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Articles from 2016 In June


These New Energy Advances Could Matter

Stanford engineers develop new technologies that provide a clean source of hydrogen fuel, and the world's first rechargeable zinc batteries. Both are potential tools for medical device designers.

Kristopher Sturgis

Stanford Zinc battery innovation
A conventional zinc battery (left) has problems with dendrites growing from the zinc anode and making contact with the metal cathode, causing a short circuit. The redesigned Stanford battery (right) employs plastic and carbon insulators to keep zinc dendrites from reaching the cathode. (Image couresy of Shougo Higashi/Stanford)

Two new studies published this month detail the efforts of a Stanford University research lab looking to address two major energy challenges: clean fuel that can power the transportation industry and renewable grid-scale energy storage.

"Most of the hydrogen supply today is produced through natural gas reforming, which releases significant amounts of carbon dioxide in the process," says Wei Chen, a postdoctoral research fellow in materials science and engineering at Stanford and one of the lead authors on the research. "However, producing clean hydrogen fuel by photovoltaic water splitting is a green process, which is of great benefit to the environment and climate."

Any kind of energy production or storage innovation is potentially good news for the medical device industry, with device designers often finding batteries to be a stumbling block. While microprocessors have exponentially improved under Moore's Law, batteries have not increased in capabilities substantially over the decades.

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

Photovoltaic water splitting is a relatively new technology that involves the submersion of solar-powered electrodes in water. Once sunlight hits the electrodes immersed in water, it generates an electric current that can split water into its individual elements--hydrogen and oxygen--all without producing harmful emissions.

Typically solar electrodes are made of silicon, which quickly corrodes when exposed to oxygen, a key byproduct of water splitting. To avoid this, Chen and his colleagues have coated the silicon with iridium and other precious metals.

"The production of clean hydrogen fuel from solar light without producing harmful emissions will be promising," Chen said. "Using an appropriate semiconductor and co-catalysts, water can efficiently and economically split into hydrogen and oxygen under solar light irradiation."

In their second study, Chen and his colleagues teamed up with Shougo Higashi from Toyota Central R&D Labs in Japan to propose a new battery design that could enable solar and wind farms to provide around-the-clock energy for electric grids, even in the absence of wind or sunlight. The new battery design is both inexpensive, and large enough to store surplus clean energy on demand.

The design of the new battery is composed of electrodes made of zinc and nickel, two inexpensive metals that provide the potential for grid-scale storage. Zinc-metal batteries have been used in the past, but they have proven to be less than ideal given their rate of failure and inability to recharge. Chen and his colleagues addressed this challenge by redesigning the battery by separating the zinc and nickel electrodes with a plastic insulator. They also wrapped a carbon insulator around the edges of the zinc electrode, all in an effort to prevent dendrites from forming and short circuiting the battery.

"The zinc rechargeable battery is important for large-scale energy storage applications," Chen says. "This new rechargeable zinc battery addresses the issue of zinc dendrite, which causes the battery to short circuit in conventional zinc batteries."

With this new design, the zinc ions are reduced and deposited on the exposed back surface of the zinc electrode during charging, which means that even if dendrites begin to form, they will form away from the nickel electrode, preventing the battery from short circuiting.

The group demonstrated the stability of their new battery when they were able to successfully charge and discharge the battery more than 800 times without shorting. The group aims to use the design as a template that could be applied to wide variety of other metal batteries as well.

The research on both studies has received support from the U.S. Department of Energy, and Stanford University's Global Climate and Energy Project--a project committed to exploring new solutions to help meet energy needs in a way that protects the environment.

Kristopher Sturgis is a contributor to Qmed.

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Why the New Clot-Removing Devices Are Revolutionary

A new study has confirmed what an earlier one hinted at in 2014--that clot-removing devices have revolutionized treatment for stroke patients who cannot tolerate clot-busting drugs.

