A couple of weeks ago I had the opportunity to interview a company that was undergoing a pivotal trial in the U.S. The company had actually received approval from the FDA to use a second generation device in the trial - because the device was already approved in Europe and had been advanced to its second iteration. While this has been an issue for a while in the med-tech space - the fact that FDA can sometimes lag behind during the approval process to this degree is a bit troubling. To my mind it hampers innovation in the U.S....
Interagency coordination at the Department of Health and Human Services is purported to be a routine fact of life nowadays, but there are signs that outside forces are pushing FDA into activity that could have a big effect on another important agency. This might be strictly a problem of perception rather than reality, but its tough to avoid the conclusion that all the emphasis on speed at FDA might run up against a rather large obstacle elsewhere at HHS. Breaking through to nowhere AdvaMed held its annual policy briefing earlier this...
It’s truly a futuristic world we live in with technology that not so long ago was only seen in science fiction. Last year, as part of a three-part series Medical Device Daily published, I explored 3-D printing and the potential for that technology, which enables us to make solid objects from...
It’s fun trying to report the news, especially when there’s so much non-news masquerading as news. But I’m sure you’re tempted to say to yourself, “this old-news/new-news/non-news dilemma is news?” Point taken. Anyway, let’s take a look at a couple of recent stories of note, newsy or not. Old news; the combo products GMP guidance FDA has issued a combination products draft guidance for good manufacturing practices compliance, but this is not the first such attempt and surely will not be the last. FDA has taken...
The Midwest might not have as much funding activity as some parts of the West Coast or other established hotbeds for innovation, but potential med-tech entrepreneurs and would be investors would be foolish to overlook this region, according to a report from BioEnterprise. The med-tech companies are consistently finding funding in the Midwest, and were even able to raise dollars during the tumultuous years following the economic meltdown. Since I began my tenure at Medical Device Daily in 2007, the region has produced strong numbers consistently. The study points out that Midwest healthcare companies attracted $1.8 billion in new investments...
The federal government seems at times determined to make a blogger’s job easier, and recent events do little to dissuade one of that view. Following are a couple of developments of interest to device makers, but we can’t be sure what’s real and what’s just more smoke and mirrors. Is corporate tax reform kaput? As we noted recently, Secretary of Commerce Penny Pritzker said in public that the administration wants revenue-neutral tax reform, but President Obama said little about taxes in the...
It’s a new year with a host of new possibilities, not to mention a few hangovers from 2014. So what will 2015 bring to the world of med tech? Let’s find out. Administration says “revenue-neutral” Will Rogers is credited with having said, “the only difference between death and taxes is that death doesn't get worse every time Congress meets.” This year might prove the exception where corporate tax reform is concerned. I say that because Secretary of Commerce Penny Pritzker is now on record as saying the...
It doesn’t take 365 days to do useful things or to stink up the joint, but a year gives us plenty to work with, doesn’t it? Following is a list of a few things that were very interesting about 2014 to put it mildly. To start, there’s the March 25 FDA notice in the Federal Register about medical device classification rules. I’ve blogged about this before, so there’s not much else to say other than that the agency seems to have bit off far more than...
My first exposure to Google Glass was in the summer of 2013, when the Medical Device Daily and BioWorld Today staff were given a chance to demo the technology at the Thomson Reuters’ Atlanta office. My first reaction to Glass, was that this was something straight out of those old Dragon Ball Z cartoons that I use to watch when I was in college. You know the ones where the character would wear glasses and a glance through the fictional technology would give the stats on his opponent, or maybe not and I’m the only anime fan here - but...
Right about this time last week, somewhere between the third slice of pumpkin pie and a turkey-induced coma, my mind drifted over some of the stories Medical Device Daily has covered in 2014 and all the things the med-tech industry should be grateful for this year. A surge in IPOs and an active M&A market were high on that list. But Thanksgiving is over and my thoughts have turned to the gift-giving season. As I tell my six-year-old every time a new toy...
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