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Unique Exhibit at RSNA Features Life-Size Virtual Autopsy System

The Radiological Society of North America's (RNSA's) annual meeting is big—really big. This multinational show has exhibits from around the world and some of the big players have just incredible space. Walking through Siemens' and Fuji Film's creations makes you feel like you are in a small city.

There is activity everywhere. Some demonstrators take the approach of periodic stage presentations. These exhibitors draw in passersby to fill seats for formal presentations. Most of the presenters appear to take a more casual approach with small armies of sales personnel ready to provide personalized guided tours. While the grand presentations tout greater precision, higher resolution, and suggest better patient outcomes, innovation can very much be found in some of the smaller corners of the show.

Anatoimage is one of the more unique exhibitors with a very engaging product on display called the Anatoimage Table. The table itself is a life-size virtual autopsy system. The system uses dual touch-screen displays horizontally mounted to form a single table. The unit has a built-in cadaver rendered using holy detailed volumetric data. Rather than being a gray color from preservative, the organs exhibit a more realistic coloration similar to living tissue. The various tools provided the user allow virtual dissection of the digital cadaver. Interestingly, as the organs are volumetrically rendered, they retain their shape allowing the user to see how the organ might look during surgical procedures with a live patient. This is definitely worth a stop when you are making the rounds on the floor.

For those of us who work on the imaging side of the industry, several manufacturers of anatomical phantoms have some nice displays. If your company is planning to develop real-time patient tracking, some of the analogs have simulated movement such as a beating heart.

With the hive of activity, patience and persistence will allow you to speak directly with the presenters. Make sure to spend a little time investigating the periphery as there are some gems to see!

 Andrew Dallas, an editorial advisory board member, frequent contributor, and president and CTO of Full Spectrum Software is representing MD+DI at RNSA. Check back frequently to get his take on this important event.

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Spotlight on Electronic Components

Strain reliefs
More than 88,000 standard, built-to-stock strain reliefs for cable assemblies are available from ISC Engineering. These discrete injection-molded components made from flexible resins such as PVC have holes sized to match the device's cable diameter and are held in place by a slot and flange. This design provides structure and support in the stressed area where the cable jacket ends and connection with the component occurs. Medical applications for strain reliefs include medical lasers, imaging equipment, and external scanners. The supplier offers an online configurator that lets designers select dimensions and view 3-D models of final designs. And for those preferring a more-hands-on approach, it provides a sample kit of 24 standard strain reliefs.
ISC Engineering
CHINO, CA

Electronic components manufacturing
A registered and ISO 9001:2008-certified full-service contract manufacturer, Plastics One Inc. specializes in the design, molding, and assembly of components and electronics for medical devices. Each product the company creates is designed with tight tolerances; even very small components, including parts that are assembled under a microscope, have tolerances equivalent to those of parts of standard and above-standard size. The manufacturer additionally produces and assembles devices for patient diagnostics and monitoring applications, nerve integrity monitoring, hearing enhancement, and sleep and respiratory studies.
Plastics One Inc.
ROANOKE, VA

High-current inductors
Precision Inc. supplies high-current inductors in four new halogen-free and RoHS-compliant technologies, all of which are available in four standard sizes and various custom formats for integration into power-conversion devices. Offered in two-pad bow-tie, three-pad bow-tie, vertical through-hole bow-tie, and three-pad configurations, these high-density inductors feature a special flat-wire, ferrite-core construction intended to save space and costs while minimizing power losses. The edge-wound flat-wire copper coil provides better efficiency than round-wire and litz-wire technologies, and the ferrite core optimizes heat dissipation, resists thermal aging, and allows less core loss than powdered-alloy cores. The inductors work with power-management ICs made by several large IC manufacturers. They can be used as drop-in replacements for standard parts or as components in custom microinverters, battery chargers, ac-dc and dc-dc convertors, and other devices.
Precision Inc.
MINNEAPOLIS