Nancy Crotti

Stryker Trevo ProVue Retrieval System
The Stryker Trevo ProVue Retrieval System allows health provides to visualize deployment for accurate placement. (Image courtesy of Stryker)

The new study, by researchers from Loyola University, showed that the Stryker Trevo and Medtronic Solitaire stent retrievers did a remarkably better job of removing clots from blood vessels in the brain than earlier devices that employed different technology.

A stent retriever is a self-expanding mesh tube attached to a wire, which is guided through a catheter. The endovascular specialist inserts the catheter in an artery in the groin and guides it to the brain. The stent pierces the clot and is then expanded, enabling the physician to then pull it out--similar to how the Fogarty catheter works, albeit with a stent rather than a balloon.

Loyola used stent retrievers on 34 patients in 2015, and 21 patients during the first six months of 2016, according to the study published in Expert Review of Neurotherapeutics by Loyola Medicine neurologists Rick Gill, MD, and Michael J. Schneck, MD.

"Stent retrievers are a major advance in acute ischemic stroke care and will have significant impact on the evolution of stroke systems of care," the researchers write. "Endovascular stroke therapy had been an 'unproven' therapy despite numerous trials of intra-arterial pharmacologic thrombolysis and mechanical thrombectomy. With the advent of stent-retriever devices, there has been a paradigm shift in the utilization of endovascular therapies for (acute ischemic stroke)."

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Gill and Schneck foresee future device improvements that will do an even better job of restoring blood flow and increasing the number of patients who could benefit, according to a statement from the university, located near Chicago.

Stent retrievers also will affect where stroke patients are treated, the study says. Paramedics will play an important role in routing higher severity stroke patients, who could benefit from stent retrievers, to hospitals that offer neuroendovascular procedures, Gill and Schneck write.

Research published in 2014 in the New England Journal of Medicine, found that using a stent thrombectomy device within six hours after a stroke benefited patients more than the clot-busting drugs.

The clot-busting drug tissue plasminogen activator (tPA) has been the preferred stroke treatment for two decades, but many stroke patients do not meet strict criteria for its use. The drug must also be given within 4.5 hours of the onset of stroke to be effective and has had less effective in patients with large clots, the study says.

In selected patients, stent retrievers can be used to remove such clots.

The study reference to those earlier thrombectomy devices included Stryker's Merci device and the eponymous Penumbra. Merci is a coil retriever made of Nitinol shape-memory wire that a neurointerventionalist deploys to pull the clot "back into the catheter, like pulling a cork from a wine bottle," according to a 2012 study published in Neurology Clinical Practice. Stryker acquired the Mountain View, CA manufacturer of the Merci, Concentric Medical, in 2011.

A meta-analysis published in the journal Stroke in February found that using the Covidien Solitaire stent retriever in addition to the clot-busting drug tissue plasminogen activator (IV-tPA) significantly improves functional outcomes in stroke patients. Medtronic acquired Covidien in 2015.

Penumbra'saspiration thrombectomy devices use a minimally invasive "vacuum" inside the artery to remove the blood clot en masse, according to the San Francisco company.

Each year in the United States, 795,000 people have a stroke. Blood clots account for 87% of strokes, which are the fifth most common cause of death in the U.S. and the leading cause of adult disability.

Nancy Crotti is a contributor to Qmed.

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Hearing Aids Over-the-Counter? No Way, Some Say

Hearing Aids Over-the-Counter? No Way, Some Say

The public floods FDA with hundreds of comments urging the agency not to change its regulations to allow hearing aids to be sold over the counter.

Hundreds of comments have poured in from the public and hearing specialists voicing their opposition to the suggestion that some hearing aids be made available over-the-counter (OTC).

Hearing aids have become an especially hot topic after a September 2015 report from the President's Council of Advisors on Science and Technology (PCAST) recommended that FDA create a new "basic" category for hearing aids and hearing tests to be sold OTC. PCAST made this suggestion against the backdrop of low penetration of assistive hearing technologies among the population that needs it, citing factors like high cost and barriers to access. The council also recommended that FDA repeal its 2013 draft guidance on Personal Sound Amplification Products (PSAPs) to allow these to be labeled for age-related mild-to-moderate hearing loss and asked the Federal Trade Commission (FTC) to facilitate a hearing-aid prescription process that would allow consumers more flexibility in choosing a device, service, and dispenser.

