There has been so much media and political focus on the medical device legislation in Europe in the first four months of 2012 that one could be forgiven for losing track of what’s exactly going on and where we are exactly in the process. Especial…

For medtech companies, interacting with Healthcare Professionals (HCPs) is a fact of life. HCPs are an integral part of the R&D process and a source of innovation and creativity throughout the development of medical devices. HCPs are also the prime…

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. …

Let’s flip the European innovation model on its head Innovation is synonymous with progress. Embracing innovation means embracing the need to improve the sustainability and efficiency of healthcare systems by encouraging new business models, unlockin…

Centralised procurement of medical technologies is an increasingly prevalent phenomenon in the EU, and one that all stakeholders in this field, whether for or against it, have strong opinions on. Purchasers have embraced centralised procurement as a me…

Having read Commissioner Dalli’s analysis of the PIP case and the Commission’s plans for strengthening the medical devices directives, it becomes clear that the medical technology industry and the Commissioner share the same view on safety and inno…

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 th…

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…

Too often  we, as stakeholders in health, forget about whom we are talking when we say “patients.”  We talk as if the patient is somewhere far away from our discussions rather than the person with whom, about whom and for whom we are having those…

When UBM Canon decided to launch the MEDTEC EMDT Innovation Awards, the PIP implant affair was not front-page news. The organisers merely thought that the contributions made by Europe’s medical technology industry in ameliorating the human condition…

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…

Universal Health Coverage (UHC) has become a hot topic among the international health community. I am sure that for all healthcare stakeholders achieving UHC would be like a dream come true. Recent demographical and epidemiological data confirms that f…

Universal Health Coverage (UHC) has become a hot topic among the international health community. I am sure that for all healthcare stakeholders achieving UHC would be like a dream come true. Recent demographical and epidemiological data confirms that f…

As the Euro zone crisis threatens to precipitate a much more fundamental questioning of the European dream, it is easy to revert to the eurosceptic homeland of vilifying apparently meaningless rules and regulations that have little real impact on the l…

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 seventie…