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Articles from 2014 In February

Think Extrusion and Beyond for Optimal Catheter Design

Today’s sophisticated catheters have become modern marvels of advanced design and polymer technology. These devices are used to perform an ever-increasing number of the minimally invasive surgeries that have revolutionized the treatment of many diseases. However, designers of next-generation diagnostic and interventional catheters face a major challenge: How can they balance the need for smaller and smaller catheters with the demand for catheters that possess strength and pushability, yet are extremely flexible and maneuverable?


Shown are an assortment of catheter types that can be produced using the materials and processes outlined in this article.

The answer: Think extrusion and beyond. For optimal catheter performance, designers need to consider the biological, physical, and chemical characteristics of polymers as well as the growing roster of breakthrough manufacturing processes. It is also necessary to leverage design expertise and implement engineering know-how in order to produce tubing for mission-critical medical device applications.

Demanding Designs

High-performance interventional catheters are used for a range of procedures in neurovascular, neurologic, cardiovascular, endoscopic, urologic, peripheral vascular, and renal denervation applications. The dimensions of the catheter shaft depend on the particular application. In the neurovascular and neurologic areas, for example, ultrasmall catheters are used. Composed of three layers—the liner, the braiding or coiled reinforcement, and the outer sheath—such microcatheters can be as small as 1.1 Fr, or approximately 0.016 in. in diameter.

On the other end of the spectrum are large-diameter catheter shafts, which are often used in such applications as abdominal aortic aneurysm (AAA) and thoracic aortic aneurysm (TAA) cardiovascular procedures. These catheters can measure up to 35 Fr, or nearly 0.5 in. Such catheter tubing often incorporates longitudinal wire reinforcement, which helps to limit stretch while ensuring flexibility.

Interventional catheters are used in minimally invasive surgeries and therapies. Generally involving 10–26-Fr devices, this type of tubing measures between 1/8 and 3/8 in. in diameter and is typically 3–4 ft in length. Many procedures start in the femoral artery as the surgeon winds the catheter through the tortuous pathways of the human vasculature into the heart or brain, twisting and moving the proximal end to position the catheter tip where it is needed. Following the deployment of the device or therapy, the surgeon removes the catheter, attempting to cause as little harm to the vasculature pathway as possible.

Constructing the Layers

Catheter shafts incorporate four layers: liner, braid reinforcement, marker band, and outer sheath.

The first step in achieving optimal catheter performance is to choose the correct materials for the liner and the shaft. Fluoropolymers, such as PTFE and FEP, excel in medical device applications because they are lubricious and biocompatible. Of all the polymers on the market today, PTFE is the most lubricious, followed closely by FEP. Both polymers exhibit versatility for extruding catheter tubing in an extensive array of diameters and shapes with single or multiple lumens. The material readily accommodates secondary processing steps such as etching and cutting, and can undergo postextrusion expansion to make heat-shrink or spiral heat-shrink tubing.

Once the appropriate materials have been selected, production of the liner is the next step in the manufacturing process. Typically made from PTFE, the liner consists of ultra thin walls and is produced in small diameters.

The next layer could consist of braid or coil reinforcement commonly made from Type 304 and Type 316 stainless steel or from nonmetallic materials such as polyester and PEEK. In order to perform well, the catheter must exhibit sufficient strength and rigidity without bending back on itself or kinking. At the same time, the device must be flexible so that it can follow a winding, sometimes tortuous path. In order to achieve this balance, catheters are frequently constructed with braiding or coiling and have a relatively rigid proximal section and a more flexible distal section.

Coiling reinforces the catheter body against kinking and ovalization of the liner while it maximizes hoop strength. Alternatively, the coiling layer can feature continuous, variable pitching, which can provide different strength and flexibility characteristics along the 3- to 4-ft length of the catheter. A braided support layer provides excellent torque transmission from the proximal to distal tip of the catheters. In addition, braid reinforcement provides resistance to crushing, kinking, or radial expansion from internal pressure while adding substantial torsional stiffness.

The final layer of the catheter shaft is known as the outer sheath. This layer is typically composed of high-performance materials such as Pebax or FEP. Additional options include PTFE, ETFE, polyurethane, polyethylene, and nylon.

Unique Tubing Elements

By incorporating a variety of construction elements, manufacturers can create a catheter shaft with unique properties. One such element, a deflectable or steerable sheath, can be used in several different applications, including transcatheter heart-valve stent and ablation delivery.