Antibacterial circuit breaker
The Model TA35 thermal circuit breaker from Schurter Inc. is available with an antibacterial protective cover that enables the device to be used to provide operational safety and reliability in such hygienic applications as medical equipment. Tested and confirmed to be effective according to ISO 22196, particularly in protecting against the growth of Escherichia coli and Staphylococcus aureus, the cover contains silver ions that prevent the growth of numerous other microorganisms as well. The breaker and cover together carry an ingress protection rating of IP65, ensuring that the sealed system withstands common cleaning agents and disinfectants. Offered in one-, two-, and three-pole versions and featuring thermal overload protection, this circuit breaker can be configured to suit customer requirements. Its illuminated or nonilluminated rocker switch can be supplied in any of six colors and with a range of selectable legends and customer-specific symbols. Switches are designed for efficient snap-in mounting in panels ranging in thickness from 1 to 4 mm.
Schurter Inc.
SANTA ROSA, CA

Convection-cooled power supply
A new series of single-output 250-W ac-dc power supplies from XP Power is suitable for medical device applications. With up to 95% operating efficiency, the convection-cooled CCB250 series generates little waste heat and does not require forced-air cooling. The series achieves an absolute minimum efficiency of 90% with a 90-V-ac input at full load. Meeting the stringent demands of the IEC 60601-1 third edition medical safety standard, the power supply complies with 2x MOPP (means of patient protection). Complete risk management files are also available, removing the burden and expense associated with achieving product compliance. In addition to being able to continuously deliver a maximum output of 250 W, the power supply features up to 300-W peak power capability, allowing the delivery of a short-term higher current. Measuring 4 × 6 × 1.5 in., the open-frame power-supply series fits into a 1U space.
XP Power
Sunnyvale, CA

Microwire harness cables
Space-saving, application-specific micro- and nanowire cables that lighten miniature medical electronic devices can be designed effectively using cable design details and micro-d and nanoconnector formats available from Omnetics Connector Corp. Carefully designed wiring harnesses can be made to fit precise dimensions and routes within miniature electronic equipment, allowing for modules that are compact, lightweight, and reliable. The manufacturer offers micro- and nanosize connectors with rugged spring pin contacts as small as 0.013 in. in diameter that provide constant connection through episodes of high vibration and physical shock. Cable-and-connector systems are designed to suit the instrument, retain high flexibility, and deliver consistent performance. In addition, wire-harness routing from one module to another always follows the shortest possible length in order to optimize signal quality. Shielded cable prevents signals from being affected by electromotive interference, and miniature stranded-copper wiring insulated with Teflon can withstand a wide range of temperatures over a long lifetime.

Omnetics Connector Corp.
MINNEAPOLIS

Reed relays
The CRF series of RoHS-compliant instrumentation-grade reed relays from Standex-Meder Electronics measure 3.4 mm high and come with an internal magnetic shield that allows engineers to stack them side by side without concern for magnetic coupling effects. Their space-saving design makes these components suitable for use in both 2- and 3-D relay matrices in low-profile environments. Suitable for such medical device applications as electrosurgical generators, portable defibrillators, and surgical instruments, the relays have a flat insertion loss curve between dc and 7 GHz, which is attained by keeping the signal path as short as possible and using an internal coaxial shield with a consistent 50-? impedance path. As a result, they are optimized not only for radio-frequency signals but also for digital signals in which the skew rate is under 40 picoseconds through the relay. The series' rugged packaging consists of ceramic overmolded with epoxy. The heat-conducting alumina substrate provides offset voltage below 1 µV and is equipped with leadless gold-plated pads that enable the relay to be surface-mounted without lead skewing or coplanarity issues.

Standex-Meder Electronics
CINCINNATI

The Trials, Tribulations, and Future of Stents

Since their emergence in 1986 for use in performing percutaneous transluminal coronary angioplasty to create patency in occluded vessels and reduce the incidence of angiographic restenosis, coronary stents have demonstrated incontestable--if not trouble-free--benefits.

Among current drug-eluting stents (DES), second-generation designs boast higher procedural success outcomes and better long-term clinical outcomes than first-generation versions, according to Syed Hossainy, Volwiler Fellow and director of the Innovation Incubator at Abbott Vascular (Santa Clara, CA). "However, there's still room for improvement in second-generation drug-eluting coronary stents, especially for patients with Type 2 diabetes," adds Hossainy, who delivered a series of well-received remarks on this topic at the recent MedTech Cardio Conference in Minneapolis. "For such patients, DES works better than bare-metal stents but not as well as in nondiabetic patients.

