Use Cases

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

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UPDATE CAPABILITIES FOR MEDICAL DEVICES BUILDING IN SAFETY AND SECURITY TO MEET REGULATORY REQUIREMENTS With the objective to achieve better results in patient healthcare and lifesaving techniques, regulatory agencies such as the U.S. Food and Drug Administration continue to announce rules and regulations to make medical devices safer and more secure for patients. In a recent 2018 announcement, the FDA released an article, "Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health," that outlines various new FDA actions to improve medical device safety. One of the components of this plan is the call for mandatory built-in capabilities providing safety and security updates to medical devices. THE CHALLENGE The challenge for medical device manufacturers is to securely, reliably, and cost-effectively build in these safety and security update capabilities. Device manufacturers can no longer consider the development phase the only or even the most significant cost driver in the product lifecycle. The ability to update is necessary to meet new and evolving FDA and other regulatory requirements for medical devices. This use case outlines solutions for designing such update capabilities into a medical device. THE SOLUTION With every problem comes opportunity. More sophisticated medical device manu- facturers can see the new guidelines as an opportunity to better understand their customers' needs and better enable interaction with their customers over the life of their product. As the use of medical devices by hospitals and patients continues to grow, new safety concerns emerge that must be dealt with to maintain patient health. Additionally, as new cybersecurity vulnerabilities are discovered, they need to be mitigated to ensure continuing patient safety. Wind River ® offers a portfolio of products, including the use of virtualization technology available with Wind River Helix ™ Virtualization Platform, the VxWorks ® real-time operating system, Wind River Linux, and the edge cloud solution Wind River Titanium Cloud ™ , that can help medical device companies create reliable software update capabilities in a cost- effective manner. MEDICAL DEVICE CHALLENGE • Build in the ability to update safety and security functions in medical device products to meet FDA and other regulatory requirements for medical devices WIND RIVER SOLUTIONS • Wind River Helix Virtualization Platform: An OS-agnostic edge com- pute platform with a real-time, embedded, Type 1 hypervisor that can manage unmodified guest operating systems running in VMs, consolidating workloads for medical devices. • VxWorks: The world's leading RTOS, enabling deterministic applications scaling from very small compute packages • Wind River Linux: Optimizing Kernel-based Virtualization Machine (KVM) technology, enabling VMs to run update functions for devices and take advantage of optional Wind River Professional Servicess • Wind River Titanium Cloud: Virtualization platform that reliably runs applications and cost-effectively enables update capabilities for medical devices 1 MEDICAL USE CASE

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