[caption id="attachment_2517" align="alignleft" width="300"] Another interesting quintet, no?[/caption]
The merry month of May is just about kaput, so let’s ask ourselves how entertaining the past five months of May have been. Entertaining, that is, if you’re a med tech geek or wonk, and it’s a cinch you’re one or both of those if you’re reading this.
The May 5, 2008, edition of Medical Device Daily included a story by MDD’s Omar Ford describing the decision by the Centers for Medicare & Medicaid Services to cover the use of artificial hearts. The decision was a landmark for patients, but one of the interesting things about the story was that CMS was at the time headed by one of those “acting administrators,” Kerry Weems. Thankfully we now have a real administrator, Marilyn Tavenner, on the job, the first to be able to say that in a number of years.
SynCardia (Tucson, Arizona) has manufactured a lot of temporary total artificial hearts since that time, including one that went into the chest of Justin Ryder, a 35-year old former professional athlete. Ryder was on the Syncardia artificial for nearly three months earlier this year while waiting for a suitable transplant.
Abiomed (Danvers, Massachusetts) has also maintained a space in the artificial heart space with the Abiocor, an ingenious fully implantable system. It’s remarkable to think that more than 30 years have passed since Barney Clark had a Jarvik 7 implanted in his chest in 1982. It really is amazing to think how much has changed in this technological area in those three short decades.
As was the case for the previous year, 2009 presented a lot of interesting content. One of the most interesting was a hearing in the Senate Finance Committee dealing with healthcare reform. The May 6, 2009, edition of MDD includes a description of how some protesters attempted to disrupt the hearing with calls for a single-payer system.
Committee chairman Max Baucus (D-Montana) called for a little civility, but his previous comments had made clear he would not push for single-payer healthcare. The calls for deploying healthcare reform “in a fiscally responsible way” echoed throughout the hearing, but that promise is looking increasingly tenuous as the ramifications of the Affordable Care Act continue to make themselves felt.
Anyone who thinks “interoperability” is a dirty word is obviously not a healthcare IT consultant, and the May 7, 2010, edition of Medical Device Daily showed once again that government can dole out money toward the search for the Holy Grail even when the knights have no idea where to look.
The federal government had announced that week it would supply providers with $200 million in healthcare IT grants despite the absence of an interoperability standard, a predicament that hasn’t been relieved by billions of dollars in HIT grants and untold effort by a wide range of interested parties. Healthcare IT interoperability would be fodder for any comic working the clubs in DC if not for the justifiable outrage over Uncle Sam’s borderline criminal abuse of taxpayer dollars.
If you like the word “innovation,” you’ll love what Eidosmed (Chicago) did with its compliance systems. According to FDA’s March 16, 2011, warning letter to the firm, Eidosmed was in the habit of maintaining design history documentation in company e-mails.
I didn’t come out and say this in the May 4, 2011, edition of MDD, but let’s face it: While this is not a good way to impress FDA, it cannot be argued the idea lacked originality.
CMS announced last year it would cover the use of transcatheter aortic valve replacements (TAVR) via the coverage with evidence development (CED) framework. It was an interesting bit of coverage in the May 2, 2012, edition of MDD, not just because the write-up had its share of acronym soup.
CMS dropped the notion of requiring that the CED trial be designed to demonstrate superiority of TAVR thanks to the objections of clinicians from just about everywhere outside of Antarctica. The decision was also interesting in that it purportedly involved the use of parallel review, a much-touted mechanism seemingly destined to never account for more than a handful of device applications per year, if any.
However, team medicine also got a big boost in this coverage decision, a rubric for clinical decision-making sure to get a lot more use than parallel review in the years to come.
The MedTech Investing Conference held each May in Minneapolis is one of the more interesting investor-focused gatherings on the calendar. It always earns accolades from attendees as representing one of the best opportunities to bring together venture capitalists, entrepreneur/innovators and corporate development types, the latter of whom are always happy to spread the message that they’re open for business.
Held for the 12th year earlier this month, the conference offered quite the reminder of the range of emotions being felt these days by those involved with or interested in med-tech.