FDA reopened the comment period on that 2013 PSAP draft guidance at the beginning of this year and also held a public workshop on "Streamlining Good Manufacturing Practices for Hearing Aids" in April 2016. The agency also opened the topic to public comments--that comment period closes June 30.

Following the PCAST report, Judith Page, PhD, CCC-SLP, president of the American Speech-Language-Hearing Association (ASHA) sent a letter to the council chairs expressing concern that the recommendations focused only on the amplification device. She wrote, "A common misconception that was evident in the PCAST report is that amplification alone will enable a person with hearing loss to hear and understand fully in the same manner that glasses can restore normal vision. A hearing aid alone is not enough to overcome a hearing disability. Treatment for hearing loss is more complex and requires a comprehensive assessment of the patient's needs in addition to a detailed evaluation of auditory function beyond the simple audiogram--areas of expertise that audiologists have specialized training to do."

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People who submitted comments to FDA tried to impress upon the agency the importance of the hearing professional's role in helping the patient. 

The majority of comments were from people who submitted a form letter that explained their belief that: 

  1. "The lay person is unable to reliably self-diagnose, self-evaluate, and self-treat hearing loss. 
  2. Most PSAPs are potentially dangerous to the hearing health of consumers due to having a maximum output that is too high.
  3. Most PSAPs lack the features to produce any benefit for the number one reason people seek assistance: speech understanding in noise."

These commenters concluded, "For these reasons, the creation of an OTC category that allows PSAPs to be labeled and marketed as hearing aids would be a huge step backward in technological sophistication and would lead to less customer satisfaction, lower adoption rates, and higher health care costs."

One commenter, a long-time hearing instrument specialist, was straightforward in his opposition to the PCAST recommendations. He wrote, "I know the care and concern it takes to properly fit Hearing Instruments, and the ongoing care that they require. For this reason I am strongly opposed the PCAST recommendation to relax the requirements and laws on the way hearing aids are correctly fit. I urge the FDA to reject the proposals."

Where will the issue go from here? More work is being done on the topic, but the winds seem to be blowing in the direction of OTC hearing devices. The Institute of Medicine, along with several agency cosponsors, including FDA, recently released the results of its study on accessible and affordable hearing health care for adults, which included a recommendation that FDA create a category for OTC hearing devices.

[Image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]

HeartWare Has a Really Serious LVAD Battery Recall

Thousands of HVADs could have faulty battery cells.

Nancy Crotti

HeartWare HVAD
HeartWare's HVAD (Image courtesy of HeartWare)

HeartWare International is recalling more than 18,000 batteries for ventricular assist devices it sold between 2013 and 2015, the company and FDA recently announced.

The batteries may lose power prematurely due to faulty cells, according to a notice from FDA, which has designated the recall Class I. The Framingham, MA-based company's HVAD system includes a pump implanted in the space around the heart and a controller that regulates the pump's speed and function.

The news comes on the heels of Medtronic's announcement that it intends to purchase HeartWare for $1.1 billion. HeartWare notified customers of the recall in January, but FDA just announced it Thursday. A Medtronic spokesperson says the medical device giant was aware of the recall when it offered to buy HeartWare

The deal, already approved by both companies' boards of directors, expands Medtronic's reach to more heart-failure patients. It also puts Medtronic on more even footing in the minimally invasive ventricular assist device market with St. Jude Medical, which acquired LVAD-maker Thoratec and its HeartMate III technology for $3.3 billion in 2015. HeartMate III won the CE Mark in October, and won FDA approval earlier last year to enlarge the pivotal trialfor the next-generation device.