Such high-performance catheter shafts can be produced with as many as eight steerable wires, enabling surgeons to control the catheter tip precisely in multiple directions. Surgeons must be able to position the catheter tip it in the right place in order to deploy the device properly.

Along with a steerable or deflectable shaft, it is often important to consider multidurometer segments along the shaft and tip—in other words, different extrusion segments with varying degrees of softness or hardness. These variations, in turn, enable the manufacturer to alter the device’s flexibility, bend radius, and deflection angles. Such variations are typically terminated with a soft radiopaque tip, which prevents tight vasculature trauma while allowing good visibility under radiographic imaging. An image of the tip informs surgeons exactly where the catheter ends so that they can position it correctly.

Metal marker bands are another construction element that provides surgeons with visibility under radiographic imaging. Composed of precious or nonprecious metals—typically silver, gold, or titanium—they are positioned along the shaft and used as a guide to distinguish between different catheter segments. Instead of incorporating marker bands, catheters can also be fitted with flexible radiopaque markers. Encapsulated with tungsten-filled Pebax, such markers provide visibility, like metal marker bands. However, while marker bands tend to be stiff, radiopaque markers are soft and pliable, enhancing the surgeon’s ability to navigate flexibly into tight vessels.

Finishing Touches

In addition to consisting of several layers and a variety of additional construction elements, interventional catheters can be enhanced with such finishing features as punched holes. For example, circular or even irregular-shaped apertures can be formed along the catheter shaft using suction. This process results in consistent and repeatable openings.

Other finishing operations include custom-shaped shafts and tips, mating hubs, and tip attachments. Shafts and tips can be specially configured to accommodate the target anatomy. Standard or custom mating hubs can be insert-molded based on the application, sterilization method, or choice of mating components. Accomplishing this task requires overmolding expertise and the ability to match the outer material of the catheter to the substrate. For catheters ranging in size from 3 to approximately 30 Fr, tip attachments can be bonded with components of different sizes, enabling the manufacturer to terminate the coil or braid precisely and ensure that the catheter does not contain exposed construction elements.

The Big Picture

In the medical device industry, extrusion is a nearly universal technology. However, while many suppliers offer extrusion services, they must also be able to make myriad other decisions in order to produce high-performance interventional catheter tubing. At each step of the process, these decisions can positively or negatively impact the overall function of the device.

Jessica Lenhardt is director of worldwide marketing for OEM at Teleflex Medical OEM and a member of the company’s executive team. An expert in precision extrusion technologies and applications, she has more than 20 years of marketing, management, and product development experience at Teleflex Medical OEM, Cardinal Health, Leica Microsystems, and Cole-Palmer. Lenhardt received a bachelor’s degree in molecular biology and chemistry from Knox College.

Bob Michaels is senior technical editor at UBM Canon.

Why MedTech Should Give Some Power to the People

         Hugo Campos and Amy Tenderich

                        Patient advocates Hugo Campos and Amy Tenderich

 In the era of Big Data, medical devices and hospitals will collect and analyze vast amounts of information in an effort to improve patient outcomes and reduce healthcare costs. But this impending influx of information is creating a data dilemma that medtech needs to resolve as the growing number of empowered patients fight for the right to access their medical device data.

“[With] implantable cardiac devices, medical device companies don’t look at patients as their customers; the patient is only the recipient of the therapy,” e-patient advocate Hugo Campos said during a patient perspectives panel at MD&M West in February. “As such, I’m expected to just consent, comply, and hope everything is all right. There’s not much room for collaboration; there are no incentives.”

Campos is hoping to change that. In 2012, he made headlines upon launching a campaign to access the data collected by his Medtronic implantable cardioverter-defibrillator (ICD). Since then, Campos has emerged as a champion of the e-patient movement and ardent supporter of providing patients with the same level of access to device data as their physicians. 

 Learn more about the innovative wireless and mHealth applications collecting data for the empowered patient at BIOMEDevice Boston March 26-27.

“People with diabetes need access to their glucose levels in order to manage their lifestyle, and the perception is that cardiac rhythm is not quite like this,” Campos said. “Medical device companies aren’t in the business of providing data to patients; they’re in the business of designing life-saving therapy, which is a fair point. But it’s important not just what the device knows in terms of the data it collects from my body… but also data in the [larger] context of other patient-generated health data.”

