Medical

20 articles

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…

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…

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…

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…

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…

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.…

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…

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…

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…

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…