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How Plasma-Based Printing Can Join Nanomaterials to Flexible Surfaces

A new way to print nanomaterials onto 3-D objects and flexible textile materials could have an array of applications, including biosensors, batteries, and integrated circuitry.

Kristopher Sturgis

"Printing nanomaterials, especially sensors and electronic materials on 3-D objects can be a game changer in additive manufacturing," Gandhiraman says.

The technique could make it much simpler and cheaper to produce devices made from nanomaterials like wearable biosensors, batteries, integrated circuitry, and other biosensing devices

"This technology could be used in combination with additive manufacturing to embed sensors and electronic circuitry as an in-line manufacturing process. The most interesting aspect is that the electric field and plasma creates highly directional printing and it is not dependent on gravity -- meaning the print head can be oriented in any direction, not necessarily facing the ground. In essence, this technology could be used to embed sensors or electronic circuitry on any complex shaped objects as they are manufactured."

In the past nanomaterials have been printed using aerosol printing techniques, but the materials have been difficult to produce given that they needed to be heated to several hundred degrees in temperature just so they could be consolidated into a thin film for use. These extreme temperatures made it impossible for researchers to print them on materials like cloth or paper as they would simply burn through.

"The inkjet printers simply spray the nanomaterials in a highly controlled fashion, so that the ink in the cartridge is placed drop by drop onto the substrate," Gandhiraman said. "In order to increase the adhesion and to achieve the required material properties, post thermal processing is required. This limits the nature and type of materials that can be processed, so printing on 3-D objects with complex patterns is not possible with inkjet printers."

However this new plasma method circumvents the issue, as it can be used at temperatures no warmer than 40 degrees Celsius, enabling them to be deposited on a variety of materials like plastic, paper, cotton, and most any other kind of textile.

Gandhiraman and his group were able to demonstrate the new method when they were able to print a layer of carbon nanotubes on paper. The group then mixed the nanotubes into a plasma of helium ions before dispensing them through a nozzle onto paper. Once on a sheet of paper, the plasma enables the nanoparticles to form a consolidated layer on the paper without any need for external heat to solidify them.

The group also found that the presence of certain molecules can actually alter the electrical resistance of the carbon nanotubes -- meaning that the change could be measured and used to determine the concentration of certain molecules. This discovery actually enabled them to print a chemical sensor that could detect ammonia gas, and a biological sensor that can detect dopamine, an organic molecule that is often linked with central nervous systems disorders like Parkinson's disease and epilepsy.

"The impact of this technology could change the way biosensors are fabricated," Gandhiraman says. "The plasma jet printing could be used for fabricating biosensors and chemical sensors. Functionalization of biosensor surfaces and surface engineering of microfluidic devices can be carried out in a fraction of seconds compared to the routine wet chemical methods that take hours. The plasma printer can also print signal transduction elements, signal amplification nanomaterials, and signal bioactive and passive coatings on biosensors and microfluidic devices in rapid fashion. The printing can also be performed on a specific location on the diagnostic device which eliminates the need for masking."

When it comes to printing, there's no question the technology has taken great leaps in the last few years. From the enhancements in 3-D printing, to the development of bioprinting as a tool for regenerative medicine, the effects of advanced printing methods continue to shape the future of med tech. Gandhiraman says this new printing method can further push the envelope, accomplishing tasks that inkjet printing simply cannot do.

The group says the new technique is ready for commercialization, and expects it to be as cost-effective as it is simple to use.

"It won't be long before you see the plasma jet printer in the manufacturing line," Gandhiraman says. "Our objective is to develop the core technology and demonstrate its applicability in a wide range of fields, including sensors and printable electronics. We hope that the full potential of the plasma printer will be realized sooner or later."



 

Abbott Could Face $1B Whistleblower Fine

Abbott Laboratories could face a $1 billion fine in a federal whistle-blower lawsuit over off-label use of stents, and allegations of Medicare fraud and kickbacks paid to hospitals and physicians for such use.

