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Articles from 2016 In May


New Philips Heart Attack Detector Runs on One Blood Drop

The Dutch medical device company says the handheld medical device is for rapid point-of-care diagnosis of heart attacks.

Nancy Crotti

Philips Minicare I-20
Philips' Minicare I-20 (Image courtesy of Philips)

Koninklijke  Philips has launched a handheld blood test that it says can cut the time to diagnose a heart attack from one hour to less than 10 minutes.

Don't miss the MD&M Minneapolis conference and expo, September 21-22, 2016.

The Minicare I-20 system measures the level of cardiac troponin I (cTnI), a protein that is excreted by the heart muscle into the blood following a heart attack. The company claims that it delivers on-the-spot test results comparable with those obtained in a laboratory, enabling the physician to decide on treatment without delay.

Philips recently won the a CE Mark for the Minicare I-20, which it has begun selling in the UK, Germany, the Netherlands, and Belgium. The company plans to roll it out elsewhere in Europe. The device is not available in the U.S.

The heart attack application is not the first for the Minicare I-20. In March 2015, announced a multi-year development agreement with Janssen Pharmaceutica N.V. to develop a handheld blood test for use with neuropsychiatric patients.

Each blood test for use with the Minicare device would have dedicated software and a single use, disposable cartridge containing the application-specific test.  The technology was designed to detect multiple target molecules at low concentrations within the same blood sample and to show the results on the analyzer display within minutes.

"The commercial launch of the Minicare I-20 system for cardiac troponin I testing represents a major milestone for us," Marcel van Kasteel, CEO of Handheld Diagnostics at Philips, said in a statement. "I am convinced that we will be able to make a real difference for patients and care providers. Minicare I-20 is designed to help care providers reduce both the time-to-treatment and time-to-discharge of patients, thereby helping to reduce crowding in emergency departments and improve the utilization of hospital resources."

It can easily take more than an hour to get the results of a laboratory test back to the physician in a hospital setting, according to Paul Collinson, MD, a consultant chemical pathologist at St George's University Hospitals NHS Foundation Trust in the U.K.

"Point-of-care testing can significantly help to reduce the turnaround time," Collinson said in the statement.

The Minicare I-20 was tested in real-life acute care settings within the European Lab2Go project, a consortium of European hospitals, according to Phillips.

The eighth largest medical device company in the world just held an IPO to spin off its legacy lighting business. The stock offering valued the lighting company at a $3.4 billion market capitalization, according to a report in Fortune.

Don't miss the MD&M Minneapolis conference and expo, September 21-22, 2016.

Nancy Crotti is a contributor to Qmed.

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Did Intuitive Surgical Fool Insurers?

Two liability insurance companies have accused the surgical robots maker of withholding information about personal injury lawsuits, a claim that Intuitive denies.

Nancy Crotti

Intuitive Surgical da Vinci
Intuitive Surgical's da Vinci technology allows surgeons to perform complex and routine procedures through a few tiny openings. Liability insurers are claiming the company hid information about lawsuits related to the technology. (Image courtesy of Intuitive Surgical)

Two insurance companies have accused a surgical-robot manufacturer of failing to disclose 700 injury claims when it applied for liability coverage.

Illinois Union Insurance Co. and Navigators Specialty Insurance Co. each sued Intuitive Surgical, Inc. on that basis in 2013. Intuitive denies those claims and countersued, claiming that the insurers acted deceitfully and broke their contracts. If the insurers win, the fast-growing medtech company will have only one year's worth of self-insurance, according to a report by Bloomberg.

Last week, a federal judge in the consolidated case denied Illinois Union's motion for partial summary judgment, unconvinced that the insurer had waived its right to rescind its policy.

Together, the insurers provided Intuitive with $25 million worth of coverage against claims of product liability. The Sunnyvale, CA, company is facing approximately 86 individual product liability lawsuits by plaintiffs alleging that they or a family member were injured or died from surgery using the company's da Vinci surgical system, according to a Securities and Exchange Commission filing.

