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Articles from 2014 In August

Assembly Moves Back Home and Gets High Tech

The field of contract medical device assembly has changed significantly in the past five years, according to Amit Arora, global market development manager at Nordson EFD (East Providence, RI). "Product features that were either too complex or cost prohibitive for companies five to seven years ago are slowly becoming mainstream." As a result, firms providing contract assembly work for medical device companies are stepping up their game.

Chris Mazelin, marketing manager at Specialty Silicone Fabricators (Tustin, CA) agrees, noting, for instance, the broader trend of miniaturization, which is continuing unabated. This is especially true for implantable devices. "Every surgeon wants to do less damage to the human body. Nearly all of the devices that are being designed and manufactured now are becoming smaller," he says.

The image, provided by Specialty Silicone Fabricators, shows an employee preparing the work space for the robot to take over and finish. The robot spreads a precise amount of a bioresorbable polymer mixed with an active pharmaceutical ingredient onto the plates. The result would be a sheet of drug-infused bioresorbable polymer. This combination product is currently in development.

Another trend is the proliferation of electronics in medical devices. The growing use of neuromodulation technology over the past decade is one major trend fueling increased demand for electronics. In addition, the steady growth in computing power and miniaturization of memory are enabling electronics to be used in unprecedented medical device applications. "The ability to put more processing power in medical devices gives design organizations the ability to do more with less," Mazelin explains. Companies that do contract assembly work for medical device markers are responding to this trend by beefing up their ability to embed electronics into products.

Technology firms serving medtech companies are also arming themselves with advanced technology such as cutting-edge robotics and lean production methods, which are enabling them to remain competitive against traditionally low-cost manufacturing destinations. "I see a lot of companies moving production and assembly back onshore," Mazelin says.

In the late 1990s and early 2000s, a significant number of medtech firms moved assembly operations offshore to save cash. But now, the cost of doing business in those counties is rising. That is happening in China, for instance, where wages are rising to be on par with those in the United States. While other low-cost manufacturing destinations exist, many of them pose their own concern in the form of logistical or ecopolitical challenges.

"The United States is going to compete in terms of its ability to innovate rather than cost alone by creating lean and efficient high-tech manufacturing processes," Mazelin says.

Contract assembly firms are investing in robotics, which can be used for an increasingly diverse set of assembly tasks. Whereas in the past, robotics technology was a natural fit for large-scale production operations, advances in robotics have broadened the scope of applications so that assembly equipment can also be used for small-scale custom operations as well.

"In the past, nearly all medical device assembly was all done manually," Mazelin says. "It has evolved into a semiautomated process."

Arora has some data to back this up. In the United States, roughly half of assembly operations are automated and the other half is still performed using manual techniques, he says. Data supporting this comes in the form of a recent webinar by Nordson EFD with 90 attendees hailing from the life sciences industry--predominately based in the United States. "We surveyed the audience, asking how many used manual dispensing in assembly. They could pick multiple options and about 50% reported using some kind of manual dispensing."

Still, the use of robotic technology is becoming more common as its capabilities increase. "Vision capability in robots is becoming standard now," Arora says. "There are a lot of companies that say 'we don't need vision,' but if they can have it at the right price, why would you not go for it? People are increasingly adopting it," he adds. "People who have shied away from using it in the past are now finding it helpful in reducing rework and the reject rate."

Vision technology can also save time during assembly operations requiring dispensing of adhesives or other compounds. "If the part you are dispensing adhesives or compounds onto has moved because of the base plate fixture, that could throw off your parameters by quite a bit," Arora says. "Using vision capability, you could make adjustments on the fly, which could save you time from not having to recalibrate."

Such systems are also becoming increasingly intuitive to use. "You can look at what you are dispensing in real time and control the robot purely using software and a computer with a very intuitive graphical user interface (GUI)," Arora says. "I would say you don't need as extensive training as you would have needed five years ago because the user interface is better. If someone has used Microsoft Windows, they could easily learn how to use the GUI to control the robotics."

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

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

What Was Your Engineering Inspiration?

What Was Your Engineering Inspiration?