During his welcoming comments, conference co-chairman Kevin Wasserstein, founder and principal of MentorCatalyst (Menlo Park, California), asked for a show of hands by those in the audience who thought the med-tech industry was in better shape than was true a year earlier, only three raised their hands. Most said they thought things were about the same, while only a handful said they thought things were worse.
Wasserstein, while taken a little aback by the count-on-one-hand number of “better” responses, said that lack of optimism to date was more than offset by the fact that the annual gathering had attracted what already was a standing-room-only ballroom full of attendees.
“Med-tech is alive and well,” he said. “That sentiment is clearly expressed by the size of this crowd,” totaling about 350 participants for this year’s version of an annual gathering presented by regional trade group LifeScience Alley (St. Louis Park, Minnesota) and conference production firm International Business Forum (IBF; Jericho, New York).
And from what I saw and heard during the jam-packed agenda of a one-day (one really long day!) conference, Wasserstein was spot-on. Attendees were highly interesting in a series of thought-provoking panels that ranged from the meat-and-potatoes sessions on how – and where – to generate investor dollars to a group of payers and providers talking about how they make coverage decisions for new technology.
Even an early-in-the-morning breakout session containing some very interesting commentary on what to look for in finding the right talent fit for a start-up device company, drew a roomful of attentive conference-goers who joined in on the lively discussion and took the time before and after the program to loosen up their networking chops.
Overall, I’d say the mood was one of something on the plus side of cautious optimism. Those in attendance clearly think the future for med-tech, while distinctly challenging and certainly changed from the growth-on-top-of-growth days that prevailed up until 2007 or so, is positive. It’s really a matter of recognizing, then accepting and then finally embracing the new realities.
To focus on two of the most important categories, those realities are that 1) cost-cutting is in full bloom, and device manufacturers definitely must be part of the solution, and 2) the falloff in venture funding isn’t temporary, so those organizing start-ups have to identify other ways to finance their early efforts, some of which eventually will come their way from the voracious corporate investors/acquirers who are trolling the med-tech waters for new technologies.
Wasserstein was a stage-setter for the new reality, referring to a set of oversized Chinese characters shown on large screens in the ballroom. The characters represented the words “danger” and “opportunity.” He said that medical innovation “also is alive and well. What we investors need to do is focus on how we can bring that innovation to market. Huge, unmet clinical needs,” remain, he said, with consumer-driven healthcare expected to presage even more opportunity for new technologies.
As was demonstrated by a heavily attended session that featured FDA honcho Dr. Jeffrey Shuren appearing electronically from his office in suburban Washington, the longtime angst-ridden relationship between the agency and the med-tech community seems to either be thawing or already has completely shed its coating of ice. As Wasserstein put it: “There are signs of intelligent life at FDA, with 26 original PMAs winning approval over the past 12 months.”
All of which adds up to a feeling that med-tech is on the verge of being back in business, albeit in a distinctly different form that earlier in the current century.
If I had to describe Jamar Rogers in just one word it would be life. More than anyone else I have ever met or spoken with, Jamar Rogers is full of life. It was evident from the first time I saw him on the second season of NBC’s The Voice and it was reconfirmed last week when I spoke with him on the phone, that this is a guy who is truly living his best life.
Jamar’s spirit and energy and courage shines through everything he does, on stage and off. One of the things that have allowed him to become the person he is today is the fact that he has learned to share his personal story of living with HIV. Recently Jamar teamed up with Ortho Clinical Diagnostics (OCD; Raritan, New Jersey), a Johnson & Johnson (New Brunswick, New Jersey) company, to support National Minority Health Month and highlight the important role diagnostic tests have played in his life.
But there was a time when Jamar was not so open about his HIV status. “I had been living with HIV for six years before I started to talk about it, because I had my own stigma and my own prejudices about it,” Jamar told me. “Then one day I caught wind that a friend of a friend had jumped off the George Washington Bridge after finding out he was HIV-positive. I just wish we could have talked about this and I could have let him know that there is life beyond that and that he didn’t have to die.”