The insurers claim that when Intuitive applied for coverage, it did not disclose that patients' lawyers had agreed to suspend suspend litigation deadlines during settlement negotiations. If the insurers had known about these "tolling agreements," they would have withdrawn their offers to extend coverage, according to the Bloomberg report.

In its litigation against Intuitive, Illinois Union says the medtech company disclosed just 24 of the 758 claims it was facing when it applied for coverage in 2013. The insurer called it "a massive concealment of claims from an insurer, potentially the most egregious in history," the Bloomberg report says.

Intuitive argues that disputes over factual issues would make cancelling the 2013 policy premature, the story continued. The company also contends that Illinois Union and Navigators knew about the tolling agreements and chose to pursue the business anyway.

Intuitive maintains that the tolling agreements represent only "potential claims" rather than incidents "likely to result in a claim" whose disclosure that the policy applications require.

Intuitive's fortunes have ridden a roller coaster in the past few years, with share prices soaring and plunging on news of various sales expansions, stock buybacks, and legal challenges.  The company reported a profit of $594.5 million for the first quarter of 2016, compared with $532 million for the same quarter one year ago. Its system costs between $600,000 and $2.5 million, depending on the configuration and location of the customer, the company reported to the SEC.

Intuitive has asked Judge John S. Tigar to force Illinois Union to provide coverage for 860 claims and Navigators to cover 111 claims, Bloomberg reported.

Although gynecology accounts for most of the surgeries performed using the da Vinci system, growth in U.S. general surgical and urological procedures spurred growth during the first quarter of 2016, the company reported. Surgeons performed approximately about 176,000, procedures in the quarter that ended March 31, 2016, up about  17% over the same quarter of 2015, the company reported.

In all of 2015, da Vinci-assisted procedures totaled about 625,000, compared with  approximately 570,000 and 523,000 procedures performed in 2014 and 2013, respectively.  

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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How Medtronic Is Beating Sales Expectations

The Reveal Linq insertable cardiac monitoring system was among the products boosting Medtronic sales.

Arundhati Parmar

Medtronic Reveal Linq
Medtronic's Reveal Linq insertible heart monitor discreetly goes under the skin of the chest. Touted as the smallest heart monitor on the market, it records abnormal heart rhythms for up to three years. (Image courtesy of Medtronic)

Buoyed by its performance in its cardiovascular, diabetes and minimally invasive therapies businesses, Medtronic reported fiscal fourth quarter sales Tuesday garnering $7.6 billion, where analysts had expected $7.5 billion.

In the quarter ended April 29, the Irish medtech firm--run out of Minnesota--had net profits of $1.1 billion, or 78 cents per diluted share. Analysts look at non-GAAP performance, and using that measure the company earned $1.27 per share beating analysts' estimates of $1.26 per share.

"With now [six] consecutive quarters of mid-to-high single digit sales growth, [Medtronic] continues to build a consistent track record for at-or-above market growth," wrote Danielle Antalffy, an analyst with Leerink Partners in a research note Tuesday.

However, the company fell short of its own projections on operating margins, a fact that did not go unnoticed by analysts, who look at margins closely.

In cardiovascular, the performance of cardiac rhythm and heart failure products stood out with overall segment sales jumping 7% in the fiscal fourth quarter of 2016 to $1.49 billion, from the same quarter a year ago.

"We believe Medtronic continues to take share in the pacemaker market, driven by the discreet Reveal Linq implantable heart monitor, and in the tri-chamber ICD market, driven by Attain Quad lead adoption," wrote Glenn Novarro, an analyst with RBC Capital Markets, in a research note Tuesday. "[Medtronic] also took share in the U.S. ICD market this quarter owing to the launch of the Evera MRI-safe ICD."

Reveal Linq is an insertable cardiac monitor that is implanted to diagnose atrial fibrillation by monitoring the heart continuously for a period of three years. Among other products, Medtronic also benefited from the adoption of the smallest leadless pacemaker--the Micra--in Europe.