A keynote by medtech inventor and entrepreneur Dean Kamen prompted one engineer to look back on what inspired his career.

By Bill Betten

Kamen spoke at the MD&M East Exposition in New York City this past June.

I recently attended a speech by inventor and entrepreneur Dean Kamen. Kamen is most famously known as the inventor of the Segway, but in this case he was being recognized as the recipient of the 2014 MDEA Lifetime Achievement Award for his contributions to the medtech industry. Listening to his keynote address at the MD&M East Exposition in New York City triggered some thoughts about my own career and what inspired me to become a scientist.

I’m a physicist (first love) as well as an electrical engineer, a dual path that has afforded me great flexibility over the course of my 30-plus-year career. I recall once, very early in my career, being mentored by a more senior engineer who told me to “watch out for the old guy in the corner.” He was referring to the very experienced engineer who would sit, listen, and then finally speak.

When he did pipe up, everyone would pay attention due to his experience and expertise. I’ve come to realize that now I’m the “old guy in the corner.”

When I was growing up, my interest in science was driven by two things: the U.S. space program and my addiction to science fiction. I wanted to be an astronaut and walk on the moon and explore the cosmos. I documented and drew every spacecraft NASA developed and kept notebooks on the space agency’s various missions. My earliest memories of reading centered around Tom Swift Jr. and the miraculous inventions he and his fellow engineers came up with in the series of books created by Edward Stratemeyer (written under the pseudonym Victor Appleton II) . I still have the complete collection of Tom Swift books. Eventually, I graduated to the science fiction writing of John Campbell, Arthur C. Clarke, Robert Heinlein, Isaac Asimov, and other authors.

I wanted to be the world’s greatest physicist, inventing wondrous things and changing the world. These interests ultimately led me to a career in science and engineering. Today, many of the inventions I used to read about in science fiction have become science fact. I have been fortunate to have been involved in many of these developments and can now look back on a career inspired by those who encouraged and nurtured my interest.

Victor Appleton II's Tom Swift books were a source of inspriation for Betten.

Kamen’s talk served as a reminder of the importance of having role models. I was energized by the space race and the desire to build great new products that would revolutionize the world. Kamen began his talk with the story of the FIRST (For Inspiration and Recognition of Science and Technology) organization, which he founded with a mission to show students that science, technology, and problem-solving are not only fun and rewarding but proven paths to successful careers and a bright future. In a world where kids idolize people who “bounce a ball or are on a stage,” science and technology aren’t seen as cool and role models are hard to come by. This is not a knock against those in other fields, but Kamen pointed out that the problems facing the world today will not be solved by politicians of either party but by scientists and engineers. He pointed out that a portion of the current crisis in healthcare is driven by a public that wants healthcare solutions with no risk and demands punishment for companies whose products result in harm. Kamen said there is an imbalance between risk and reward that has driven many companies to introduce products outside of the United States first.

He also told the story of his own inspiration. Kamen left college to develop the world’s first insulin pump after a conversation with his brother, then a medical student. He worked to develop the product and ultimately sold the company to Baxter International, becoming a millionaire at a relatively young age. This invention was followed by many others, including a number of medical devices. The Segway, for which Kamen is best known, had its roots in the development of a wheel chair equipped with gyroscopes that enabled it to maneuver up and down stairs and allow paraplegics to stand. His many inventions also include an improved peritoneal dialysis system that enabled patients to have dialysis at home, an arthroscopic irrigation pump, improved stents, and a prosthetic arm sponsored by the Defense Advanced Research Projects Agency (DARPA).

Kamen told a particularly engaging story about the inspiration for the prosthetic arm. He was visited by a U.S. Army colonel who noted that during the Civil War, soldiers were sent off to war with muskets. When they were injured, their limbs were often amputated to save their lives. They were then sent home with “a stick and a hook” to replace the appendage. In today’s conflicts, we have soldiers equipped with millions of dollars of equipment. Yet, when they lose a limb, we still send them home with “a plastic stick and a hook.” This impassioned colonel told Kamen that he intended to return some day with a raisin and a grape, challenging him and his engineering team to develop an arm with the fine motor control to pick up a raisin and the strength control to pick up a grape without crushing it and eat it. Kamen indicated that such a project was impossible, and the colonel left.

