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10 Medtech Recalls that Shocked the Industry—Tiger Paw System II

10 Medtech Recalls that Shocked the Industry—Tiger Paw System II

Tiger Paw System II

A recall of Maquet Medical Systems' Tiger Paw System II was announced in March 2015 after it was found that "incomplete closure" of the system could cause heart tissue tears and bleeding.

The Tiger Paw System II is made by Laax, Inc., which is owned by Maquet Medical Systems. The device is a staple used in open surgery to block off the left atrial appendage of the heart.

According to the FDA recall release, Maquet Medical Systems received notice of one death and 51 adverse event reports.

             

[Image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]  

10 Medtech Recalls that Shocked the Industry—Intra-Aortic Balloon Pumps

10 Medtech Recalls that Shocked the Industry—Intra-Aortic Balloon Pumps

Maquet Intra-Aortic Balloon Pumps

Some of the intra-aortic balloon pumps (IABP) made by Maquet Datascope Corporation were recalled in March 2014 because the device's fan assembly could malfunction and cause the device to stop with any alerts.

According to the FDA recall release, a malformed retaining ring in the fan assembly could make the fan stop. Without the fan cooling, the device's power supply could overheat and cause the pump to shut down.

Because IABPs work by inflating and deflating a balloon to temporarily help circulation and blood perfusion, device stoppage might have dire consequences for the heart and other organs.

According to FDA, Maquet Datascope received over 100 reports of device problems and one death.

             

[Image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]  

10 Medtech Recalls that Shocked the Industry—NaturaLyte

10 Medtech Recalls that Shocked the Industry—NaturaLyte

NaturaLyte

Fresenius' NaturaLyte Liquid Bicarbonate Concentrate was recalled in April 2014 because of its potential to "develop higher than expected bacteria levels during its shelf life," according to the FDA recall release

NaturaLyte is a product used in a hemodialysis machine for patients with acute and chronical kidney failure. According to FDA, the Halomonas bacteria was found in the concentrate. Use of bacteria-contaminated concentrate could result in adverse events like bacteremia and sepsis. There have been reports of two injuries and one death that might be related to NaturaLyte, FDA notes.

             

[Image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]  

10 Medtech Recalls that Shocked the Industry—Flexi-Seal CONTROL

10 Medtech Recalls that Shocked the Industry—Flexi-Seal CONTROL

In April 2014, a Class I recall of ConvaTec's Flexi-Seal CONTROL Fecal Management System Kit was announced. According to the FDA recall release, the company did not file for 510(k) clearance of the product. The device is intended to be used in patients with fecal incontinence.

The device is known to be defective because the balloon doesn't inflate or deflate completely, the auto-valve doesn't prevent inflation beyond 45 mL and leaks at the inflation port. FDA reports that these flaws may lead to rectal damage, leakage or expulsion of the device, and skin injuries due to fecal contact.

There were 12 serious injuries and one death reported in Flexi-Seal CONTROL patients between February 2013 through March 2014.

             

[Image courtesy of OHMEGA1982/FREEDIGITALPHOTOS.NET]  

10 Medtech Recalls that Shocked the Industry—Covidien Defibrillation Electrodes

10 Medtech Recalls that Shocked the Industry—Covidien Defibrillation Electrodes

A recall was initiated in September 2014 for Covidien defibrillation electrodes and electrodes made by Covidien and distributed by other brands. These electrodes are connected to automated external defibrillators to help shock the heart back into a normal rhythm. 

However, the electrodes named in the FDA recall announcement had a connector compatibility issue with the Philips FR3 and FRx Defibrillators. According to the recall notice, there were two injury reports, with one resuscitation delay that might have played a part in the patient's death.

             

[Image courtesy of NUTDANAI APIKHOMBOONWAROOT/FREEDIGITALPHOTOS.NET]  

Here’s Why Patients Stop Using ConsumerMed Products

Here’s Why Patients Stop Using ConsumerMed Products

The "ConsumerMed" product category is expanding quickly, but few makers have figured out how to keep users faithful for the long term.