Medtronic's cardiovascular products have also benefited from the fact that the company has a full suite of products that can be safely used under MRI. As MRI becomes a common diagnostic tool, more patients and doctors are looking for implantable products that are MR-Conditional and allow full-body scans without being compromised by the magnetic field of the MRI machines.

In the Diabetes group, Medtronic had sales of $496 million, a 6% growth from the same period a year ago. Outside the U.S., the MiniMed 640G System with Enhanced Enlite continuous glucose monitoring sensor performed well and the company is on track to file a premarket approval application for its MiniMed 670 insulin pump to FDA before the end of June.

In the Minimally Invasive Therapies Group, sales increased to $2.45 billion, a 3% growth from the same period a year ago. The segment benefited from the overall market trend of moving open, invasive surgeries to minimally invasive procedures.

However, the company grew only modestly in its Restorative Therapies Group, that include its spine and neuromodulation businesses, which have continued to perform poorly. The spine business saw sales fall 1% to $737 million, from the fourth quarter of 2016. Neuromodulation sales declined 5% to $494 million from the comparable, year-ago period.

The end of April is also the end of Medtronic's fiscal year and the company's CEO described it as a "transformative year" where it was busy integrating the largest medtech acquisition ever--the $49 billion Covidien buy--along with doing many other things.

"It was a year where, in addition to executing a large, complex integration, we closed 14 additional acquisitions, totaling $1.5 billion," CEO Omar Ishrak said in the earnings call with analysts. "It was a year where we launched a number of ground-breaking new products, and extended our thought leadership within value-based healthcare."

Despite the progress, analysts were a bit concerned about the company's gross margins margins in the quarter. Non-GAAP GM was 68.8%, well below consensus' 69.8%, a result that Sean Lanvin, an analyst with BTIG found "surprising" while some ascribed a portion of this decline to currency fluctuation.

"Gross and operating margins again fell below not only us and consensus [estimates] but also management guidance for the quarter, which could reinforce what we believe are ongoing investor concerns about the company's ability to deliver on its positive operating leverage targets post-COV [acquisition]," wrote Antalffy.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Arundhati Parmar is a senior editor at UBM.

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"Failure to Train" Not a Basis for Suing Medtech Firms

"Failure to Train" Not a Basis for Suing Medtech Firms

A recent court ruling from California strengthens the hand of medtech manufacturers against plaintiffs who might seek to argue they were injured because companies didn't properly train surgeons. 

Robyn S. Maguire

In late April, the California Court of Appeals delivered a blow to plaintiffs who file lawsuits against medical device manufacturers based on an alleged "failure to train" physicians on how to use prescription medical devices. The decision in Glennen v. Allergan is significant because the field of available product liability claims against Class III manufacturers has narrowed considerably since 2008, when the United States Supreme Court held that lawsuits challenging the safety and efficacy of devices approved by FDA are federally preempted. 

In that case -- Riegel v. Medtronic -- the takeway was that FDA alone has the authority to police the safety of devices, not lay juries.  As a result of Riegel, plaintiffs have been persistent in developing theories that escape federal preemption and which are instead characterized as "parallel claims"--i.e., claims that align with, rather than add to, the requirements set forth in the federal Food, Drug, and Cosmetic Act (FDCA). 

Lawsuits alleging a manufacturer's "failure to train" are appealing to plaintiffs, at least initially, because they seem to relate to facts and circumstances outside FDA's purview. These claims focus less on the manufacturer's conduct during research and development of a device (unquestionably within FDA's review), and more on the company's conduct after the product is brought to market.  In short, they zoom in on what the product representative said, did, or failed to do, to make the physician familiar with the device before using it. 

And therein lies the problem. 

Stripped to its core, a lawsuit premised on a "failure to train" boils down to allegations that the company neglected its duty to provide physicians with important safety information about the device--the same elements of a so-called "failure-to-warn" claim. But because FDA's premarket approval process encompasses a review of device labeling and other warnings, those claims, whether couched as "failure to warn" or "failure to train" are, as the Glennen case confirms, preempted. 

