From sci-fi to sci-fact, healthcare supply chain spies Star Trek wonder
by Rick Dana Barlow
Nearly a baker’s dozen years into the 21st century and 3rd millennium, flying cars remain the fancy of fantasy and science fiction aficionados, while telephones have gone mobile, smart and wireless, functioning as hand-held minicomputers and automated life organizers.
Still, medical technology has seen its share of futuristic developments, ranging from improvements in laparoscopic and traditional open surgery devices to other medical/surgical, diagnostic imaging, laboratory and therapeutic products.
Healthcare Purchasing News sought to explore, identify and shine its exclusive and unique spotlight on those new products and existing product enhancements, revisions and updates that debuted since 2001 to date. We solicited input from readers and sources, winnowing the suggestions to what we determined were the most innovative, noteworthy and pioneering products and product categories making a difference in healthcare delivery. The first product debuted in 2001; the latest in early 2013.
HPN also tapped a quartet of technology analysts, experts and observers for their insights on clinical/medical technological development between the first dozen years of the 20th century and the same period 100 years later to compare the differences. Even amid overarching themes that may seem familiar, clear differences have emerged.
“At the start of the 20th century, innovation focused on understanding the human anatomy and technologies to support that, such as X-ray technology,” observed Thomas Skorup, FACHE, Vice President, Applied Solutions, ECRI Institute. “By the end of the 20th century, this understanding of the human anatomy and physiology had been translated into curative treatments at an organ level for various diseases.
“The start of the 21st century has seen a focus on understanding human and disease physiology at a molecular level with gene typing and proteins,” Skorup continued. Toward the end of the 21st century, I would fully anticipate the analogous translation of this molecular understanding into disease preventive and treatments at a molecular level.”
Charlie Whelan, Director of Consulting, Healthcare & Lifesciences, North America, Frost & Sullivan, sees “more focus now on chronic disease and less on infectious disease and acute conditions” than in the distant past, and more collaborative now.
“A hundred years ago there really was no formal medical device industry because there were so few real devices that a company could sell,” Whelan indicated. “Consequently, any innovation came from individual physicians and scientists who had a great deal of latitude to do whatever they wanted to patients and making any claims they felt like. Now, industry and the clinical community are equal partners that work together.”
Whelan also noted that the current time focuses more on globalization, in terms of research, market demand and product development; includes much greater liability and regulation of the field; features more science and less art, more digital and integrated; stresses more consumer empowerment and emphasizes innovation tied to commercial profit.
So which individual products and collective product categories did HPN list as some of the coolest tools of the 21st century to date? Read on.
If any technology defined and set the tone for device development and dreamscaping in the 21st century, Given Imaging’s “Pill Cam” raised the bar in 2001. Previously, endoscopic imaging involved sliding a flexible tube equipped with a camera down the esophagus for upper views – esophagus, stomach or part of the small intestine – or through the rectum for lower views – rectum and part of the small intestine -, the middle section of the gastrointestinal tract was uncharted territory, save for traditional open exploratory surgery. Then Given Imaging installed a tiny camera with a lens and multiple LED lights in a capsule about the size of a large vitamin for the patient to swallow. The affectionately named Pill Cam recorded and transmitted images as it trekked through the GI tract, hearkening back to the old “Fantastic Voyage” film that miniaturized scientists in a spaceship to travel through a soldier’s body while he lay on the operating room table.
“Capsule endoscopy eliminates the likelihood of a patient requiring additional imaging examinations for certain gastrointestinal conditions, reducing radiation exposure, costs and hospital time,” contended Jennifer Van Pelt, Senior Technology Analyst, Hayes Inc.
INTERVENTIONAL MEDICINE. Dominating this category, of course, is the stent, drug-eluting kind, in particular.
“No list of big medical device launches in recent memory would be complete without the launch in 2003 of Cypher, the first drug-coated stent in the United States,” Whelan said. “Billions of new dollars entered the industry driven by that one sector, creating significant opportunities for new interventional devices to follow, funded by investment dollars chasing the same big payday. While the coronary market is not as hot as it once was, interventional medicine continues to be one of the most lucrative and fastest growing market segments now exploring new applications in treatments for hypertension and pain, as well as heart valve replacement.