Kevin Young

The line between consumer products and regulated medical devices is blurring, as a new category, "ConsumerMed" products, invades the market. Fitness trackers. Home blood pressure monitors. Oral care products. Sleep assist devices. They're all marching into this uncharted--and valuable--territory, estimated to reach $10.6 billion by 2017.

Hear Kevin Young speak about Top Trends Impacting the healthcare IoT in 2017 at the BIOMEDevice Boston Conference on May 4.

Although some companies have succeeded in this area, many discover it's difficult to identify the necessary attributes for consumer acceptance. Why? They often push new technologies without fully understanding consumer behavior, needs, and desires. These products fail to connect with users, and companies are unable to encourage proper and continued use. Studies indicate that 33 percent of consumers stop using their fitness tracker in the first six months, and other ConsumerMed products face similar adoption and adherence challenges.

Pharmaceutical companies have long explored patient behavior and ways to improve medication adherence an issue plaguing the industry with nearly half of U.S. patients failing to take their medications properly, including some who stop taking their prescribed medication entirely. The magnitude of this issue has forced drug companies to dedicate significant time and effort to address this adherence challenge.

With the rapidly expanding ConsumerMed device category beginning to face similar adoption and adherence issues, there are four lessons that can be learned from the pharmaceutical industry:

1. People don't believe in the long-term benefit. Many patients stop using a medication because they don't understand the overall benefit or believe that it will work for their specific needs. Pharmaceutical companies have been addressing this issue through education and creating opportunities to facilitate ongoing communication between the patient and the healthcare community. Similarly, ConsumerMed manufacturers are in a position where they can educate users on the benefits of device adherence through a more informative or consultative sale of the product and continued education once the product is sold.

Another way to address this challenge: Help consumers visualize the possible long-term benefit of their treatments. ConsumerMed companies have the opportunity to open a window into a "future you." Financial service companies do this by providing a view of their customers' retirement years based on their current financial behavior and planning. They then offer a clear and concise visualization of how modifying certain behaviors today can affect their future financial state and lifestyle.

2. The psychological burden. One of the main causes of poor adherence is the challenge of patients remembering to take their medication. This isn't surprising. Changing consumer behavior, and encouraging new daily habits, can be extremely challenging.

ConsumerMed devices are well positioned to address these aggressive challenges. ConsumerMed devices should become so convenient and comfortable that they invisibly fit into our lives. In cases in which a device can't be worn or incorporated into products used daily, organizations should find other ways to fold them into our routines. They should be designed to resonate with consumers so that they're encouraged to display them in their homes, allowing them to act as a visual use reminder.

Technology can help. ConsumerMed devices have an advantage because these products often inherently contain electronic elements. If desired, reminders can come to consumers through their smartphones, email, or even text messages from family members.

3. The desire for immediate results. A significant motivator for pharmaceutical adherence is the gratification that patients receive when the medication demonstrates immediate effectiveness. However, patients often stop using a medication when they have an asymptomatic condition and don't experience any physiological or psychological benefits of taking the drug. Products should take this into consideration and make "small wins" visible to consumers. These can be as simple as a text message at the end of the day if you achieved your health objectives, or an awards/points system.

These companies also need to capitalize on opportunities to improve "sense making." Consumers now experience data overload as their health and wellness devices providing a flood of information--without the ability to evaluate the data in a meaningful way. For instance, a health dashboard could translate collected data into clear and useful consumer-facing information and suggestions for behavior modification. The Apple Watch has successfully addressed this through their Activity app. The app encourages activity through short-term goal setting and reminders and congratulates the user when he or she has reached daily goals.

An additional issue with this product category is that many ConsumerMed devices do not sufficiently leverage the opportunity to connect to a larger health and wellness ecosystem. These devices can monitor and provide feedback but, without being connected to a larger information sharing system, they work in isolation. There are opportunities to connect devices to healthcare professionals, family members, or an overall health plan. Similarly, as ConsumerMed devices become a daily part of people's lives, companies will be able to provide a more beneficial and significant longitudinal assessment of use.

