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Are human genes patentable in Europe and the US?

In June, the US Supreme Court issued its opinion in the Myriad case (Association for Molecular Pathology v. Myriad Genetics Inc.).  The Supreme Court had been asked a seemingly simple question: “Are...

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Boosting Personalised Medicine – A Patient Perspective

Hockey, sailing, golf, football … As an avid sports fan, I used to enjoy all those kinds of activities with great enthusiasm – until the day I became paralysed. Some of you may remember me from the...

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Why do the mHealth Grand Tour?

Why do the mHealth Grand Tour, I mean, I’ve never been a sporting cyclist (yes, I’ve commuted by bike for years but not a 100 miles a day) nor am I a huge Tour de France fan, neither do I have...

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My first twelve months at EDMA and Eucomed

While enjoying my holidays I was reminiscing a bit about my time in Brussels and thought I I‘d share my reflections with you. A little over a year ago, on 16 July 2012 to be precise, I joined EDMA and...

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How One Diagnostic Test Can Save Billions of Euros Per Year

In the past, percussion of the abdomen, taking temperature, or tasting sugar in urine were considered diagnostic standard of care methodologies. Today, invitro diagnostics (IVD) provide additional...

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Innovating the way we innovate

Our value creation capabilities based solely on R&D investment are not generating as much growth as they used to. According to PwC’s “Operating performance in the Medtech industry: Trends and...

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Pacing the implementation of the new IVD regulations

Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for in vitro diagnostics (IVD) rather than a bureaucratic...

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The Future of MedTech in Europe. Time to change your business model?

It’s increasingly clear that the Medical Technology (MedTech) industry is going through an unprecedented level of change. In Europe, budget pressures are impacting market access and reimbursement....

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The Future of MedTech in Europe. Time to change your business model?

It’s increasingly clear that the Medical Technology (MedTech) industry is going through an unprecedented level of change. In Europe, budget pressures are impacting market access and reimbursement....

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Raising patients’ awareness on treatment options for cataract

The rapid ageing of the European population has urged the need for prevention and proper treatment of age-related diseases. Amongst these priorities and priority diseases, Cataract is today the major...

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Beyond rhetoric: MEPs need facts to make an informed decision on medical...

Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud...

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Always read the small print…on the ENVI proposal for the reprocessing of...

Caveat Emptor, or ‘Buyer Beware’, is a commercial rule favouring the seller, now largely extinct due to modern consumer legislation. But the European Parliament’s ENVI Committee, in its amendment on...

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Europe needs to invest in IVDs during times of austerity

According to EDMA’s 2012 European In Vitro Diagnostics (IVD) Market Statistics Report, the in vitro diagnostics market in Europe has decreased 2.2% in 2012. These results had been predicted in the...

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Europe’s most vibrant startups are in medtech

Does Europe have a proper start-up culture? Are we doing enough for young professionals? According to Neelie Kroes, Vice-President of the European Commission, in her article for the World Economic...

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Same-day Testing and Treatment, STAT

Imagine walking for most of the day to get to the health center nearest your community, carrying your young child who is very ill. When you arrive, the doctor takes a sample from your child to perform...

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What mobile diagnostics can do for the rest of the 90%

Consider the cell phone. As an engine of change, it is a romantically disruptive one, a technology that crisscrosses borders and thrives on connection in all its forms – to networks, to people, to the...

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Regulations, assessments – in the end it’s about patients’ access to therapies

The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will...

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Hats off to policymakers for encouraging multidisciplinary wound care

Despite the overwhelming impact that wounds have on healthcare systems, many people are still unaware of the risks for developing wounds when entering a healthcare setting.  In fact, 27-50 percent of...

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5 WHO Insights into conquering the medtech mismatch

One central theme revolved around the Second World Health Organisation’s Global Forum on Medical Devices – the WHO recognises medical devices as an investment and not a cost. However, there is a...

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Hylke Sieders and the search for a more personal healthcare for SCI patients

In my article in the newsletter of last August, I told you about the standard rehabilitation support I receive as outpatient of spinal cord injury (SCI), and how I have had to work for access to more...

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