[caption id="attachment_647" align="alignleft" width="280" caption="Can't stop staring at me? You're a med-tech geek!"][/caption] We all find ourselves immersed in our work at times, but some jobs have tremendously broad appeal while others don't. For instance, lots of people want to own a vineyard, but even people who don't care for the idea like to talk about wine.
In comparison, there are people like me whose heads are full of things most people don't care about. One day a few months back, I sauntered about mulling over the med-tech policy ramifications of something or other. Some time later, I noticed a police officer following me in his cruiser as I wandered.I started explaining this predicament to him and it dawned on me that he wasn't interested. Not even a little bit. I came out of it and said to myself “Oh, for Pete's sake, would you listen to yourself? He doesn't care!”
Then he pointed to the cars and trucks hurtling past at dozens of miles per hour (which they don't often do on Interstate 66 in this part of Virginia).
That's when it dawned on me: I'm a med-tech geek.
Since that day, I've learned to accept my condition. No, there are no 12-step groups for this, but I'll be okay thanks to something Master What's-his-name said about finding one's purpose in life. He said, “follow your inner geek, Grasshopper,” or something like that.
Do you ever wonder if you're a med-tech geek? Here's how to figure out if you are. I should warn you, though: If only one applies to you, you're already in grave danger.
If all five apply to you? Oy.Five: You look forward to conferences like Transcatheter Cardiovascular Therapeutics because there's always an FDA town hall discussion of device-specific guidances, some of which run disturbingly close to 100 pages. Four: You can finally pronounce “February” correctly because you had to learn to say “defibrillator” without sounding like an idiot. However, this has not helped with your “nukular” problem in the least. Three: You think the object in this picture is fascinating, even if you haven't the foggiest idea what it is or what it's used for. Two: You start telling someone you meet at Starbucks about a new Medicare coverage analysis and you keep going even after his eyes glaze over and his jaw goes slack. You keep at it until his eyes roll back in his head and he starts drooling like a St. Bernard.
When the ambulance arrives, you defiantly bellow “defibrillator!” from a safe distance.One: You're the last one on your street to find out that some people use transcutaneous electrical nerve stimulators in foreplay.
Late last month, the American College of Radiology Imaging Network (ACRIN; Philadelphia) along with the National Cancer Institute’s Lung Screening Study Group released the results of the National Lung Screening Trial (NLST). The study supports the idea that CT Screening in older, heavy smokers can reduce mortality rates by 20% compared to standard chest X-rays. Nearly 53,000 current and heavy smokers between the ages of 55 and 74 at 33 sites across the U.S. were enrolled in NLST. (See full study here)
It should be pointed out however that the study results show that CT Screening in these patients turned up a high number of false positives (96%) - which creates a problem before this technique can fully be adopted.
But as the saying goes in med-tech one technologies' problem is another technologies' opportunity to provide a solution. (Okay, I confess, I just made that one up).
Med-tech companies now have an opportunity to fill in the gaps in CT Screening that this study points out. Those who jump on this quickly will reap the benefits of the study findings - while those who wait, will spend the next few years playing catch-up.
One company is quickly jumping on the findings provided by NLST, and getting the word out about their technology. VisionGate (Phoenix) reported on yesterday that its LuCED test could reduce false-positives in cancer screening. Scarlett Spring, the president of the company, spoke with me and indicated there was already strong interest from several academic to have the LuCED test evaluate some samples.
More companies ought to come forward. This study is going to shine a spotlight on a lot of technologies that could have been on the backburner. It's going to take imaging and screening to a whole new level and med-tech companies need to be prepared for the ride.
I remember reruns of a cartoon about a character named Tooter Turtle, who was always appealing to Mr. Wizard to send him back in time for some form of jollies or other, and when the whole thing went south, Tooter would yell out, “help Mr. Wizarrrrrd!”
At which point, Mr. Wizard would cluck about the futility of it all in his central European accent and bring Tooter back with the incantation, "drizzle, drazzle, druzzle, drome; time for zis one to come home."
I never had any idea what that drizzle-drazzle stuff was all about, but it worked for Mr. Wizard. Maybe it was because he had that charming, casually elitist Habsburg dynasty thing going on (The peasants are revolting but you're not so bad when you make an effort, dahhhhling). Who was I to argue?
By the way, please don't write me nasty letters about the Wayback machine being an invention by Mr. Peabody, paleo-techno-geek and friend to Rocky and Bullwinkle. I'm taking liberties here. I'll be more circumspect when they start flying me around in corporate jets.Without too much more ado, here is a glimpse into the med-tech past, courtesy of Medical Device Daily.
