医疗器械的设计更新能力

Build in Safety and Security to Meet Regulatory Requirements The top objective of the U.S. Food and Drug Administration (FDA) andother regulatory agencies is to provide healthcare patients with accessto safe medical devices that meet their healthcare needs. With the majorpriority to achieve better results in patient healthcare and lifesavingtechniques, regulatory agencies such as the FDA continue to establishnew rules and regulations to make medical devices safer and moresecure for patients. In a 2018 announcement, the FDA released an article,“Medical Device Safety Action Plan: Protecting Patients, Promoting PublicHealth,” that describes new FDA actions to improve medical devicesafety. A major component of this plan is the call for mandatory built-incapabilities providing safety and security updates to medical devices. MEDICAL DEVICECHALLENGES •Accelerate devicetime-to-market•Reduce development,deployment, and ongoingmaintenance•Meet stringent regulatorycompliance requirements•Update or replace legacy,stand-alone devicesand systems•Utilize safe and secureover-the-air wireless commu-nications to update systemsor transmit medical data•Improve flexibility and agilityto deploy new technologies•Connect and managemedical devices andhealthcare facility systems•Ensure system security fromoutside intrusion THE CHALLENGE Medical device manufacturers must meet the FDA challenge of buildingsecure, reliable, and cost-effective safety and security update capabilitiesinto their medical technology. No longer is the development phase the onlyand most significant cost driver in the medical product lifecycle. The built-incapability to update the system is required to meet new and evolving FDA andother regulatory requirements for medical devices. This use case outlinessolutions for designing such update capabilities into a medical device. THE SOLUTION This new update requirement has become a golden opportunity for medicaldevice manufacturers to bring innovation to medical technology, especiallygiven the growing use of medical devices by doctors and patients in hospitalsand at home. Now, new safety and security concerns merge with the medicaldevice system operation that must maintain patient health and treatment. Additionally, as new cybersecurity vulnerabilities are discovered, they needto be managed to ensure continuing patient safety. WIND RIVER SOLUTIONS Wind River®offers a portfolio of products and modern tools that can helpmedical device companies create and deploy secure, reliable softwareupdate capabilities in a cost-effective manner. These include the use ofvirtualization technology available with Wind River Helix™ VirtualizationPlatform; the VxWorks®real-time operating system; Wind River Linux;and Wind River Studio, the first cloud-native DevSecOps platform forembedded development. •Wind River Studio:A cloud-native toolset for developing,deploying, operating, andservicing mission-criticalintelligent systems acrossthe edge •VxWorks:The first and onlyRTOS in the world to sup-port application deploymentthrough containers, helpingto meet rigorous certificationstandards for safety, security,and performance in connectedmedical devices Wind River Helix Virtualization Platform Helix Platform consolidates multi-OS and mixed-criticality applicationsonto a single edge compute software platform, simplifying, securing, andfuture-proofing critical infrastructure solutions. It provides a safe, secure,and reliable software development environment with a Type 1 hypervisorsolution for medical technology systems as well as for other industries. •Wind River Linux:Theindustry-leading open sourceoperating system with a com-prehensive suite of products,tools, and lifecycle services tobuild and support intelligentedge solutions This virtualization platform manages and allows the creation of virtualmachines (VMs) on a single compute platform with a mix of operatingsystems and mixed-criticality workloads to allow greater flexibility, safety,and security, as required for today’s medical devices. Helix Platform’shypervisor can manage multiple VMs running VxWorks, Wind River Linux,and other guest operating systems such as Windows®and Android. Itsupports multiple software applications, including those for safety-criticalor security systems, running together or segregated. •Wind River HelixVirtualization Platform:Areal-time, embedded, Type 1hypervisor that consolidatesmulti-OS and mixed-criticalityapplications onto a singleedge compute software plat-form, simplifying, securing,and future-proofing criticalinfrastructure solutions suchas medical equipment Thus, safety-critical applications on a medical device can be reliably runand updated via the network and wireless over-the-air (OTA) connections.To protect patients, medical device architects can use our industry-leadingvirtualization technology to segregate different software applications intoindependent VMs in separate partitioned processor cores as necessary, tomore easily main