But do the majority of patients really need—or even want—access to their medical device data?

For e-patient advocate Amy Tenderich, founder and editor of the blog DiabetesMine, the question is much more fundamental than that. “Is the patient respected? Is the patient considered a partner in their own care? Is there some level of acceptance that the patient might be able to do something with that data and might want to have the right to see the data collected about their own body?” she asked during the MD&M West panel. “There is the quantified-self group who want to look up everything, and they should have the freedom to do that. Other patients may not want to have the mountain of data, and they may not know what to do with it.”

The issue of granting patients access to medical device data is certainly a slippery slope. On one hand, informed patients may be more compliant and attentive, helping them to better manage their condition and, in turn, cutting costs out of the system. But unfettered access to device data could introduce a host of new issues, headaches, and possibly hazards.

Take, for example, the patient who wants data and then misinterprets or misuses it. Such a situation could pose a serious threat to patient safety—or at the very least prompt panicked calls to physicians. Lee Ehrlichman of LifeWatch Services noted during a presentation at MD&M West that FDA even questioned the depiction of an ECG waveform on the screen of the company’s Android-based medical smartphone. “They’re concerned that we’re going to scare people; they’re not going to understand what their ECG is, what is that waveform telling you? [FDA] wants it out,” he said.

Despite the complexity, it’s an issue that needs to be addressed. “This [issue is] not going to go away; I think it’s only going to become more ubiquitous as younger patients start getting these devices,” Campos said. “As the younger folks who are growing up with technology start getting these devices, I don’t think they’re going to settle for no access.”

He has a point. The next generation of tech-savvy, data-driven patients likely won’t sit idly by while they’re denied access to the data their own bodies are producing. Especially in the looming age of Apple’s rumored iWatch and other biosensing devices.

Part of the solution will likely come from an increasing emphasis on actionable data that will simultaneously sate patients’ appetite for data while aiming to improve outcomes. “The people who are designing the products can help us by making the data useful,” Tenderich said. “But at the same time, the core issue of this patient movement is that medical device design is about us. It’s about the lives of the people who are wearing these things all the time and the impact that these devices have on our lives.” That logic is tough to argue. 

 —Shana Leonard, group editorial director, medical content

CarePredict Debuts Remote Health Monitoring for Seniors

The CarePredict Tempo sensor features interchangeable wristbands. (Courtesy CarePredict Inc.)

Startup CarePredict Inc.(Davie, FL) has announced that it is accepting preorders for an expected Fall delivery of its first product, the CarePredict Tempo.

Tempo is a next-generation tracking system designed to help the children and caregivers of aging-in-place seniors to keep tabs on their loved ones' health 24/7 without having to actually be present all the time.

The Tempo system, which incorporates patent-pending technology, consists of a wearable sensor which tracks activity - walking, running, sitting, standing, or lying down - and location within the home. The wrist-worn sensor, which features interchangeable bands for different looks, can detect arm movements, body posture, and walking speed. It transmits data and charges wirelessly, so there are no cords or plugs.

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.

In a story for MIT Technology Review, Susan Young spoke with Satish Movva, the company's CEO and founder. "This isn't a FitBit for granny," said Movva. It is designed to track activities and alert someone of any unusual changes. "If someone is lying down in the bedroom, then they are probably sleeping. But if someone is lying down in the bathroom, then there is potentially an issue," Movva explained to Young.

The sensor makes use of a small, battery-operated beacon in each room to send location and activity data to one wall-plugged hub. The hub uses an existing Internet connection or its own connection to send data to CarePredict's servers.

The CarePredict servers analyze the data and store it, looking for changes over time and trends in the patterns of daily life which may indicate an incipient health issue. If the system detects changes in the wearer's daily patterns, it sends an alert to the designated person by text message, e-mail, or push notification. An example, the company says, is if someone is taking longer and longer to climb a flight of stairs.

Users can log into their loved one's private account from any computer to track data, see alerts, and manage who's in their care network. There is also a mobile app.

The CarePredict device and company were conceived by Movva, who describes himself as a "Visionary Tech Leader Disrupting Healthcare" on his LinkedIn page. Movva had created a homecare and hospice SaaS platform while at Interim Healthcare, which was spun off and commercialized with Movva at the helm. This company, which Movva says processed $550 million in customer transactions in 2012, was sold to "a legacy software vendor."

