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Articles from 2015 In February


How a Tampered MRI Sparked a Huge GE Recall

The recall involves every MRI system with superconducting magnets that GE Healthcare has ever made--nearly 13,000 of them going back to 1985.

Chris Newmarker

GE's Optima MR450w was one of the MRI systems implicated in the recall.
GE's Optima MR450w was one of the MRI systems implicated in the recall.

FDA recently designated as Class I a massive GE Healthcare recall related to the erroneous disabling of an MRI system's magnet rundown unit, eliminating a method to quickly shut the system down in an emergency situation.

Incidents involved some MRI systems in India, and involved either service personnel or equipment users disabling the magnet rundown unit, according to a GE Healthcare news release.

The Mumbai Mirror had a different take on the situation back in November, reporting that GE engineers told an inquiry committee set up by Tata Memorial Hospital that this switch was removed from all the company's MRI machines in India. The switch was removed after a helium gas release at one of the centers caused by a patient fiddling with the switch. 

A delay in shut off, however, can potentially result in life-threatening injuries when metal objects are brought into a magnetic field around an MRI. The FDA says there were two reported injuries when hospital employees entered an MRI room carrying a metal container. The Mirror reports employees at Tata Memorial Hospital remained stuck to an MRI machine for four hours.

The recall involves all GE Healthcare MRI systems with superconducting magnets. In all, more than 30 MRI models were recalled.

GE Healthcare has sent an Urgent Medical Device Correction letter to all its customers informing them of the danger, and instructing them to perform a short test that confirms if the magnet rundown unit is functioning properly and has not been disabled.

The letter also says a GE Healthcare service representative will visit to inspect the Magnet Rundown Unit.

"If the MRU test does not perform as described in each of the 4 steps above, with the specified LED lighting in each step, GE Healthcare strongly recommends that you stop using the system, and immediately call your GE Healthcare representative," - See more at: http://www.diagnosticimaging.com/mri/everything-you-need-know-about-ge-mri-recall#sthash.nI5pmLI7.dpuf
"If the MRU test does not perform as described in each of the 4 steps above, with the specified LED lighting in each step, GE Healthcare strongly recommends that you stop using the system, and immediately call your GE Healthcare representative," the letter states. - See more at: http://www.diagnosticimaging.com/mri/everything-you-need-know-about-ge-mri-recall#sthash.nI5pmLI7.dpuf
Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

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

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A Practical Tubing Materials Alternative to PVC

Styrolution touts its diverse styrenics product portfolio as alternates to products commonly used in the medical device market, such as PVC

Chris Newmarker

Styrolutoin and Microspec Tubing
Microspec has partnered with Styrolution to use styrenics to replace PVC for its highly flexible multi-lumen tubing. (Image courtesy of Styrolution)

Add styrenics to the list of medical device tubing materials being touted as alternatives to PVC and other commonly used products in the space.

Styrolution's Styroflex is a styrene-butadiene block copolymer (SBC) with the properties of a thermoplastic elastomer, and its Styrolux resins are a range of thermoplastic styrene-butadiene copolymers (SBC).

It was about a year ago that Microspec (Peterborough, NH), a market leader in medical tubing, announced it would partner with Styrolution (Frankfurt, Germany) to use the two materials to replace PVC for its highly flexible multi-lumen tubing. Such tubing makes it possible to administer different medications from one access point.

"Designers and manufacturers are looking for an alternative," says Alex Silvestre, global director of Healthcare & Diagnostic at Styrolution, which has its U.S. headquarters in Aurora, IL. The company is a joint venture between BASF and INEOS, with a focus on styrene monomer, polystyrene, ABS Standard and styrenic specialties.

Styrolution is already one of themarket leaders in providing PS (polystyrene) and ABS in labware and respiratory devices. In other device applications, its Terlux (MABS), Zylar (MBS), and Clearblend (MBS) lines are well established and recognized brands amongst some of the larger OEMs.

Offering another alternative material in the tubing space makes sense.