4. Cost. Cost continues to be a significant barrier for pharmaceutical patient adherence. Millions of people can't afford the medications that are prescribed to them. The cost of ConsumerMed devices or consumables can be a significant barrier to initial adoption or long-term adherence. To improve affordability, ConsumerMed device companies should explore ideas such as new distribution or business models. For example, many people stop using a health-and-wellness product because once they discover their personal usage patterns, the device loses its utility. In fact, some contend that the point of all these products might be to increase our self-awareness and eventually wean us from them.

Companies might confront this issue by creating device rental options for consumers. People would be able to rent their ConsumerMed device at a lower cost than purchasing the unit, and then return the device once it has served its purpose. This might be a model that would work well for all the parties involved.

Kevin Young is senior vice president of product experience at Continuum, a global innovation design consultancy.

[Image courtesy of FRANKY242/FREEDIGITALPHOTOS.NET]

Medtech Job Market Heats Up

Medtech Job Market Heats Up

Jamie Hartford

A rising tide lifts all boats, as they say, and medtech employees today are floating high thanks to increased revenues, the return of funding to the sector, and robust hiring by top companies. Those factors are contributing to what recruiters are calling—for the second year in a row—an employees’ market in the medical device and diagnostic industry.

Get the topline data from our 2015 Medtech Salary Survey report or download the entire dataset free to get breakdowns by job description.

 Medtech companies, it seems, simply can't find enough qualified candidates to fill their open positions.

“Every company and region I’m aware of is looking for talent and having a difficult time getting it,” says Brian Cole, managing partner and medical device practice leader at Dallas-based recruiting firm Kaye/Bassman International. “There’s just not enough qualified, skilled people out there to help these companies."

Yet, despite the shortage of attractive candidates, Cole says companies aren't rushing to make a hire. " I think they’re all—even though there aren't a lot of good people out there—being patient and looking for the right person," he says. "I think they’re all getting frustrated with not finding enough people, but then they're a lot more open to paying more to get them when they do find them."

Phil Nachman, principal at Boston-area medtech recruitment firm Nachman BioMedical, says overall industry salaries aren't making a huge leap. "If anything, it's a modest increase, nothing spectacular," he insists. "A few percentage points to keep up with the cost of living."

But with demand for qualified medtech workers outstripping supply, other recruiters say employees have the upper hand in salary negotiations.

“We’re seeing a larger increase in counteroffers, larger increases in long-term incentives, larger increase in year-over-year raises, and unexpected bonuses,” says Chris Miclot, sales manager at Orlando, FL, recruitment firm Legacy MEDsearch.

Cole reports an uptick in sign-on bonuses, which he says are almost becoming standard, and adds that firms are open to more generous paid time off allowances.

“Most companies are agreeing to offer three weeks vacation,” he says.

Behind the Trend

As medtech has shrugged off the effects of the Great Recession over the past few years, a number of factors have converged to benefit industry employees.

For starters, venture capital investment in the segment has picked up, with funding in the medical device industry jumping 22% versus the prior year during the second quarter of 2015, according to a report from PricewaterhouseCoopers (PwC) and the National Venture Capital Association (NVCA). IPOs have also been on a tear, with strong market debuts from medtech firms like Nevro and ConforMIS—all good news for startups.

“We’re seeing smaller companies getting a little bit of legroom,” Miclot says, adding that could help inflate salaries for employees who work for them.

On the other side of the coin, larger companies have seen a return to revenue growth following the financial crisis, which has led to an uptick in hiring. According to market research firm Evaluate Medtech, 14 of the top 15 medtech companies by market capitalization increased their headcount last year.

Another factor that may be weighing in some employees’ favor is competition from other industries for talent. As medical devices have become more software-intensive in recent years, medtech companies increasingly find themselves bidding against consumer tech companies for software engineers, Nachman says.

“Google and Microsoft both have centers in the Boston area, and they can pay a lot to attract employees or give them free pizza or whatever else they do,” Nachman says. “Medtech has to attempt to keep up with that.”

Medtech also seems to be a graying industry. The median age of respondents to MD+DI's 2015 Medtech Salary Survey was 46, and 40% were age 50 or older. More than 45% of respondents say they been in the industry for 15 years or longer, versus just over 16% who have worked in medtech less than five years. If that's any indication of the industry as a whole, medtech could be looking at a wave of retirements on the horizon.