The startup's other employee is Krishna Vedala, PhD, chief science officer, who led the construction of the sophisticated Tempo system. Vedala's online bio says he specializes in how to get the most meaning from data. Vedala has developed and published algorithms for land-mine detection and the intra-operative monitoring of patients during spinal surgeries.

CarePredict also has a board of advisors that the company says includes doctors, specialists, and healthcare entrepreneurs.

Stephen Levy is a contributor to Qmed and MPMN.

Medline Guidewires Recalled over Serious Coating Problems

The FDA recently designated a Medline Industries guidewires recall as Class I. The Medline guidewire is identified as the ACME Monaco Guidewire .035x150 3MMJ TCFC item number 88241, with affected products distributed between March 2013 and August 2013. The guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries. It is meant to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The guidewires in question, however, have the potential for the coating to flake off of the wire, according to the FDA. A Class I designation means the agency believes that the faulty guidewires could cause serious adverse health consequences or death.

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.
Mundelein, IL-based Medline sent recall notifications to customers in August 2013, telling them to examine their inventory, and affix a provided sticker on the affected kits warning users that the Acme Monaco Guidewire .035X150 3MMJ TCFC item number 88241 has been recalled and should not be used. Customers were told to return the affected guidewires to Medline, though they could replace the affected guidewires with sterile product and use the rest of the kit. The FDA has listed the product codes and lot numbers for the recalled guidewires: 054372-1-1A, 054372-1-1B, 054372-1-2A. As of February 28, this was only the second Class I medical device recall listed on the FDA's site for the month. The other was Teleflex Medical Inc.'s voluntary recall of a faulty tracheal tube.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

Could Adaptive Design Have Saved Medtronic’s Renal Denervation Clinical Trial?

 Could Adaptive Design Have Saved Medtronic’s Renal Denervation Clinical Trial?

Medtronic shocked the medical world in January when it announced that its so-called HTN -3 trial to treat patients with stubbornly high blood pressure had failed to meet its primary efficacy endpoint.

The results showed that the Symplicity Renal Denervation System could not reduce blood pressure in patients six months after the procedure.

That led the Minnesota device maker to suspend further enrollment in U.S., Japan and India.

Plenty of head scratching has followed given that two prior clinical trials testing the same product, albeit on a smaller number of patients, produced expected results that met all endpoints.

Now, one contract research organization believes that had HTN-3 incorporated adaptive design, perhaps the shocking result at the end could have been avoided. 

What is adaptive design?

Vicki Anastasi, Senior Vice President, Medical Devices, Aptiv Solutions

Very simply, the trial design assumes a plan by which interim data can be analyzed at specified intervals, which can then prompt companies to make adjustments to their trial.

“It is a built-in insurance policy around your study where you can look at sample size re-estimation, population enrichment. You could stop early for futility or efficacy in the various arms of your study,” explained Vicki Anastasi, senior vice president, medical devices at global contract research organization Aptiv Solutions.

Aptiv Solutions has a stake in the wider adoption of adaptive design given that the CRO has developed a software tool to create such trials. Its called ADDPLAN (Adaptive Designs – Plans and Analyses).

But Anastasi points out that this trial design is gaining currency at the Center for Devices and Radiological Health at the FDA. CRDH has approved around 120 trial designs using the adaptive approach, between 2007 and 2012, she said.

The more complex and large the study, the better it may be suited for adaptive trial design. That is especially true for renal denervation studies that evaluate patients with varying symptoms, condition etiologies, and need to compare the new devices with existing drug treatments.

Bernard Sweeney, Senior Vice President, Medical Devices, Aptiv Solutions

“Medtronic’s third trial indicated that there are risks in the studies and there is a complexity that perhaps wasn't considered at the time, and therefore if one's going to work in this area in the future, it would be sensible to perhaps use a design that gives you a bit more flexibility and ability to have a look at the results on a regular basis and change the study if need be,” said Bernard Sweeney, senior vice president, medical devices and Anastasi's colleague at Aptiv Solutions.

Of course others have their own preliminary rationale for why Medtronic’s clinical trial failed. St. Jude Medical’s CEO Dan Starks speculated whether it could have been because of the first-generation technology used.