Nancy Crotti

The jury trial began this week in U.S. District Court for the Northern District of Texas in Dallas, 10 years after former Abbott and Guidant sales representative Kevin Colquitt brought the allegations. Illinois-based Abbott obtained Guidant Corp.'s vascular business in a 2006 multibillion-dollar transaction that involved Boston Scientific and a competing bid by Johnson & Johnson.

Colquitt argues that Abbott deliberately marketed bile-duct stents for vascular use without FDA approval, trained physicians in how to use them, and offered them guidance on how to bill Medicare for the off-label procedures. In its defense, Abbott says that such off-label use was common knowledge and widely accepted since the 1990s.

"Physicians have chosen to use biliary stents in vascular stenting procedures as the standard of care for more than a decade.  This practice benefitted countless patients," Abbott spokesperson Darcy Ross wrote in an email statement. "Reimbursement was not only permitted under the Medicare regulations, but also the right decision for patients at the time."

FDA sent Abbott and Boston Scientific (no longer a defendant in the case) a letter in 2010 expressing concern about use of biliary stents in vascular procedures, according to court documents.

"It is clear that many more of these stents are used in the vasculature, for which they are not indicated, than the biliary tree, for which they are indicated," the agency wrote, noting that biliary stents are Class II devices that need only 510(k) approval, while vascular stents fall into the more highly regulated Class III category requiring premarket approval.

Colquitt's attorney, Chris Hamilton, told the jury that Abbott had conducted "an experiment on senior citizens," according to a report on the trial by Bloomberg. Hamilton also said the company "hid the paper trail and buried evidence of malfunctions," including that of a patient who lost a leg and died after one of the stents was implanted, the news service reported.

Losing at trial could cost Abbott up to $1 billion, as the federal whistleblower law allows for mandatory treble damages and statutory fines of $5,500 to $11,000 per claim, according to Patrick Burns of the nonprofit Taxpayers against Fraud organization.

"I think it's going to be hard for Abbott to convince a jury that the company had the unilateral right to pay kickbacks to doctors to put non-FDA approved stents into patients without even informing patients," Burns wrote in an email. "This was Russian Roulette with wives, daughters, and parents."

The trial in Dallas will cover some of the devices described in the $5.48 million settlement Abbott made with the federal government in 2013 over alleged kickbacks to physicians, according to the Bloomberg report. The news service estimated that the Dallas trial would last three weeks.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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What Could be the Next Frontier in Wearables?

What Could be the Next Frontier in Wearables?

An engineering executive from a wearable cardiac monitoring company muses on the future of wearables and remote monitoring in healthcare. 

Arundhati Parmar

Wearables and digital health technologies are spurring the remote monitoring of chronic patients, forever transforming the brick-and-mortar model in healthcare and improving its delivery.

These technologies have the power to bend the arc of healthcare costs by reducing hospitalizations, amont other things. That is the firm belief of Brian Kronstedt, manager of hardware product development at Preventice Solutions, which sells the FDA-cleared BodyGuardian, a wearable cardiac and activity monitoring device. 

But when asked what could be the next frontier in wearables development, Kronstedt donned his visionary hat to look into the future.

We’ve had Holter devices, ECG cardiac monitoring devices for a long time, but wouldn’t it be great if you could determine glucose levels from a wearable or fluid accumulation from a wearable or blood pressure from a wearable?" Kronstedt said.
 

Kronstedt will be speaking about how to disrupt healthcare through remote monitoring at BIOMEDevice Boston Conference, at the Boston Convention Center, April 13-14


He noted that currently there are wearables with Bluetooth connectivity that can talk with third party devices, but that there is a real opportunity in onboarding other capabilities on to the wearable.

While that would truly bring new capabilities to the wearable, Kronstedt did not downplay the challenges of developing such a device.

"In the medium terms, there is an opportunity to do glucose monitoring onto an ECG wearable as we know it today., [but] this is very much on the bleeding edge of possibility from a technical perspective," he acknowledged.