In Gomez v. St. Jude Daig Division, the alleged failure to train physician on how to use Angio-Seal product were preempted where FDA specifically reviewed the manufacturer's labeling and training materials. 

Furthermore, as a court observed in the case of Sons v. Medtronic, even if a "failure to train" claim were not preempted, "it is well established that a medical device manufacturer is not responsible for the practice of medicine." That is, there is a critical point at which the manufacturer's duty to the physician ends and the physician's duty to the patient begins. 

The court acknowledged both of these principles in Glennen. 

In this case, the plaintiff alleged that defendant Allergan failed to adequately train physicians on how to use the Lap Band, a weight loss device used to limit food consumption in severely obese patients. The twist in the case was the way in which the plaintiff described her claim. Instead of alleging that Allergan was required, but failed to provide specific training to her doctor as part of the premarket approval process, she instead claimed that the physician made mistakes during surgery that evidenced inadequate training on behalf of the manufacturer. 

This was a creative, but nevertheless defective, legal theory. 

The court swiftly dismissed these allegations, holding that FDA's "[premarket approval] process does not obligate Allergan and like manufacturers to follow their products into the surgery room."  It also found the plaintiff's attempt to create a parallel claim unconvincing. To that end, the plaintiff claimed that Allergan's alleged breach of FDA's Quality Systems Regulations (regulations that govern the procedures manufacturers must follow to safely design and manufacture medical devices) resulted in a failure to train physicians. 

The Court held that there was "nothing in the language of these [regulations] to suggest that they are intended to address the quality of a manufacturer's physician training program." It refused to write a new provision into the FDCA requiring that "medical device companies who are required to provide training to physicians as a condition of premarket approval must insure such training is designed to satisfy the standard of care applicable to medical malpractice actions." 

Although prior cases have rejected a naked "failure to train" claim as preempted, Glennen adds heft to these decisions by clarifying the potential field of parallel claims against Class III device manufacturers. Had the plaintiff alleged that Allergan failed to provide the training on which FDA conditioned its approval, she may have fared better in this case. 

The creative, if not strained, allegations of her complaint, however, could not stand up to the robust Premarket Approval scheme.  For now, Glennen confirms that a manufacturer's training, or the provision of information concerning how to use a Class III medical device, is protected under the doctrine of federal preemption, just as true failure-to-warn claims should be. Regardless of how they are alleged, failure to train claims appear to be off-limits in product liability lawsuits.
 

Robyn S. Maguire is a partner in Nutter's Litigation Department and a member of the firm's Product Liability and Toxic Tort Litigation and Business Litigation practice groups. She focuses her practice on complex civil disputes, with an emphasis on drug and medical device and land use litigation cases. 
 

Nominate Young Innovators for MD+DI's Medtech 30 Under 30

Nominate Young Innovators for MD+DI's Medtech 30 Under 30

We're planning to recognize young talent in the medtech industry with our list of Medtech's 30 Under 30. Tell us who you think should make the list!

Hologic Launches New Option for Women With Uterine Fibroids

Hologic Launches New Option for Women With Uterine Fibroids

MyoSure Reach from Hologic will help physicians access and remove hard-to-reach uterine fibroids. 

Nancy Crotti

The MyoSure Reach Device from Hologic

A new device introduced at the recent American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting in Washington, D.C. has the potential to offer relief to women suffering from uterine fibroids.

Marlborough, MA-based Hologic is betting that its MyoSure Reach device will provide better access than current treatments to remove hard-to-reach uterine fibroids. In fact, MyoSure Reach can get three times closer to the uterine wall than previous generation devices, making it easier for physicians to remove growths in the upper third of the uterus, where up to 28% of polyps and 42% of fibroids are found. The distance from the distal tip to the cutting window of the new device is less than 1 mm, compared with 3 mm for other devices, according to the company.

