MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, November/December 2015

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Q M E D . C O M / M P M N M E D I C A L P R O D U C T M A N U F A C T U R I N G N E W S N O V E M B E R / D E C E M B E R 2 0 1 5 2 1 SPECIAL FEATURE: SOFTWARE Advantages of Linux for Medical Device Applications Linux is gaining ground in the medtech sector. Here are six reasons why. Brian Buntz T he number of computers running Linux is steadily growing. Android, the most popular mobile operating system, is based upon the Linux kernel. And the operating system is gaining share on systems ranging from Chromebooks to mainframes and electronic appliances to medical devices. The software is a popular choice in the Internet of Things realm as well. The San Francisco–based nonprofit Linux Foundation expects the OS to continue to gain traction in industrial niches including robotics, manufacturing, and medical industries, thanks to the launch of its Real-Time Linux collaborative project, or RTL for short. Enterprise Linux companies like SUSE are also offering software-development services to meet the unique needs of medical device companies. Here are six reasons the Linux operating system is well suited for medical device applications: 1. Linux Is Used on More Computing Platforms Than Any Other OS One of the biggest appeals of Linux is that it scales from top to bottom. There are more than a billion mobile devices running Android, which is based on the Linux kernel. And it spans to the biggest mainframes and high-performance supercomputing cluster. Remember IBM's Watson that was on Jeopardy? That's running Linux. Even in the medical system realm, Linux fits the entire range, whether you have a very large system, like a medical records repository, MRI, or a very small laboratory device that is sampling body fluids or chemicals. 2. Linux Is Well Suited for Safety- Critical Medical Applications While Linux can be used for everything from mobile device to mainframes, it can also be used for safety-critical diagnostic and therapeutic applications. For example, SUSE Linux Enterprise Server is used on a PET/CT scanner that shoots pictures at a millisecond rate as it rotates around the body. This Linux distribution allowed the PET/CT scanner manufacturer to comply with the regulatory process for a CT machine, which requires considerable security and stability. 3. Linux Is Open Source Linux creator Linus Torvalds played an important role in establishing the Open Source movement with his selection of licensing and collaborative approach. Anyone can modify the Linux kernel and the countless software projects based on the GNU General Public License, which has given rise to an array of Linux flavors and compatible programs. The SUSE flavor of Linux, for instance, has been around for more than 20 years, and, for the entire time, the company has been guided by Open Source principles. The company works with the Open Source community on hundreds of projects, ranging from basic software updates to large cloud and Big Data software for companies including the likes of Teradata, Office Depot, and Ford. SUSE is also used for KVM for IBM z Systems, an open source-based server virtualization for IBM mainframes and many other hardware architectures. The Open Source model has attracted substantial interest from software developers from the 1990s to present. Open Source software affords considerable freedom of choic when it comes to software tool options for given applications. And, of course, there is not a barrier of having a user ask for permission up front to use them for their purposes. This goes back to the ability of Linux to scale. A user can pick and choose whatever they want in order to develop the solution they want. A user building a supercomputer will use a different component or set of components compared to a developer doing an embedded medical device. 4. Linux Is Secure Linux continues to have a good reputation in terms of security. The Open Source community is an asset here as well. Linux pioneer Eric Raymond has been cited as saying "given enough eyeballs, all bugs are shallow," which basically says that there are always people looking at security aspects and developing patches to address them. SUSE, for instance, has an entire security team as well. The company does code scans looking for problems and develops patches to address them in security updates, in conjunction with the greater Linux community. This provides a tight feedback loop for addressing security concerns. 5. Linux Can Help Speed Medical Device Development There are an array of Open Source tools available for medical device applications, and a number of firms offer commercial support to ensure that such tools comply with the relevant standards and regulations, as well as testing and validation requirements. SUSE, for instance, offers a variety of focused tools and services to help medtech companies streamline medical device software development. That is one of the places SUSE excels. As a smaller company and with its heritage and engineering background, there is a focus on automating processes as soon as possible to allow rapid scaling and repeatability. Linux packages are granular. The Open Build Service allows users to leverage one source file to deliver multiple package formats. They can submit a change and rebuild them all automatically even across multiple Linux distribution and hardware architecture targets. This technology is used by SUSE to create all of its packages and is itself Open Source. There is another tool called SUSE Studio that provides the ability to custom craft a software appliance from an Internet browser. Users can export and test a custom operating system for an array of hardware or output image formats including medical devices. They can use this service to create a custom-crafted solution, with even their own packaged software, that is ready to run out of the box. 6. Enterprise Linux Firms Offer Regulatory Support for Medtech Firms Medical device companies using Linux in their products can take advantage of the support offered by providers of commercial entities with experience with medtech regulatory matters. SUSE, for instance, pairs its customers with members of its services and engineering teams to facilitate product development. Because every device can have its own regulatory quirks, SUSE's medical division works hand in hand with engineers to assist them as they are developing products. For instance, SUSE collaborates with medical device companies on software that needs to be frozen before the company applies for a 510(k). There is a lot of work done prior to this 510(k) application, and if a customer has to do clinical trials for the product in question, the device's operating system may still need to change during the course of trials or before final FDA clearance. That is all done as a coordinated effort between SUSE engineers and its customers' engineers. 6

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