Polyvinylchloride (PVC) materials containing di(2-ethylhexyl)phthalate (DEHP) plasticizers are still common in a range of medical devices. But worries of DEHP's potential toxicity have caused Europe to crack down on its use in medical devices. FDA has not been as concerned, but that could change, too, Rudi Gall, managing director of polymer components company Raumedic, Inc. (Leesburg, VA), wrote in Qmed last year.

Silvestre thinks styrenics are a strong contender as an alternative. He listed off a number of reasons:

  • Materials such as Styroflex and Styrolux have a density advantage when compared to some other resins, so medical device manufacturers in some cases can use 20 to 30% less material.
  • For tubing applications, they can be used on existing machines including extrusion and injection molding equipment, avoiding a major manufacturing retooling.
  • There is improved bonding performance with components made of different materials.
  • Yellowing from e-beam or gamma ray irradiation sterilization is only temporary--which makes products made from styrenic materials aesthetically pleasing.
  • Styrolution's variousHD Service Packages also helps customers such as Microspec navigate the regulatory certifications and qualifications when it comes to adopting the new materials.

One drawback is that styrenic based materials cannot be steam sterilized because of their characteristic vicat temperatures. But many health providers are trending towards e-beam or gamma ray irradiation sterilization instead, according Silvestre.

"You need a material that meets the physical demands of the application, complies with existing regulatory standards, and is also aesthetically pleasing." Silvestre says.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

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

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What Device Makers Must Do to Make Wearables Work

Wearable medical device revenues are expected to explode from $2.8 billion in 2014 to $8.3 billion in 2019, according to analyst firm Mordor Intelligence. Healthcare startup funding surged to $4.1 billion last year, representing a 125 percent increase compared to 2013, and out of that sum, medical wearables were in the top-five categories to receive funding.

But while analyst forecasts and the fact that venture capitalists are betting billions of dollars and euros that medical wearables will pay off, hurdles remains before the devices can live up to their promise. Before the medical community begins to routinely adopt medical wearables as part of standard medical care practices, here are five hurdles that remain before wearables can begin to play a major role in the healthcare industry.

Convincing Consumers Their Data Is Safe 
Medical device wearables will transfer personal and private information to a data repository, which will often be on a cloud server. While intercepting that data flow from individual devices is not that lucrative of a target for hackers, a database containing millions of personal and healthcare-related records that wearables have uploaded can represent a potential goldmine for data thieves. Device makers and third parties that receive and store the data will need to convince consumers that their information will remain both reasonably private and safe before consumers will adopt the technology.

“Someone could always try to intercept data from individual wearables, but that is not the main concern,” Amichai Shulman, CTO for security firm Imperva, said. “Instead, attackers have a real incentive to access the data aggregation point associated with wearables from many users.”

Among security features device makers should offer, wearable data connections will likely need to be encrypted and users should have to enter a password to access data on the device. Understanding Health Information Privacy (HIPAA) regulations must also be strictly adhered to protect data stored on servers. But unfortunately, HIPAA compliance is not always enforced as much as it should be, Shulman said.

“A pre-emptive approach must be taken to make sure that HIPAA is adhered to before wearables become more popular,” Shulman said. “In two to three years, hackers will have more incentives to attack medical device wearable databases. If we start applying the regulation today, then most of the devices can already be locked down when they become more popular in the future.”

Consumers generally trust their physicians and healthcare providers, but they will likely be wary of third parties that manage the transfer and storage of their data. They will be especially concerned about non-healthcare providers that may broker their data for marketing, insurance, or other purposes.

According to Vaughn Kauffman, principal and U.S. health industries new entrants leader at PwC of PricewaterhouseCoopers International, more than half of 1,000 consumers surveyed in a study said they trust clinicians with their data more than they have faith in other parties to protect their privacy. “In order to retain that trust, companies will need to be transparent about what is being done with the data,” Kauffman said. “Companies need to make their data privacy policies crystal clear. The general trend of using wearable and do-it-yourself technologies will continue to rise and companies need to make sure information that is being passed back and forth with the consumer is being handled correctly and the information provided is the right information.”