Mainly a probem for women between 30 and 40, uterine fibroids are benign growths that develop from the muscle tissue of the uterus, and very often can cause changes in mentruation, according to the website of ACOG.

"These women are typically complaining of heavy bleeding," said Atlanta obstetrician-gynecologist Michael Randell in an interview.

Randell, who was not involved in the design of the MyoSure Reach, has used it in his practice and gave the company feedback before it launched the product.

The procedure is done vaginally. The physician dilates the cervix and places a telescope lens into the uterus with a camera attached. The camera transmits high-definition video enabling the physician to find the growth and remove it using a device threaded through an operative channel in the scope, he said.

The MyoSure Reach is an improvement on resectoscopes, which are also used to remove fibroids and polyps, according to Randell. Hysteroscopy is the method is used to remove fibroids that protrude into the cavity of the uterus. A resectoscope, which is inserted through the hysteroscope destroys fibroids with electricity or a laser beam, according to the website of ACOG. Although this surgical procedure is not able to remove fibroids deep in the walls of the uterus, it often can control the bleeding these fibroids cause. 

That's where the MyoSure Reach, which can probe further, can come in handy.

It cuts the polyp or fibroid into pieces that it removes by suction and stores in a sac for testing and because MyoSure is a mechanical device, the physician may use a saline solution to distend the endometrial cavity first.

Rectoscopes, which are electrical devices, require different solutions that do not conduct electricity but can have side effects in the patient, Randell said. They also cut the tissue into chips that float around in the solution, obscuring the physician's vision, he added.

MyoSure Reach is the fourth iteration of Hologic's hysteroscopic tissue removal system. The new device removed 25% more tissue than a predecessor device in a simulated bench model, the company said. FDA gave the original MyoSure 510(k) clearance back in 2010. The current iteration of the product is available in the United States and Canada, and has CE mark in Europe.

MyoSure Reach is part of Hologic's gyneologic surgery business. In the second quarter, sales of that segment increased 16% to $91 million, compared with the same quarter of 2015. Those results include MyoSure sales of $35.4 million, that jumped about 29% from the same period in 2015.

Nancy Crotti is a freelance contributor to MD+DI.

Study: Stronger Regulation Needed for Women's Health Devices

Study: Stronger Regulation Needed for Women's Health Devices

Women's health devices have been in the spotlight in recent years for all the wrong reasons. Laparoscopic power morcellators fell out of favor after being linked to spreading or advancing undetected gynecologic cancers, and Essure permanent birth control has drawn increased scrutiny as female patients have reported adverse events and called for regulatory action.

Now, a study by medical residents has found FDA requirements for obstetrics and gynecologic devices approved in the past 15 years have not been tough enough. 

The study, "Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology from 2000 to 2015: Process and Problems," was published in the June issue of Obstetrics and Gynecology. Study authors found that of the 18 obstetrics and gynecology devices that received PMA approval between January 2000 and December 2015, only 14 met their primary clinical efficacy endpoint and that almost half of the approved devices had been studied with nonrandomized controlled trials.

Get inspired to innovate in medtech at the MD&M East Conference, June 14-16, in New York City. 

Just 12 of the 18 devices were required to be followed with postmarket surveillance and one of the devices that was not subject to postmarket surveillance was later pulled from the market for patient safety. In all, there were three devices taken off the market. The researchers wrote that all three of these devices were not referred to or did not receive a recommendation for approval by an FDA advisory committee on obstetrics and gynecology devices. Two of these devices also did not show a benefit in pivotal trials. 

The study authors wrote, "Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices."

The researchers focused on devices approved through FDA's PMA pathway, the toughest regulatory route for devices. Senior author Steve Xu, MD, a dermatology resident at Northwestern University Feinberg School of Medicine, said in a news release, "Despite this being the most stringent patheway, and despite the fact that we've had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses."

