Medical

45 articles

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…

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.…

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,…

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…

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…