Some things in life are obvious, such as what Vice President Joe Biden is thinking. Other things? Not so much. Here are three things I don’t understand about the medical device tax. One: Why make it a tax on revenues? One suspects industry would be less exercised if the 2.3% tax had been applied to profits rather than revenues. Yes, device makers will play accounting games, and Max Baucus, chairman of the Senate Finance Committee, was most likely looking at things from 40,000 feet, so perhaps the difference was lost on him. Still, someone must have told Baucus that device...

OK, social media mavens – this one’s for you. This coming from someone who, whenever I see or hear a reference to a Tweet, automatically rack up the chorus to Bobby Day’s golden oldie “Rockin’ Robin” (yes, and the Jackson 5, but Bobby Day’s was the original, in 1958): “Rockin' robin (tweet tweet tweet) Rockin' robin (tweet tweet tweet) Oh rockin' robin well you really gonna rock tonight” But I digress . . . This is about the use of social media to discuss health issues. According to a recent PricewaterhouseCoopers (PwC) report, more than 40% of all U.S. adults...

With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation - and in the healthcare sector no less - the FDA user fee reauthorization act. Last week, the U.S. House of Representatives reaffirmed passage of the FDA user fee reauthorization act in a 387-5 roll call vote taken after an earlier voice vote. The House affirmation followed close on the heels of the earlier congenial vote on the act by the Senate, a nearly unanimous 96-1 approval. The groundwork...

The story behind the problems with Riata electrophysiology leads made by St. Jude Medical has yet to be fully fleshed out, so it’s only natural that there is still a lot of uncertainty. Here are the top five questions I have. Five: What is the role of the surgeon? I have no idea what it takes to implant these things, but I haven’t seen data on lead fractures by center or implanting physician. We know doctors make mistakes, but how will the specialty societies respond if it turns out that skill and experience play a role? Leaving this question entirely...

A patient lies tethered to a hospital bed with sensors and wires taking readings. Their mobility is severely limited and, on top of that, healthcare professionals have to be in a position where they can maneuver through these wires to treat the patient. This is a scenario that plays out in many hospitals throughout the country. But that could change if the Federal Communications Commission (FCC) approves a measure that would expand the spectrum capacity for Medical Body Area Networks (MBAN), or wireless patient monitoring systems that use low-cost wearable sensors and allow clinicians to remotely monitor vital signs of...

I consider myself an omnivore, but I never much cared for the taste of crow. All the same, it seems there’s some bird meat on the menu thanks to a blog I posted last year about the problems Medtronic was having with Infuse. On the other hand, I’m not alone. The U.S. Dept. of Justice has a heaping helping of the stuff on its hands. As I wrote last August, Medtronic agreed to pay Yale University $2.5 million to review adverse events connected with Infuse, a bone morphogenic protein product that had become conspicuous for allegations that adverse events were...

When my Great-Grandfather became too elderly to care for himself I watched my grandmother take him in and care for him. When that same grandmother became elderly herself, I watched my aunt take her in and care for her. And someday it will be my turn to care for one of my elderly parents (please God, just don’t let it be my mother-in-law). But what if we had robots to take care of our elderly parents for us, or at least fill in during the day while we’re at work? An emerging robotics company in Houston is actually exploring that...

As a member of the media, I’m not exactly unaware of the pitfalls of my profession but it might be time to take a look at some of the coverage of proton beam therapy in recent months. Frankly, most of the mainstream media coverage failed to paint a complete picture and in the process trampled on vital details. On the other hand, some hospitals perhaps could use a lesson in basic economics because you don’t have to install a $300 million cyclotron facility to get protons in your hospital or clinic. Click here for an example of mainstream media coverage...

The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be sure the off-the-record discussions were intense. Now with the International Medical Device Regulators Forum coming together, the time has come to ask what the future of international medical device regulation holds. First let’s examine the obvious. The chatter about demonstrations of efficacy as a requirement for a CE mark has been going on for some time, and the flap over...

An Army wife friend of mine is diabetic and has been taking insulin for eight years. Last fall she and her husband were moved to a new duty station where she was assigned a new primary care manager at a military hospital that shall remain shameless – oops, I mean nameless. When she tried to order her diabetic supplies, including insulin, a representative of the hospital told her she couldn’t possibly be diabetic because they didn’t have any record of her diabetes. I have experienced similar frustrations with the same military hospital because of my own unusual medical history. It...