However, Kamen described being restless at home that night, tossing and turning in bed, and realized how hard it would be to turn over without arms. Inspired by that vision, he launched a project to develop a prosthetic arm to meet the colonel’s challenge. While much work remains to make it cost effective and widely available, the arm has already enabled one amputee to spoon milk and cereal into his mouth, feeding himself for the first time in 19 years.

Kamen’s latest challenge is the delivery of clean water to people across the world. In a recent article in Popular Science, he estimated that approximately half of the hospital beds in the world would be emptied if the people had access to clean water. That would have a far larger impact on human health than all of the medical devices in the world combined. His engineering organization, DEKA Research, has developed a compact water purification system, called Slingshot, that can generate 250 gallons of drinkable water per day on less power than is required to run a portable hair dryer. As another demonstration of engineering prowess, Kamen’s team also developed an energy-efficient Stirling generator to help power the Slingshot with basically any material that will burn. He is currently collaborating with Coca-Cola to distribute this life-saving apparatus around the world.

Kamen’s passion reminded me that we engineers and scientists are problem solvers. The problems facing our world today may be solved by the engineers of tomorrow—perhaps those students who are engaged in the FIRST robotics competitions today.

My challenge to you is to remember your source of inspiration and to reach out to inspire the next generation of problem solvers, whether by volunteering as a robotics coach or educator, or just by telling a story before you’re the “old guy in the corner.”
Who or what was your engineering inspiration? How are you working to inspire the next crop of innovators? Let us know in the comments below.

Bill Betten is vice president of business Solutions at Logic PD. He also serves on MD+DI’s editorial advisory board.

Of 2 Medtronic Acquisitions Announced This Week, Only 1 Is Noteworthy

Of 2 Medtronic Acquisitions Announced This Week, Only 1 Is Noteworthy

No offense to the Dutch company Medtronic acquired this week, but it's the second acquisition the Minnesota device maker announced a day later that is worth paying attention to.

And it's not just because the second acquisition was more expensive.

Here's the facts:

On Tuesday, Medtronic announced that it is buying Sapiens Steering Brain Stimulation, a deep brain stimulation firm for about $200 million in cash. The company, based in Eindhoven, the Netherlands, is developing a DBS lead with 40 individual stimulation points. The company will become part of Medtronic's neuromodulation business, and in the future serve as a as a global research and development center for that business. The acquisition is a small, tuck-in acquisition that all large companies make from time to time to give them access to a technology they do not have in their portfolio. 

On Wednesday, the medtech giant announced that it has bought its remaining stake - 70% - in Italian firm NGC Medical SpA for $350 million. Previously Medtronic owned 30% of the company based in Tolochenaz, which will now serve as the managed services arm of Medtronic's Hospital Solutions business.

And here's the money quote from the news release that explains why this transaction made sense to Medtronic and how it is seeing the role of medtech firms change in the future.

"I am delighted that NGC will join Medtronic and add to our growing offering to hospitals and health systems," said Rob ten Hoedt, executive vice president and president of Medtronic's EMEAC region. "As we are all acutely aware, current models of delivering healthcare are not sustainable, and Medtronic is intent on finding new ways to partner with physicians, hospital systems, patients, payers and governments around the world to meet their cost and access challenges and to deliver high quality healthcare."

In fact, the news release notes how Medtronic has saved $6 million in just one year to Maastricht University Medical Center in the Netherlands by making the hospital more efficient. Medtronic didn't clearly specify in what ways the hospital became efficient, but more generally the Hospital Solutions Business can help improve patient care and system efficiency through the Medtronic's ability to integrate data, medical technology and services.

