As medical devices become more connected, addressing the issues of runaway healthcare costs and healthcare access, robust, reliable and secure performance in medical device design are defining differentiators. For over 30 years, QNX® has been providing a full-featured, multi-core development platform that exceeds the most demanding requirements for reliability, performance, data safety, and security. With QNX's IEC 62304 conforming OS, field-proven portfolio of pre-integrated technologies, solutions, and a broad partner ecosystem, developers can focus on their IP in application design and functionality, leaving the platform heavy lifting to us.
Choosing the right realtime operating system (RTOS) partner can simplify certification processes, can provide clear product differentiation and help to reduce your risks as well as realize significant bill of materials (BOM) and cost advantages.
Further reductions in costs and efforts can be achieved in a project by leveraging the QNX® OS for Medical that is 3rd party certified and declared compliant to IEC 62304. The burden of compliance is lifted from the medical device manufacturer and proof is provided directly from QNX through certificates of conformance and extra support documentation. Documents such as Hazard and Risk Analysis, User Responsibility Guide, and Technical Safety Case documents are available to aid in your regulatory submission.
Safe, secure connectivity option/drivers for wireless and wired communications.
There is great disparity between medical devices today and what healthcare enterprise customer want. Software comes from the OS vendor and many ecosystem vendors that need integration. This all leads to workflows that are manually and archaic, handwritten paper and Post-it notes, SMS and pagers. The healthcare world would like to see medical devices better interconnected with IT systems resulting in automation, analysis that spans multiple discrete systems, increased compliance and adherence.
In order for this level of connectivity to occur medical device manufacturers need networking and connectivity technology (Bluetooth supporting health device profiles, Wi-Fi, cellular), encryption and certification, and security, hardened/certified computing platforms. QNX supports numerous communication protocols across the healthcare application space.
Patient security is an important issue but upholding patient safety is of utmost concern to medical device manufacturers.
A connected medical device is a vulnerable and exposed medical device. Medical devices are the key pivotal points of attack in most hospital networks. They represent visible points of vulnerability and are the hardest endpoints to remediate. Any software beyond a patch provided by the manufacturer might negatively impact FDA approval, but worse compromise patient security and safety.
To address the ever-increasing security threats facing medical device manufacturers, QNX has advanced security mechanisms that are built directly into the QNX operating system that protect devices from malicious attacks. These can be used to ensure that all processes, including drivers and filesystems, execute in user-mode, greatly reducing the ability of compromised processes. Further, it is possible to divide the filesystem into encrypted domains, as well as to randomize the address space layout for further protection against malicious intent.
The security attack surface of the system can be further reduced by utilizing a unique ability to control settings that govern and protect which operations a process can perform, with granularity down to the system-call level. As a result, embedded developers no longer have to give processes root permissions and access to the entire system in order to gain access to necessary system resources.
Beyond the OS, we can provide our customers with elliptical curve cryptography IP offering FIPS 140-2 levels of security. This is a minimum requirement when servicing the veteran’s administration or various branches of the military.
Accelerate your new product introduction and allow your experts develop and fully leverage your IP while allowing QNX to do the heavy lifting by supporting the operating system. Development life-cycle is paramount. You can forget about the need for finding, sourcing, configuring, and compiling your open source software by leveraging QNX OS for Medical; effectively jump start your development and eliminate risks.
Further downstream, unlike open source OSes there is no need to worry about managing asynchronous patches affecting a majority of your source base. This takes time, costs real dollars and consumes real resources. Make it across the chasm and don’t concern yourself with the burden of software maintenance and focus your ‘IP’ or Intellectual People, on your secret sauce.
The total cost of ownership for a project consists of many factors that may not be immediately apparent. A simple decision based on a shallow analysis of the cost of obtaining and licensing the source code is insufficient. When evaluating an OS for a medical device it is critical to compare the cost of such big-ticket items as development cost, maintenance cost, support cost, and opportunity cost.
The Linux operating system provides for open access to its source code, this has led companies to initially choose Linux as a viable development platform, on the perceived basis that its cost is less than commercial alternatives. Anyone considering using Linux for a medical device project needs to be prepared to make an informed decision about the relative merits over choosing a stable and certified platform like QNX.
A big differentiator that the QNX operating system offers is clean intellectual property (IP). The origin of the entire OS is known and transparent. Unlike open source software where the lack of traceability can bring sublicensing and liability issues to the forefront.
QNX offers the means to support issues, custom engineering, open source integration and license compliance all to help you get back to what you do best, your own application software.
Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements and industry pressures. Medical device manufacturers must develop increasingly complex devices in timelines that are more typical of consumer-grade electronics, but difficult to meet in a regulated industry. In order to meet these challenges, extensive ecosystem partnerships are increasingly leveraged to meet the performance and time driven demands in medical device development.
Beyond our corporate partner relationships which all apply here, QNX offers a medical partnership channel that reflects a vibrant medical device centric ecosystem that includes segment experienced Independent Design Houses, Semiconductor Partners, Application Software Developers, through Testing and Validation services. Call it our one-stop-clinic.