““We note that the trial was done with a first-generation technology,” Starks said. “It may be that, among other things, the technology was too early stage. Was the technology too hard to be used effectively in an expanded environment? Was there a placebo effect? The news raised more questions than it provided answers.”

Medtronic is expected to release details about the failed trial at the American College of Cardiology Conference in Washington, D.C., March 29-31.

[Photo Credit: hh5800] 

-- By Arundhati Parmar, Senior Editor, MD+DI

LeMaitre Vascular to Lay Off 10%; Will Seek New Money

LeMaitre Vascular
The EndoRE Remote endarterectomy device as shown on LeMaitre's website.

Despite posting record sales of $17.9 million in the fourth quarter of 2013, LeMaitre Vascular Inc. (Burlington, MA) has told the Securities and Exchange Commission (SEC) in its Form 8-K filing that it intends to lay off about 10% of its workforce, amounting to about 30 jobs.

The company has not made any public announcement regarding the layoffs; the only indication has been a statement buried in the Form 8-K. According to the SEC form, the company has embarked on a plan "intended to improve operational efficiencies." This will include a "reduction in force of approximately 10% of the workforce and other cost-cutting measures." The filing goes on to say that the layoffs will be implemented in the first quarter, and the company anticipates that they will cost between $200,000 and $400,000  to accomplish.

LeMaitre Vascular makes a variety of products for the treatment of peripheral vascular disease, including such devices as catheters, and patches and grafts.

In its annual report, the company said that profits for the three months ended December 31 were $746,000, or 5¢ per share. This was up 6.9% compared with the same period in 2012. Full-year profits rose 24.5%, to $3.2 million, or 20¢ per share. This was on sales of $64.5 million, for top-line growth of 13.8% over the 2012 figures.

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.

In a separate press release, LeMaitre Vascular announced that it would be presenting at three investor conferences during March. The release says, "Management will provide an update on the company at all three conferences." Since they aren't likely to spend the time and money to make such presentations simply to tell the venture capital world how well they're doing, it seems a near certainty that they're looking for new investors.

According to the release, posted on The Wall Street Journal website, the company will first participate in the Cowen and Company Healthcare Conference at the Boston Marriott Copley Place in Boston, MA, on Monday, March 3. The second is the ROTH Conference at The Ritz-Carlton, Laguna Niguel in Dana Point, CA, on Monday, March 10. And the third presentation  is at the BTIG Medical Technology, Diagnostics, and Healthcare IT Conference at The Cliff Lodge in Snowbird, UT, on Tuesday, March 18.

Stephen Levy is a contributor to Qmed and MPMN.

Using Nitinol and Lasers to Make Articulated Endoscopic Tool Tips

In minimally invasive and natural-orifice transluminal endoscopic surgery, doctors require articulation in surgical tool tips to improve dexterity and gain access to hard-to-reach areas. Because surgical tool tips generally afford only straight-line access, articulation adds an extra degree of freedom. While as much as 90° of articulation is desirable, assembling conventional hinged joints at this scale is challenging. To overcome the difficulty of creating endoscopic tool tips affording the required level of articulation, researchers at Penn State University (University Park) have developed a compliant articulation structure using nitinol to achieve a large deflection angle and large force in a compact size.

Three nitinol tubes were processed using a Miyachi Unitek laser tube cutter. The thin features exhibit oxidation resulting from heat effects.

To produce a surgical tool tip with as much as 90° of articulation, the researchers needed to use a highly flexible, biocompatible material that can withstand very large deformations. However, a preliminary analysis indicated that the articulation angles achieved using stainless steel are quite small. Instead of stainless steel, they therefore determined that they could expect to obtain an appropriate articulation angle and sufficient blocked force using nitinol in the compliant articulation structure. "We are taking advantage of the superelasticity of nitinol, which means that in a certain range, we can achieve a very large deformation for a small increase in stress," explains Mary I. Frecker, professor of mechanical engineering and bioengineering and director of the Learning Factory at Penn State University.

"Large force is needed to be able to perform useful surgical tasks such as grasping or dissecting tissue," Frecker remarks. "At the same time, a large articulation angle is needed to be able to reach beyond the straight line of the surgical tool tip. These two objectives compete with each other, so we have used finite element analysis and optimization to find the design with the best tradeoff."

