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Solutions for Medical Sector Use Case

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Driving Digital Transformation in Healthcare SOLUTIONS FOR THE MEDICAL SECTOR THE CHALLENGE As medical device developers and manufacturers strive to deliver high- quality products at a profit, a number of interrelated challenges exist. Manufacturers are under pressure to accelerate time to market—a particular challenge when introducing new medical functions that require lengthy clinical trials and certification processes. At the same time, they are trying to hold down the costs of development, deployment, and ongoing system maintenance. But quality cannot be compromised for cost savings or faster cycle times. Products must meet stringent compliance requirements for safety, security, and industry standards across projects. And ultimately, patients' health and lives are at stake. The concept of the "connected hospital" and greater connectivity among healthcare providers holds the promise of further advancements, such as centralized patient monitoring and data-enabled predictive medicine. Though today's devices can be designed for connectivity from the ground up, many facilities will be facing extensive efforts to replace legacy, standalone, manually monitored devices. And with increased connectivity comes the increased risk of malicious hacking, with potentially threatening consequences for privacy and life. The FDA has issued strict guidance on cybersecurity for medical devices. Security at both the network and device levels needs to be addressed early in the design phase in order to meet compliance requirements and to guarantee the privacy and safety of patients. Moreover, operators need assurance that devices will be secure throughout their lifecycle despite frequent updates and patches. MEDICAL USE CASE MEDICAL SECTOR CHALLENGES • Accelerate device time-to-market • Reduce development, deployment, and ongoing maintenance • Meet stringent regulatory compliance requirements • Update or replace legacy, standalone devices and systems • Improve flexibility and agility to deploy new technologies • Connect and manage medical devices and healthcare facility systems • Ensure system security from outside intrusion WIND RIVER SOLUTIONS • Wind River ® Helix ™ Device Cloud: Remotely monitor, manage, secure, and update hundreds to thousands of networked devices and equipment remotely in the Internet of Things • Wind River ® Titanium Cloud ™ : Enable digital transformation from legacy hardware to a virtualized computing environment, reducing IT infrastructure and increasing agility • VxWorks ® and Wind River Linux: Employ the industry-leading real-time operating system and open source operating system that help meet rigorous certification standards for safety, security, and performance in connected medical devices 1

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