“Baby Boomers are slowly making their exit, and I think we’ll see it even more over the next five to 10 years,” Miclot says.

What’s Hot, What’s Not

While recruiters say employees in most medtech positions today enjoy a certain amount of bargaining power when it comes to salary talks, that’s not true across the board.

Changing regulatory requirements mean regulatory and legal affairs professionals, as well as those working in quality affairs/quality control are perennially in demand. And thanks to medtech’s push for continuous innovation, companies always need R&D and product design engineers.

On a more granular level, Nachman says software engineers, bioinformaticians, systems engineers, and project managers are especially in demand as medical devices are growing more complex.

But circumstances aren’t as favorable for employees in some positions.

With the medtech industry increasingly turning to outsourcing to fulfill its manufacturing needs, headcounts are shrinking in production and manufacturing occupations, recruiters say. Last year’s M&A mania is also expected to take a toll, as some companies that have gone through a merger are likely to consolidate their manufacturing facilities.

Recruiters also predict industry consolidation will lead to a culling of the ranks in management.

“When you go through M&A, you don’t need two VPs; you only need one,” Cole says.

Sales, marketing, administration, and finance professionals may also suffer as companies combine. “Some of the reasons companies merge are to get savings out of those areas,” Nachman says.

In some cases, the casualties from consolidation could extend even further. Cole says the effects of last year’s megamergers largely have yet to be felt, but he predicts the ax will fall eventually.

“There are going to be layoffs in the short term,” Cole says. “With Zimmer Biomet, there are going to be a lot of them because they both play in hips and they both play in knees and other areas. There have to be a lot of redundancies.”

As a result, Cole expects hiring in Warsaw, IN, to cool, but says offers continue to be extended to medtech employees at a fast clip in other medtech hubs.

Recruiters agree that the San Francisco Bay Area—which also leads the nation in medical device venture funding, according to PwC and the NVCA—continues to be the hottest area for medtech hiring. Boston and Southern California (San Diego and Orange County, in particular) remain good bets for industry job seekers, although the jury is out on Minneapolis. Nachman says the Twin Cities area is still a hotbed for medtech hiring, but Cole insists the cardiovascular hub is only “lukewarm.”

Up-and-coming hiring hubs, Miclot says, are Dallas and Austin, TX. “We’re seeing an influx of biotech run into Texas thanks to the state’s corporate tax reform,” he says.

In terms of segments, recruiters report an influx of hiring in emerging areas such as regenerative medicine, health IT, wearable devices, and neuromodulation, which Cole says is “one of the hottest sectors—if not the hottest sector—in the industry."

As patients are reconsidering procedures put off during the recession, hiring is also picking up in the dental, ophthalmology, and orthopedics spaces. Cole says companies making orthopedic extremity devices in particular need qualified employees, while hiring in the usually hot spine sector has slowed.

“Diabetes continues to be aggressively hot, especially with Google and Apple trying to play in the space,” he says, adding that cardio, on the other hand, remains strained. “FDA is still making that tough for them.”

Hiring is also picking up in the area of combination devices as pharmaceutical companies continue to creep into medtech territory, Nachman says.

Maximize Your Salary

With a red-hot job market giving employees an edge in salary negotiations, what can you do to maximize your advantage? Recruiters have some tips.

Without pensions keeping them in place, medtech employees today are more transient than ever, switching jobs every three to five years. “It’s becoming more and more important and more and more special to be a longer tenured employee within a company,” Miclot says.

Medtech companies value industry experience, Nachman agrees, and sticking with the same employer allows you to highlight your accomplishments—although longevity today is relative.

“If you’ve been there for three years and managed a large project that made an impact on corporate growth, that gives you some wiggle room,” Miclot says.

It’s also important to keep an open dialogue with your manager about where your career is going. “You need to find out from your boss whether your expectations and their’s align,” Cole says.

If you don’t like what you hear, it may be time to consider taking your talents elsewhere.

Get detailed data about salaries in the medical device and diagnostic industry, including breakdowns by job description, in our free Medtech Salary Survey report.