A PricewaterhouseCoopers report has previously described the arrangement between European hospitals and Medtronic as "risk sharing for efficiency savings—guaranteed and underwritten—and clinical outcomes.” In other words, as hospitals win by cutting costs through improving care and clinical outcomes, Medtronic shares in the savings. If the hospital fails to achieve cost savings, Medtronic also bears the burden

This is the kind of business model disruption that experts at PwC, L.E.K. Consulting and other firms have been urging medtech companies to engage in. Winning the future will mean more than just technological prowess and innovation.  The fact that Medtronic went from owning 30% of NGC Medical to buying it outright shows that the most prominent medtech firm in the world has realized that's its fortunes are inextricably tied to the financial fate of its hospital customers.

And that makes this purchase significant. It's probably better for healthcare overall as well. 

[Image Credit: user winhorse]

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

St. Jude Medical Resolves 2009 FDA Warning Letter

St. Jude Medical Inc. yesterday confirmed in a press release that FDA concerns over products manufactured in Plano, TX, detailed in a nearly five-year-old warning letter, have been resolved.

The letter, dated June 26, 2009, regarded an FDA Form 483 List of lnspectional Observations from an earlier visit. At issue were neuromodulation device operation flaws that impacted products at St. Jude-owned Advanced Neuromodulation Systems Inc., later St. Jude Neuromodulation Systems Inc., following an FDA inspection of the plant on March 5 through April 6, 2009.

The plant produces spinal cord stimulation systems to treat chronic core and limb pain. Devices include a rechargeable or a primary cell implantable pulse generator (IPG), an external multiprogram trial stimulator (MTS), implantable leads, an external patient programmer, and an external charging system.

Officially, the devices did not conform with "Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820."

St. Jude had explained in a response to the inspection that it intended to remove defective MTS trial stimulators impaired with a known software defect. The neuromodulation manufacturer planned to ship replacement IPG chargers in the field and redesign the charging systems of the IPG to correct lack of stimulation, communication errors between the implant IPGs and their charging systems, and corrupt programs.

FDA's warning letter said St. Jude's corrective actions were good steps but "they did not address the gaps in [the] company's design and production controls that caused the quality problems in the first place." This week's good news on resolving the 2009 violations was welcomed.

"We're pleased to have resolved the concerns identified by the FDA at our Plano manufacturing facility," Daniel J. Starks, chairman, president and chief executive officer at St. Jude Medical said in the release. "We take quality and compliance seriously and are committed to meeting and exceeding patient, physician, and regulator expectations in these areas."

Recently, St. Jude Medical has addressed other regulatory troubles. A 2012 inspection of a plant in Sylmar, CA, resulted in an FDA Form 483 warning letter with 11 quality control and documentation issues. This June, FDA cleared the plant of the citations but warned that it would continue to monitor the plant.  

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Anastasia Thrift is a contributor to Qmed and MPMN.

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Medtronic Wins FDA Nod for Auto-adjusting Pacemaker

The FDA has approved a new Medtronic pacemaker that automatically adjusts heart failure patients' cardiac rhythms according to their needs.

The cardiac resynchronization therapy-pacemaker, Viva CRT-P, also works for patients with atrioventricular block (AV), according to a statement by the Fridley, MN-based company. Studies showed that the pacemaker's AdaptivCRTalgorithm slashed 30-day hospital readmissions for heart failure by 47% and atrial fibrillation-related hospitalizations, emergency department or clinic visits by 55%.Heart failure is a leading cause of 30-day hospital readmissions, according to an April 2013 studyby the federal Healthcare Cost and Utilization Project.

The algorithm's trial and sub-analyses showed that it:

  • Increased by 12% cardiac resynchronization for patients with normal AV conduction over a six-month period.
  • Reduced by 21% heart failure hospitalizations at one year, compared to historical CRT trials.
  • Reduced by 46% patients' risk of atrial fibrillation at two years.

The pacemaker also uses diagnostic tools to identify patients at risk of readmission to the hospital.

The company also announced the first implants in a clinical trial that will compare patient and healthcare system outcomes--including patient mortality and hospitalizations--in heart failure patients who have the cardiac resynchronization therapy-pacemakers with the AdaptivCRT algorithm, versus patients receiving standard CRT. The randomized study will enroll approximately 3,000 patients worldwide, who will be followed at three and six months after randomization, and then every six months until the trial is complete.