Skorup agreed. “The stent and stent-graft have revolutionized the treatment of vascular disorders, such as cerebral and abdominal aortic aneurysms, and coronary and peripheral artery stenosis.”
While Van Pelt acknowledged the stent’s challenges, she added that stents contributed to the development of a necessary offshoot. “Although there are still debates regarding the effectiveness of drug-eluting stents compared with bare-metal stenting, these combination drug-metal/polymer stents paved the way for combination drug/device therapies.
But the stent isn’t interventional medicine’s only hero, just the most popularized and publicized. One up-and-comer is Surefire Medical’s – http://surefiremedical.com – new Infusion System designed to deliver medication beads to tumors more accurately.
“Interventional radiologists have been delivering treatments into every organ system in the body for decades,” said Steven Citron, M.D., Interventional Radiologist, Radiology Associates of Atlanta P.C., serving Piedmont Hospital. “Many of these therapies involve the infusion of tiny beads into the blood supply of a tumor imbedded within an organ.
“The challenge and the art of doing so effectively and safely centers around the ability to deliver these beads to the target tumor with as little exposure of the remainder of the host organ or adjacent organs as possible,” Citron continued. “The procedure involves directing a catheter within the arterial system to the target organ, then selectively into the specific arteries feeding the target tumor, delivering as many beads as possible in order to completely occlude the tumor’s blood supply to achieve tumor cell death and necrosis.”
Before Surefire Medical’s new catheter system, according to Citron, interventional radiologists had to use end-hole catheters that led to vascular resistance and blood flow reversal in the artery as more beads were injected.
“As more beads are injected, an increasing number of beads flow backwards away from the tumor, which is termed reflux,” he said. “This results in the inadvertent delivery of beads to non-target vascular beds, both within the host organ and outside of it. In some cases, this non-target delivery can have deleterious effects on the host organ’s function, adjacent organ function, and increases the morbidity of the treatment. In the case of therapies within the liver, for instance, reflux can result in diminished liver function, including liver failure, severe ulceration of the stomach and small intestine, and inflammation of the pancreas. Unfortunately, these complications can be lethal.”
So Surefire essentially created something that resembles a windsock that expands to the wall of the blood vessel between heartbeats, but collapses a bit when the heart pumps blood toward the target organ, which focuses more of the beads on the targeted tumor, according to Citron.
LOW-DOSE CT. Some suggested multi-slice computed tomography as a key third millennium development because it “significantly reduced imaging time, offered better image resolution/quality and improved throughput of trauma patients,” all of which it did … starting near the end of the 20th century. The days of single-slice CT seem rather frontierish and quaint now as the initial surge to 4- and 16-slice models became the standard in the late 1990s, followed by the more high-definition-oriented 32- and 64-slice models for high-end cardiovascular work in the early 2000s to the “Slice Wars” between several prominent CT manufacturers that culminated in a 256-slice model hitting the market several years ago and more than 400 slices being shown in development.
But the real development in CT in recent years involved the emphasis on delivering an accurate image while lowering the dose of radiation given to the patient. The movement began in the pediatric areas as studies initially highlighted the dangers of excessive radiation exposure in children being imaged and quickly expanded to adults exposed to seemingly unnecessary CT images. What started as a bolt-on technology to manage and reduce dose delivered by new and existing CTs in operation now have been incorporated within new CT units and is quickly becoming the industry standard.
OPTICAL LIGHT IMAGING. “While amazing advances in medical imaging were made in the last century that led to the development of CT, MR and ultrasound that have revolutionized medicine, fundamental advances in these modalities have begun to slow,” Whelan said. “Some point to advances made in the last few decades in the light spectrum technologies, such as near-infrared spectroscopy and optical coherence tomography, as the next big field of medical imaging on the horizon. In the last decade, dozens of products have been launched in the field that can visualize cancer in situ, determine tissue oxygenation during surgery, illuminate veins to better guide IV needle placement and many other applications.”