Back to today's challenges, Kronstedt noted that the current crop of wearables and digital technologies have overcome the device development hurdle, but managing the data is a headache.

"Huge strides have been made in the wearable hardware space, that is the medical device and the relatively straight forward part," he said.

And he would be correct. Just in the wearable cardiac monitoring device space, there's iRhythm Technologies and its Zio XT Patch, Medtronic's Seeq as well as BoduGuardian Heart and then there's AliveCOR's Kardia - a device that can snap on the back of an iphone or wearable like a wristband. 

But while the hardware problem has been managed, the data can pose a headache. Especially for products like Preventice's BodyGuardian Heart that can be worn up to 30 days to help in detecting arrhythmias. 

"If you have tens of thousands of these devices out in the field, that could translate to hundreds of thousands of events of asymptomatic or symptomatic events that are coming in daily to a monitoring center," Kronstedt said. "Just managing that big data is a challenge."

The value of such technologies is not just the continuous monitoring but more importantly in deriving insight out of the mountain of big data being generated, he said.

But that is a beast that is yet to be tamed. 

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com  and on Twitter @aparmarbb

Register for the BIOMEDevice Boston Conference, at the Boston Convention Center, April 13-14, to stay on top of industry trends.

FDA Proposes Ban on Powdered Gloves After Years of Review

FDA Proposes Ban on Powdered Gloves After Years of Review

Marie Thibault

This week, FDA announced a proposal to ban most types of medical powdered gloves in the United States, citing a significant risk to patients and providers. The proposal comes years after FDA began gathering evidence on the risks of powdered gloves and almost two decades after a report from the agency deliberating on the issue.

The proposal includes banning powdered patient examination gloves, powdered surgeon's gloves, and absorbable powder used to lubricate surgeon's gloves. FDA noted that use of these types of gloves is declining and pointed out that the proposed ban does not extend to powdered radiographic protection gloves, which don't seem to be available on the market. 

"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said CDRH director Jeffrey Shuren, MD, in a news release this week. "We take bans very seriously and only take this action when we feel it's necessary to protect the public health."

Get inspired to innovate during Massachusetts Medtech Week—register for BIOMEDevice Boston 2016, April 13-14.

Indeed, the proposed ban would make powdered medical gloves only the second medical device to be banned by FDA, The Washington Post pointed out this week, joining prosthetic hair fibers on the banned list.

FDA is making the proposal because of the risk of injuries it said includes respiratory allergic reactions, severe airway inflammation, wound inflammation, and post-surgical adhesions. While normally FDA tries to address concerns through safety communications or product labeling, the agency wrote, "As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which—if finalized—would ultimately remove them from the marketplace completely."

FDA has been aware of some of the potential problems with medical glove powder for years. Back in September 1997, the agency put out a Medical Glove Powder Report noting that it had received requests for a ban. In that report, CDRH wrote, "Immediately banning the use of glove powder would cause a market shortage that could result in inferior products and increased costs. Doing nothing to address the problem of airborne allergens which are carried by glove powder, would appear to be an abrogation of FDA's responsibility to protect public health. It appears that neither extreme offers a viable option." Instead, the report's recommended options included either giving consumers enough information to make an informed decision or deciding to ban powdered medical gloves at some point in the future. 

Public Citizen asked FDA to ban powdered surgical latex gloves twice, in 1998 and 2011. In a statement this week, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said, "The FDA had the legal authority to ban these gloves in 1998. The agency should have used that authority to protect hundreds of thousands of hospital workers who have been exposed to the powder. Had the FDA initiated the process of banning powdered medical gloves in 1998 instead of 18 years later, hundreds of thousands of health workers and patients would have been spared preventable, often life-threatening adverse reactions."