Mark Castellani, MD, at Sparrow Hospital in Lansing, MI, and Edward J. Schloss, MD, at The Christ Hospital in Cincinnati performed the first implants. Bruce Wilkoff, MD, director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic, is chair of the AdaptResponse trial's steering committee.

Medtronic has also made significant progress in developing miniaturized cardiovascular devices. It has stiff competition from St. Jude Medical Inc. February of this year saw the first U.S. implant of Medtronic's Micra leadless pacemaker and global launch of its tiny Reveal LINQ Insertable Cardiac Monitor System.

In March, St. Jude Medical announced the first European enrollments in its Nanostim Leadless Pacemaker Observational Study as it moves forward with efforts to commercialize next-generation pacemaker technology.

St. Jude Medical, which first invested in Nanostim (Milpitas, CA) in 2011, bought the company last October for $123.5 million just after the company received the CE Mark for its device. As part of the deal, St. Jude Medical agreed to pay an additional $65 million if regulatory and sales milestones were hit.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Nancy Crotti is a contributor to Qmed and MPMN.

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Patients' Advocates Support Reclassification of Surgical Mesh

Patients' Advocates Support Reclassification of Surgical Mesh

By Jim Dickinson

Several advocacy groups are voicing strong support for a proposed FDA order to reclassify surgical mesh used to repair transvaginal pelvic organ prolapse (POP) from Class II to Class III.

Consumers Union, the policy and action arm of Consumer Reports, and its related patient safety network advocates say in a recently posted comment that they also support reclassification of surgical instruments used for mesh insertion from Class I to Class II and a requirement that makers of current mesh products submit a PMA.

The groups fault FDA for delays in proposing the orders and express concern that the proposal does not include mesh used to treat stress urinary incontinence (SUI).

“Since the use of surgical mesh for this purpose is also marketed after completing only a 510(k) review,” the letter says, “there will continue to be no clinical evidence as to the safety and effectiveness of the mesh product used for this purpose. Requiring clinical evidence of effectiveness and safety for POP and not for urinary incontinence could result in off-label use of the SUI product for both purposes, subverting the safety policies that this proposed order intends to put into place.”

A comment letter from the National Center for Health Research echoes strong support for the POP order and expresses concern that there is no proposed reclassification of surgical mesh for SUI.

“Surgical mesh is a permanent implant, failure of which can and has caused serious adverse health consequences for hundreds of thousands of women and men,” the letter says. “Reclassification of mesh for POP and SUI to Class III and requiring well-designed, long-term studies is essential to ensure that all transvaginal surgical mesh products are safe and effective.”

Finally, 11 members of the Patient, Consumer, and Public Health Coalition comment that the change “will help to ensure that devices intended to improve women’s health are supported by evidence of safety and effectiveness.” It, too, voices support for reclassification of SUI mesh and surgical instruments.

Jim Dickinson is MD+DI's contributing editor. 


FDA Faulted for 510(k) Processing that Ignores Data

FDA Faulted for 510(k) Processing that Ignores Data

By Jim Dickinson

When a medical device firm submits a 510(k) premarket notification to FDA and then duly receives a not substantially equivalent (NSE) letter in response, it could be excused for thinking that the scientific data it included in its submission had been reviewed and found wanting.

But many times—and perhaps mostly—that’s not the case, according to a recent client update issued by Minneapolis-based law firm DuVal & Associates, which is also seeking industry resistance to a second FDA effort to change the 510(k) program.

In the update, the law firm says CDRH ignores the submitted data when it performs so-called “stage-gated reviews” on 510(k)s—cursory assessments that lead to NSE letters when a statutorily mandated full review of the data might actually help the device meet the substantially equivalent definition.

It is not acceptable for the center to make a legal or regulatory equivalence determination in a stage-gated review without looking at any data, DuVal & Associates contends.

“We know that FDA for decades did not apply ‘stage-gated reviews’ as they are being interpreted and applied by FDA today,” the firm writes in its client update. “Today FDA averts its eyes, ears and does not even speak about data if it can avoid it . . . The statute and regulation actually require that FDA consider all ‘the information submitted’ to it, not some of it, or the amount FDA chooses in its discretion to review.”

