European Union, has been especially important as the latest iteration of the Directive will see medical devices falling within its scope from about April/May 2014.

By Andy Vaughan Eucomed Environment Consultant

debate brussels
Regulation

Posted on 08.02.2011

Brussels starts healthy debate on Medical Device Recast

Recent events in Brussels are pointing to a fresh, healthy airing of views and more robust debate on the Recast. (By the way, I’ve noticed that everybody says ‘Recast’ but not too many people know what a ‘Recast’ is. So for all those legal and regulatory ‘techies’ among you, click here, all others steer clear!). […]

By John Brennan Director Regulations and Industrial Policy