As a member of the trade press, I get a kick out of how routinely some people in the mainstream media and the population at large routinely assume that device makers are driven by greed and that doctors are morally flawless creatures who spend all their spare time pondering the public weal and woe, continuously devising ways to ensure their passage through the Pearly Gates with constant acts of selflessness. And then I see the parties weighing in on the question of Medicare coverage for the Sapien aortic valve made by...

As the wife of an active duty service member, I really hate to complain about the military healthcare system. There are a lot of benefits to being covered under Tricare, the military’s healthcare plan. But in the five years that I have been an Army wife I have observed and experienced some of the limitations and nuisances of relying on the military’s healthcare plan. So without further adieu, here is The Good, The Bad, and The Ugly of my military healthcare experience. The Good: I am enrolled in Tricare Prime, a managed-care option similar to a civilian HMO. Prime enrollees...

Healthcare reform has as a million audiences, and it's interesting to see what some of them are reading about the Patient Protection and Affordable Care Act (ACA). Let's look at an opinion piece appearing recently in the New England Journal of Medicine penned by a trio including Michael Chernew, PhD, perhaps the most influential healthcare economist in Washington. Chernew and his co-authors remind that calculations of Medicare costs typically consists of a comparison of the world with and without the ACA, stating that the ACA has to do better than healthcare inflation of about 5.5% in order to impress the...

After Johnson & Johnson (J&J, New Brunswick, New Jersey) said that it was going to discontinue its work in the drug eluting stent (DES) market, my eyes then began to focus on Medtronic (Minneapolis), which has recently taken a beating in the wallet and court of public opinion with its bone growth product, Infuse. I began asking myself how much longer before Medtronic finally abandons ship on this application. I mean if there ever was a shining example of a device that has caused problems for a company then Infuse is it. The med-tech juggernaut was dealt what one would...

Much has been made of the slow-down in device approvals at FDA's Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the agency to another lashing in the court of public opinion. But let's face it, FDA gets some pretty shabby treatment on Capitol Hill, too. I recall a hearing in which then-Senator Hillary Clinton (D-New York) grilled incoming FDA commissioner Andrew von Eschenbach, MD, like a common criminal. She and Sen. Patty Murray (D-Washington) never allowed von Eschenbach to completely answer...

By Michael Harris BioWorld Senior Editor Well, not everything at once, if you want to enjoy and appreciate the proceeds of your clearance sale!   So, how much of our bodies could we afford to sell in order to significantly upgrade our financial status and remain healthily functional? We could conceivably sell organs and components such as one kidney, sperm, bone marrow, eggs, hair, even genitals, and go from middle class to millionaire in time for the next tax season. Now, what about selling off components in transactions that are currently illegal, immoral or not technologically possible yet, including stem...

Back in the early days of Medical Device Daily – in fact, it might even have been in the relatively brief very early period of time when the new publication was known as Medical Device Week – it’s likely that few if any healthcare-related companies got more frequent mention in our pages than MedCath. Thinking back on that time, it seems like news stories on the high-flying operator of heart-focused specialty hospitals were appearing in MDW and then MDD with amazing regularity. It was “MedCath reported this week plans to open a new hospital in . . .” or “MedCath...

  The title of this posting pretty much says it all, but I'm paid to tap out words on my keyboard. So here we go. Remember FDA's draft guidance on when to file a 510(k)? Among the things it stipulates is that if a manufacturer makes a change that requires a new 510(k) filing, the manufacturer cannot cite any predicates other than those that were already cited in that device's filing. So what's a device maker to do? Cite every potential predicate it can. Why? You have to ask? Yes, yes, FDA wants to cut down on the use of...

  As the saying goes, there are things we know we don't know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting. FDA to put brakes on surgeon training? FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor's training of doctors in...

In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit. This is not an exhaustive list of things that could arise in the last half of this year, but these are all pretty big, and a lot of people will be watching carefully. FDA meeting on IOM 510(k) report: FDA recently invited all interested parties to talk about the recommendations made recently by the Institute of Medicine regarding the 510(k) device clearance...