The conflicting design requirements were modeled in a finite element analysis using two performance metrics: the free articulation angle and the blocked force. In the analysis, the articulation angle was defined as the maximum angle that can be achieved without exceeding the material stress limit, and the blocked force measured the ability of the compliant articulation structure to withstand or induce an external force.

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.

Because of its hardness and its sensitivity to thermal and mechanical effects, processing nitinol can be difficult to work with, according to Frecker. While it can be micromachined using a variety of manufacturing methods--including milling, drilling, sawing, EDM, and photochemical etching--the researchers opted for pulsed laser processing because of its high processing speeds and flexibility.

"There are real challenges in using conventional machining techniques to produce features at the scale required for endoscopic surgical procedures," Frecker says. "As such, many medical device suppliers are investigating laser micromachining and microwelding. In addition, a number of manufacturers are successfully using these technologies in production."

Among the laser machines that the researchers used to process nitinol-based articulation structures was the Sigma laser tube cutter from Miyachi Unitek, a 1064-nm, 200-W single-mode fiber laser system featuring a repetition rate of 1.5 kHz and a pulse energy of 50 mJ. The system was equipped with a 500-µm output nozzle and supplied with a 55-psi coaxially driven flow of O2 assist gas. Producing a clean, smooth cut in less than 5 sec, this equipment was able to process nitinol tubes with a minimal heat-affected zone and surface roughness on the order of 5 µm. The system's short focal length and single-mode beam profile enabled the researchers to achieve a small spot size, helping to increase fluence and localize heat effects.

"This is a relatively new technology, and people are still interested in learning how to optimize the process to minimize detrimental material effects and maximize cost effectiveness," Frecker comments. "Parameters such as wavelength, pulse duration, pulse energy, and ancillary processes during laser manufacturing will impact the superelastic properties of advanced alloys such as nitinol."

Bob Michaels is senior technical editor at UBM Canon.

CEO of Secretive Blood Testing Firm Speaks

Theranos CEO Elizabeth Holmes looks at one of her company's sample vials. (Courtesy Theranos Inc.)

The CEO and founder of futuristic blood testing firm Theranos Inc. (Palo Alto, CA), Elizabeth Holmes, has broken her customary silence to grant Wired magazine a softball interview published online on February 18. The article didn't really tell us anything new about the blood-testing company or its plans, but did include a glamor shot of the 30-year-old Holmes complete with "Hair and makeup by..." credit. Not the usual stuff of CEO photos.

Still, something must be afoot at Theranos, even if it's only that they've decided the time has come to raise their profile. 

Theranos intends to revolutionize blood tests. It says it can perform a "full range" of lab tests on a single drop of blood, and do it faster and cheaper than a standard lab. In fact, Theranos says that if all blood tests in the United States were performed using its technology, it would save Medicare and Medicaid more than $200 billion over the next decade. The company says its tests are standardized and automated to subtract the error-prone human element from the procedure. According to Theranos' website, their "patented technology can analyze samples as small as 1/1000 the size of the typical blood draw." And their tests "are certified in our CLIA laboratory and cover a full range from blood, urine, and other samples."

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.

Last fall, after about 10 years of development, Theranos opened its first in-store sample-collection location at a Walgreens pharmacy near its headquarters. A month later, two more locations were added, in Phoenix and Scottsdale, AZ. In an interview with the Wall Street Journal's Joseph Rago last September, Holmes said her long-term goal was to have a Theranos collection site "within five miles of virtually every American home." And they have a deal with Walgreens that may soon put that goal within reach.

Not only for its long incubaton period, Theranos is not your ordinary Silicon Valley startup. According to Ron Leuty in his story for the San Francisco Business Times, the company has raised "at least $100 million over the past 10 years."

And Rago says the Palo Alto research park space the company currently occupies was "once home to Facebook, and before that, Hewlett-Packard." The place must have the vibes of success just emanating from the walls.

And their board of directors includes some heavy hitters indeed. Sitting on the board of this startup are former secretaries of state Henry Kissinger and George P. Shultz, former secretary of defense William J. Perry, and former senator Sam Nunn. Also on the board are Richard Kovacevich, former Wells Fargo CEO and chairman of the board, former commandant of the US Naval Academy and retired admiral Gary Roughead, and retired Marine Corps general James N. Mattis.

So one wonders what Theranos might have up its sleeve. Are they merely preparing for a wider rollout, or is it something else?

