Johnson & Johnson’s year did not get off to a great start. Not that last year was any better. I mean the company report lagging sales in its medical device’s market. But the start of 2016, led off with the Brunswick-N.J.-based company reporting that it would lay off about 3,000 people from its medical device division. Or about 6 percent of all medical device jobs and about 2.5 percent of J&J’s global workforce - for those of you that dig percents instead of raw numbers. Most of the layoffs would come from the orthopedics, surgery and cardiovascular segments and result...
It’s often interesting to see and hear the things that go on at FDA advisory hearings, and the Feb. 18 hearing for leadless pacemakers proved to be no exception. I’ll admit at the outset that I’ve always been of the view that these advisory committee members are charged with making up their own minds about the questions the agency poses to the panel, but maybe I’m just naïve, yes? One of the questions the agency posed to the panel was whether a post-approval study for a leadless pacemaker could include patients who...
It was interesting to hear the President become archly ambitious about the oncological equivalent of a moonshot during his most recent State of the Union address. The President said veep Joe Biden would take the lead on an effort to break down "silos of data," which Biden said recently would halve the time needed to make advances in cancer care, and those in the private sector might be wondering how much of this talk of silos has to do with NIH's draft clinical trial data disclosure rule. By...
The mood was pretty somber going into Heartware’s (Framingham, Mass.) breakout session during the 34th annual J.P.Morgan Healthcare conference. But why wouldn’t it be? It’s not everyday that a med-tech CEO has to discuss halting a European trial on one of its most promising technologies. But that’s exactly what Doug Godshall, Heartware president/CEO did. Godshall, who took the leadership position of Heartware in 2006, delivered the bad news across a sea of somewhat disenchanted faces during the conference. He did a great job, but honestly, is there ever a “good way” to deliver bad news? You see, Godshall revealed...
Device makers like to grouse about FDA, but they're not the only ones who feel they have an axe to grind. Recent warning letters suggest the agency is more frequently making use of detention to deal with violative products of all kinds from all kinds of places outside the U.S., but do the data support that idea? Let's peruse the FDA warning letter database to find out. Can you say 'quadruple'? According to the FDA warning letter search tool, the agency applied detention to 16 OUS companies in 2015 (the list...
2015 was another of those years with some interesting developments, some good, some bad. The biggest news of the year is that the device tax has been suspended for two years as a result of the budget deal between the GOP-led Congress and the Obama administration, but the tax presumably kicks back in as of January 2018. That's not necessarily a problem for industry if recent electoral trends hold. One question is why the administration agreed to the device tax suspension despite President Obama's avowed opposition to any change to the tax. The answer starts...
Disc jockeys like to do two-for-Tuesdays and three-for-Thursdays, but we're not spinning music at MDD Perspectives. Today we go into full rebellion mode by offering a Thursday two-fer. Take that, hegemonistic radio stations! MAC, re-MAC, and MAC again Writer Jim Boren is noted for having said a good bureaucrat's guidebook would include the recommendation, "when in doubt, mumble; when in trouble, delegate." Has CMS taken this advice to heart? The reason I ask is that Medicare administrative contractors (MACs) typically fly under the radar screen, but lately not so much. A Medicare...
It takes a real grown-up government agency to admit when it has bungled the job, or maybe it just takes a good thrashing in the court of public opinion. Of course, there are government agencies that simply mumble into their coffee mugs about "fixing the problem," assuming they acknowledge their stumbles in the first place. Let's take a moment to look at two rather peculiar stories about government agencies that have appeared recently in Medical Device Daily. CMS walks back from the precipice We all remember the story about a recent decision by a Medicare administrative contractor (MAC) to not...
FDA's device center is busily punching up draft guidances again, but today we're back into the faces-and-places discussion just like last time here at MDD Perspectives. This time, the churn is on Capitol Hill, which is also where two tax issues seem likely to end up on a more or less fast track to nowhere. Paul Ryan's dirty job Let's get one thing out of the way quickly. If you were Paul Ryan, would you want the job of Speaker of the House of Representatives? I'd pass, but it appears he has...
The policy realm of medical devices is rarely quiescent, but the current pace of activity is conspicuous. There are a couple of juicy legal issues churning these days, but we’re also watching a changing of the guard at some pretty important organizations. Some observers have misgivings about one case in which a clear line of succession has already been laid out, but one might ask whether those skeptics are missing something. Califf, authorship and the election The argument for and against Robert Califf as the next FDA commissioner took a turn for the more fascinating recently with the disclosure that...
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