Another problem facing coronary drug-eluting stents involves patients with small-vessel, long, and diffuse-disease chronic total occlusions, Hossainy comments. But notwithstanding the problems associated with treating these patient cohorts, current technologies have significantly pushed the boundaries of where drug-eluting stents were six or seven years ago.

These successes should not obscure the fact that DES strategies have not been able to make much of a dent in treating the peripheral vasculature--for example, the distal superficial femoral artery (SFA) and vessels below the knee. These applications, Hossainy says, are the major unmet clinical need. "Whether DES or drug-coated balloons, none of these technologies have turned out to be effective."

Treating common pathobiologies in the peripheral vessels is complicated by the fact that the legs are subjected to chronic and cyclic extravascular forces. "When you walk, bend, sit, or stretch, a significant amount of fatigue affects stents in the SFA," Hossainy states. "Permanent implants do a great job in more unperturbed areas, but the moment they're implanted in the SFA, they cause constant trauma to the vessel. No matter how good the stent or the coating is, the trauma is going to remain because of the motion."

This is where bioabsorbable stents come in. "Initially, such implants will act as load-bearing scaffolds," Hossainy notes. "Over time--in a controlled and gradual manner--the scaffold will lose structural continuity and thus relieve the stress on the vessel. This transient scaffolding will enable the vessel to behave close to its native, unstented state, eliminating any chronic mechanical insult resulting from the extravascular forces on the otherwise stiffened, permanently stented vessel."

Although Abbott and other companies are conducting clinical trials to test the efficacy of bioabsorbable stents for peripheral applications, the time lag between initial human trial data and commercial launches in non-U.S. markets typically takes two to three years. And achieving FDA approval could take another three years. Until then, patients will have to be patient.

Carbon Nanotube Yarns Flex Their Muscles

Artificial muscles from twisted carbon nanotube yarns infiltrated with paraffin wax could eventually be used in such medical device applications as catheters.

The power of carbon nanotubes is being marshaled to develop artificial muscles. Capable of being twisted together, woven, sewn, braided, or knotted, the yarn-like material can lift more than 100,000 times its own weight and produce 85 times more mechanical power than natural muscles of the same size. Developed by researchers at the University of Texas at Dallas (UT Dallas), together with scientists from Australia, China, South Korea, Canada, and Brazil, the material could eventually be used to manufacture a range of products, including such medical devices as catheters for minimally invasive surgery.

The artificial muscles are made by infiltrating a volume-changing 'guest,' such as paraffin wax, into the twisted carbon nanotube yarn. After the wax-filled yarn is heated using either electricity or light, it increases in volume while contracting in length--a result of the helical structure produced by twisting the yarn.

"The artificial muscles that we've developed can provide large, ultrafast contractions to lift weights that are 200 times heavier than possible for a natural muscle of the same size," remarks team leader Ray Baughman, professor of chemistry and director of the Alan G. MacDiarmid NanoTech Institute at UT Dallas. "While we are excited about near-term applications possibilities, these artificial muscles are presently unsuitable for directly replacing muscles in the human body."

Muscle actuation can occur in 25/1000 of a second, and the contractile power density of both actuation and the reversal of actuation is 4.2 kW/kg. To achieve these results, the researchers twist the guest-filled carbon nanotube muscles to produce coiling. When free to rotate, the wax-filled yarn untwists as it is heated. And when heating is stopped, this rotation reverses. Such torsional action can rotate an attached paddle to an average speed of 11,500 revolutions per minute for more than 2 million reversible cycles. Pound-per-pound, the generated torque is slightly higher than that obtained for large electric motors, Baughman comments.

"The remarkable performance of our yarn muscle and our present ability to fabricate kilometer-length yarns suggest the feasibility of early commercialization as small actuators comprising centimeter-scale yarn length," Baughman notes. "The more difficult challenge is in upscaling our single-yarn actuators to large actuators in which hundreds or thousands of individual yarn muscles operate in parallel."