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

The 5 Most Overpaid Medtech CEOs

1. Stephen MacMillan, HologicCompensation Rank: 4Company Performance Rank: 18Hologic provided MacMillan with generous awards to recruit him in December 2013, during the first quarter of Hologic’s fiscal year ended September 27, 2014. Much of the $24.5 million compensation the former Stryker CEO received came from $15.3 million in stock awards under MacMillan’s employment agreement.It was slow going, however, under MacMillan’s initial leadership of the Bedford, MA–based diagnostic and medical imaging equipment maker. Revenue only grew 1.5% during the 2014 fiscal year, 14th among the 18 companies analyzed, and earnings of $17.3 million were less than 1% of revenue from the previous year—though it did mark a turnaround from the nearly $1.2 billion that Hologic lost during the 2013 fiscal year.MacMillan, however, appears to be more than earning his keep this year. Hologic had the best performing stock among large medical device companies during the first nine months of 2015. Its stock value was up more than 45% during the time period. Hologic says it has been seeing accelerated adoption of its FDA-approved Genius 3D mammography systems. 3-D imaging is able to detect 41% more invasive cancers than standard 2-D imaging, according to Hologic.Continue >>

The 5 Most Overpaid Medtech CEOs

Chris Newmarker and Brian Buntz

September 18, 2015

Public interest in ballooning CEO pay spiked recently, after the billionaire Republican presidential candidate Donald Trump called it “disgraceful” and “a total and complete joke.” Speaking to his populist base, he stressed the need for reinvigorating U.S. manufacturing but essentially argued that CEOs are already overpaid: “I know companies very well and the CEO puts in all his friends…and they get whatever they want you know because their friends love sitting on the board.”

Here at Qmed, we delved into corporate SEC filings to figure out which CEOs arguably get paid more than they should, comparing their pay to their company’s financial performance.

We ranked overall compensation for CEOs at 18 of the largest medical device companies publicly traded in the U.S. We then compared the compensation rank with a company performance ranking based on four factors: revenue growth, five-year stock performance compared to the S&P 500, earnings growth, and total revenue (as a control for size).

Here are the five CEOs whose compensation ranking was much larger than the company performance ranking:

Continue >>

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7–8.

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3-D Bioprinting and the Future of Regenerative Medicine

A professor at Drexel University is working to use 3-D printing to design scaffolding to harness the body's inflammatory response to promote healing.

Kristopher Sturgis

Kara Spiller

Kara Spiller, an assistant professor, school of biomedical engineering at Drexel University is looking into the use of 3-D printing to study how human bones heal after breaking. Printing out bone precursors, she is helping shed led on how bone and other tissues heal, and she is working to discover the precise amount of inflammation that is needed to optimize healing.

"Inflammation is critical for the repair of all tissues," she says. "If you inhibit inflammation, you inhibit healing. On the other hand, too much inflammation can lead to serious problems and impair healing."

Her group is working to understand which aspects of the inflammation process are responsible for promoting healing, and which aspects slow it. "Once we know that, we can design strategies to promote just those beneficial aspects while minimizing the detrimental parts in order to maximize tissue regeneration using the body's own natural healing mechanisms," Spiller says.

(Note, she'll be speaking on the subject at the upcoming MD&M Philadelphia event, held on October 7-8, 2015.)

In the following Q&A, Spiller further examines the role of inflammation and touches on her work to design 3-D printed tissue scaffolds.
 

Qmed: Part of your research has involved exploring inflammation and how it can help you predict the healing of diabetic ulcers. Is this because you were able to use inflammation as a biomarker that helps you predict healing behavior?

Spiller: Exactly. Once we understood that cells of the inflammatory response must progress through a particular sequence of behavior states in order for healing to occur, we could track that sequence as a biomarker. Because inflammation is important in the healing of all wounds, we're now exploring the application of this idea to other types of wounds.

Qmed: How did this information lead to the design of specific scaffolding that promotes healing behavior based on the body's inflammatory cells?

Spiller: We're taking two approaches to design scaffolding to harness the body's inflammatory response to promote healing. First, we're investigating materials that are known to be successful in causing healing in patients to try to understand how they affect inflammatory cells, which would allow us to further enhance the healing behavior of those scaffolds or to apply those principles to design of scaffolds for other applications. In the second approach, we're chemically modifying the scaffolds to force the inflammatory cells to exhibit specific sets of behavior, such as those that would promote blood vessel growth.