In a May 2013 "Viewpoint" column in JAMA Surgery detailing the evidence of potential complications linked to powdered medical gloves, the authors from the University of Virginia School of Medicine noted that an FDA representative had said a favorable decision on a petition for a ban would be announced in April or May 2012. "We have been notified by the FDA that this is the longest delay the FDA has ever made in announcing its response to a Citizen Petition," the authors wrote at the time. They also noted then that less than 10% of U.S. health care workers use powdered medical gloves.

FDA put out a call for public comments on the risks and benefits of powdered medical gloves in February 2011. It also perfomed an economic analysis on the impact of a ban and determined that because many non-powdered alternatives exist, it would not hurt healthcare delivery.

The proposed rule is open for public comment through June 20.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Images courtesy of SERGE BERTASIUS PHOTOGRAPHY/FREEDIGITALPHOTOS.NET]

Philips to Pay $35 Million to Settle Medicare Fraud Charges

The Respironics division of Philips has agreed to pay $34.8 million to settle allegations that it offered kickbacks to companies that bought its sleep apnea masks. 
 
Brian Buntz
 
Philips' Murrysville, PA-based Respironics division was accused by the Department of Justice of offering free call center services to suppliers of durable equipment to sway them to buy their sleep apnea masks. The company has agreed to pay $34.8 million to resolve those charges without admitting guilt. The fine would be one of the larger fines levied on medical device companies in 2015 or 2016 but would be significantly less than the $646 million that Olympus stands to pay over endoscope kickbacks.
 
In a statement, principal deputy assistant attorney general Benjamin C. Mizer stated that kickbacks threatened public confidence in the U.S. healthcare system. "Americans deserve to know that when they are prescribed a device to treat a serious healthcare problem, the supplier's judgment has not been compromised by illegal payments from equipment manufacturers.
 
Respironics was accused of offering DME companies with call center services to help their clients satisfy patients' resupply needs at no cost, provided their clients' patients received Respironics masks. If the companies used competitors' products, they would have to pay a monthly fee according to the number of patients who used the masks, according to the U.S. government, which claimed the conduct occurred from April 2012 and to November 2015. The arrangement was said to be part of Respironics' "Fit for Life" program. 
 
The company described that program as a "resupply solution [...] designed to acknowledge [current] operational and economic challenges by offering providers an efficient way to serve patients through a lifetime of care, while also effectively coordinating [...] payer and industry requirements."
 
The company advertised its "EncoreResupply and medSage services" helped clients efficiently "identify and contact patients who are eligible to receive a new mask" as part of an "automated outreach program."
 
Of the $34.8 million total, approximately $34.14 million will go the federal government and approximately $660,000 to various state governments according to their Medicaid participation. 
 
The settlement was the result of a lawsuit originally filed by Gibran Ameer, who will win $5.38 million as part of the civil settlement. 
 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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How Plasma Can Print Nanomaterials on Flexible Surfaces

A new way to print nanomaterials onto 3-D objects and flexible textile materials could have an array of applications, including biosensors, batteries, and integrated circuitry.

Kristopher Sturgis

Plasma"Printing nanomaterials, especially sensors and electronic materials on 3-D objects can be a game changer in additive manufacturing,"declares Ram Prasad Gandhiraman, a research scientist at Nasa Ames Research Center (Mountain View, CA).

The technique could ultimately make it simpler and cheaper to produce devices made from nanomaterials like wearable biosensors, batteries, integrated circuitry, and other biosensing devices

"This technology could be used in combination with additive manufacturing to embed sensors and electronic circuitry as an in-line manufacturing process," Gandhiraman says. "The most interesting aspect is that the electric field and plasma create highly directional printing, and it is not dependent on gravity -- meaning the print head can be oriented in any direction, not necessarily facing the ground. In essence, this technology could be used to embed sensors or electronic circuitry on any complex shaped objects as they are manufactured."

In the past, nanomaterials have been printed using aerosol printing techniques, but the materials have been difficult to produce given that they needed to be heated to several hundred degrees in temperature so that they could be consolidated into a thin film for use. These extreme temperatures made it impossible for researchers to print them on materials like cloth or paper as they would simply burn through.