The authors also discussed how potential changes to FDA regulation, via the 21st Century Cures Act that is making its way through Congress, might impact device approvals. Jessica Walter, MD, first author and a resident in Feinberg's obstetrics and gynecology department, referred to the legislation in the news release, "There are provisions that would broaden the definition of the 'valid scientific evidence' manufacturers need in order to prove medical benefit. Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective."

Proponents of the 21st Century Cures Act say the legislation will make the device review process more efficient and allow faster access to highly innovative products without sacrificing safety. But the public's view hasn't been so rosy, with a recent poll showing half of respondents don't want to see changes to the process. 

[Image courtesy of ATIBODYPHOTO/FREEDIGITALPHOTOS.NET.]

Effectively Leveraging Advances in Health IT to Improve Patient Safety

Effectively Leveraging Advances in Health IT to Improve Patient Safety

How are innovations in health IT allowing better patient care and preventing all-too-common medical errors?

Peter Ziese, PhD, MD

Patient safety continues to be a top priority for health care providers and hospital administrators, but as care expands beyond the four hospital walls, so must our approach to patient safety. While the challenge is ongoing, new medical and consumer technologies continue to evolve within the health care industry, providing new, improved ways for providers to address this issue. While these technological solutions can play an integral role in better addressing patient needs, the first step to successful integration is evaluating how new technology can help eliminate preventable medical errors and improve the patient experience across the health care continuum.

Mobilizing the Patient to Reduce Infections

According to The Center for Disease Control and Prevention (CDC), 1 in 25 U.S. patients suffer from hospital acquired infections (HAI) each year, and hospital acquired infections (HAIs) directly result in prolonged stays in the ICU - with some patients even extending their stay up to 3 times the average visit. With HAIs resulting in an estimated additional cost of $30 billion each year, this also presents a major patient safety challenge that hospitals must prioritize.

Technology advances are making it possible for hospitals to address and reduce infections to improve patient recovery and limit complications. For example, wireless and other mobile technologies can make it possible for patients to move freely in their room or around the hospital, while providing clinicians with constant updates on a patient's health to help detect the early signs of an infection. Making movement a priority can help patients avoid issues such as pneumonia which can lead to sepsis--a life threatening condition--as well as bedsores and other conditions that can slow down the recovery process. Additionally, leveraging non-invasive and wireless technologies give the patient the ability to move around and get out of the hospital bed, leading to positive effects to their mental disposition.

To reduce infections, hospitals are also turning to non-invasive alternatives wherever possible. With the standard ventilation process, clinicians intubate patients bypassing the natural infection-preventing barriers like tonsils, consequently exposing the lungs to a higher risk of infection. In fact, ventilator-acquired pneumonia (VAP) is the second most common HAI, and while there are several points of contact when a patient can be vulnerable to infection during ventilation intubation, hospitals can reduce these risks by leveraging non-invasive technologies. A non-invasive alternative uses a mask that is simply placed on the nose, limiting exposure to infections and allowing the patient to stay mobile during their recovery. Research has shown a direct correlation between increased mobility and better patient outcomes specifically in those undergoing prolonged mechanical ventilation.

Using Patient Data for Early Detection and Intervention

Although emerging technologies such as the availability of real-time patient data has delivered benefits to ensure quality patient care, it has also posed some new challenges when it comes to patient safety. For example, clinicians now receive hundreds of alerts, patient calls and monitor alarms, making it difficult to prioritize actions. As technology evolves, alarms must also get smarter, striking a balance between sensitivity and specificity to eliminate the ongoing challenge of alarm fatigue. These smarter alarms make it easier for providers to transition care beyond the bedside without losing the ability to detect when something is wrong and intervene as needed.

Technologies that offer alarm management capabilities can also help clinicians triage alerts, enhancing patient safety and reducing non-actionable alarms for clinical staff. Similarly, early warning scoring (EWS) technologies support real-time patient vital signs--such as blood pressure, heart rate, respiratory rate and body temperature--while producing a single alert for when the patient is showing signs of distress. Technologies that aggregate patient data in real-time and support early detection can help clinicians make informed decisions and take preventative action. Additionally, allowing clinicians to have access to these alerts on the go can further support earlier response, regardless of the caregiver's or the patient's location.

