Wind River Blog Network

Healthcare and the 'Internet of Things'

By Santhosh Nair

The healthcare industry is embracing the 'Internet of Things.' From the advent of mHealth, to healthcare personnel bringing their own devices into the hospitals, to consolidations that are happening up and down the value chain, the healthcare industry is finally embracing its version of the Internet. It’s a topic that I discussed recently in a

Q&A session with Intel Embedded Community. With the ability to provide affordable care to the masses topping the lists of political and socioeconomic agendas globally, we need to make a lot more progress on this front.  Here are some on why we're still not where we need to be in terms of the global adoption and institutionalization of these concepts.

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Medical Device Security

By Jeff Fortin

A recent study published by GAO caused quite a bit of uproar over medical device security. The GAO declared in its report [read more] that the FDA has not put enough oversight in the premarket approval (PMA) of certain medical devices that are susceptible to threats. In the report the GEO referred to an experiment described in the 2008 IEEE Symposium on Security and Privacy. The experiment was conducted by a number of experts in security, medicine and engineering. They demonstrated the potential for a hacker to expose patient information as well as interfere with the correct operation of a medical device. The FDA has agreed to the GAOs insights – however pointed out that there have been no real world threats that have been reported to date.  According to the FDA, it did consider unintentional threats for information security, but did not consider information security risks from intentional threats until recently. In summary, the HHS – governing body for the FDA, concurred with the GAO recommendations and have initiated activity in this direction.  Medical device manufacturers must take the threat of security seriously.

Of all medical devices, devices that are implantable, portable or used in a home health scenario represent a growing concern for security and information privacy. I refer to these classes of devices as embedded medical devices. Developers and manufacturers of embedded medical devices are increasingly exposed to security risks as these devices become more complex and also connected to open networks. The good news is that in responding to this threat they need not operate in a vacuum nor do they need to re-invent the wheel. Best practices exist in other industries that can be leveraged by medical device manufactures. Of them the most straightforward is to design your products with security in mind. In other word, design for security. Here are a few things to think about when you design your medical devices.

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Connected Health: Optimism on the Horizon

By Santhosh Nair

There are telling signs that mHealth is rapidly moving up the adoption curve. 

Earlier this year, Fuld & Company, a pioneer strategy consulting firm, conducted a national war gaming contest where leading business schools stress tested m-Health strategies of companies – ranging from large companies such as GE and Medtronic, to startups like Independa.

A few of the key takeaways from the exercise were:

• Mergers, alliances and licensing agreements are inevitable – the partner ecosystem is very important
• The value is in data integration, not killer applications
• A back office service industry will emerge as a new service model
• User centered design is the key to success

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Open source in Medical Devices: Part of the Cure or Part of the Disease?

By Ido Sarig

The Economist recently published a very interesting article on the merits of open source in medical device development, which raises some questions and sparks an important discussion. 

In general, it is more common to see open source adoption in non-regulated industries. However, we are seeing it more and more in regulated industries primarily because it encourages rapid innovation at far lower costs.  That said, it is important to caution those in the regulated industries (aerospace & defense, medical, industrial automation, energy, automotive) towards embracing open source concepts without investing in lifecycle management tools to support the building of safe and effective devices.  [Proprietary software on the other hand, is a better fit for companies that design devices in environments where changes are few and far in between. Proprietary software also enables better control of the ecosystem, the lower the stack you go.]

As the Economist puts it, “exposing a design results in safe products.”  Maybe…Designing a device or ecosystem with safety in mind, results in safer products, hence the need for “design for safety.”  The FDA mandates a safe and effective design for any devices that gets approved in the US market -- this requires companies to have better control of their ecosystem.  Done proactively, this is an efficient method for product development; however, done reactively, companies incur a lot of costs and overheads trying to make open source fit.

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How Are You Reducing Radiation?

By Pete MacKay

A few years back the FDA launched an initiative aimed at reducing radiation exposure in patients undergoing CT scans.  Clearly there are concerns with exposing the human body to ionizing radiation, and due to the prevalence and popularity of these imaging techniques the FDA feels they are in a position to ensure proactive steps are taken to minimize exposure.  They cite studies done in 2009 showing this total exposure to have nearly doubled in two decades in the US population.