Inhalable insulin: Oh to believe again
Today I'm going back only as far as five years because at the rate of technological and policy developments in the world of medical devices, five years is way back, indeed.On this date, July 11, in 2006, Medical Device Daily ran a story on an agreement between Novo Nordisk (Bagsvaerd, Denmark) and Aradigm (Hayward, California) in which the latter sold patent rights to its technology related to glucose control. At that point in time, Nordisk was working on its inhalable insulin technology and agreed to pay Aradigm $27.5 million for the patented technology. If you're thinking Aradigm got the better of the deal, you're probably right. Nordisk got into a patent fight with Pfizer (New York), maker of Exubera, in August that year and both firms' products were off the market in two years. There's a saying we have in the trade press about things like that, and it goes pretty much like this: Ouch.
Override this!: Bush threatens to veto MIPPAOn this date in 2008, Medical Device Daily reported that President George W. Bush had threatened to veto H.R. 6331, the Medicare Improvements for Patients and Providers Act of 2008, which among other things papered over a cut of more than 10% to Medicare Part B doc fees and tacked on a raise of about 1%.
According to govtrackus.com, the President did indeed slap a veto on the bill, which the the House and the Senate overrode the very same day, July 15. The House came up with 383 aye votes to only 41 nays while the Senate came up with 76 votes in the affirmative versus 24 votes to the contrary.
How can it be that the sustainable growth rate overhang has nearly tripled in just three years? Is this some kind of magical healthcare multiplier? FYI: The bill also put an end to competitive bidding for clinical lab services that bill to Medicare.
Perhaps the most remarkable thing about MIPPA is that it gave us something that rhymes with HIPAA, otherwise known as the Health Insurance Portability and Accountability Act of 1996. When I heard about MIPPA, I think I said something like, “HIPAA and MIPPA were on the wall. HIPAA fell off. Who was left?”
Attorney forecasts pushback from Capitol HillAnd from July 12, 2010, which is really, really close to this date last year (July 11, 2010 was a Sunday and we don't publish on Sundays), Medical Device Daily reported that Jeffery Gibbs of the law firm of Hyman Phelps & McNamara (Washington) talked about the tighter scrutiny of devices by FDA. Gibbs apparently asserted that the changes underway at FDA are more sweeping than the changes imposed by David Kessler, MD, who led the agency during a near total shutdown of the 510(k) pipeline in the 1990s.
Gibbs also said during a conference call that some firms in the U.S. “will not submit 510(k)s, they’ll scale back on plans and they’ll focus on operations overseas now,” which he said was “leaving a bad taste in some people’s mouths on [Capitol] Hill.” Gibbs said, “whether this will translate into concrete action from legislators is unknown.”Consider it known. The latest member of Congress to sit FDA down for a chat is Sen. John Kerry, but also on that list is Sen. Al Franken (D-Minnesota), he of Saturday Night Live fame and not exactly the kind of guy you'd characterize as a hack for industry, at least not when he was elected in 2008. Of course, he is from Minnesota, isn't he?
All the same, if you're working at FDA and Al Franken tells you you've gone overboard, you're either living in Bizarro World – a possibility I can't rule out when I'm watching “World's Dumbest” on the television – or you've just flat-out gone too far.What do I think industry is saying about all this congressional fuss and bother? Probably what Anthony Michael Hall said in the movie “Sixteen Candles” when the object of his lust had agreed to terms. “This … is getting good.”
A few weeks ago, I made the mistake of going into the gym around 6 p.m. That's the time when all the body builders and athletes tend to circulate in the area.
I also made the mistake of getting on the treadmill next to someone who obviously looks like he runs track for a living. After seeing him run close to 10 mph without breaking a sweat - and I was struggling to do six - I left the gym dejected. The competition in there was just too great. How could I possibly keep up with someone who can do a mile in what looks to be three minutes flat?
A couple of weeks ago, Johnson & Johnson (J&J) did something similar. Faced with increasing competition in the drug eluting stent market, the firm threw in the towel and said that its Cordis Business unit would discontinue its Cypher line and stop development of its upcoming Nevo stent.
Apparently increased competition coupled with criticism that DES may increase the risk of potentially fatal clots in the form of late thrombosis were the two main culprits for J&J's demise in developing the stents.
It should be pointed out that J&J will continue to make stents for blood vessels outside the heart, particularly in the legs and feet, and is developing one to treat life-threatening aneurysms in the abdominal aorta, a major vessel that distributes blood to arteries below the waist.
So, they're not entirely giving up on the stent business, just DES. But in the meantime, what does this say for the DES market? At the current moment I'd say the market is in a state of flux. In the next few months, I think we're going to see med-tech firms scramble to pickup that market share that J&J is abandoning.
I even think that we could probably see other firms try to acquire J&J's Cypher technology, more specifically these firms might make a play for the Nevo stent. A J&J spokeswoman that MDD spoke to when the story first broke, didn't confirm or deny that there was a possiblity that the company could put the technology up for sale.
Whatever happens, it will be interesting to see how this new development impacts the continuing story of DES.