It was then that Jamar Rogers, who at the time was just beginning his journey on The Voice, decided to tell America he was HIV-positive. But his is not a story of tragedy; it is a story of triumph. “And I have gotten the most out of the experience,” Jamar told me. “Because it has freed me to live my life.”
“Diagnostic testing obviously saved my life. When I went into the emergency room almost eight years ago now, I was deathly ill and it was in the emergency room that they not only tested my blood but were able to read my blood and because of those results I was able to make informed decisions,” he said. “You really can’t accomplish the things you want in your life until you know what’s going on in your body.”
And Jamar emphasizes the importance of all diagnostic testing, not just HIV testing. He wonders, for example, if his grandmother had been tested sooner for heart disease if she would have had more time.
Jamar recently visited Ortho Clinical Diagnostics and performed a song called “Where Would I Be Without You” from his upcoming album to show his gratitude to the people who develop diagnostic testing, like the people at OCD. “I feel like the people that work for Ortho Clinical, they’re kind of the unsung heroes. Nobody ever sees their faces,” he said. “And I just wanted to thank them and say ‘you know what guys? I see you’.”
To watch Jarmar’s performance at Ortho Clinical Diagnostics, click here. He also encourages everybody to take an active role in their healthcare by getting regular blood tests and discussing the results with their doctor. “I find that when I tell people to get their blood tested and they get their results back they’re like ‘what’s next?’ If you download the Know Your Numbers guide from Ortho Clinical’s website it explains everything,” Jamar says.
I admire Jamar Rogers for choosing to live his best life. But doing so comes with a price. “The cost is living and enjoying life, even when there are others who would like to take that right away from you,” he writes on his blog. “The cost is being a teacher, a healer … educating ignorance even when it hurts. The cost is taking a leap of faith and trusting that the net will appear. The cost is deciding, once and for all, that every life deserves dignity and sometimes you have to be the one to fight for that dignity. Living with HIV hasn’t been easy but it has been a blessing because I finally recognize my strength. I’m a fighter and I choose to leave a legacy.”
The latest news about the Internal Revenue Service does nothing to comfort those who have to routinely interact with the agency, but it does seem to tie in with other behaviors by the Obama administration, regardless of whether anyone at the White House “knew about it.”
So what does all this mean? Let’s take a look at some recent developments and ask ourselves where exactly the problem in Washington is located.
First, the IRS scandal, consisting of a systematic targeting of tax groups with words such as “tea party” in their names, makes clear the agency is not to be trusted. Argue all you want that’s an over-the-top statement on my part, but the IRS will have to earn our trust again. The machinery of government is too powerful to simply let this pass.
This is not the first time the IRS has gone astray. The administrations of Jack Kennedy, Lyndon Johnson and Richard Nixon all fell prey to that temptation. And I really don’t give a bleep whether White House spokesman Dan Pfeiffer thinks the question of whether the IRS targeting of conservative groups is illegal. It’s quite important, Mr. Pfeiffer, and your obvious disregard for that question raises very serious questions about you and your boss.
With the device tax in play, does anyone in the medical device or diagnostics business still feel comfortable speaking their mind about anything?
The media and government: What kind of relationship?
The news that the Department of Justice had gone way out of bounds to obtain the phone records for a number of reporters and editors at the Associated Press is even more off-the-wall when one considers that the AP went out of its way to cooperate with Obama’s DoJ on the timing of an article around which this story appears to revolve. The President has had more than fair treatment from the vast majority of the press since the day he announced he would run for the presidency, but his policies suggest something bordering on paranoia, as this story at Huffingtonpost.com indicates.
Let’s not forget that the Center for Devices and Radiological Health had a list of reporters it generated in pursuit of the problem with documents leaked by renegades at CDRH. I previously indicated I had no problem with CDRH keeping track of what suspect employees were doing on government computers, and I still don’t. But keeping a list of reporters with whom these renegade employees had contact is far beyond what the agency needed to deal with malfeasance on the inside. And one of the factors that led to this problem is that those in civil service are very nearly impossible to dismiss. That was a problem at CDRH and one suspects the IRS story will shine a light on that very issue as well.