Several factors come into play with cause and effect here, and the FDA is exploring several different perspectives.  Preventative measures start with educating patients, clinicians, and technicians, and altering approaches to therapy planning and the decision process around imaging studies.  The emergence of highly connected health enterprises (and society in general) enables a proposal to track cumulative dosage using tools like a national dosage registry and a patient medical imaging record – who knows, maybe just like Fido runs around with a chip in his neck we might all someday be implanted with a dosimeter along with our medical record?  Kidding aside, the obvious place to start with dosage reduction is with the device manufacturers themselves.

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Wind River and Android – 5 great years, with many more to come

By Dan Noal

It was 5 years ago this week that I got an email from our CEO who had just met with Andy Rubin and Rich Miner at the Googleplex. Google had invited us to talk privately and confidentially about what would become Android.  Other companies were already on board, and they asked us to join the small group of companies collaborating with them as part of the nascent Open Handset Alliance. They talked big about disrupting the entire mobile phone ecosystem and solving the fragmentation problem with so many competing Linux based phone stacks emerging at that time. They painted a vision where open source Android would dominate the mobile phone space and migrate to adjacent markets.  We knew that they had credibility from Danger, we knew that Google had tremendous momentum and power they could leverage.  We discussed it internally, and without much debate we replied “where do we sign?” and started to roll up our sleeves. 

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Medical Device Interoperability: Collaboration is the New Competition in the Connected Health Ecosystem

By Santhosh Nair

A hospital is one of the most complex ecosystems that exist today. Nowhere else exists a more diverse array of players, devices and standards as a hospital. Information must flow seamlessly through the hospital ecosystem, and this needs to be sustained through the life of the patient, for treatment and care to happen in a meaningful manner. The bar for safe and effective use of devices is very high, which is why so few devices make it to market – and why many devices fail after market.

Enter medical device interoperability.  This week I spoke at the Medical Device Summit in Boston on the topic of interoperability, and it is clear that it is a very hot topic in the healthcare segment right now.

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IEC 62304, EN 62304...Confused?

 By Nikhil Chauhan

The requirements of IEC 62304 and EN 62304 are identical.  Both, IEC 62304 and EN 62304, share the same genealogy and are well recognized software life cycle standards. The only difference is that they are promoted by two different standardization bodies. IEC (International Electrotechnical Commission) and CENELEC adopted the same standard concurrently.

IEC 62304 is a worldwide recognized standard from IEC that defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

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The Future of the World ‘Wired’ Mind?

By Pete MacKay

I never thought neurophysiology could be made so interesting – or blended with philosophy for that matter – but this is what author Michael Chorost does in his book World Wide Mind.  Recently one of our Project Managers forwarded a link to an interesting PBS News Hour piece pondering “Will ‘Bionic Bodies’ Offer High-Tech Hope to the Disabled?”.  The clip covered the exoskeleton from Berkeley Bionics, coincidentally featuring John Fogelin, former CTO of Wind River and an original author of the VxWorks RTOS.  It also featured one of my personal heroes, Dean Kamen, as well as an interview with writer and cochlear implant recipient Chorost, who discussed his latest book, World Wide Mind.

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Android Security – making sense of all the choices

By Chris Buerger

Last week’s public release of the Security Enhanced (SE) Android project and associated source code is hailed by many as an important foundational step to add a new set of options to create secure Android devices. While the recent release of the code base by the National Security Agency (NSA) is familiar territory for Android experts such as Wind River who have been designing and implementing comprehensive security layers to a wide spectrum of Android devices for a few years now, the portrayal of this development in the media as an all-encompassing security solution grossly oversimplifies the complex subject matter that Android security represents.

Simply speaking, compiling and flashing the SE Android code base on to your Nexus S will not make it completely 'secure.'

Wind River has been enabling Android devices for close to five years now. Based on that experience and over a decade of pioneering mobile Linux-based devices, four key security-related points stand out.

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Hacking Insulin Pumps for Fun and Profit

By Ido Sarig

Last month, I had the opportunity to take part in the Amphion Medical Forum in Minneapolis, where the theme was security challenges facing Medical devices. Amphion is a forum that brings together thought leaders from academia, business, government and technology, which was founded to provide a medium for these visionaries to define solutions to some of the issues, such as safety and security, which affect the new interconnected economy, the “internet of things”.