The firm says that the statute doesn’t compel the agency to do a stage-gated review “and determine, on its own without ever looking at data, whether the device meets the statutory definition.”

“It is to be based upon a review of ‘the information submitted to FDA,’ without limitation or qualification,” the firm contends. “So FDA must look at all the information submitted to it in making its determination of whether the new technological characteristic raises different questions of safety and effectiveness and the data support a clearance.”

The firm also shoots down the possibility that the agency is conducting stage-gated reviews in an attempt at efficiency. “. . . actually FDA is short-changing the applicant and itself, because FDA may actually learn something from the data. Moreover, sponsors are paying for the more thorough review,” the firm writes.

DuVal & Associates also argues that Congress had intended CDRH to review 510(k)-submitted data in making substantial equivalence determinations.

“FDA as an organization is normally data-driven, but FDA seems to want to be able to make a judgment call on whether different questions are raised based upon its lone impression, without the benefit of data,” it says. To avoid doing so relies too much on “FDA intuition,” and this can “vary by CDRH divisions and the individuals whom FDA employs—some with vast experience and some quite naive and inexperienced,” it adds.

The law firm further contends that staged-gated reviews were spawned by CDRH’s 1986 Guidance on the CDRH Premarket Notification Review Program (K86-3), which was written when many argued that no data were necessary to even make a substantial equivalence determination.

DuVal & Associates notes that the guidance said the center “normally will require performance testing data to substantiate equivalence if a new device has an important descriptive difference in comparison to marketed devices within its type, and it is not clear from an initial review that the device has an intended use or technological change that makes it NSE….”

Saying it will normally require performance data “creates a presumption that FDA should review the data and not the other way around,” the firm says.

In a second attack on CDRH efforts to change the 510(k) program, DuVal & Associates in July urged AdvaMed and the Medical Device Manufacturers Association to oppose CDRH’s recent draft guidance on 510(k) benefit-risk factors “because it continues the assault on and erosion of the 510(k) program as we have known it.”

In the document, Benefit-RiskFactors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, the firm says the agency is again “essentially attempting to do indirectly what it cannot do directly, because it is not a legislative body, i.e. it cannot legislate change through its administrative interpretation of the 510(k) program.”

The firm contends that while guidance documents are intended to help industry understand the agency’s thinking on the 510(k) program, they instead result in changes and further muddy the waters, as well as often require companies to submit even more data.

“In short, FDA is, once again, over-thinking the 510(k) program,” the firm concludes.

Jim Dickinson is MD+DI's contributing editor.


Submit Your Entries For 2014 Dare-to-Dream Medtech Design Challenge


If concerns about funding, FDA, and reimbursement did not cause you sleepless nights, what dream medical device would you design? The editors of MD+DI invite you to participate in the 2014 Dare-to-Dream Medtech Design Contest.

Submit a 400-word-maximum description by answering the following four questions. Please email a good-quality image or rendering of your device to An entry is not complete without either of these.

Create your free online surveys with SurveyMonkey , the world's leading questionnaire tool.

Smartphone App Can Detect Jaundice in Newborns

An app called BiliCam uses a smartphone's camera and flash in conjunction with a color calibration card to diagnose jaundice in infants. A common condition in infants--especially those born prematurely, jaundice symptoms are typically mild for most babies. In some cases, however, jaundice can cause severe harm and be potentially be fatal to the infant if left untreated.

Skin that turns yellow can be a telltale sign of jaundice, and is a possible indication that the newborn is not eliminating the chemical bilirubin, a natural byproduct made in the liver. If left untreated, it could lead to brain damage and a potentially fatal condition called kernicterus.

The BiliCam can be used by parents at home to detect jaundice in infants.

Developed by engineers at the University of Washington, the smartphone app is said to be simple and quick to use. A parent or health care professional need only place the calibration card on the baby's belly, then take a picture with the card in view. The card calibrates and accounts for different lighting conditions and skin tones. Data is then sent from the photo to the cloud, and is analyzed by machine-learning algorithms. Finally, a detailed report on the newborn's bilirubin levels is sent to the parent's phone in minutes.