Improving the At-Home Patient Experience

As we continue to the shift to a value-based care model, clinicians need to look at the programs and processes to improve transitions of care to keep patients healthy, even after they've left the hospital. With a focus on reducing readmissions, providers and clinicians need to leverage monitoring tools to ensure that once a patient is discharged, they can recover well at-home with minimized risk of complications.

Remote monitoring technologies can play a larger role in home patient care while ensuring patient safety. For example, connected sensors can help ensure a patient's vital signs are being consistently monitored even after hospital discharge. This enables the clinical staff to contact the patient remotely from the hospital for a quick check-up on their vital signs, address any irregularities, and connect directly with the patient to intervene in the case of a more serious problem or emergency. Connected technology can improve patient recovery time, reduce rates of readmission, and ultimately keep the patient's safety at the center of their care.

When effectively utilized, health care IT can play a key role in improving patient safety by continuously engaging patients in order to keep them informed in how their care develops. In addition, collaboration across the health care continuum is critical to ensure that the needs of several stakeholders--from doctors and nurses to patients--are considered as technology continues to evolve. As a result, the power of health IT will be properly harnessed to improve clinician workflow, hospital procedures and ultimately, patient safety.

Peter Ziese, PhD, MD, is head of sales and marketing at Philips Patient Care and Monitoring Solutions.

[Image courtesy of SMOKEDSALMON/FREEDIGITALPHOTOS.NET]

Heal an Injured Knee? You Need to Listen

Georgia Tech researchers hope their wearable device-- which records and graphs sounds inside injured knees-- will help soldiers and athletes.

Nancy Crotti

Georgia Tech knee sound device
The Georgia Tech device uses both MEMS microphones and piezoelectric strips to pick up sounds. (Image courtesy of Georgia Tech)

Those snap, crackle, pop sounds coming from your knee may someday help physicians discern the extent of an injury and how it's healing.

A research team led by a former NCAA discus thrower is working on a device that can transcribe those sounds into a moving graph, according to a statement from the Georgia Institute of Technology. The knee band has microphones and vibration sensors to listen to and measure the sounds inside the joint.

Omer Inan, an assistant professor of electrical and computer engineering, was a three-time NCAA All-American in the discus at Stanford University. Having whirled around like a tornado and squatted with 500-lb. loads, he knows about knee pain. Onan had been thinking about developing such a device for some time.

"I would always feel like my knee was creaking or popping more if I was putting more stress on it," Inan said.

He pitched his idea to the Defense Advanced Research Projects Agency (DARPA), which was looking for research proposals on wearable technologies to assist rehabilitation. A paper on the device has been published online in the journal IEEE Transactions in Biomedical Engineering online. DARPA's Biological Technologies is sponsoring the research.

The quest to detect useful sounds posed some challenges. The knee joint is surrounded by fluid, which blunts sound waves that are exiting the joint for the skin. Also, when a patient moves around, that causes extraneous noises that can drown out useful sounds.

"The fact that the measurement has to occur by definition during movement is a challenge, because you can't just tell the person to be still and avoid motion artifacts," he said.

The researchers combined microphones with piezoelectric film. The film is a hypersensitive vibration sensor and collects the best sound, but it is very sensitive to interference. The microphones placed against the skin make for an ample backup and for a more practical device.

The knee monitor also takes advantage of a technical advancement you will find in your smart phone. Micro-electromechanical systems microphones, or MEMS, integrate better with current technology than microphones based on previous technologies, and that also makes the microphones downright cheap-50 cents to a dollar-for a very affordable device.

If paired with medical research, Inan's acoustic device could lead to inexpensive, wearable monitors, which could benefit athletes who have overburdened their knees, and elderly patients who have slipped and fallen. DARPA's interest is to cut down on repeat battlefield knee injuries and help get soldiers back to duty safely.