I participated in a panel that discussed the challenges and risks posted by the latest generation of wireless medical devices, and how proper Fuzz Testing, such as the capability offered by Wind River Test Management in conjunction with our partner Codenomicon, can help alleviate some of that risk.

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Cloud to Service Endpoints – The Missing Link

By Paul Anderson

I remember as a kid I was fascinated with phones. The idea that you could pick up the phone, dial it, and talk to someone on the other end was pretty neat. And… at the time, a phone was an elegantly designed electro-mechanical work of art, and it was fun to take them apart to try and figure out how they worked. I could understand how the phone itself worked, but as a kid, what happened after those two wires headed off to the pole was somewhat of a mystery to me. Eventually I came to understand the massive infrastructure that allowed reliable telephone service into the home to be possible. Hats off to Alexander Graham Bell, the inventor of the telephone.

When you think of a basic phone, it seems like such a simple thing. It can receive, it can transmit, and it can provide bidirectional signaling. Receiving and transmitting is obviously important, and it took a while for folks to figure out how to do both simultaneously without a bunch of extra wires and things. Signaling is equally important. The user of the device needs to know when someone is trying to contact them, and to be able to establish contact with someone else out on the network. A phone is actually a very clever thing, particularly when one thinks of what people did with what they had at the time, particularly in a world before the transistor.

But, what is a phone really? It is a service gateway. In its most simple form, it provides telephone service. That service then allows connectivity to other services, like the ability to call the plumber when your sink gets clogged, or order a pizza. Quite amazing! 

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Linux in Medical Devices

By Ken Herold

Linux is the operating system of choice for a wide range of medical devices, from vital sign monitors to hospital bedside “infotainment” systems to complex imaging and scanning equipment. Yet not all Linux is alike. Because patients’ lives may be in the balance, software used in medical devices must meet stringent regulatory guidelines to assure that it will perform as promised, and the provider must be able to pass audits of its development methodologies. Trying to cobble together solutions from pure Linux without commercial support puts the burdens of testing, validation, documentation and compliance on the device manufacturers and their developers – an onerous, time consuming and complex process that can turn “free” Linux into a very costly proposition.

There are, of course, commercial vendors of Linux who provide value-added, stabilized versions of the open source software, along with board support packages. Service, support and documentation levels, however, vary widely among them.  Some chip vendors provide software solely to drive processor sales and with many vendors, the relationship ends with the sale.

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Achieving Seamless Connectivity and Compliance for Mobile Healthcare

By Santhosh Nair

For the makers of medical devices used in mobile healthcare, connectivity is becoming increasingly critical.

Devices are becoming more intelligent and controlling more and more aspects of patient care, clinical diagnostics, and hospital administration. And they are interacting not just with people—expanding our ability to communicate and share information—but also with each other. They control systems that literally keep people alive. Machine-to-machine (M2M) interaction, delivered by ever-smaller, ever-smarter components, allows for new levels of “situational awareness” and analytics, revolutionizing medical practices.

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Why I Do What I Do

By Pete MacKay

As an embedded systems architect I have a unique perspective.  Computer technology has permeated so much of our society that I get to see ‘inside’ of things.  I’ve sent baggage (and myself) through scanners at airports I wrote software for and stood behind teachers talking about an educational handheld I played a key role in designing.  I can tell you more than you want to know about that phone you’re talking and texting on, or that GPS system giving you driving directions, and even know a little about how web searches affect salmon in the Columbia River.  Suffice it to say our actions have impact, but sometimes I wonder how this impact in turn drives our decisions regarding what we choose to do with our lives.

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Medical Devices, Life Savers

By Nikhil Chauhan

There's no doubt, medical devices are saving the most precious elements of nature - people's lives. The World Health Organization's video below highlights the importance of medical devices to health care.  Medical devices need to be secure and safe. My colleague Santhosh elaborated in a recent blog post on how FDA's 510(k) process is under scrutiny amidst the growing medical device recalls. 

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Qualifying Your Vendor

By Ken Herold

Every medical device manufacturer marketing their device in the US must comply with regulations such as 21 CFR 820.50 Subpart E Purchasing Controls. This applies to all outside components they wish to incorporate into their device, including software. In part, this requires the manufacturer to:

“(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.”