Stephen Levy is a contributor to Qmed and MPMN.

How Warping Sound Waves Could Boost Ultrasound Imaging

Airborne sound waves can be warped using a device known as an acoustic field rotator made of metamaterials. Researchers from across the world have tapped metamaterials to develop everything from invisibility-cloak like devices to superlenses.

This, however, represents the first time that metamaterials have been used to warp sound waves in a manner to how they've been used to bend electromagnetic or liquid waves.

The scientists, based in China and in the United States, suspect that the ability to use metamaterials to precisely tune acoustic wavefronts could improve medical ultrasound devices, potentially boosting their contrast as well as the accuracy of ultrasound-based diagnosis of abnormal tissue.   

acoustic field rotator
A schematic of an acoustic field rotator. Image courtesy J.Cheng/Nanjing University.

The researchers describe the significance of their accomplishment in Applied Physics Letters:

We have theoretically designed and experimentally realized a metamaterial-based acoustic field rotator that can be tailored to rotate the acoustic wavefront by a certain angle. For airborne sound, the designed field rotator simply comprises an array of identical plastic plates. The rotation effect and the broadband functionality of the resulting device have been demonstrated both numerically and experimentally. Excellent agreement is observed between the numerical simulation and experimental results. The realization of acoustic field rotator has offered possibility of acoustic manipulation and may have potential application in situations in need of special controls of acoustic wave.

The team plans to refine the design of the acoustic field rotator, which they state is still "the simplest proof-of-concept device." Future designs could further improve the ability to manipulate sound waves.  

It is not, however, the first time that researchers have stated that metamaterials could be used to boost ultrasound. Several years ago, for instance, scientists based in Berkeley, CA and Spain proclaimed that metamaterials could be used to boost ultrasound resolution by a factor of 50.

Other researchers have explored using metamaterials to convert ultrasound waves into optical signals.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz and Google+.

Congress Seeking to Limit FDA Oversight of Low-Risk Software

The drumbeat to limit FDA's regulatory authority over various software systems is growing.

Many interested parties are worried that FDA will act to regulate Electronic Medical Records (EMRs) and Electronic Health Records (EHRs) with the same rigor that is applied to the software running a radiation therapy machine.

Boston Globe reporter Tracy Jan spoke with Dan Haley, vice president for government and regulatory affairs of Athenahealth (Watertown, MA), a health information firm. "Right now, the FDA has the authority to regulate all of health IT," Haley said. "They say they exercise discretion to pick and choose which technologies they regulate. From our perspective, that is just not a tenable state of affairs."

In her article, Jan continues, "Backers of FDA regulation say digital records systems sometime contribute to prescribing errors and other patient mix-ups that can have dangerous, even fatal, consequences. Bad or missing data in a patient's computer record, for instance, can lead to catastrophic medication errors.

"But the health care industry, including many top hospitals as well as manufacturers of the systems that manage digital records, want looser regulation. They contend that submitting to FDA safety reviews would slow the pace of innovation and make software upgrades difficult."

Find out more about the medical device industry and medical device components at BIOMEDevice, March 26-27, 2014 in Boston.

In October, the bipartisan Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act was introduced in the House of Representatives. This bill seeks to amend Section 201 of the Federal Food, Drug, and Cosmetic Act, limiting FDA's authority to regulate medical software. It would also provide guidance to FDA regarding its mobile medical app regulations.

The Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 is the Senate's answer to the SOFTWARE Act. Sponsored by Senators Deb Fischer (R-NE) and Angus King (I-ME), the bill "seeks to develop a more specific regulatory framework for health IT that promotes innovation and job creation while protecting patient safety."

The PROTECT Act of 2014 (the date is necessary because there have already been a few Protect Acts in the past) would clarify FDA's regulatory process for healthcare IT to make sure it primarily focuses on technologies that pose the most health risks, and ensure that low-risk products are not the focus of oversight. It would also exempt certain categories of low-risk clinical and health software, such as EMRs and wellness apps, from the medical device tax.

Whichever of the two bills becomes the basis for the final law, we just hope the legislators will decide one important issue: Are those digital patient files supposed to be called Electronic Medical Records, or Electronic Health Records? The two are often used interchangeably but the government insists there is a difference between the two.

Stephen Levy is a contributor to Qmed and MPMN.