HeartWare has "multiple technologies" in development for even less-invasive devices for patients with end-stage heart failure, according to Medtronic. The medtech giant estimates that the global VAD market at approximately $800 million,  and predicts it will grow by tens of millions of dollars in next couple of years.

Indeed, both the Medtronic and St. Jude Medical acquisitions of LVAD companies could expand the technology's reach, and perhaps boost innovation, Qmed's sister media outlet MD+Di reports.

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The latest recall, one of a series for HeartWare, affects devices used in heart-transplant candidates who are at risk of death from end-stage left ventricular heart failure. If the HVAD system is not connected to an additional power source shortly after the low-battery alarm sounds, the pump will stop working and the patient could die, according to FDA.

No deaths have been directly attributed to the batteries' failure, but several adverse events have been reported.

This recall includes batteries used on HeartWare HVADs carrying the serial numbers BAT000001 to BAT199999 and model number 1650, manufactured from May 19, 2013 to July 1, 2015 and distributed from May 21, 2013 to July 31, 2015. A total of 18,631 units were recalled nationwide, FDA noted.

VADs have been plagued with problems and competition in the field is fierce. HeartWare's stock plunged in January on news of lower earnings and uncertainty over whether the company would set a date for a new clinical trial of its less invasive,next-generation MVAD system. The company halted a trial for the CE mark in October due to "certain algorithms, which appear to increase the potential" for blood clots in the pump, a potentially deadly condition associated with ventricular pumps in general.

Since FDA approval of the devices, there has been an increased rate of pump thrombosis (blood clots inside the pump) among people using Thoratec's HeartMateII, and a high rate of stroke among people using the HeartWare HVAD, FDA says. There have also been bleeding complications.

HeartMate II received FDA approval as a bridge-to-transplant device in 2008 and a destination therapy device in 2010. HeartWare's HVAD received approval as a bridge device in 2012.

Nancy Crotti is a contributor to Qmed.

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Stay Informed: A Medtech Reading List

Stay Informed: A Medtech Reading List

Check out MD+DI's recommendations for what medical device and diagnostic professionals should be reading to stay on top of changes in the industry.

There are a few days of holiday relaxation left, which means there's plenty of time to kick back and immerse yourself in a good book. But rather than passing the time with a paperback thriller, why not read something that can help you in your career?

Here are a few books medtech professionals might want to check out.

Don't miss MD&M West in Anaheim, February 7-9, 2017.

[Image courtesy of WINNOND/FREEDIGITALPHOTOS.NET]

The Defend Trade Secrets Act's Implications for Medtech

The Defend Trade Secrets Act signed into law in May filled a gap in existing law and allows companies to protect their trade secrets across state lines and outside of the United States. Here's how to capitalize on this important legislation.

Angela Dremann and Rick Park

Imagine you are a medical device startup developing bioabsorbable stents. One morning, your key R&D engineer tells you that he is giving notice--taking with him years of expertise that he has developed at your company. While you may be sad to see him go, you are also concerned: This employee has had access to hospital customer lists, your physician consultants, and clinical data, and he knows the proprietary laser technique your company uses to manufacture stents at low cost. What prevents him from taking your company secrets--your trade secrets--and giving them to your biggest competitor?

Learn how to secure intellectual property protection for 3-D printed models and devices September 22 at the MD&M Minneapolis conference.

The Defend Trade Secrets Act

The Defend Trade Secrets Act (DTSA), passed by Congress on April 27, 2016, and signed into law by President Barack Obama on May 11, 2016, aims to improve the protection of trade secrets. The goal of the DTSA is to fill an existing gap in the law and allow companies to protect their trade secrets across state lines and outside of the United States.

Before the DTSA, when trade secrets were stolen, there were generally only two possible legal routes. First, the Economic Espionage Act of 1996 provided for federal criminal penalties for individuals found guilty of stealing trade secrets across state lines or to benefit a foreign country. Individuals found guilty could be subject to large fines. However, while the guilty parties could be penalized, this law had limited provisions to provide compensation to the owner of the trade secret. A second option was to file a lawsuit in state court. However, the laws governing trade secrets vary, sometimes widely, from state-to-state. To protect its trade secrets, a company would have to make sure that it complied with the trade secret laws of all of the states relating to the theft. Having to file lawsuits in multiple states to protect one's trade secrets can be a significant resource drain.