In a practical sense, this means that if they want to build on top of third-party software such as an operating system, they will need to provide their quality or purchasing department information about the development environment of that software. The goal is to be sure that the software is appropriate for the intended use of the medical device itself. The amount of scrutiny a particular component (software or otherwise) is given is determined by the effect its failure would have on the patient using it.  A medical device manufacturer may have an in-house questionnaire that they fill out for all of their suppliers.  These are often not geared toward software and can be lacking, putting extra pressure on the (poor) engineer that is charged with proving the quality of the software they are about to incorporate into their life-saving device.  Without a stamp of approval from the purchasing department, that software isn’t going into any product.  A software vendor experienced in the healthcare market will have prepared documentation with this task in mind. 

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A Medical Device Platform: Beyond the Operating System

By Bill Graham

With the release of the new Wind River Platform for Medical Devices it's a good time to point out the breadth of products and services that make up a modern embedded solution suite. In fact, our medical solutions go well beyond the products that make up the Platform. The Platform for Medical Devices provides the main components: VxWorks RTOS, middleware, networking, development tools and BSPs.

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FDA's 510(k) Process Under Scrutiny

By Santhosh Nair

In September of 2009 the FDA commissioned an independent committee review of its 510(k) process, the most common method medical device manufacturers use to bring lower-risk products to market.  In their resultant report, the Institute of Medicine (IOM) recommended a complete overhaul.  Although the FDA has dismissed the recommendations, they are continuing to refine the 510(k) process. This has caused a polarization of the industry experts, those supporting the IOM view and those against it. Those who oppose the current 510(k) process point to the FAA guidelines for more rigor, others point to the FCC guidelines for speed and efficiency, and some advocate for a newer, simpler, better process for lowering the barriers to entry and increasing the number of devices that make it to market. Those who support the 510(k) processes, primarily incumbent medical manufacturers, cite that there is no public health crisis with medical device approval that warrants an overhaul.

In my opinion, we need to evolve the current approval process, but overhauling may not be the right answer, and could tilt the balance in the wrong direction by increasing costs and reducing access.

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Test Management 4.0: Reduce Risk by Understanding the Impact of Change

By Ido Sarig

Big day today, we just announced the release of our latest version of Wind River Test Management, WRTM 4.0, the culmination of several years of hard work - kudos to our engineering team!

In the coming weeks, I will be covering many of the new features of WRTM 4.0 in detail in a series of separate posts, but today I wanted to give you an overview of some of the new things you can look forward to.

I’ll start by sharing a quote from Wind River customer GE Healthcare on how Test Management is helping their business -- a real testament to the value that Test Management delivers.

"Wind River Test Management has tremendously helped us improve the productivity of our firmware testing team, significantly reducing the overall development cycle time. And although we already had more than 20 tools as part of our test and development process, test plans and test results were still mostly paper based.  Wind River Test Management easily integrates with our existing solutions, such as HP Quality Center, to provide a complete automated regression testing suite running tests remotely on the target and collecting valuable metrics for tracking test progress and software quality. GE Healthcare operates on a ‘zero defects’ policy and Wind River helps ensure that this policy is met much faster than before."

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Fish Finders, Embedded Linux and Graphics

By Paul Anderson 

Here I am up at rustic cabin in Northern Wisconsin enjoying some time off the grid. I feel like Ralph Waldo Emerson getting in touch with nature, and exploring Transcendentalism, except for one minor detail: I have a wireless connection. Emerson was quoted as saying “Nature hates calculators,” and I’m not sure what he would think about the billions of connected devices scattered across the landscape. Not to worry, I’ll be back unplugged soon enough and enjoying some quality time in the “digital free zone.”

I tried my hand at some fishing this week on the little lake we are on. Even though I’m a gadget person in general, I am a very low tech fisherman. With the help of my brother in law, my kids and I just fished the old fashioned way, with a pole, hook, bobber, and worm. It didn’t take long to find the fish, or for the fish to find us. However, there are plenty of high tech anglers out there that use everything from advanced weather forecast maps, fish finders, and even underwater cameras. I find all that technology interferes with the peace of mind that I am looking for when doing things like fishing, but perhaps that is because I am fully immersed in technology as a career.