Unfettered executive “privilege”
It’s probably a bit early to describe the current administration as paranoid, but there’s no denying that those in government are routinely tempted into abusive behavior. The four-year investigation into Medtronic that concluded last year and led to exactly nothing at all is fresh on the minds of device makers, and the author of DoJ’s Thompson memo, Larry Thompson, suffered no backlash at all for writing a policy that amounted to government extortion of the private sector. Both those actions commenced during the administration of George W. Bush, so clearly this is not just a problem for Democrats in the White House.
In my mind, the real nail in the coffin for device makers is the 2010 enforcement declaration by former FDA chief counsel Ralph Tyler, who had advised FDA commissioner Margaret Hamburg to not just aggressively use whatever authorized enforcement levers the agency had at its disposal, but to also employ any available levers that were not explicitly forbade by the statute. That announcement should have warned drug and device makers that things had changed in Washington – not for the better – and to top it off, Hamburg endorsed the idea.
I’m not sure I’m ready for a membership in the Cato Institute, but all this makes people wonder whether there is something insidiously wrong with our system of governance, and it’s not just Capitol Hill. It’s even more the executive branch, which seems too often to think it has carte blanche to do whatever it pleases, a mindset characteristic of the police states of the 20th Century. Whatever the failings of Congress, the executive branch’s abuse of federal government agency leverage presents the clearest threat to private citizens and the private sector in general.
We would all do well to bear all this in mind in the years ahead because we all have the capacity for tyranny encoded into our DNA. I’m sure Edmund Burke will forgive me for bastardizing his famous quote, but let’s face it: All that is required for the ascendancy of tyranny is that we all sit around like sheep and allow it.
The danger is especially grave when government starts to believe in itself as the infallible first principal in our individual destinies, a belief that is a total inversion of the Constitutionally imposed limits on the federal government, not to mention the beliefs of the authors of the Constitution themselves. We should all be extremely wary of a federal government thus deluded into believing in its own deification.
[caption id="attachment_2449" align="alignleft" width="221"] just give me another five minutes[/caption]
OK, I admit it, I love to sleep! If I need any more reminders that I am getting old – thinning hairline, constant aches and pains, the imminent arrival of reading glasses – the fact that I really enjoy going to bed early should be a sign. To me, nothing is more relaxing than a good book and some peace and quiet before nodding off; 10:00 is usually about right. Accompanying me on the bedside table is a sound machine which creates soothing background noise to help drown out the outside world (which is usually the TV in the other room by my night-owl wife).
But, while we were awake, sleep has become a serious business. A search at clinicaltrials.gov revealed 3,246 sleep disorder studies are currently conducted worldwide. In addition, a recent survey conducted by the Pew Center showed 60% of respondents track health indicators such as weight and exercise, and 33% track health indicators or symptoms, like blood pressure, blood sugar, headaches, or sleep patterns. Of this study population, 21% say they use some form of technology to track their health data, such as a spreadsheet, website, app, or device.
For those of us more inclined towards technology, the options are many. Open up the app store on your smartphone or tablet and type in “sleep cycle.” Of the 134 choices that popped up on my phone, the Sleep Cycle Alarm Clock (99 cents to download) from Maciek Drejak Labs is the most prominent. The user places the phone under the sheets near the pillow before getting into bed. Since you move differently in bed during the different phases, Sleep Cycle uses the accelerometer in your phone to monitor your movement to determine which sleep phase you are experiencing. The goal of the app is to wake the user in the lightest sleep phase, which feels like waking without an alarm clock – it is a natural way to wake up where you feel rested and relaxed. Say you normally get up at 7:30, the Sleep Cycle will determine within a half hour the best possible time to wake you peacefully from slumber. No more smashing the alarm clock against the wall; you might be less inclined to smash your smartphone, but that’s a personal choice.