There is also a law known as the Uniform Trade Secrets Act (UTSA), passed in 1979, that was intended to provide some of the DTSA's advantages. However, the UTSA was not passed by all 50 states, and some states that did adopt the UTSA added their own unique state-specific clauses.  

The DTSA creates a federal action that allows companies to sue in federal court for injunctive relief or compensatory damages. As the DTSA is a federal act, it would allow a company to protect its trade secrets nationally and internationally.  

Another advantageous tool provided under the DTSA is that a company can ask the court to grant an ex parte seizure order (without needing to give notice to the accused thief or beneficiary of the stolen trade secrets) that would allow federal marshals to seize all property necessary to prevent the sharing of stolen trade secrets. This type of seizure order is especially powerful because it can be granted quickly and the accused thief or beneficiary does not have an opportunity to respond or use procedural delay tactics. However, it is important to note that ex parte seizure orders may only be granted under "extraordinary circumstances."

How It Impacts Medtech

The DTSA carries significant implications for the entire medical device and diagnostic industry--proprietary data, such as patient data; proprietary laser cutting techniques for stents, catheters, implants, and other devices; hospital customer lists; physician information; pricing data; company financials; and software for healthcare wearables, frequently rely on trade secret protection. As discussed, the DTSA's federal uniformity will allow companies to operate more confidently under simpler, more centralized and consolidated legislation.

In today's day and age of easily transferable data, the trade secrets of an entire company can be stolen in seconds on a single USB flash drive. The DTSA is tailored to this era of fast and easy dissemination of information. Proponents of the DTSA tout the ex parte seizure provision as one of the legislation's key strengths. As the ex parte seizure order may be given without notice to the accused thief, it is intended to mitigate the effects of misappropriation by taking swift action before stolen trade secrets are widely disseminated.

Although ex parte seizure orders are limited to "extraordinary circumstances," critics of the DTSA fear that ex parte seizure orders could subject startups and other small businesses to legal bullying. Through a threat of litigation and seizure of proprietary data, the DTSA could create trade secret trolls that subsist on blackmailing companies into early settlements of meritless cases.

Despite these potential drawbacks, the DTSA provides a powerful new platform for enforcement and protection of intellectual property rights. Patent protection for many technology sectors (including algorithms and software) has become more challenging following passage of the America Invents Act and several recent Supreme Court decisions. Therefore, trade secret protection, strengthened somewhat under the DTSA, may prove a viable option for many medical device and diagnostic technologies. Trade secrets, unlike patents, potentially have an unlimited lifespan, provided reasonable efforts are made to maintain secrecy. Also, trade secret protection can be relatively simple and inexpensive: Trade secret owners need only take reasonable steps to protect the information.

Make the Most of the Law

To capitalize on the benefits of the DTSA, companies should systematically identify confidential information for trade secret protection. To qualify as a trade secret, the information must derive its value from being generally unknown to the public. Once identified as a trade secret, the owner must take reasonable measures to maintain the information's secrecy. While the law only requires "reasonable security measures," what is reasonable for a particular circumstance is determined on a case-by-case basis. Therefore, confidentiality agreements (with third parties as well as appropriate provisions in employee and consulting agreements), firewalls, physical locks, security guards, and/or other measures to protect trade secrets may be useful. It is also important to note that the standard of "reasonable" may vary from company to company--a sophisticated company may be subject to a more rigorous standard under the law than a mom-and-pop shop. Regardless, establishing an effective trade secret inventory and having company rules clearly outlining standard trade secret protective measures may be the foundation for subsequent, successful trade secret enforcement.

Angela Dremann is an associate at Knobbe Martens, a law firm specializing in intellectual property.