Free Webcast to Focus on Sealing and Handling of Medical Microporous Materials

The next installment in our continuing “MedTech Trends” webcast series is titled “Navigating & Understanding the Sealing and Handling of Medical Microporous Materials.” Scheduled for November 28 at 1:30 EST, the webcast will put you in touch with experts from Pall Life Sciences. Attendees will gain a better understanding of the characteristics of widely used microporous materials and learn to navigate through the selection process. 

The webcast will be kicked off by a presentation by Jacques Hestres, Product Manager, Medical OEM Microporous Materials at Pall Life Sciences and Kurt Heinkele, who is the Senior R&D Engineer at the company. A live Q&A will follow. 

Register only once and have access to all installments of the Medtech Trends in 2013 Webcast Series

Webcast, Medtech Trends, Freescale, Low-Power, Medical Devices, Energy Efficiency, Energy-Efficient Medical Devices

The Old Medtech Business Model Is Unsustainable. Now What?

Since 2007 to present, much of the world has faced financial turmoil. At the same time, medical costs throughout much of the world have continued to soar. The med device space, which several years ago, was often referred to as "recession proof," has proven to be anything but. In 2012 alone, the industry has been hit with waves of layoffs and, in the last few years, the sector has seen dwindling venture capital investment.

Over a person's lifetime, Medicare benefits paid out by the system greatly exceed the money paid into it, according to a study by the Urban Institute.  

In the United States, the uncertainty around healthcare reform has been a sizable concern. But the underlying fact remains: the business model behind most medical device products is not nearly as attractive as it was even a decade ago, when venture investments in the broader lifesciences sector outperformed the tech industry.

It's no surprise then that cost pressures are growing. "We hear every day that we can't afford what we are doing [in healthcare]," said AliveCor founder David Albert, MD to an audience of cardiovascular device industry professionals at the inaugral MedTech Cardio conference. "There may be no agreement on how we deal with it, save that we are going to spend less."

In the future, however, it is practically certain that there will be more emphasis placed on personal responsibility in healthcare--personally and financially. Money will be the driver of this trend while technology enables it.

In particular, mobile technology will be a key driver of this trend. "Absolutely there is hype [surrounding the mobile health (mHealth) field] but hype usually precedes real change," Albert said, pointing to the recent spate of articles on the subject and conferences dedicated to the mHealth field.

In many ways, this trend is already underway. Consider how common it has become for patients to read up on health-related topics using sites like Wikipedia. "The fact is that people are getting more engaged. Cardiovascular technology is not going to be immune to that. So sit back and figure out how crowd-sourced product vigilance-hundreds of millions of people around the world will impact our monitoring of devices."

What happens when Quantified Self adherents become patients? "I mean, these people monitor their bowel movements. They monitor their sleep. They monitor everything," Albert said. "And they believe that n=1 is science. But they are the beginning of a movement."

So who is responsible for the consumer-driven revolution in healthcare? Albert asked. "[Steve Jobs] is is the guy you need to blame," he joked. "As he said: the iPhone changed everything. And the most conservative views I've seen are that by 2020, there won't be dumb phones. Every phone will be a smart phone," he said. "These are cloud-connected programmable 1990s supercomputers."

The debut of the iPhone, and the generations of ever-more-powerful mobile devices following it, have changed consumers' expectations--for consumer and healthcare technology. 

To offer a sense of scale, Albert explained that Apple Computer could buy every cardiovascular medtech company with the cash they have in the bank," he said. "They made $8 billion profit in a disappointing quarter."

Mobile device functionality will only continue to increase in years to come. "The number of sensors in smartphones will go up dramatically in the next five years," Albert said. "Maybe, [one day, smartphones] will listen to our coronary arteries. Maybe as Eric Topol talks about, these will be ultrasound machines. Maybe patients at home will do their own scans," he added. "That is not science fiction. That is just slightly beyond where we are today. That is really engaging the consumer."

As payors pressure consumers to become more responsible for their healthcare, the medical device industry's margins will shrink. In many areas, they are already shrinking. Look at the cardiac stent space, for instance.