Upon awakening (refreshed and ready to take on the day!), the user is privy to all sorts of data on his or her sleep cycle for that night. You can find out the total time spent in the bed, of that time, what percentage of it was “quality sleep.” It keeps track of your statistics over time, so you can view a graph your sleep cycle.
Another device that has been getting attention is the fitbit one. The fitbit one ($99) consists of a wireless wristband that is always on and tracks all the user’s movements and patterns, including sleep. Slip into your wrist band at night, and it’ll measure your sleep cycle. Once the data syncs, graphs on your dashboard (via your smartphone) will reveal how long you slept and the number of times you woke up, giving you a sleep quality score. Over time, you can apply what you learn to help you sleep more soundly. The device also has a silent wake alarm that gently vibrates to wake you at your desired time, without disturbing your partner. This device is all-encompassing as it keeps track of your total fitness levels and lifestyle (steps taken, calories burned, distance traveled, stairs climbed, hours slept, and quality of sleep).
Full disclosure: I haven’t tried these myself (or any of the other numerous sleep aid devices). Call me old fashioned, but for now I will stick with my tried and true methods – comfortable bed, sound machine (set to rainstorm, please), and an automatic brew coffee machine. Sometimes variables, like my lab’s cold nose and panting breath in my face, take care of waking on its own.
[caption id="attachment_2457" align="alignleft" width="150"] A 3-D ultrasound image of a fetus in the womb[/caption]
Remember when expectant parents would go around showing off their ultrasound pictures to 350 or more of their family, friends, co-workers, neighbors, and old classmates? Neither do I.
Yet on any given day I can see 3-D ultrasound pictures posted by Facebook friends I only vaguely remember from school. Awe, it’s a picture of your uterus, you shouldn't have. No, really, you shouldn't have!
Socially speaking, this trend is downright disturbing, especially when the mother-to-be makes it her profile picture. Now her fetus is available for the entire world to see, regardless of her privacy settings. These are the same women who will later post status updates throughout their entire labor. I'm not kidding.
Don’t get me wrong, diagnostically speaking, there have been some remarkable advancements in ultrasound technology that offer tremendous advantages for obstetricians and their patients. Take the latest addition to Royal Philips Electronics’ ClearVue family, for example.
The ClearVue 650 includes 4-D technology and Tissue Doppler Imaging to allow clinicians to quickly inform patients about any rare or complex heart abnormalities in the fetus. It also produces clear images to more accurately determine gestation age, date of conception, and other important information about the fetus’ well-being and heart health.
I’m not saying expectant parents should not be excited about their keepsake ultrasound pictures. I’m not even saying they shouldn't share them with close family and friends. But these are intimate images that, in my humble opinion, are better shared offline.
In a recent issue of Medical Device Daily, Integrity Life Sciences (ILS; Tampa) reported that FDA will investigate the use of robotic surgery, a move said to be sparked by a tripling of adverse events reports between 2008 and 2012.
The company statement indicates that the more than 1,400 U.S. hospitals deploying surgical robots have filed enough reports to render a report rate that is a "higher than acceptable rate," although the announcement acknowledges that the data do not clearly disclose whether "the failure is attributable to the robot itself, operator error, the FDA marketing clearance process, or the training provided by the manufacturers." Integrity says that FDA indicated that it will "make a further determination in this matter and offer industry guidance."
The ILS statement indicated that a soon-to-be-published paper by a researcher with Johns Hopkins University (Baltimore) likely sparked FDA's interest. Martin Makary, MD, said to be one of the authors of the paper, is purported to have alleged that adverse events are under-reported.
The Food and Drug Administration asked surgeons at key hospitals to list the complications they may have seen with the machines, which cost about $1.5 million each and were used last year in almost 500,000 procedures. The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training.
The surveys were sent to hospitals that belong to a product safety network overseen by the FDA. What the agency is trying to determine is whether a rise seen in incident reports sent to the agency are “a true reflection of problems” with the robots, or the result of other issues.
In a move that seemingly looks to head off any of the trouble for the machines, David Samadi, MD, appears to have borrowed a page out of the National Rifle Association (Washington) handbook, noting that the surgical robots don’t make mistakes, rather, the surgeons using the machines are the ones responsible for potentially catastrophic surgical errors.
