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I was diagnosed with Diabetes Type I in December 1997 at the age of 19. I had just graduated from high school, moved to the city, started university and was in the middle of applying for Harvard and MIT scholarships. I thought personal computers and Microsoft Windows 95 uncool, had gone through my range of Ataris and C64s, and was proud owner of my first Apple Macintosh Performa – 56k modem and all. And my first, brick-like cellphone was soon to be exchanged for Nokia’s 7622, one of the first mobile phones with WAP technology: Internet on the go.

Lately I hear and read a lot of people asking for a Pre-Market Authorisation process for medical technology in Europe, or PMA process as it’s known, similar to the one in the US. Even the European Parliament voted (narrowly) for a resolution in which they call for a PMA approach. And that made me think, hold on a second, don’t we already have an approval system in Europe for high risk products?

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 deserved recognition. But in the aftermath of the wall-to-wall coverage of the French breast implant scandal, it’s more important than ever to celebrate and trumpet the achievements of this remarkable industry.

Incontinence is a condition that often gets associated with age. When we think about incontinence we tend to think first about elderly people and that’s normal because over 60% of nursing home residents are affected with some kind of incontinence (from mild to severe). However, European studies estimate that between 4% and 8% of the total population are affected, regardless of age. As our populations grow older, it is fair to say that more and more people will suffer from it. This could be your neighbour’s condition and you wouldn’t even know about it!

Proponents of greater regulatory harmonisation and cooperation will have been heartened by FDA chief Peggy Hamburg’s comments at the Advamed 2010 conference on Wednesday 20 October. She was quick to acknowledge that, in a changing world with vastly increased trade, the FDA could not continue to operate on an old-fashioned model designed for a time […]

Like much of the business community I have had plenty of time for thought and reading. A 24 hour trip to Milan has turned into a five day marathon. Both reading and experience have stimulated thoughts about the operation of markets. Firstly, after several hours on Thursday, I managed to secure a hotel room in […]