"The inkjet printers simply spray the nanomaterials in a highly controlled fashion, so that the ink in the cartridge is placed drop by drop onto the substrate,"Gandhiraman explains. "In order to increase the adhesion and to achieve the required material properties, post thermal processing is required. This limits the nature and type of materials that can be processed, so printing on 3-D objects with complex patterns is not possible with inkjet printers."

This new plasma method circumvents the issue, however, as it can be used at temperatures no warmer than 40°C, enabling them to be deposited on a variety of materials like plastic, paper, cotton, and most any other kind of textile.

Gandhiraman and his group were able to demonstrate the new method when they were able to print a layer of carbon nanotubes on paper. The group then mixed the nanotubes into a plasma of helium ions before dispensing them through a nozzle onto paper. Once on a sheet of paper, the plasma enables the nanoparticles to form a consolidated layer on the paper without any need for external heat to solidify them.

The group also found that the presence of certain molecules can alter the electrical resistance of the carbon nanotubes -- meaning that the change could be measured and used to determine the concentration of certain molecules. This discovery enabled them to print a chemical sensor that could detect ammonia gas and a biological sensor that can detect dopamine, an organic molecule that is often linked with central nervous systems disorders like Parkinson's disease and epilepsy.

"The impact of this technology could change the way biosensors are fabricated,"Gandhiraman says. "The plasma jet printing could be used for fabricating biosensors and chemical sensors. Functionalization of biosensor surfaces and surface engineering of microfluidic devices can be carried out in a fraction of seconds compared to the routine wet chemical methods that take hours. The plasma printer can also print signal transduction elements, signal amplification nanomaterials, and signal bioactive and passive coatings on biosensors and microfluidic devices in rapid fashion. The printing can also be performed on a specific location on the diagnostic device which eliminates the need for masking."

When it comes to printing, there's no question the technology has taken great leaps recently. From the enhancements in 3-D printing, to the development of bioprinting as a tool for regenerative medicine, the effects of advanced printing methods continue to shape the future of medtech. Gandhiraman says this new printing method can further push the envelope, accomplishing tasks that inkjet printing simply cannot do.

The group says the new technique is ready for commercialization and expects it to be as cost-effective as it is simple to use.

"It won't be long before you see the plasma jet printer in the manufacturing line," Gandhiraman says. "Our objective is to develop the core technology and demonstrate its applicability in a wide range of fields, including sensors and printable electronics. We hope that the full potential of the plasma printer will be realized sooner or later."

 Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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Medical Devices May Have Been Stolen from Military Facility

The federal government is investigating whether a federal employee took medical equipment from a naval facility in Bethesda, MD, and attempted to sell them online, according to a report by NBC News.

Nancy Crotti

At least $18,000 worth of medical "dummies," tubing devices and electronics were reported stolen in December from the Naval Support Activities Washington complex, the oldest naval installation in the United States. In an affidavit, the agent reported finding some of the missing items listed for sale on eBay.com under an account of a training facility employee at the base, according to a search warrant application obtained by NBC.

Court filings revealed that the devices had been stored in an unsecured storage locker in a military health care training facility at the compound. An officer at the facility, known as Uniformed Services University of the Health Sciences, recognized one of the laryngoscopes offered on the website "due to unique broken piece of plastic on the device," the network reported. Federal investigators subpoenaed eBay to obtain information about the seller, who still had items posted on the site yesterday, NBC said.

The National Criminal Investigative Service, which is looking into the matter, declined to comment to the news network, citing the ongoing investigation. The complex also includes Walter Reed Medical Center and U.S. Department of Veterans Affairs facilities.

Tenants of the facility include Walter Reed National Military Medical Center and a number of other medical buildings.

While reports of stolen medical devices are rare, they occasionally make headlines as do reports of stolen intellectual property for medical devices.

For instance, in 2014, we reported on an engineer who had previously worked at Becton, Dickinson and Co. (BD; Franklin Lakes, NJ) and C.R. Bard Inc. (Murray Hill, NJ) who admitted to stealing trade secrets from the two global medical technology companies.