Samadi, Chief of Robotics and Minimally Invasive Surgery and Vice Chairman of the Department of Urology at the Mount Sinai Medical Center, performs a high volume of robotic prostate surgeries and argues that more stringent robotic surgery training requirements are the solution to protecting patients.
Samadi has performed more than 4,500 robotic prostate cancer surgeries, employing Intuitive Surgical’s (Sunnyvale, California) da Vinci surgical robot in his SMART Samadi Modified Advanced Robotic Technique (SMART) prostate removal procedure.
Samadi stressed the safety of robotic surgery with one critical caveat--the robot does not perform the surgery. That responsibility, he says, falls squarely in the hands of the surgeon.
"The robot is a tremendous technology that reduces time in the operating room and improves patient recovery. But you have to know what you're doing; the learning curve cannot be overlooked," he said.
Samadi expressed concerns that the training recommendations for these surgical robotic systems may be "watered down" by some hospitals eager to acquire and promote the innovative technology. "Many hospital-level requirements for performing robotic surgery are insufficient," cautioned Samadi. "We're now seeing the fallout of institutions that may have rushed to market with a shiny new robot and less experienced surgeons. My hope is that the FDA can lead us to enforced national standards for robotic surgeon training and specific procedure experience. Our patients deserve that level of safety and assurance."
In a Bloombergstory, Intuitive said it faces 26 lawsuits from people alleging injuries tied to its da Vinci surgical system, according to a regulatory filing in April. The company also has entered into agreements with some plaintiff lawyers temporarily suspending the statutory deadline for filing suits for other patients who say they were hurt by robotic surgery, it said. Intuitive has seen a “substantial increase” in such claims, according to the filing.
The Bloomberg story discussed how the stress and complications from a lengthy prostate operation assisted by an Intuitive Surgical robot hastened a patient’s death from heart disease.
The patient, Fred Taylor might have lived five more years, and had a much better quality of life, had he never suffered the consequences of the botched robotic procedure in 2008, John MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told a jury as a state court trial entered its third week in Port Orchard, Washington.
“A number of complications put stress on his heart and his body in general,” MacGregor said. “I think the prostatectomy and the aftermath of his prostatectomy accelerated his cardiovascular disease and hastened his death.”
Lawyers for Intuitive have argued that Taylor never should have been a candidate for robotic surgery because of his obesity, and that he didn’t regularly take his prescriptions to control his heart-disease risks.
Under cross examination by defense attorney Jeffrey Johnson, MacGregor agreed that Taylor’s out-of-control diabetes, morbid obesity and his family history of cardiac disease risks put him at greatest risk for eventual death from coronary artery disease. Defense lawyers had previously said that medical records indicate Taylor’s health conditions were better controlled when Taylor was in a hospital or a rehabilitation facility.
After seven hours of trouble with robotic surgery on Taylor in September 2008, urologist Scott Bildsten and other doctors turned to traditional surgery and then emergency care to repair a rectal laceration. Bildsten had performed 100 successful prostatectomies using a traditional procedure and hadn’t used the da Vinci system on a patient unassisted.
Bildsten testified that while Intuitive deemed him ready after one day of the company’s training and two supervised operations, he now knows he needed more training to perform the robotic surgery unassisted.
So what do you think, is operator error strictly to blame for the problems with these robotic surgical systems, or are there flaws of the HAL 9000 variety contained within the devices?
If someone would have asked me three years ago what Necrotizing enterocolitis (or NEC for short) meant, then my response would probably be a blank stare, followed by I'll have to get back to you on that. That's often the reply I give to people when I'm not sure of an answer.
But if someone were to ask me today what NEC means, the answer would probably be a bit different. I think the first thing I'd say is, "Well how much time do you have for me to answer that question honestly?" For simplicity's sake, we can just say that it is a condition often seen in premature infants where portions of the bowel undergo necrosis or tissue death. It impacts about 10% of infants born at under 29 weeks, and about a third will die.
