88 results

IVD
Value

Posted on 26.10.2012

What’s the purpose of a diagnostic test?

In vitro diagnostic (IVD) tests are likely to be a part of everyone’s life, in many cases, more than once. Yet most people do not know what these tests are or what they do.

By Lluís Bohígas Santasusagna Director, Institutional Relations, Roche Diagnostics

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

Wound care
Access Value

Posted on 23.02.2012

Challenges in chronic wound care: the need for interdisciplinary collaboration

Many Germans suffer from chronic wounds (mainly leg, pressure or diabetic foot ulcers) and their numbers grow by 650,000 annually. Wounds of all sorts have a major impact on patient function and quality of life, and may be life-threatening. In addition, providing wound care is a significant cost to the healthcare system. These types of wounds alone are an estimated annual financial burden for healthcare payers of €5 billion.

By Johannes Georg Böttrich Member, Eucomed Advanced Wound Care Sector Group Dr. rer. nat. / Medical Scientific Affairs OPM B. Braun Melsungen AG

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

childsplay
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

healthcare-spend
Global Value

Posted on 01.12.2010

An often heard but seldom fully-understood story…

A new report by the OECD makes sobering reading as it makes the point that continued expansion of spending in developed countries is unsustainable. Reading the reported highlights, a couple of statements jumped out at me. “Healthcare costs are escalating rapidly, driven by population aging, rising relative prices and costly developments in medical technology. Public […]

By John Wilkinson Former Chief Executive of Eucomed

2007-07-19 Mother and daughter
Value

Posted on 21.04.2010

Patient safety and public perception: transparency, transparency, transparency…

Patient safety and public perception: transparency, transparency, transparency…In scanning the disparate output of the EU machine I came across a thought provoking survey of EU citizens on the subject of patient safety. Perception surveys are scientifically questionable as  they deal in the currency of (often poorly informed) individual’s views. Politically and from a policy perspective […]

By John Wilkinson Former Chief Executive of Eucomed