medlatest Editorial

Whilst it has been a short week because of the May bank holiday, it has also coincided with a quiet … continue reading “This Week’s “View From The Med” Online Now”

If medtech was opened up a bit you’d have to believe things would get better. Poorly performing products wouldn’t last long and the good ones would float to the surface. Of course zero regs is an unpalatable position, but a bit of transparency might be an improvement over today’s opaque clinical performance picture.

New Medical Device Regulations are inching forward with the latest draft proposals. Just because they’re happening doesn’t make them better though, as pointed out by industry body Eucomed as it reminds us what we’d be losing (and what we wouldn’t be gaining) by moving to a US PMA style system.

Two main court cases attracted our interest this week. While the situations contrast, the common thread of patient suffering runs through both cases.

It’s all very well getting aerated about medical device failures, but it’s equally very easy to throw out the baby with the bathwater. We consider whether draconian regs would do what they’re intended to do, and whether they’d stifle innovation in the interest of…well, nobody.

We’ve opined before about the weird regulatory divide that sees life-saving technologies withheld from U.S. patients while being freely available in Europe. It seems the clinical community shares the view,as one physician/author shows her frustration at the continued unavailability of Abbott’s MitraClip.

Imagine the pain of being the mother of a kid who made a big mistake ten years ago, aged only 14, and stabbed one of his peers. Now the Saudi government’s appointed judiciary has decided that unless you cough up $250K they’re going to divide his spinal cord and paralyse him for life. As a medtech pro, how do you feel about exporting to this country?

Don’t scoff at social media. Used well it can be a great adjunct to your life, whether a medic or a medical technologist.

Back on the quest for regulatory nirvana, this week’s editorial looks at two events which arguably characterise the state of … continue reading “Medlatest’s Weekly “View From The Med” Online Now”

The Left Atrial Appendage is a troublesome little design feature. It doesn’t appear to possess any purpose and can be the source of clots, especially in AF patients, leading to an attendant stroke risk. So let’s block it off? Eu regulators seem happy with that idea, U.S. less so, which again shows up our differences.

Eucomed has joined the campaign trail with its pointedly critical campaign aimed at derailing the tougher measures being proposed by EU regulators. And it has a point, devices being on average 3 years slower to market in the U.S. But we remain unsure as to whether that’s an altogether bad thing.

In the western world’s chase for technological advancement and the less savoury side of human nature it occasionally brings to the surface, perhaps we should reflect on the life of the Iraqi girl with one leg and no prospects. Just to even things up a bit.

Are these big medical specialty congresses meant to be showcases for technology? If so, stick highlights package on daytime TV and let’s see who watches. I would.

Would you fit tires to your car without selecting them yourself? Nope. Would you even buy toilet paper or deodorant on the same basis? Nope. So why do you let someone else decide which medical device is best for you? Should you be asking more questions? And should medtech companies be including you in their communications campaigns? We discuss.

We’ll probably get responses from angry market intelligence companies claiming their work is brilliant and important. What will be more interesting will be to see if the purchasers of these things feel the same way. OK, it’s personal, but I don’t think I’m entirely a lone voice.

We’re not campaigners for anything other than a solid evidence-based approach when it comes to healthcare provision. And we’re not alone. So how can homeopathic medicines continue to be provided by the UK’s NHS free at the point of “need”? The scientists in us cannot let this one lie without drawing attention to it.