My family found out first hand what this disease is when it claimed the life of my 3-week-old son, Aaron. Now, there's not a day that goes by when I don't think about my son or the disease and how it changed the life of my family.
Last month, however, I stumbled across some interesting research that might give other parents who have premature infants a chance to diagnose and catch the disease before it can do much harm. Researchers have discovered that abnormal gut bacteria in premature babies can be found days before the onset of NEC according to a study in BioMed Central's open access journal Microbiome. The research also shows that babies who later went on to develop NEC had a lower diversity of gut bacteria 4-9 days after birth, increased level of Firmicutes or Enterobacteriaceae, and lacked the Propionibacterium found in healthy babies. In other words, this could eventually turn out to be a strong predictor of NEC. But it's still in the initial phases.
I put this in MDD's special section Diagnostics Extra, nearly two weeks ago. I'm going to be honest with you, it was perhaps one of the hardest things that I've ever done. At some point I selfishly asked myself why couldn't they have had something like this for Aaron - why couldn't this research be fully realized and used. But, then I realized that the news needs to get out and that there needs to be some strong awareness regarding the disease.
I thought it only fitting that perhaps - I write about this now, to not only get the awareness out about this research, but also to give my son a voice, who - if he survived - would turn 3-years-old on Monday.
[caption id="attachment_2417" align="alignleft" width="300"] Medical science boldly going[/caption]
The pages of Medical Device Daily are chock-full of outstanding content, but here are three stories from the month of April that caught my eye.
Taking the eye out of ouch
Seventh Sense Biosystems announced a registration trial for its TAP (touch-activated phlebotomy) device, which is one of those things that in times gone by was strictly the stuff of science fiction television shows. As my colleague Amanda Pedersen wrote in the April 3 edition, the TAP makes use of microneedles to obtain blood from the capillaries, and can dispense a small dose of anti-coagulant to keep things moving if need be.
This is real Star Trek stuff if you ask me. The company’s CEO, Howard Weisman, perhaps understated the case when he told Amanda the device got around “the pain and anxiety” of routine blood draws “because you don’t see the needle.”
I don’t see myself as particularly squeamish, but I don’t look at needles at all. I turn my head if I need a shot. In my view, you have to be a little crazy if you actually watch it all happen.
Three cheers for Seventh Sense, but tell me again who got sixth?
Consolidation in diagnostic services
Thermo Fisher and Life Technologies shook hands over a deal that would give the latter’s shareholders about $76 a share in a consolidation in the life science services industry. Both companies offer diagnostic lab services, and the terms of the deal make it a purchase coming to close to $14 billion plus any remaining debt on Life Technologies’ books, which may run to about $2 billion.
As Omar Ford wrote in the April 16 edition of Medical Device Daily, Thermo Fisher needed some help from a couple of investment banks to pull it off, which indicates the firm’s board of directors saw this as either too good to pass up or vital to the company’s future … or both. In any case, the deal probably won’t close until early next year.
Will a bidding war for Life Sciences ensue?
Collegiality at hospitals an issue?
Medical errors are still a topic among physicians and policymakers, and former Medical Device Daily executive editor Jim Stommen authored a two-part interview with Frederick Southwick, MD, of the University of South Florida about this.
Southwick told Jim – who I might note is something of a legend among the editorial staff at MDD’s publisher, AHC Media – that one of the impediments to efforts to tamp down on iatrogenic disease and injury is a cultural one. Southwick said hierarchies are of sufficient stiffness in many hospitals that “there is not a sense of collegiality that’s needed in order to foster teamwork.” He also remarked that hospital staff “tend to be disorganized in the way we communicate.”
Don’t get me wrong, I love technology as much as the next policy wonk, but if Southwick is right on the hierarchy point, it’s another demonstration of the need for we humans to get out of our own darn way. This is something technology cannot fix.
I’m not saying I never have such issues, and I’m also not saying I’d trade places with a doctor. People in all lines of work tend to lead with their egos, but when running unchecked in a hospital, this very understandable human impulse can cost lives.
But who, besides Southwick, is talking about it?