Those who are following the medical device tax repeal story might also be buried in the weeds of the budget sequester, the continuing resolution and so on, and not without reason. After all, the resolution of these issues has a lot to do with how Medicare spending unfolds over the next seven months and beyond. Much of the current hope for a repeal of the device tax seems to revolve around tax reform, so the question at this point is what will the tax reform discussion look like and whether it is viable as a vehicle for the device...
There has never been a shortage of negative news regarding the U.S. healthcare system, and for good reason. I could write a whole book on the subject, just based on my own bad healthcare experiences. But this is a mere 400-word blog, not a book, and I would rather spend it on a positive note. After suffering from painful digestive problems for far too long, and getting absolutely nowhere with local doctors, I finally...
She was probably a little more than 5-feet-tall... and close to 160 pounds of pure muscle. On a day unlike any other, I crossed the path of this 60-year-old woman (though she doesn't look a day over 40) who is an avid bodybuilder, at the gym I often work out in. We were both headed to a piece of equipment to do pull-ups - I was by myself, she was with a cadre of women that she was training. As I was about to get on the machine she cut me off rather quickly and hopped on it before I...
Earlier this week, I had the privilege of attending the Southeastern Medical Device Association's (SEMDA) annual conference. It was a tremendous opportunity to meet the players in the med-tech space that are located close to the office where Medical Device Daily is published. I would have to say that this conference did not disappoint. The presentations were lively; the speakers were great and the topics were very relevant to the med-tech industry. Perhaps one of my most favorite speakers was Jon Ellenthal, a partner and President of TEDMED, a company focused on innovation and breakthrough thinking across all of health...
ATLANTA - With a substantially strong turnout the Southeastern Medical Device Association (SEMDA) kicked off its 2013 conference earlier today. Hosted at the Georgia Institute of Technology Global Learning Center, the organization's annual conference featured speakers ranging from Medical Device Manufacturers Association President/CEO Mark Leahey to Jeff Shuren, MD, director of the Center for Devices and Radiological Health (even though he was speaking from an offsite location). SEMDA seemed to have its finger on the pulse of med-tech firms' concerns even more so than last year. As in past years the themes seemed to center around dealing with strained funding...
A clumsy attempt to address the Medicare Part B physician fee problem has nagged at Washington for a decade, but it appears Congress is ready to put a doc fix in play. Whether it’ll happen depends on politics and, as a skeptic might argue, some accounting sleight-of-hand, but it appears this is a now-or-never moment. As has been widely noted, the Congressional Budget Office recently released a report proposing a lower figure for the budgetary effects of a repeal of the sustainable growth rate (SGR) mechanism than has been calculated for some time. Instead of the average figure of $30...
Ask anyone in the med-tech field, or any other manufacturing field for that matter, where the largest majority of emerging markets for their businesses reside and chances are they will say somewhere in Asia, with China being the first country to likely cross their lips. With more than 600 billion people and a combined GDP of $2.3 trillion, the ten nations that make up the Association of Southeast Asian Nations (ASEAN) are already experiencing dramatic economic growth. This is especially true of the medical device market, which in 2012 was worth more than $4 billion. Roughly 65% of the $4...
It has been said there are shortages in this world, but there has never been a shortage of bad ideas. In fact, the opposite seems to be true. Here are three really crummy ideas we should all hope end up thoroughly debunked. FDA does comparative effectiveness research We’ve tackled this idea before, but unlike fine red wine, this one isn’t improving with age. The Institute of Medicine released a report recently stating that FDA should “have a more rigorous approval process for new technologies,” arguing that...
In October of last year, Medtronic made headlines when it reported that it was going to acquire Changzhou holdings, a China-based company that is a provider of orthopedic devices, for $816 million. Now the acquisition, in my opinion was perhaps the loudest shot fired in the battle to maintain a dominant presence in China one of the fastest growing emerging markets. Last month, Stryker responded in kind with its plan to acquire Trauson Holdings, a China-based firm that specializes in products for the spine for $764 million. After listening to a webinar from Millinneum Research Group, about the Top 10...
The new year is underway and a few things of interest to med tech firms have already cropped up. Here are three of the more interesting developments in the world of medical devices (and it’s only for the month of January). Duval files petition to stay substantial equivalence guidance I’ve never filed a citizen’s petition, but something tells me it entails more work than making a cup of coffee, so I’ll assume that regulatory consultant Mark Duval thought he was on to something in filing a petition to have FDA...
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