Mobile cardiac telemetry is another example where this is already happened. Consider that CardioNet had a $47-million IPO in 2007. In the following year, the company's stock went up to higher than $30 per share. In November 2012, the stock is worth about $2.

Similar companies such as LifeWatch and eCardio have seen similar drops in their valuation.

The broader trend of thinning margins is leading investors, as well as industry insiders, to question the basic business models of the cardiovascular device space--and the life science industry at large.  The old notion of losing money on every study and making it up with volume has become an unsustainable business model.

What are cardiovascular device and other medtech companies to do? Consider consumer business models. "The free my data [movement in healthcare] does not mean make my data free," Albert said. "Many of today's mHealth solutions require subscriptions."

"Consumerization will grow markets. Margins are going to go down. The only thing you can [reply on is]: margin times number equals revenue and profit," Albert said. "My notion is: we must expand our markets. And we must discover new applications."

"Consumerization is early but it is coming to cardiovascular healthcare. Technologies like smart phones, cloud computing, are enablers but the changing economics and increased personal responsibility are the drivers of this," Albert said. People like Hugo Campos, Eric Topol, Leslie Saxon, and the Quantified Self movement are the vanguard," he added. "Change creates opportunity. I admonish those attending and the companies they work for to embrace it."

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Prosthetic Arms Have Room for Improvement

Advances in lower-limb prosthetics in recent years have been nothing short of remarkable, as double-amputee Oscar Pistorius proved at the Olympic Games in London this past summer. But upper limb prosthetics still have a ways to go. While nearly all lower-limb amputees choose to use prosthetics, almost half of upper-limb amputees forgo them, according to a recent article in the New York Times. 

"Learning to Accept, and Master, a $100,000 Mechanical Arm," is the latest installment in the paper's "The Hard Road Back" series, which chronicles the struggles of veterans returning from the wars in Iraq and Afghanistan. The story focuses on Corporal Sebastian Gallegos's difficulties in adjusting to the robotic arm that has replaced the right arm he lost in an explosion in Afghanistan.

For medical device designers, it also provides insights into the experience of a patient using their products. The story tells how Gallegos, who underwent targetted muscle reinnervation surgery to improve his ability to use the prosthetic arm, struggles to use the device. He must perform exhausting "mental gymnastics" to control the prosthetic, is embarassed by its sounds and appearance, and is frustrated by his inability to perform simple tasks such as tying his shoes or helping his wife put togehter furniture. He even broke one of his prosthetics while surfing.

Though upper-limb prosthetics such as the Pentagon's DEKA Arm (see video below) are making strides, there's clearly an opportunity to create a better prosthetic arm. Is the industry up to the challenge? 

Jamie Hartford is the managing editor of MD+DI

PVC Film Avoids Phthalates, Resists Gamma Sterilization

Teknor Apex's calendering process provides films with thickness uniformity, consistent physical properties, and thermal stability.

While such phthalates as DEHP have historically been the most commonly used plasticizers in the medical industry to ensure that PVC compounds achieve the desired level of flexibility, toxicity concerns have been associated with phthalates over the years. As a result, manufacturers are demanding viable alternatives to phthalates such as citrate plasticizers, which exhibit excellent biocompatibility and cytotoxicity characteristics. Responding to this need, Teknor Apex Co. (Industry, CA) has developed a medical-grade PVC film that fits this bill.

"Citrate plasticizers provide similar benefits to phthalates for device manufacturers with respect to both the performance of the device as well as the manufacture and assembly of the device," remarks Rod Fischer, director of sales in Teknor Apex's vinyl division. A producer of both plasticizers and medical-grade PVC compounds, the company claims that its MF-165-J3R-79NT film is unique not only because it uses nonphthalate plasticizers but also because it can resist gamma irradiation--one of the most aggressive sterilization methods.

The new film's performance capabilities, according to Fischer, can be attributed to the company's calendering process. Fusing flexible vinyl compound and passing it through a series of synchronized nip rolls, this process offers thickness uniformity, consistent physical properties, and thermal stability. In addition, this manufacturing technique enables the company to offer the film with various embossed finishes.

