Wind River

17 articles

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…

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…

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…

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…

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…

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…

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…

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…