Getting the Protocol Rite
The electronics industry has a mixed track record when it comes to compatibility. While this is not necessarily a problem for many consumer electronics device types, compatibility problems could put a brake on medical device wearables’ adoption. Different communications protocols, for example, would make it difficult for healthcare providers to connect to different devices that patients might wear if a single communications standard is not in place. 

“Right now, the data that wearables produce is fragmented and often incompatible across devices.  In the near term, we are seeing a few companies trying to drive interoperability, but the wearables market still has to go through a ‘shake up’ in order to figure out which companies will lead the way,” Kauffman said. “For all of this to work, not only will the sensors and devices need to ‘talk’ to each other, but standard protocols need to be developed for the integration of user-generated data into traditional healthcare.”

Smarter Devices
Medical wearables have so far been limited to communicating blood pressure, glucose level, EKG, and other medical readings to the users’ smart phones and other data-collection hubs. However, consumer and their healthcare providers will look for devices that can do more, such as offering deep analysis of medical readings. 

In order to do that, devices makers will have to make their embedded chipsets smarter for advanced applications that consumers will want. The components inside will also have to become more powerful than they are now in order to better process the information. 

“Wearables right now are still a companion device to a smart phone. They do not have the processing power or the visual display to make them fully a ‘hub’ for all health data analysis and visualization,” Kauffman said. “They currently are ‘sensors’ with some limited visualization. The real horsepower comes from the smart phone, and will likely remain there in the short term.”

Consumers Must Like them
Medical device makers must keep in mind that consumers will opt for medical device wearables that will not interfere with their daily lives and that remain discrete. According to a recent study by researchers from the Polytechnic University of Madrid (UPM; Universidad Politecnica de Madrid), for example, patients have a strong preference for wearables that remain hidden from view. Patients also almost invariably prefer using their smart phones to collect data over wearing a bulky data-collecting device attached to their belt.

The good news is that device makers are developing wearables that are discretely embedded in clothing or fashionable articles, such as watches. “Today we are only seeing the emergence of wearables in the simplest form factors,” Kauffman said. “In the future, the technology associated with wearables will be embedded either in traditional brands and other form factors that are not only fitness focused, but are for everyday use, such as compression socks for diabetics with sensors for fluid or flow.”
 
Wearables must thus not only be comfortable, but they also must be fashionable, Kauffman said. “Much like the smart phone, wearables are becoming a fashion accessory and a form of individual expression,” Kauffman said. “However, in some cases, the focus right now seems to be on those devices that go on the wrist or hip.  But we can very easily see health wearable earrings, necklaces, clothes, tattoos, etc. having a dual use of health and an individual’s expression and style.”

Wearable But How Robust?
Wearables that are meant to be constantly attached to the body will thus need to keep working wherever their user goes, which could be in wet and harsh environmental conditions. However, the jury is still out on how robust wearables will really have to be, since they have yet to adopt them on a massive scale. Consumers, for example, may be unwilling to pay extra for an ultra-sturdy device, even if it can be worn around the clock. 

“It is unclear how durability of a device plays a role in the decision process for consumers and is different to [how consumers will expect wearables] to offer richer and more interactive usage of the data and how that data may change their health premiums or provide greater visibly in how to improve aspects of their health,” Kauffman said. “Again, we are seeing where more fashionable (and some cases less durable) options coming out that consumers will be drawn to as well.”  

Bruce Gain is a freelance writer.

St. Jude Medical Settles, Closing Out Riata Suits

St. Jude Medical Settles, Closing Out Riata Suits

Four years after it stopped selling the Riata and Riata ST defibrillator leads, St. Jude Medical has agreed to settle most of the device-related ongoing U.S. lawsuits and unfiled claims. The company will pay at most an estimated $14.25 million to settle approximately 950 cases and claims, including attorney fees and administrative expenses.