"What most people don't know is that musculoskeletal injuries of the knees and ankles are among the top reasons for discharge for active duty service members," Inan said.

The problem may seem fixed months later, but too often it's not, and the knee is vulnerable to re-injury, he added.

The acoustic pattern an injured knee produces is more erratic than that of an intact knee. The researchers are graphing out the recorded audio and matching it to the joint's range of motion to see where exactly in the leg's extending and bending the knee creates creaks and pops. The result has peaks and squiggles that resemble an electrocardiogram or other physiological signal, according to Georgia Tech.

Inan hopes that medical research will build on the acoustical sensing technology his group is designing, decoding the sound into useful patterns.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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This Is the Closest Device to a Tricorder Yet

Chest-worn patch tracks both biochemical and electrical signals, sending the info to a smartphone.

Nancy Crotti

San Diego tricorder wearable
The Chem-Phys patch records electrocardiogram (EKG) signals and tracks levels of lactate. (Image courtesy of University of California, San Diego)

Engineers at the University of California, San Diego have developed the first flexible, wearable device capable of monitoring both biochemical and electric signals in the human body.

The Chem-Phys patch records electrocardiogram (EKG) signals and tracks levels of lactate, a biochemical that is a marker of physical effort, in real time, according to a statement from the university. It could be the closest thing yet to the mythical tricorder of Star Trek fame.

The device can be worn on the chest and communicates wirelessly with a smartphone, smart watch, or laptop. It could have a wide range of applications, from athletes monitoring their workouts to physicians monitoring patients with heart disease.

The patch includes a flexible suite of sensors and a small electronic board. The nanoengineering and electrical engineering researchers describe their work in the May 23 issue of Nature Communications.

The researchers' biggest challenge was making sure that signals from the two sensors didn't interfere with each other. They used screen printing to manufacture the patch on a thin, flexible polyester sheet that can be applied directly to the skin. An electrode to sense lactate was printed in the center of the patch, with two EKG electrodes bracketing it to the left and the right. Engineers went through several iterations of the patch to find the best distance between electrodes to avoid interference while gathering the best quality signal. They found that a distance of 4 cm (roughly 1.5 in.) between the EKG electrodes worked best.

Researchers also had to make sure the EKG sensors were isolated from the lactate sensor. The latter works by applying a small voltage and measuring electric current across its electrodes. This current can pass through sweat, which is slightly conductive, and can potentially disrupt EKG measurements. So they added a printed layer of soft, water-repelling silicone to the patch to keep the sweat away from the EKG electrodes.

The sensors were then connected to a small custom printed circuit board equipped with a microcontroller and a Bluetooth Low Energy chip, which wirelessly transmitted the data gathered by the patch to a smartphone or a computer.

The patch was tested on three male subjects, who wore the device near the base of their sternum while doing 15 to 30 minutes of intense activity on a stationary bike. Two of the subjects also wore a commercial wristband heart rate monitor. The data collected by EKG electrodes on the patch closely matched the data collected by the commercial wristband, according to the university. The data collected by the lactate biosensor closely followed data collected during increasing intensity workouts in other studies.

Plenty of wearables measure steps, heart rate, or both.  However, hardly any measure chemical signals such as lactate, according to electrical engineering professor Patrick Mercier.

"One of the overarching goals of our research is to build a wearable tricorder-like device that can measure simultaneously a whole suite of chemical, physical and electrophysiological signals continuously throughout the day," Mercier said in the statement. "This research represents an important first step to show this may be possible."

The device has implications for athletes as well as for cardiac patients. Mercier and nanoengineering professor Joseph Wang have been fielding inquiries from Olympic athletes about the technologies that the university's Center for Wearable Sensors produces. Wang's team worked on the patch's sensors and chemistry, while Mercier's team worked on the electronics and data transmission.

Next steps include improving the way the patch and the board are connected and adding sensors for other chemical markers, such as magnesium and potassium, as well as other vital signs. 

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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