medlatest Editorial

So the EU (European Commission) funds a collaborative project to develop a technology that addresses a very real (and rather high profile) clinical need. Collaborating companies benefit and so thrive and employ more people, in so doing addressing the need to do just that. This new continental collaborative concept might just work and if it does everyone’s a winner.

Whichever side of the argument you come down on, you’ll have noticed the 2.3% device tax debate and will no doubt have a view. We explain why we’re giving the campaign air time.

You say potato, I say prosthesis. While somehow a therapeutic cranberry capsule has uniquely found its way to market as a medical device, we’re scratching our heads about the whole affair.

We can’t even harmonise the spelling of the word harmonize, so what chance of bringing our regulatory processes closer together?

US regulatory agency the FDA issues very public warning letters to companies which are then trotted out around the media so we can all revel in the organisations pain. But would this level of openness be well received in Europe where medical device regulations seem to be in the media’s crosshairs too frequently for the industry’s own good.

We get really really fed up with medical device companies trotting out lightweight press releases about newly CE marked products, like we’re all going to say “great” and rush out to use them. This is a plea to companies to provide their evidence and let us decide whether it passes muster.

Whether you’re Synthes, J&J, Boston Scientific or especially Cameron Health, it’s been a pretty good week. Now all we need to do is see a resolution to the endless regulatory debates both sides of the pond and we’ll be happy. Won’t we? Did somebody say 2.3% device tax?

Beautiful kids make great poster girls for campaigners trying to cut regulatory red tape and speed new technologies to market. But will the balance between too strict and too lax ever end up as “aaah, just right”?

When politicians get involved in issues some of us have spent decades involved with, the result is bound to have a few badly thought through components. In the case of the European MEPs they’ve done an acceptable job of identifying the medtech regulatory issues, tinged with a bit of populist reactionary stuff that would serve nobody.

The FDA has chosen attack as its best form of defence this week as it adopts a very aggressively critical stance over EU regulatory failings. It’s a bit rich though isn’t it when data suggesting EU regs are harming patients seems to be thin on the ground.

FDA’s new report ostensibly focuses on patient safety… US patient safety that is. So it’s missionary work, but people of the rest of the world, who’s access to the newest medical technology is less restricted, might argue they’re fine as they are thanks.

68% of patients surveyed don’t think the medical devices industry is good at practising ethical marketing. Should we be surprised? Interesting survey from a global patient group audience.

Some really informative items have been floating around this week. It’s especially noteworthy that Thoratec’s Heartmate II® Ventricular Assist Device has seen its 10,000th patient. It’s a sobering thought that many of these patients would not have had a chance without the technology.

When is a published paper a thinly disguised marketing study? One man clearly has a view.

We need a Pacemaker Peacemaker if we’re to see an end to the ICD “troubles” don’t we? Still, if you can look past the week’s big spat there’s still plenty of positive (and a bit of negative) news from the medical devices world.

A US consumer protection website is urging regulators to move more quickly and decisively in dealing with the thorny subject of transvaginally inserted organ prolapse meshes.