ROBOTICS. You can’t talk about futuristic products and omit robots. Beyond the radiofrequency identification-controlled mail, food and supply delivery carts and portable vacuum cleaners healthcare organizations have seen and used their fair share of robotic tools. Perhaps the most obvious example of robotic use involves Intuitive Surgical’s seminal da Vinci Surgical System for minimally invasive procedures, which came of age back in the late 1990s as the next generation of surgical techniques for a variety of specialties. While carrying a hefty price tag and a necessary training regimen, this technology boasted certain patient safety advantages inherent in “keyhole” surgery, including surgical accuracy, as a cost justification.
Skorup extolled the field of surgical robotics in the 21st century. “The daVinci robotic system has advanced the precision of endoscopic surgery for complex and intricate procedures, such as prostatectomies and hysterectomies,” he noted.
Where Intuitive Surgical applied robotic technology to minimally invasive surgery, however, Accuray ventured a step further in specializing in noninvasive surgery. Its CyberKnife Robotic Radiosurgery System delivers beams of high-dose radiation to cancerous and non-cancerous tumors in the body, including the prostate, lung, brain, spine, liver, pancreas and kidney.
Overlapping robotic surgery somewhat was this idea of telepresence that enabled and equipped physicians to deliver care over long distances and from remote locations. After a heated patent feud between the two primary robotic surgery technology makers at the turn of the century — Intuitive Surgical and Computer Motion — culminated in Intuitive Surgical acquiring its rival, the CEO of its rival then left to put telepresence into practice by launching InTouch Health in 2003, maker of the RP-7 robot – RP for remote presence -. The RP-7 allowed operating surgeons to be trained by mentors thousands of miles away and facilitated face-to-face contact between doctors and remote patients.
Skorup cited “bedside telemedicine robotic systems that facilitate remote specialist consultations” as a key technological development.
Whelan concurred but noted that telemedicine continues to evolve. “While the early precursors to modern telemedicine were being set decades ago, the field did not begin to blossom until recently when broadband connectivity began to become more common,” he said. “Modern healthcare is data-driven and seeking ways to improve quality and reduce costs. Telemedicine solutions, such as remote patient monitoring, mHealth, telepresence and others will become the norm in the near future.”
He further outlined telemedicine’s continuing challenges. “Telemedicine should be more developed than it is now, but reimbursement and business models have limited its adoption,” he said. “The technology, along with the whole field of healthcare IT, has enormous clinical capabilities, but it has to operate in a currently dysfunctional system with competing financial interest. Look at the advances made and the innovations in other fields and ask why we haven’t seen those transfer over to healthcare.”
“DISINFECTOBOTS.” One of the more curious and certainly convenient developments in the area of robotics involves the “mash-up” with sterile processing, specifically room disinfection amidst the backdrop of superbugs. Within the last decade, several companies have developed and marketed their own room disinfection systems on wheels that emit radiation to nail surface bacteria and bugs that may be missed by ordinary humans manually cleaning with chemicals. The Four Horsemen of the Surface Pathogen Apocalypse — STERIS, Tru-D SmartUVC, Ultraviolet Devices and Xenex Healthcare Services — tap into the power of ultraviolet – UV – radiation to prevent the spread of infections. Think of it as more than just HD housekeeping and environmental services.
BIONIC LIMBS. “Bionic legs and arms were considered futuristic in the 1970s in The Six Million Dollar Man and The Bionic Woman TV series,” Van Pelt said. “But now military veterans who lost limbs in combat and paralyzed stroke/trauma victims can be fitted with full-body robotic exoskeletons or electronic prostheses for significantly improved functioning.”
In fact, 31-year-old amputee Zac Vawter implanted himself in the record books last November when he climbed 103 stories to the Skydeck of Chicago’s famous Willis Tower – formerly Sears Tower – while wearing a thought-controlled 9-pound aluminum robotic leg, reportedly costing $8 million. Researchers tailed him along the way to collect data as they prepare a version for general consumer application. Still, several companies in Europe already have brought their own versions to market that sport a knee and foot powered by microprocessors. They include Össur with its Symbionic products and Otto Bock with its Genium brands.