Rick Park is an associate at Knobbe Martens.

EU Device Approval Always a Win? Not So Fast

EU Device Approval Always a Win? Not So Fast

New findings published by The BMJ may give some proponents of speedy device approvals pause. It's well-known that high-risk medical devices often win approval or clearance more quickly in the European Union than from FDA. But those fast approvals and clearances may come at a price. 

Data from a cohort study shows that medical devices first approved in the European Union had almost triple the rate of safety alerts and recalls, according to authors of the study, "Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States."

The findings come at a time when regulators around the world have been considering the pros and cons of various approval processes for devices. There are efforts in the United States to streamline the FDA device regulatory process while the European Union is working to update its device and IVD rules.

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Researchers from the United States--Harvard University, Harvard Medical School, and Brigham & Women's Hospital--and the King's College London in the United Kingdom found a total 309 new medical devices were approved in the European Union between 2005 and 2010. Of these, 75 (24%) devices were considered major interventions. Two-thirds of the 309 devices (206) were also approved in the United States and 63% of these (129 devices) were first approved in the European Union. 

The authors found that nearly a quarter of the devices (73 devices) had a recall or post-marketing safety alert. When analyzed using multivariable Cox regression modeling, the devices approved first in the European Union had a 2.9-fold higher rate of safety alerts and recalls and a 4.6-fold higher rate of recalls compared to those devices that received FDA approval first.

"Our findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms, underscoring the urgent need for transparency to make truly informed decisions," the study authors wrote.

There were published pivotal trial results for just 37 (49%) of those 75 devices considered major interventions. 

The authors called for a public database of all CE-marked devices and decisions, as well as approaches that might offer both safer and speedier commercial access, such as combining higher evidence requirements with a faster reimbursement process.

Of course, these findings aren't proof that FDA has taken the perfect tack to regulation, either. A study published in May found that FDA requirements for obstetrics and gynecologic devices approved over the past 15 years were not tough enough.

[Image courtesy of ANANKKML/FREEDIGITALPHOTOS.NET]

Here's How Medtech Cyber Attacks Are Evolving

Here's How Medtech Cyber Attacks Are Evolving

The trend of cyber crime is intensifying, as medical devices are used to infiltrate hospital networks. Cybersecurity experts examine how the latest attacks are growing more sophisticated and what healthcare networks and medtech vendors should do to fight back.

Cybersecurity experts have been keeping a close eye on cyber attacks within the healthcare industry, and the news isn't good for medical devices. In a new report, "Anatomy of an Attack--Medical Device Hijack 2" (MEDJACK 2), authors from TrapX Security made it clear that medical devices continue to be a source of weakness used by hackers to access hospital networks. 

The report authors reviewed attacks that took place between late 2015 and early 2016 and highlighted the fact that the hackers used malware targeting older versions of Windows, making specific medical devices that still used these older versions prime targets. What's more, these devices do not have endpoint security software, and since workstations (with endpoint security software) using newer versions of Windows were not impacted, these attacks were not likely to be detected.

"Based upon the forensics from these case studies and others, we conclude that MEDJACK.2 attackers are intentionally moving to old variants of attack vectors to specifically target medical devices knowing they have no additional security protections," the authors wrote. 

Take part in the roundtable discussion on "Cyber Security, Compliance, and Patient Privacy" at the MD&M Minneapolis Conference, September 21-22.


This week's report follows the publication of the MEDJACK 1 report a year ago, in which TrapX experts detailed situations where medical devices were hijacked to gain access to hospital networks. The latest MEDJACK 2report points to more frequent, evolving cyber attacks that continue to exploit medical devices.Carl Wright, executive vice president and general manager at TrapX Security, said in the report, "The attacker rapidly finds and exploits the medical devices to establish secure and clandestine backdoors from which to exfiltrate patient data, damage operations and then perhaps exit with a coup de grace such as a ransomware attack."

