medlatest Editorial

The only news in town this week is that Medtronic and Covidien are to merge, forming a new “offshore” entity. Strategic fit good: Tick. Tax consequences good: Tick.

Robotically assisted surgery is in the spotlight again as one commentator says it doesn’t justify its cost. Our weekly editorial discusses whether providers have much choice about whether to invest if they’re to remain current and competitive.

Physicians are clever folk when it comes to clinical matters, but surveys find they know relatively little about the price of the devices they use. We argue that simple price transparency can change this and potentially save a fortune.

Let’s not get started on whether membership of the European Union brings good things or whether it would all be better if we had more autonomy. There’s not much room for middle ground in the debate, rather like the current Renal Denervation exchanges.

Eucomed’s Chief Executive, Serge Bernasconi is making sure medtech industry’s voice is being heard right until the last minute as final wording is being inked into the new medical device directives. Highlights from his newly issued blog included here.

Whatever PR fluff is attached to them, the numbers you see in financial press releases are mostly capable of withstanding forensic scrutiny. For that reason we’re falling back in love with them, despite their rather anodyne nature.

Well, why even try to resist the opportunity to pun our way through the Winter Olympics? This week’s View From The Med gets all cynical about our industry, but concludes we can get it right if we put patients first.

The fallout from Medtronic’s Symplicity HTN-3 Renal Denervation study just keeps coming. This week we’ve even seen one medtech giant pull out of the business, a year after their first sale. We deliberate about what it all means for the regulators and the evidence lobby.

The apparent rapid demise of renal denervation therapy in the past few weeks means probable indefinite delays in getting one single device to the US market. We ponder where this leaves the therapy in Europe where many devices have been approved for marketing and used in thousands of patients.

Could renal denervation’s effect really be all placebo? That is almost impossible to believe. But something’s afoot and investigators and commentators are already speculating about what that might be.

When companies call themselves global, it’s usually a description of all the places they sell to or in, or it’s an aspiration. Either way, Thanksgiving reminds us that when the US has a day off, it all goes a bit quiet.

Humour and medicine go together like fish and custard, right? This week’s editorial challenges the convention and concludes that for SME’s a bit of humour might set them apart. Done in the best possible taste of course.

The EU parliament’s plenary vote has gone through, with many of the ENVI committee’s proposals left intact. The good bits at least. The plainly bonkers concept of a European “PMA-style” approval process for higher risk devices has seemingly gone.

Will October 22nd 2013 be remembered as the day medtech died? New EU regulatory rules are likely to be voted in tomorrow, and if they say yes to the whole lot, the consequences for the medical devices industry are likely to be catastrophic. EU patients will be denied the latest technologies in years to come, largely because of a PIP implant scandal which far from characterises the industry.

Nothing’s perfect, so why regulate it as though it is, goes the argument against tighter regulations. Especially when doing so would mean less innovation, less investment and no obvious reason why patient safety would improve.

Medtech industry is focused on the significant matter of the punitive and unfair sales tax. Companies would do well to stop taking EU market access for granted though, as new rules will slow things down and increase costs to beyond FDA levels. This is serious.