Modern high end fish finders, GPS units, and other electronics equipment used in the outdoors have become much more sophisticated. The users of deeply embedded devices have come to expect a graphical user interface, low power consumption, and reliability. A similar trend can be found across a spectrum of deeply embedded devices, including industrial control panels, medical equipment, military applications, and of course, consumer equipment.

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FDA Outlines Oversight of Mobile Medical Applications

By Peter MacKay

2011 is turning out to be an evolutionary year for the growing mobile healthcare industry.  In 2007, the iPhone, while not the first handheld applications platform, arguably revolutionized the way modern consumers use telephones.  Around this time healthcare visionaries also foresaw the integration of what I call “user space” with medical enterprises, and a general change in the way ‘patients’ interact with providers – or even take charge of their own wellness.  In addition, the Continua Healthcare Alliance was born, a consortium uniting healthcare and technology companies to focus on standardizing connected devices.  I predict this standardization will drive commoditization (as the inverse – utilizing consumer platforms in healthcare – takes hold), and the Android platform has accelerated this movement.

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Strengthening Security for Connected Medical Devices

By Santhosh Nair

Three years ago an article in the New England Journal of Medicine reported that computer hackers could gain wireless access to implanted pacemakers and shut them off, or reprogram defibrillators to deliver fatal jolts of electricity. This generated an avalanche of press worldwide about the hidden risks of medical devices, followed by requisite hand-wringing from politicians and promises of stiffer regulations. For this and other reasons, makers of medical devices have been steadily increasing their focus on security. They realize that the threat is far broader than a hacked ICD. Embedded software is part of everything from CT scanners to imaging systems to intensive-care ventilators. And the fact is, the rapid growth in the number, the intelligence, and the interconnectedness of medical devices has created an upward spiral in security threats. 

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Highlights and hot topics from the Medical Devices Summit

By Santhosh Nair

There were a lot of great takeaways from the Medical Devices Summit that I attended last week in San Diego.  Wind River solutions architect Pete MacKay gave an excellent presentation about medical devices design, cloud and Android that was very well received and Intel ECG presented on embedded security and isolation/protection in medical device design.  Wind River had a booth where Michel Chabroux and Gabriel Quiroz showcased our Atlantis platform for connected medical devices - they demonstrated data traversing from an edge device (a weighing scale), all the way through the aggregator device to the final application.

Throughout the event, the topic that seemed to be on everyone’s mind was compliance.  Not surprisingly, conversations around regulations and compliance overshadowed many of the technology discussions.   Most of these talks centered on how to manage risk in your development process, the importance of having excellent design controls in place, managing suppliers and variance in your supply chain logistics, and how to navigate the regulatory maze and not get caught up in the trivia. 

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Wind River Named "Transformational"

By Ido Sarig

Voke, Inc. has just released its annual “Market Mover Array Report on Application Lifecycle Management (ALM)," and we’re very pleased to see that Wind River’s Device Lifecycle Management solutions were favorably reviewed, and ranked as  “Transformational” - the highest category, reserved for vendors that are changing the tone and direction of the market! 

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When embedded software testing is a life or death issue

By Ido Sarig

When I was in high school, there was a popular TV show called “Moral Dilemma” that aired in my native country. It featured a panel of professionals such asdoctors and lawyers who discussed “life or death” issues related to their daily work:  Would you represent and defend a client charged with murder after he confided in you that he indeed killed his victim? A kidney has become available for transplant – do you operate on the rich, 85-year-old patient who promised to bequeath a million dollars toward the creation of an organ bank at your hospital, or provide the kidney to the teenager who was just accepted into the country’s most prestigious college?

The show portrayed these professions as dealing with the most important moral issues imaginable, and by implication, relegated other professions to a lower rung on the ladder. As someone growing up from a family of engineers, I knew engineers can have significant roles to play and I definitely had respect for other professions not represented on this TV show. However, it did get me to thinking: Were there also life or death issues in software?

Fast forward 30 years, and I know that there are indeed life or death scenarios in the world of engineering and software. Embedded software is a vital element in the majority of today's sophisticated medical devices—and when it fails, disastrous results follow.

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