Also in 2014, we wrote about a GE Healthcare engineer who stole millions of files from his employer and sent them to China. And then in 2015, we reported that another engineer had admitted to stealing trade secrets from Boston Scientific related to the company's Mustang catheter, which he helped develop. 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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3-D Printing Market Expected to Grow 40% Annually

The technology will make good on its promise to enable the Third Industrial Revolution, says the investment firm Ark Invest (New York City).  

Brian Buntz

ARK Invest

Sure, 3-D printing has been hyped. But in many ways, the technology is undervalued, maintains ARK Invest, which anticipates that the annual growth rate for the technology will be approximately 40% for the next five years. "It is $5.5 billion dollars today. We see it going to $40 billion by 2020," says ARK Invest analyst Tasha Keeney, who recently wrote a white paper on the subject.

Little Consensus on the Technology's Potential

Global estimates for the 3-D printing market vary widely according to various estimates. The most optimistic firms--such as McKinsey and ARK used top-down models to arrive at their figures. "The highest estimates were from McKinsey, which is predicting that the market will expand to be worth anywhere from $180 to $490 billion by 2025," Keeney says. "We think that most analysts in the lower end of this range are taking today's growth rates and extending them outwards. But ARK and McKinsey are estimating the percentage of the market that could adopt 3-D printing and derive their calculations for the future market size from that."

Using a top-down projection of 3-D printing's future could be wise. Consider how firm Wohlers, which has used a bottom-up approach, has nearly doubled its estimates for the 3-D printing market in 2020 timeline twice. "Their 2012 estimate was $6.5 billion. In 2013, their estimate was $10.8 billion. And in 2014, it shot up to $21 billion." Wohlers' 2016 estimates are expected later this year.  

In any case, it is difficult to make projections about the market size because 3-D printing is still in its infancy--despite having been around in some form or another for decades. "If you look at the total addressable market, -- prototypes, tools, molds, and end-use parts--it is the hundreds of billions of dollars," Keeney says. "But the penetration is still relatively low.

While 3-D printing is most commonly used for prototyping, there is still considerable room for growth in this market niche as well as in other sectors. "The end-use-parts market is currently next to nothing. That is the next wave we see as being the largest addressable market." A good example is the shoe market. Already, companies like Under Armour, Nike and Adidas are beginning to use the technology in shoes. Expect more 3-D printed end-use parts in the consumer and medical sectors to follow.

Despite the tremendous potential, in 2015, the public stocks of many of the big 3-D printing company were discounted, including major players Stratasys and 3D Systems. "There is a massive opportunity for growth that is not being recognized. Right now, the market is at the sweet spot of the saddle adoption curve," Keeney says.

Big Potential amidst Big Challenges in Medicine

One of the most promising market niches for 3-D printing is medical device manufacturing and healthcare at large. "Some market niches have adopted 3-D printing early. The entire hearing aid market uses 3-D printing. None of the companies that stuck with traditional manufacturing are still around," Keeney says, adding, "the entire industry adopted 3D printing within 500 days." In addition, 3-D printing is used in Align Technology's Invisalign plastic teeth molds that provide an alternative to metal braces

There is a lot of movement as well in the 3-D printing software space. The technology can be used to assist with surgical planning and to make custom-fit orthopedic implants, for instance. This can save both money and time. "In the case of knee implants, for example, sometimes orthopedic surgeons would have to carve away bone to get knee implants to fit in some patients. Custom implants would do away with the need for that."

Still, there are also unique hurdles for medical applications of 3-D printing--regulation being one factor that can slow adoption of the technology. The company Materialise, for instance, had developed a unique technology that made it possible to pre-plan knee replacement surgeries and 3-D printed surgical guides using 2-D x-rays rather than CT or MRI scans. Late last year, the company received a Not Substantially Equivalent (NSE) letter from the FDA, effectively putting on hold the marketing of the technology in the United States.