According to a company press release, “the parties have not admitted any liability or the validity of settled product-liability claims and will request dismissal of the settled Riata-related cases throughout the country.”

Riata leads were recalled by St. Jude in November 2011 because the silicone coating insulating the electrical conductor wires within the lead was found to erode prematurely. Leads like this are used to transvenously connect the implantable cardioverter defibrillator (ICD) generator to the heart in order to deliver shocks when needed. According to FDA, the usual lifespan for an ICD lead is about 10 years or more, but Riata silicone insulation was found to erode much earlier, after about four years. Premature insulation erosion sometimes led to externalized electrical conductor wires and device malfunction.

St. Jude took the Riata and Riata ST leads off the market in December 2010, notifying doctors in a letter. The company sent an updated advisory letter to physicians in November 2011 and the next month, FDA classified this as a Class I recall. Today, there are approximately 90,000 Riata and Riata ST leads in use worldwide, according to an e-mailed statement from St. Jude spokesperson Kate Stoltenberg. She added, "we are committed to post-market surveillance studies to further advance our insight into the performance of our Riata and Riata ST leads, and to enhance patient safety."

In a Securities and Exchange Commission (SEC) filing Thursday, St. Jude stated that on December 17, 2014, it agreed to enter into the settlement and had set aside approximately $15 million in the last quarter of 2014 for payment. As of January 3, 2015, St. Jude had over $1.4 billion in cash and cash equivalents on its books. Plaintiffs have until March 16 to sign on to take part in the settlement.

There are three lawsuits in the U.S. that will not enter into the settlement, according to the SEC filing. In addition, a proposed class-action suit filed in Canada remains ongoing.

In its December 2010 letter, St. Jude pointed to its newer generation defibrillation leads with Optim insulation, noting that the new insulation showed a significant reduction in lead abrasion versus the silicone insulation used with Riata and Riata ST. Scrutiny, including published journal articles, began to focus on these Optim-insulated leads.

"Durata lead performance continues to meet expectations by all measures. Our confidence in the Durata lead performance is backed by a comprehensive collection of data that continues to demonstrate its strong safety and reliability...Data from up to 7 years surveillance continues to demonstrate strong reliability and safety in more than 11,000 Optim-insulated leads," Stoltenberg said in an e-mailed statement.

Over the past couple years, investors have shifted attention away from Riata and Durata, instead concentrating on the potential of new devices like St. Jude's CardioMEMS implantable wireless heart monitoring system.

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

[Image courtesy of RENJITH KRISHNAN/FREEDIGITALPHOTOS.NET]

Analysis: Large M&A Deals Rarely Do Well In Medtech

Analysis: Large M&A Deals Rarely Do Well In Medtech

Last year was the year of the megamerger, a trend that many believe will continue through to this year.

But a new report finds that very large mergers and acquisitions rarely create value in the medical device industry. The opposite is true of pharmaceutical deals.

The report from management consulting firm McKinsey entitled "Value Creation in Medical Device M&A" evaluated 396 deals over a 15-year period between1999 to 2014, including a deeper dive into 22 deals that were worth $750 million or more. The analysis found that compared with pharmaceutical deals, large medical device deals are neutral when it comes to total returns to shareholders. Further, stock multiples "decrease 13% following a large deal, representing lower growth expectations for the combined company."

The story does not get any sunnier for operating margins that do not grow noticeably. In fact "economic profit in aggregate shrinks in these transactions," according to the report.

Contrast that with the value created through pharma deals (the second bar chart is in dollars). 

"Pharmaceutical acquirers have managed to deliver approximately three times the margin improvement and multiple billions of dollars more in economic profit than medical device acquirers," wrote report co-authors Myoung Cha, principal; Josh Kopp, engagement manager; and Gerti Pellumbi, principal.

As the industry is in the throes of a new wave of consolidation, the report recommends thinking very carefully about doing deals. The best strategy in terms of mergers and acquisitions is what the management consultant company describes as a "programmatic" M&A strategy. 