The research team will present the results in Seattle at the Association for Computing Machinery's International Joint Conference in September. The app is only one of several recent developments in smartphone technology used for diagnostic purposes, and represents a growing interest in incorporating everyday smartphones into basic medical screenings. James Taylor, a professor of pediatrics and medical director of the newborn nursery at the UW Medical Center, recently spoke to university news about the effectiveness of the app.

"Virtually every baby gets jaundiced, and we're sending them home from the hospital even before bilirubin levels reach their peak," Taylor said. "This smartphone test is really for babies in the first few days after they go home. A parent or healthcare provider can get an accurate picture of bilirubin to bridge the gap after leaving the hospital."

The results of the app could provide insight into whether the newborn needs a blood test, the gold standard for detecting dangerously high levels of bilirubin. Currently there are a few noninvasive jaundice screening tools available in some hospitals and clinics, but the instrument costs several thousand dollars and isn't available for home use. This leaves most parents with a basic visual assessment to judge whether or not their newborn is showing increasing signs of yellowing skin, a stressful and often inaccurate method. The BiliCam could provide an affordable, practical, and easy-to-use alternative screening method for parents when they first return home with their newborn.

The researchers plan to test the BiliCam on up to a thousand additional newborns, specifically those with darker skin pigments to test its efficiency across various skin types. The hope is that they can continue to refine their algorithms to account for all ethnicities and skin colors, which in turn, could prove useful for parents and healthcare professionals in developing nations where jaundice accounts for many newborn deaths.

"We're really excited about the potential of this in resource-poor areas," Taylor said. "Something that can make a difference in places where there aren't tools to measure bilirubin, but there's good infrastructure for mobile phones."

Researchers believe that the app could be in use by doctors and healthcare professionals as an alternative screening method within a year's time. They have also filed patents on the technology, and hope that the app can be approved by the FDA for home use within a couple of years.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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Telemedicine Could Save U.S. Employers Billions

Telemedicine Could Save U.S. Employers Billions

Telemedicine is beneficial not just for patients, especially those in rural, remote areas without easy access to healthcare.

Turns out that U.S. employes can win big if they start to offer it to their employees.

A recent report from Towers Watson, a global professionals services company, shows that U.S. employers would save $6 billion annually if all employees and their dependents used currently available technology-enabled healthcare interactions "in place of face-to-face visits to the doctor, urgent care center or emergency room (for appropriate medical problems)."

"While this analysis highlights a maximum potential savings, even a significantly lower level of use could generate hundreds of millions of dollars in savings,” said Dr. Allan Khoury, a senior consultant at Towers Watson, in a news release highlighting the report findings. “Achieving this savings requires a shift in patient and physician mindsets, health plan willingness to integrate and reimburse such services, and regulatory support in all states.”

A 2014 Towers Watson survey of U.S. employers with at least 1,000 employees showed that 37% of them expect that by 2015 they will offer employees telemedicine consultations as a cheaper alternative to ER or office visits for nonemergency health issues. Currently, 22% of employers said they offer telemedicine vists to employees.

Another 34% of employers said they are considering offering telemedicine in 2016 or 2017 to employees.

Towers Watson's research indicates that one in seven primary care visits are for conditions that could likely be handled through a telemedicine route, states Dr. Jeffrey Levin-Scherz, a senior consultant at Towers in an email. Specifically it could be a telephone consult or a video consult that replaces the office visit. And some employers are even offering telemedicine kiosks that allow measuring vital signs like blood pressure and temperature, skin examinations with high-resolution cameras, and even lung exams with high technology microphones.

Companies that make such telemedicine kiosks to employers include Computerized Screening Inc. which was founded back n 1978 and upstart company HealthSpot

Insurers are also helping to boost this trend toward employers offering telemedicine services to employees, according to Levin-Scherz. But there are still some regulatory challenges - for instance, state by state regulation hampers the ability to provide a uniform telemedicine services across the nation.

Yet with the advance of technology, more telemedicine office visits are going to happen in the future, Levin-Scherz believes.