One of the most promising applications of 3-D printing technology is its use to produce tissue. While there have been a number of successful clinical examples of this--for instance--the implantation of 3-D printed tracheas, don't expect 3-D printed organs to do away with the need for organ transplants in the near future, Keeney says.

The company Organovo has gotten considerable attention for its ability to produce liver tissue samples. "The samples have been used mostly for toxicity testing so far," Keeney says. "I see that as a fascinating application of 3D printing. It could potentially replace animal testing, although, right now, it is being used as a test before animal testing." It's anybody's guess when the technology might be ripe to create a 3-D printed functional liver, but it is not likely to be anytime soon. "The main challenges aren't even on the 3-D printing side but also the cellular culture side," Keeney says.  

Other challenges remain for the 3-D printing market overall, Keeney says. The current choice of materials is somewhat limited, but many companies are working on developing new ones--especially on 3-D printed metals.

Another general challenge is that there is a significant learning curve when it comes to 3-D printing. According to a McKinsey survey, about 40% of manufacturers were unfamiliar with 3-D printing beyond press coverage.

Still, for companies choosing to embrace 3-D printing, the decision will be well worth it. As the recent ARK white paper summarizes, "the world has seen only a glimpse of the technology's ultimate potential." While the technology has been overhyped in the past five years or so, the technology is poised to make good on its promise to enable the development of custom and better-designed products.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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Besides Reimbursement, What's Blocking CardioMEMS' Adoption?

Besides Reimbursement, What's Blocking CardioMEMS' Adoption?

There are more challenges to the heart failure monitoring device than just reimbursement, according to a new survey of physicians.

Arundhati Parmar

St. Jude Medical had hoped that its CardioMEMS heart failure system would be successfully adopted by physicians keen on preventing costly readmissions of congestive heart failure patients.

However, stymied by coverage rejections from Medicare Administrative Contractors (MACs), revenue of the product has caused revenue declines and a lackluster adoption of the device. Stung, the Minnesota device maker is seeking a national coverage decision from the Centers for Medicare and Medicaid Services (CMS) to relieve its reimbursement woes.

But a small survey shows that there are other reasons besides reimbursement, even though it is the biggest factor, that is preventing greater use of the device. When asked if reimbursement were not an issue, would physicians implant CardioMEMS, 69% said yes, but 31% were focused on other factors. That should be somewhat concerning to the company.

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The chart below was created from that BMO Capital Markets survey of 26 physicians who were allowed to pick one or more options describing the obstacles to the device's adoption. It resulted in 55 responses.

In a research note highlighting the results of the survey last week, Joanne Wuensch, a BMO Capital Markets analyst, was taken aback that 38% responses showed that physicians wanted to see more clinical data.

"While the patient’s understanding of a permanent diagnostic tool and a change in managing heart failure patients (e.g., labor) to cover the influx of data did not surprise us, the one response we were quite surprised by was the number of physicians looking for more clinical data (as there is actually quite a bit, and while the company is in the process of recruiting patients for its post-approval study and has not yet started enrolling patients in a European monitoring study, both of these will take time before we see any results)," she wrote.

That indeed is surprising given clinical trial data is the main weapon that St. Jude Medical is wielding to change the minds of reimbursement authorities. 

Meanwhile, a majority of physicians - 46% - said they will be implanting CardioMEMS in only 0-5% of their patients. In other words, there are quite a number of physicians who likely believe that it will take time to incorporate the technology in their practice or that their is limited use of the product, or, obviously, reimbursement challenges are hindering adoption, Wuensch noted.

Getting over the reimbursement hump is the first big challenge for St. Jude Medical, but the company best be prepared to face that it is not the only factor holding back the device.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com  and on Twitter @aparmarbb

10 of Medtech's Greatest Women Medtech Innovators

To commemorate Women's History Month this March, Qmed has created a [summary] of some of the most outstanding female inventors in the medical device field. 
 