Put simply, programmatic acquirers do small deals every few years. 

"Looking at the longer-term performance of M&A programs, we find that smaller and higher-frequency M&A programs deliver better shareholder returns than other deal programs, including big deals," the report said. "With another wave of consolidation ahead for the medical device industry, we believe large deals have a role, but they should be carefully considered in the context of a programmatic M&A strategy.

30 Years of Milestones That Mattered for Medtech

1985Michel Mirowski (right) and Morton Mower (left) show off an early automatic defibrillator prototype. A robot called the Unimation Puma 200 placed a needle for a brain biopsy under CT guidance—one of the early milestones for robot-assisted surgery. The Nucleus Mini22, the first cochlear implant, was approved by FDA.

TPEs' New Edge in Medtech: Supporting Blood Contact

Thermoplastic elastomers (TPEs) are regarded as workhorse materials with an ever-widening scope of applications in the medical device industry.

Brian Buntz

TPE can be used for a range of medical device applications and is frequently used to make syringes.
TPE can be used for a range of medical device applications and is frequently used to make syringes.

TPEs are now suitable for use in applications requiring direct blood contact for a limited amount of time. One company offering such a grade is Kraiburg TPE, a German-headquartered firm with U.S. operations based in Duluth, GA. "There are various medical device applications that require limited blood contact. And we now have grades in our Thermolast M line that can be used for those types of applications," says Katherine Olano, a distribution and marketing specialist at the company.

"There are some grades that support up to one day of blood contact and some go up to 30 days, depending on the type of use," adds Dr. Allen Donn, a product development engineer at Kraiburg TPE. "And then you have three different classifications that specify how they are used."

One of the primary benefits of TPEs, which are generally transparent or translucent, is that they span a wide range of Shore A durometers. Kraiburg TPE itself offers many materials within the range of 20 to 70 Shore A, however the company has several grades that extend up to 90 Shore A. The softer grades are frequently used for over molding in medical device applications. Other uses of the material include grades specified for adhesion to polycarbonate. Grades are also available that are engineered to have a low coefficient of friction, making the material suitable for plungers and the like. Grades that offer soft-touch sealing are a good fit for respiratory masks.

Another benefit of TPEs is their stability, and a range of grades are available that have been through considerable testing as specified by standards such as USP Class 6 requirements and ISO 10993.

Kraiburg also offers a grade with optimal rigidity and elasticity--up to the Shore D range, and resealing grades, TM3RST and TM4RST, with hardnesses in the 30 to 40 Shore A range, that are ideal for resealing. "If you have a septum or a vial where you need to withdraw samples from repeatedly, these grades are designed for just that type of application. They have been tested through standard protocols for standing up to repeated testing," Donn says. "These grades can sometimes replace natural rubber but can greatly simplify the manufacturing process." The grades used for resealing and for syringes are two of the most commonly used in the medtech sector.

The company's Thermolast M line of medical-grade TPEs are manufactured in the company's German facilities that have a dedicated production line used exclusively for the manufacture of the medical grade materials.

"One of the key aspects useful for the medical industry is that we have agreements with our raw-material suppliers for long-term delivery. If there are any changes, we give our customers 24-month notice so they have time to get it through their system as well," Donn explains. 

As MD&M West draws to a close on February 12, check back on our blog for more show-related coverage.

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

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Bill Seeks to Protect FDA User Fees Against Sequestration

Bill Seeks to Protect FDA User Fees Against Sequestration

Marie Thibault

A bill intended to protect FDA user fees from sequestration was reintroduced Wednesday in the U.S. House of Representatives. This legislation would ensure that the agency’s user fees, which come from device manufacturers and are used to review drugs and devices, would be unaffected by sequestration cuts.