"In our process, we deliver the melt-compounded PVC to the calender rather than to an extruder, as some film producers do," Fischer explains. "This calendering process enables us to produce films with well-developed and tightly controlled physical and mechanical properties, in addition to manufacturing the wider-width films available from a calender process." The technique also allows the firm to uniformly control the gauge, or thickness, of the film to meet customer requirements across the specified width. The films are available in thicknesses ranging from 0.006 to 0.020 in. and with widths up to 60 in.

Teknor Apex's R&D activities have shown that citrate plasticizers are the best all-around alternative to phthalate plasticizers for medical device applications, Fischer notes. "While other options are certainly viable, they involve different performance, manufacturing, and assembly considerations. And when all considerations are weighed, such noncitrate alternatives come at even a higher premium cost than DEHP."

 

Free Webcast: Design Low-Power Medical Devices

Patient compliance is the single biggest reason for medical therapy failure. To improve compliance, medical device designers must constantly work to make their devices smaller, more discreet, and easier to use.

Low-power medical devices can achieve all of those goals. Better energy efficiency leads to smaller and longer-lasting batteries, ultimately making medical devices more portable and encouraging proper use by patients.

Join us for “Empowering Patients with Energy-Efficient Medical Designs,” a free Webcast sponsored by Freescale.

This Webcast will cover:

  • Freescale’s low-power design methodology.
     
  • The Kinetis L series of microcontrollers.
     
  • Hardware and software techniques to lower the power of your medical designs.


Leading the discussion will be experts from Freescale, the global leader in embedded processing solutions. Systems engineer Eduardo Montanez and David Niewolny, the company’s healthcare business development manager, will take your questions after their presentations

This free Webcast takes place December 5, 2012, at 1:30 p.m. EST.

Register only once and have access to all installments of the 
Medtech Trends in 2013 Webcast Series

Webcast, Medtech Trends, Freescale, Low-Power, Medical Devices, Energy Efficiency, Energy-Efficient Medical Devices 

Why Our Healthcare System Is Like LinkedIn

Waste is a big problem in healthcare. As much as one-third of U.S. healthcare spending is for naught, argued author Shannon Brownlee in her 2008 work “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.” A PwC report titled “The Price of Excess” went even further, stating that more than half of the country’s healthcare spending is waste.

It’s certainly not hard to point to inefficiencies in healthcare and there is plenty of finger-pointing to go around amongst the various entities in the healthcare web. For instance, on the clinical side, there is widespread redundant testing. On the patient side, there is a significant problem of noncompliance with doctor’s orders—whether they be to take a medicine daily, lose weight, or change one’s diet. The fee-for-service model has been implicated in medicine’s ever-growing costs, too, as have the healthcare ecosystem’s high operational costs.

The degree to which information technology can address waste in healthcare is fascinating. Artificial intelligence, or at least computer-driven analytics, can almost certainly help us greatly improve the value of healthcare our healthcare system. The question is when. At present, healthcare spending may be slowing, but overall costs continue to climb.

The need for a data science revolution in healthcare has never been greater as medicine becomes more personal, information driven, and mobile, and the web that is our healthcare system grows ever more complex.

In these respects, our healthcare system is similar to social platforms like LinkedIn. And one of the reasons that LinkedIn has been so successful is its reliance on analytics technology and data science. In essence, the site leveraged the power of numbers to address its most important needs.

The Harvard Business Review recently pointed out that about six short years ago, LinkedIn had close to 8 million accounts but, as the article explains “users weren’t seeking out connections with the people who were already on the site at the rate executives had expected.”

Following the lead of LinkedIn’s data scientist Jonathan Goldman, PhD, LinkedIn debuted the “People You May Know” feature, which caused the number of personal connections across the site to skyrocket. The feature became one of the biggest drivers in the site’s burgeoning success.

Our healthcare system needs open data streams and problem solvers like Goldman, who, as the above article explains, “make discoveries while swimming in data.” Such people “are able to bring structure to large quantities of formless data and make analysis possible. They identify rich data sources, join them with other, potentially incomplete data sources, and clean the resulting set. In a competitive landscape where challenges keep changing and data never stop flowing, data scientists help decision makers shift from ad hoc analysis to an ongoing conversation with data.”

Where are the data scientists in healthcare? We need them fast... 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.