Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me. I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway...
MONTREAL ‑ At this week’s American Society for Human Genetics annual meeting, where there is a whole genome sequence there is somebody bringing up privacy concerns. Do you really want your genome data to be laid bare? Will it start in a research database, move to your doctor’s office, and soon enough be found floating around on the Internet? Most of those privacy concerns focus on medical issues, which makes a lot of sense. Certainly, most people would not feel warm and fuzzy about having their insurance companies know that, like Craig Venter, they have a higher-than-average risk of developing...
Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...
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...
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...
This week’s report of remissions in three advanced leukemia patients after immunotherapy has generated quite a lot of excitement in the media – which, in turn, has led to some backlash amongst the twitterati and in the blogosphere, noting that two complete remissions plus a partial one don’t make a blockbuster. Or anything, really, that will be broadly useful within the next few years. Mainly, when I look at these controversies, I am grateful that I write for such a smart audience. If you are reading this blog, chances are that you work in the biopharmaceutical industry – and if...
Most of us had to take a course or two in economics to get a bachelor’s degree, but few of us remember very much from those lessons. I can't say for certain that Econ 101 is where I first heard the expression “return on investment,” or ROI, but it's an expression that has stuck with me ever since. The notion may gain greater prominence where healthcare payers are concerned in the years to come, thanks to the well-publicized Medicare crunch, but it's tough to imagine that the congressional Gang of 12, charged with finding further ways to close the U.S....
Now that the U.S. House of Representatives has voted down a higher debt ceiling for the U.S. government, Congress can go back the drawing board on deciding how many Medicare spending cuts the voters and stakeholders can stomach, but as always, there are pockets of concern within the larger picture. The picture for device makers is somewhat complicated in part because the Medicare Part B “doc fix” is a $30 billion-a-year overhang that will be tough to resolve, not just because of the positions taken up on each side of Capitol Hill. On the Senate side, Kent Conrad (D-North...
Top 10 reasons interventional cardiologists should be happy By MARK McCARTY Medical Device Daily Washington Editor Dear Interventional Cardiologist, Worried about Medicare reimbursement for the Next Great Stent? Concerned that FDA's massive regulatory girth will squash your drug-eluting balloon groove? Not to worry. Here are the top 10 reasons you should be thrilled with your choice of specialty. Number 10: PCI numbers are flat of late, but just watch that Baby Boom fill your waiting room in the years to come. Number 9: The transradial (through the wrist) route is gaining acceptance as an approach to coronary intervention. Number 8:...
President Barack Obama unveiled his deficit reduction plan last week, calling for a mix of spending reductions and tax hikes that the White House claims would cut federal deficits by $4 trillion over the next 12 years without gutting popular programs such as Medicare and Medicaid, a challenge that may be difficult to achieve given the level of debt in the U.S. Obama's plan calls for a repeal of the Bush-era tax cuts on families making more than $250,000 annually. The president also called for the creation of a "debt fail-safe" trigger that would impose automatic across-the-board spending cuts and...
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