Use Cases

Update Capabilities for Medical Devices Building in Safety and Security to Meet Regulatory Requirements

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Wind River Helix Virtualization Platform Helix Platform provides a safe, secure, and reliable software development environment with a Type 1 hypervisor solution. This virtualization platform manages and allows the creation of virtual machines (VMs) on a single compute platform with a mix of operating systems and mixed-criticality workloads to allow greater flexibility, safety, and security, as required for today's medical devices. Helix Platform's hypervisor can manage multiple VMs running VxWorks, Wind River Linux, and other guest operating systems such as Windows ® and Android. It supports multiple software applications, including those for safety-critical or security systems, running together or segregated. Thus, safety-critical applications on a medical device can be reliably run and updated via the network. Medical device architects can use our industry- leading virtualization technology to segregate different software applications into independent VMs in separate partitioned pro- cessor cores as necessary, in order to more easily maintain, patch, or replace current software with new safety or security updates. VxWorks VxWorks is a real-time operating system found in more than 2 billion devices in medical, industrial, transportation, and defense solutions. VxWorks is proven in mission-critical medical applications, where security is paramount. Its small footprint enables devices to meet hard real-time operating requirements in scaling from small to large medical devices. It works on all major processor architectures, Arm ® and x86. Best-in-class, pre-integrated security functionality in VxWorks includes foundational security capabilities for devices, communication, and management for security and privacy. VxWorks provides documentation for medical device manufacturers for inclusion in compliance-related vendor qualification, and for use in premarket submission to the FDA. Wind River Linux Wind River Linux is the Linux distribution of choice for IIoT software developers who want a combination of open source flexibility, commercial grade reliability, and support to help achieve low total cost of ownership. Wind River Linux delivers vital components for the productization and commercialization of any medical device or Internet of Things (IoT) device. The KVM hypervisor is a component of Wind River Linux. A Linux solution can be utilized with a Wind River Linux platform for the medical device system. To provide the capability to easily update FDA-approved and security functions in a medical device, Wind River Linux, with its KVM hypervisor capability, can run applications in various VMs running Wind River Linux, VxWorks, or another guest OS. An FDA-approved or security application or functions would each be running in their own separated VM, so they are safe from interference or conflicts from applications in other VMs. Each medical application and security VM can be easily updated via the network, or a mirrored VM can quickly be updated and then swapped with the updated functions. Wind River Professional Services can support a medical device company in developing a Wind River Linux solution that can easily update VMs and be secure, protecting the operations and data on the medical device. Wind River Titanium Cloud Product Family The Titanium Cloud product portfolio provides an application- ready software platform that runs virtual functions with high reliability and is built to support the intensive performance, reliability, and security requirements of the world's most demanding computing and communications networks. If you are looking to consolidate control systems in a cloud environment (on premise or centralized), Titanium Cloud provides the low latency and reliability needed. Titanium Cloud is built from the ground up to be secure and flexible and is capable of in-service upgrades and hitless patching so you can keep your systems up to date without having to take them down. MEDICAL USE CASE Medical Device Medical Application #1 Medical Application #2 Application #3 Application #4 VM 1 VxWorks (Safety Critical) VM2 Wind River Linux VM 3 Windows VM 4 Third-PartyOS (Safety/Non-Safety) Wind River Helix Virtualization Platform – Hypervisor 2 Multi-core Hardware Figure 1. Example of a Helix Virtualization Platform with virtualization running medical applications in virtual machine partitions 2 | Use Case

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