In the U.S., the Vanderbilt Center for Intelligent Mechatronics, with funding from the National Institutes of Health, developed its own almost-ready-for-prime-time robotic lower limb prosthesis and also is developing “an anthropomorphic prosthetic arm and an advanced exoskeleton to aid in physical therapy,” according to the university.
But Van Pelt didn’t limit bionics to the limbs as evidenced by the Star Trek: The Next Generation TV series and spate of films. “Star Trek’s Geordi LaForge, played by Levar Burton, was blind, but had surgery and was implanted with a device called VISOR for ‘Visual Instrument and Sensory Organ Replacement.’ In February 2013, the FDA approved the Argus II Retinal Prosthesis System, which resembles the VISOR and is implanted in patients with severe retinitis pigmentosa to help them see.” Later in the films, the character’s visor technology was replaced by individual ocular implants.
PORTABLE SCANNERS. While modular X-ray rooms pre-dated 2000, serving as a cost-effective bridge for facilities looking to upgrade to digitized and digital imaging capabilities, portability began turning heads during the first decade of the 21st century. From computed tomography (CT) and magnetic resonance imaging – MRI – for bodily extremities to portable ultrasound and X-ray wands for obstetrics and orthopedics, technology convergence brought the power of imaging into your hands. Today, clinicians are starting to use wireless hand-held devices about the size of your TV remote to perform the types of imaging that previously required dedicated room scheduling, patient transport and the presence of multiple caregivers.
“The Tricorder from Star Trek, a handheld medical scanner, was originally thought to be an unachievable technology,” Van Pelt marveled. “A scanner you hold in your hand? Well, now we have handheld X-ray and ultrasound scanners.”
But Skorup provided a dose of reality, lamenting that the electronic health record and clinical decision-support has been slower than many have anticipated. “In Star Trek, patients are scanned with a wand and then provided a customized and immediate treatment that is very effective. Today, we have many of the technologies, such as monitoring and imaging systems, to gain the clinical information to make immediate diagnoses. However, a lack of effective information integration often delays a physician’s ability to make an immediate, fully informed diagnosis.”
SMART PHONES. Move over Angry Birds and Fruit Ninjas, scheduling, streaming videos and texting capabilities. Clinical and administrative healthcare professionals are using “apps” to manage and review everything from inventory levels and purchasing details to patient vital signs linked to electronic medical records. You’ll be hard-pressed to attend any clinical trade show and not find a number of companies touting the benefits and convenience of smart phone apps to keep yourself plugged into your patients’ well-being and the technology helping them.
“LAB ON A CHIP.” Following alongside smart phone applications, the “miniaturization of clinical laboratory analyzers allowed development of point-of-care testing at the bedside, emergency department and surgery,” Van Pelt insisted. Basically, with this technology clinicians brought the lab to the patient instead of the patient to the lab with far-reaching cost, safety and satisfaction implications.
ADAPTIVE RADIOTHERAPY. Skorup promoted the emergence of stereotactic body radiosurgery as a major development because it offered “the ability to deliver higher dose of radiation therapy more accurately using image-guidance that allowed treatment of tumors such as lung tumors that were not possible before.” In fact, stereotactic radiosurgery was used for neurology procedures back in the 1990s and branched out into other anatomical regions in the early 2000s under the monikers Intensity Modulated Radiation Therapy – IMRT – and Image-Guided Radiation Therapy – IGRT -. But the key developments during the last decade or so involved the continued focusing, honing and targeting of the radiation beam to concentrate on the cancerous tumor without affecting the surrounding healthy tissue. In essence, radiation therapy has a come a long way in that treatment now is more acute than ever before, either through various types of external beam technology or particle therapy, such as proton therapy.
AUTOMATED EXTERNAL DEFIBRILLATORS – AEDs -. “It’s hard to remember, but 10 years ago these devices were not as pervasive as fire extinguishers, but they are now,” Whelan argued. “Whereas other medical advances have only made marginal improvements to improving quality of life, extending life by a short period of time or increasing clinical efficiency, AEDs have already saved thousands of lives. The Red Cross believes proper use of the devices could save up to 50,000 lives per year. The devices are affordable, easy-to-use and proven to work. Sudden cardiac arrest kills hundreds of thousands of people every year, and AEDs are proven to be the most effective emergency care that can be delivered to improve the changes of saving someone’s life.”