Qmed: Do you think that identifying similar biomarkers to help predict healing behavior will be an increasing area of interest in the future of wound healing and regenerative medicine?

Spiller: Absolutely. We're starting to learn that every patient has a different immune system, and that affects their response to treatment. Differences in patients' immune systems probably explain why some patients respond to certain treatments while others do not. We hope that by measuring biomarkers related to inflammation, we can develop a personalized medicine approach to tailor a patient's treatment to their specific needs.

Qmed: The conference seminar agenda touched on the idea of wound healing through the development of "smart" biomaterials. Can you tell us a little about some of these "smart" biomaterials, and how they might play a role in the future of wound healing and/or tissue regeneration?

Spiller: It's still very early, but we're working on developing wound dressings that usher the cells of the wound through the necessary phases of inflammation in response to signals released from the wound itself, so that each phase occurs when the wound is ready for it.

Qmed: Are there any specific "smart" biomaterials that you think could have a transformative impact in the realm of medical device technologies, and how do you think we could see these materials manifested into useable technologies?  

Spiller: Many researchers are working on regenerative medicine strategies that use the body's own cells to promote tissue repair, ensuring that the strategy is automatically tailored to the specific patient's needs. These technologies are largely under investigation in academic laboratories, so translating these ideas into useable technologies will take close collaboration between companies and academic researchers.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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Google Beefs Up Life Sciences Unit with NIMH Hire

Earlier this week Google announced that it had hired Thomas Insel, former director of the National Institute of Mental Health (NIMH) to be a part of its growing Life Science group. Insel was brought on to apply the company's vast technological resources toward mental illness.

Jordan Brandes

Thomas InselThomas Insel has been a part of the NIMH since 2002 and has had a fundamental role in practical clinical trials, autism research, and the role of mental illness. He is a member of the Institute of Medicine, a fellow of the American College of Neuropsychopharmacology, and is a recipient of several awards including the Outstanding Service Award from the U.S. Public Health Service.

Google's interest in detection and treatment of mental illness is interesting and could possibly lead to the development of new treatment modalities. A recent Fortune post states that Google may leverage its analytics to better understand conditions such as Alzheimer's and autism. The article even goes so far to state that "mental health devices may be technology's next big business."

In any event, Google's growing involvement in mental health is worth keeping an eye on, as it may possibly lead to the development of novel technologies to treat mental health disorders, according to William Betten, a medical industry consultant based in the Minneapolis area. "Insel is incredibly qualified for the position. I think he's going to look at how to bring new tools and capabilities to the mental health field that weren't there before. More specifically he will shed light on the fact that there are more alternatives in the field of mental illness than just using pharmaceuticals. He is going to look at how to bring in new tools to the mental health sector, especially as it relates to medical devices and analytics."

Google's Life Sciences group is the first company to operate under the newly formed Alphabet umbrella. Currently, the division is developing a glucose-monitoring contact lens with Swiss drug maker Novartis. "The GLS team is developing new technologies to transform healthcare," Insel said in a statement released on NIMH's site. "I am joining the team to explore how this mission can be applied to mental illness. That the life sciences team at Google would establish a major exploration into mental health is by itself a significant statement--recognizing the burden of illness from psychosis, mood disorders, and autism as well as the opportunity for technology to make a major impact to change the world for the millions affected."

Google's entrance into the industry of mental illness could bring about larger changes as well. "This gives Google instant creditability. I don't know that it will drive things in the mental health industry but it's exciting and breaks traditional stereotypes of how the business is run," Betten says. He addsthat bringing Insel on board could help to shed more light on mental illness and maybe help to remove the stigma typically associated with the subject.

"Google does not have the silver bullet for mental illness but the convergence of medicine and consumer devices creates an exciting new way of doing business in the medical industry. Money is still the question and how they plan to monetize the services that Insel will be providing. Having communication companies moving into the mental health sector opens up that space," explains Betten.

As Inself himself explains in his statement, the mission of the GLS team is about creating technology that can help with earlier detection, better prevention, and more effective management of serious health conditions.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

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