Qmed Staff
 
A groundbreaking probe for removing cataracts was developed by a woman--as was the radioimmunoassay, the microelectrode, the modern syringe, and many other technologies. Read on to learn about some of the most important contributions to medicine from female innovators.  

1. Marie Curie

Marie CurieMadame Curie is one of the first people that many people think of when thinking of famous historical scientists who happened to be female. Along with her husband Pierre, Marie Curie discovered radium and polonium and helped lay the groundwork for the development of the x-ray and to cancer treatments. Curie ultimately received a Nobel for the discovery of radioactivity--the first woman to do so. 
 

2. Patricia Bath 

Patricia BathIn 1986, Patricia Bath invented the Laserphaco Probe system for removing cataracts--a laser-based system that made removal of cataracts more accurate and less painful.  Bath was both the first African-American to finish a residency in ophthalmology in 1973 and the first African-American female doctor to win a medical patent in 1988.
 

3. Rosalyn Yalow

Yalow, a medical physicist, partnered with Solomon Berson to invent the radioimmunoassay. The breakthrough enabled scientists to subsequently analyze minute quantities of "biologically active substances" including blood and tissue as well as viruses. The technique ultimately found use in identifying viruses such as hepatitis in blood banks and was also used to calculate optimal drug doses. Yalow eventually won the Nobel for her work in 1977.  

4. Flossie Wong-Staal

Flossie Wong StaalWong-Staal helped discover the HIV and mapped its genes by cloning the virus in 1985. That accomplishment led to the development of a genetic map of the virus, which paved the way for blood tests for HIV. A Chinese-American virologist and molecular biologist, Wong-Staal was also the first to clone the virus. The Institute for Scientific Information had honored Wong-Staal as the top woman scientist of the 1980s.

5. Ida Henrietta Hyde

Ida Henrietta Hyde invented the microelectrode in the 1930s. Hyde was also the first female to graduate from the University of Heidelberg, the first woman to perform research at Harvard Medical School, and the first to be elected to the American Physiological Society.

6. Ann Tsukamoto

Tsukamoto came up with a technique for stem cell isolation--a feat that had long perplexed scientists. The breakthrough ultimately led to further advances in oncology. 
 
Tsukamoto ultimately was listed on a 1991 patent for the process of isolating human stem cells.  
 
She is now continuing her work on stem cells at a company known as Stem Cells Inc. 

7. Letitia Geer

syringeThe modern medical syringe owes its existence to Letitia Geer, who developed the device in 1899. Before her invention, syringes had to be operated with two hands. She received a patent for the device (a drawing from the application is shown at right), which was described as "a hand-syringe" comprised "of a cylinder, a piston and an operating-rod which is bent upon itself to form a smooth and rigid arm terminating in a handle, which, in its extreme positions, is located within reach of the fingers of the hand which holds the cylinder, thus permitting one hand to hold and operate the syringe." 

8. Rosalind Franklin

The English chemist Rosalind Franklin has been credited by some with being the first to discover the structure of DNA. While that is debated, Franklin was certainly a pioneering molecular biologist, creating x-ray photographs of DNA. Her images, which were taken using a machine that Franklin had customized, provided substantial evidence for the structure of DNA. Francis Crick and James D. Watson used one of Franklin's images to come up with their model of DNA, which they published in 1953. 

9-10. Betty Rozier and Lisa Vallino

Lisa VallinoThe mother and daughter duo Betty Rozier and Lisa Vallino (pictured) came up with an intravenous catheter shield, which has made the use of IVs safer and easier. Vallino, a nurse with considerable experience in the ER and pediatric wards, came up with the idea for a polyethylene device--shaped similar to a computer mouse--that would work as a sort of IV house. Vallino partnered with her mother, Betty Rozier, on the device and the two won a patent for their creation in 1993. Vallino is currently the president and clinical director of I.V. House--the company named after the invention. Rozier is now president emeritus of the company and served as the president from 1991 until 2011. 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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