AUTOMATED PUNCH. Imagine being an orthopedic surgeon working to repair your patient’s bones while potentially harming your own bones, joints and ligaments. Historically, that’s what happened to surgeons using the traditional manual bone punch, which required some strength and ultimately led to fatigue and damage, such as carpal tunnel. What to do? Automate it. Powered by compressed air, the pneumatic kerrison bone punch called KAIRison by B. Braun’s Aesculap unit is a balanced, ergonomically designed device that enables surgeons to change shafts quickly and simply and includes a safety mechanism that blocks the trigger for cleaning. The KAIRison is to the surgeon what the nail gun is to the builder/contractor and is the equivalent to power steering and anti-lock braking systems in automobiles.
YOU’RE SO VEIN. If you’ve ever had your blood drawn or needed an IV inserted you probably wince when you remember how that phlebotomist or nurse struggled to locate a suitable vein and seemed to practice more on your arm than on the orange in class. Technically, those painful incidents should be waning as two revolutionary products using near-infrared light gain in popularity: The VeinViewer – http://www.veinviewer.com, which debuted in 2003 and occupies a prominent spot in the medical innovation wing of Chicago’s Museum of Science and Industry, and AccuVein – http://www.accuvein.com -, which launched in 2009, with a removable hand-held unit about the size of a television remote. Both exhibited at last month’s AORN Congress in San Diego. Now a decade on the market, the VeinViewer direct-projection vein illumination device comes in three versions, the VeinViewer Vision and VeinViewer VisionXTN, either on a standalone mount or on an articulating arm, and the hand-held VeinViewer Flex, which is slightly smaller than a hand-held car vac. The AccuVein AV400 unit, which carries a list price of about $6,000 and reportedly is used by more than 2,000 hospitals globally – roughly 1,500 in the U.S. – fits in the palm of your hand and projects a red hued vein illumination rather than the green of its older competitor.
HITS THE SPOT. 3M Health Care – http://www.arizant.com/spotonsystem – demonstrated its new 3M SpotOn temperature monitoring system at AORN Congress last month that allows clinicians to continuously track a patient’s temperature perioperatively via a single-use sensor affixed to the forehead. The sensor can be disconnected from the sensor cable in the patient room and reconnected in the surgical suite and then the recovery room and back again. The sensor includes a memory chip that visually projects the patient’s temperature for two continuous hours for clinicians to see.
HEARTBEAT VIEWS. Would you like to know what the next-generation stethoscope looks like? We’ll give you some hints: It’s no longer one- but two-dimensional in that it displays heart sounds in wave form. HD Medical – http://www.hdmedical
group.com/products.html – brings it to market in the U.S. this year. The company calls its device the ViScope 100, an “audio visual cardiac anomaly indicator” that displays heart sounds in wave forms or phonocardiograms. The clinician can record heartbeats and freeze-frame the waveforms to pinpoint anomalies and even murmurs, as well as transfer the waveforms to a computer.
GOOD VIBRATIONS. Probably one of the simplest innovations in this century emerged from Actuated Medical. Its Tube Clear In-Patient Tube Clearing System is designed to prevent tube replacement and delays in feeding and medication regimens due to clogging and the need for cleaning. Basically, the reusable Control Box causes a single-use Clearing Stem inserted into the tube to vibrate and free up the clog while keeping the tube in-patient. Last year Actuated Medical – http://actuatedmedical.com – told HPN it was applying this vibration concept to needles and since then debuted the Resonance Assisted Insertion Lancet – RAIL – that uses “low-frequency micro-vibrations to make needles glide more smoothly into tissue.” Currently, RAIL is designed for veterinary and laboratory research applications but the company is working on versions for humans — specifically, epidurals, regional anesthesia delivery and bone biopsies.
Original Article: http://www.hpnonline.com/inside/2013-04/1304-PS-ClinicalTech.html