Congressman Leonard Lance (R–NJ) and Congresswoman Anna Eshoo (D–CA) reintroduced the FDA Safety Over Sequestration (FDA SOS) Act. The act was originally introduced in July 2013, when FDA could not use approximately $85 million in user fees because of sequestration. Legislation passed in January 2014 gave FDA access to these funds again, but Lance and Eshoo hope to prevent another impact to user fees in case of a repeat sequester. The FDA SOS Act would be an amendment to the Balanced Budget and Emergency Deficit Control Act of 1985.

“Passage of this important bipartisan legislation is vital to protecting the FDA’s access to industry user fees. These resources will help ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective. Too many life-saving innovations and therapies are needlessly compromised by the short-sighted decision to sequester these funds,” Congressman Lance said in a press release.

Congresswoman Eshoo said in a press release, “The FDA’s user fees are 100 percent private sector dollars. If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive. Whether one agrees or disagrees with sequestration, private dollars should not be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely and potentially lifesaving therapies.”

The bill has won backing from several trade groups and manufacturers, including AdvaMed, Medical Device Manufacturers Association, the California Healthcare Institute, and the HealthCare Institute of New Jersey.

AdvaMed released a statement supporting the legislation, saying the FDA SOS Act “is a win-win-win for FDA, the industry and the millions of American patients who will benefit from more timely access to innovative medical technologies.”

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

[Image courtesy of NAYPONG/FREEDIGITALPHOTOS.NET]

Dexcom Becomes Profitable for the First Time

Dexcom Becomes Profitable for the First Time

"Yes, it happened. We have earnings per share."

That's how the Kevin Sayer, CEO of Dexcom, the maker of continuous glucose monitoring systems, described a major milestone in the San Diego company's history - achieving profitability in a quarter. Dexcom was founded in 1999 and went public in 2005.

It's good news to deliver particularly in one's first earnings conference call, held Wednesday, as CEO. Sayer took Dexcom's helm in January. 

In the quarter ended Dec. 31, the company had net income of $1.3 million, or 2 cents per share, compared with a loss of $2.6 million or 4 cents a share in the same quarter in 2013. Analysts had expected that the company would have a loss of 3 cents per share in the fourth quarter.

Revenue jumped a whopping 64.3% to to $84.3 million in the fourth quarter, up from $51.3 million in the fourth quarter of 2013. And for the 12 months of 2014, revenue climbed at a similar eye-popping rate to $257.1 million from $157.1 million in 2013.

Analysts were impressed.

"DexCom ended an unprecedented growth year in 2014 in a big way, announcing its first quarter of profitability," wrote Gregory Chodaczek, an analyst with Sterne Agee in a research note Thursday.

But he expects the company won't be able to immediately deliver profits in every single quarter from now on.

"Despite ending the year with positive earnings, we do expect Dexcom's GAAP EPS to dip back into the negative in [the first half of 2015]," he added.

Still, Dexcom has a lot going for it. Sayer also announced that the company has filed a PMA application with the FDA regarding its G5 CGM, where the product is integrated on the patient's phone and therefore becomes fully mobile. All 15 volumes of the PMA submission were filed earlier this week, he said, noting that FDA could approve it before year end.

That is the "next major new product launch" from the company, wrote Danielle Antalffy, an analyst with Leerink Partners, in a research note Thursday.

She added:

"With a steady flow of continued product evolution ahead, Dexcom is clearly setting itself up for a significant runway of sustainably strong 35%-40% product sales growth. And while in the near term, Dexcom isn't likely to maintain GAAP profitability every quarter, the company has at this point more than validated its business model and proven its ability to operate long term as a standalone company."

Wearable Health Devices to Watch: W/Me

Phyode's W/Me device goes beyond other wearable activity trackers to include capabilities such as sensing breath and providing insight about a user's autonomic nervous system and mental state. The wrist-worn device uses the company's proprietary Life Spectrum Analyzer and a coating designed to improve its accuracy. A companion app can be used for breath training and analytics.    
 

          


Continue to "5 Futuristic Wearable Devices That Will Blow Your Mind"

[video via PHYODE]