Greg Enriquez, CEO of TrapX Security, said in a press release, "MEDJACK 2 shows that MEDJACK 1 was not an anomaly but rather highlighted the beginnings of a growing trend, a trend that's become prevalent as attackers leverage sophisticated attack techniques to steal sensitive patient data while remaining undetected."

The MEDJACK2 report points out that in 2016 there have already been cyber attacks at 18 North American hospitals and outlines examples from three hospitals involving a variety of capital equipment and imaging systems, including a radiation oncology system, an X-ray machine, and a picture archiving and communication system (PACS). In addition to these particular systems, the authors noted that other vulnerable devices include diagnostic equipment, therapeutic equipment, life support equipment, and others, often using old operating systems and proprietary internal software.

These hospitals were not inexperienced nor were they turning a blind eye to cybersecurity. Rather, the authors pointed out that one had "a very strong security operations team" and "had previously engaged several penetration testing teams." Another hospital had endpoint security, intrusion detection software, as well as gateway and internal firewalls implemented. The third hospital had "considerable experience in cyber security . . . and were using their current technology consistent with best practices." 

"Medical devices are 'black boxes' and their internal software operations are not visible to the hospital cyber defense team. They run out of date operating systems, such as Windows 7 or Windows XP which are highly vulnerable and almost completely unprotected," the authors wrote.

While attackers could use the medical device "backdoor" to corrupt device data, measurements, or performance, the authors also pointed out that attackers have primarily focused on stealing patient data.

There are a number of ways hospital networks and medical device vendors can combat cyber attacks. Here are some of the report's recommendations:

  • "Isolate your medical devices inside a secure network zone and protect this zone with an internal firewall that will only allow access to specific services and IP addresses." 
  • "Implement a strategy to review and remediate existing medical devices now." 
  • "Implement a strategy to rapidly integrate and deploy software and hardware fixes provided by the manufacturer to your medical devices." 
  • "Implement a strategy to procure medical devices from any vendor only after a review with the manufacturer that focuses on the cyber security processes and protections." 
  • "Implement a strategy for medical device end-of-life."
  • "Implement a strategy to update your existing medical device vendor contracts for support, maintenance and specifically address malware remediation."
  • "Manage access to medical devices, especially through USB ports." 
  • "Evaluate and favor medical device vendors that utilize techniques such digitally signed software and encrypt all internal data with passwords you can modify and reset." 
  • "Improve your own ability, even when a device is selected, to allow your information security teams to test and evaluate vendors independent of the acquiring department." 
  • "Utilize a technology designed to identify malware and persistent attack vectors that have already bypassed your primary defenses." 

Moshe Ben Simon, TrapX Security cofounder and vice president, said in the release, "Healthcare organizations need to implement strategies that review and remediate existing medical devices, better manage medical device end-of-life, and carefully limit access to medical devices. It becomes essential to leverage technology and processes that can detect threats from within hospital networks." 

[Image courtesy of JSCREATIONZS/FREEDIGITALPHOTOS.NET]

Philips Respironics Proves Digital Health Really Works

Philips Respironics Proves Digital Health Really Works

Nancy Crotti

Telling sleep apnea patients they need to use a continuous positive airway pressure (CPAP) machine is kind of like telling smokers they need to quit. They know it's good for their health, but it's hard to change.

Patients have reported that CPAP devices, which force air through masks to keep them breathing steadily, are noisy, uncomfortable, even claustrophobic. Healthcare providers have tried using education, apps, and coaching separately to get patients to stick with the program, without much success. CPAP adherence rates, which matter not only to patients' health but to companies seeking CMS reimbursement, remain abysmal. CMS requires a minimum of four hours of CPAP use over 70% of the nights during a consecutive 30-day period within the first 90 days of use.

Learn how to develop devices that generate data for evidence-based medicine at the MD&M Minneapolis conference, September 21-22, 2016.

Philips Respironics, a division of Royal Philips that makes CPAP devices, decided a full-court press that combines education, apps, motivation, and live coaching in the early days of patients' CPAP use might make a difference. The company's internal study showed dramatic improvements, according to a prepared statement.

