医疗器械开发商面临的三大挑战

resources and extending development timelines. Forinstance, the large choice of processors and GPUswith new AI, ML, and graphics capabilities adds to thecomplexity. It also creates challenges for the softwaresystem development driving the hardware components.Therefore, selecting the right operating systems,virtualization and containerization technologies,the application software, and modern developmentmethods is crucial. Wind River has extensive expertisein providing a proven portfolio of system software,development services, and cybersecurity support thatutilizes the latest hardware components.Challenge 3: Cloud IntegrationThe utilization of cloud technology and services hasgrown tremendously over the last decade, and themedical and healthcare industries have become partof this technology change. Medical device developersface several challenges in integrating cloud technologyand services in new devices. These challenges can bebroadly categorized into regulatory, technical, security,and operational issues.•Regulatory:The regulatory challenge when cloudtechnology is part of the solution is, as with theother device components, compliance with stringentrequirements set by agencies such as the FDA (USA)and the EMA (Europe). Validation and documentationprocesses can be complex.•Technical:Ensuring interoperability betweendifferent systems and platforms is a significanttechnical hurdle. Medical devices must seamlesslycommunicate with each other and with IT systems.The difficulty is achieving this given diverse cloudservices and the need to function across networksecurity boundaries.•Security:Patient data, the operation of the medicaldevice, and the entire medical facility system mustbe secure and protected. The security of databoth in transit and at rest in the cloud is crucial,and it requires major effort to meet regulatoryrequirements.•Operational:The operational challenge with cloudtechnology as part of a medical device is thecomplexity of integrating cloud services into existingworkflows and infrastructure. Developers mustensure that new cloud-based solutions don’t disruptcurrent operations or compromise performance. 2Let’s discuss the top three challenges that makeup this overall challenge.Challenge 1: Regulatory RequirementsFirst, regulatory requirements. Recently, the Foodand Drug Administration (FDA) added cybersecurityrequirements to the regulations for medical devices.They now constitute the number-one challenge. As aprerequisite for FDA approval, device manufacturersneed to share with the FDA how they are securing theirdevices. Additionally, they must detail how the companywill respond to cybersecurity incidents in the field.Wind River is working with our medical devicecustomers to address these requirements byproviding secure and performance-oriented operatingplatforms, the system (RTOS), Yocto Linux–basedWind River Linux, and the Zephyr open sourcesolution for microcontrollers. Additionally, WindRiver customizes those platforms for the specifichardware and software needs of the OEM and oftenmaintains the platforms for its customers to ensurethat the latest relevant common vulnerabilities andexposures (CVEs) are addressed on an ongoing basis.Finally, Wind River works with customers to addressother regulatory requirements, such as IEC 62304certification, and implement modern cloud-basedDevSecOps tools and processes to build in securitybest practices from the outset.Challenge 2: Hardware SupportThe broad array of hardware products for medicaldevice development poses a significant challenge fordevelopers. The extensive options for processors,semiconductors, motion controllers, sensors, andmore require careful selection and evaluation.Considerable time and expertise are needed to identifythe most suitable components. Next, integrating thesediverse components into a cohesive medical solutionintroduces compatibility issues, differingcommunication protocols, and technical complexities,complicating the development process. And furtherincreasing the challenge, developers must ensure thatall hardware meets regulatory standards for safetyand efficacy and is supportable for, usually, a decadeor more.Rapid technological advancements necessitatecontinuous learning and adaptation, straining Wind River has deep experience and expertise in using cloud technology and services to enhance software devel-opment and in supporting cloud services as a component of equipment, systems, and devices across industries, in-cluding medical and healthcare.Wind River Support for Development ChallengesSolving these top three challenges for medical device developers is a priority. Wind River has been working closelywith developers to provide a proven portfolio of products and modern cloud-based development tools and servicesthat help companies meet regulations; achieve certification; strengthen cybersecurity, safety, and reliability; andmodernize software development.•Wind River Studio Developer:Based on what we’ve seen, DevOps is sti