Philips analyzed data from 4383 new CPAP patients who used its Patient Adherence Management Service (PAMS) and a control group of 54,455 new patients not participating in PAMS but who were registered with the company's database. The analysis showed that 79.5% of the PAMS participants reached the Medicare definition of CPAP adherence within 90 days, compared with 63% in the standard care control group. The PAMS patients attained nearly 66% and 75% CMS compliance adherence rates at 30 days and 60 days respectively, compared with 50% and 59% of patients in the control group.

PAMS uses the company's CPAP devices, software, patient engagement app, and about 40 coaches based in Pittsburgh to answer patients' questions over the phone.

Durable medical equipment suppliers asked Philips three years ago for help in upping adherence, according to Mark Aloia, a Philips psychologist.

Aloia has been studying CPAP adherence for 20 years.

The disorder affects about 2% of women and 4% of men in the middle-aged work force in the United States, with higher prevalence rates among the elderly and African Americans, according to one study published in 2013.  Untreated, obstructive sleep apnea is associated with impaired cognition and mood, hypertension, vascular disease, and increased risk of motor vehicle accidents risk.

Patients learn all this but still resist using the devices, despite healthcare providers' and manufacturers' best efforts.

"When we've addressed those factors, it doesn't change behavior," Aloia said.

Patients don't feel confident using CPAP or trust that it will make them feel better, and have also complained of not having enough support, he added. Durable medical equipment companies, under pressure from CMS and competition, don't have the time to provide that support, according to Aloia.

"There's been a whole shift in the entire sort of healthcare milieu that has made it in some ways even harder to help a user to adopt this somewhat difficult therapy," he said.

Philips has coached about 150,000 patients since it began piloting live coaching for CPAP users in 2012, Aloia noted. The company debuted a patient app in 2013 and updated it in 2015. Now it's offering to sell the combination to durable medical equipment providers. The company declined to reveal prices.

Aloia has found that patient adherence to a CPAP regimen is as much psychology as it is anything else.

"The real measure of the success of our products is how much you as a user believe in it, how much you as a user feel confident that you can use it and that it's meaningful to your health," he said. "For many, this is a lifesaving therapy, and it's only a lifesaving therapy if they use it."

Nancy Crotti is a frequent contributor to MD+DI. Read more of her work at http://nancycrotti.com.  

Medtronic Applies for Artificial Pancreas PMA

Medtronic has filed for U.S. FDA approval of its MiniMed 670G insulin pump.

Qmed Staff

Updated June 29, 2016

Medtronic MiniMed 670G

The MiniMed 670G insulin pump, which its maker Medtronic touts as the world's first hybrid, closed-loop artificial pancreas, now has an application submitted before FDA, a Medtronic spokesperson confirms.

Medtronic officials expert a ruling from FDA within a year, Bloomberg reports.

"We are pleased we are making progress towards bringing this meaningful technology to people with diabetes in the country," says Medtronic spokesperson Janet Kim.

The company's CEO Omar Ishrak had already told analysts that an application was expected before the end of 2016.

The 670G marks the fourth of six stages Medtronic is going through to develop what has been a holy grail for diabetes devices for decades: a almost entirely automatic "closed-loop" insulin pump system that does away with the constant glucose testing and insulin adjustments that diabetes patients presently go through.

Medtronic has been boasting of a 124-patient study that found the 670G increased the amount of time patients were in the desired blood-glucose range, without any severe complications, according to a report in the Star Tribune of Minneapolis

Diabetes treatment is an increasingly important area for Medtronic. Diabetes group sales were up 10% during the quarter ended April 29, driven largely by sales of the MiniMed 640G insulin pump outside the United States. Insulin pump sales overall grew by more than 30% outside the U.S.

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

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

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[Image courtesy of Medtronic]

A previous version of this story used an incorrect model number for the new pump. The pump is the 670G.