Medical platform development requires a security-focused mindset, making system protection a priority in the earliest stages of system design. Just as features like authentication and encryption are essential to the security of medical data, smart steps should be taken to harden the system itself. One step includes securing the software stack to minimize the attack surface for safe and effective long-term performance.

Fig. 1 – An embedded OS provides a longer lifecycle and additional security features for an optimized OS image or software stack. Coupled with other hardening techniques, creating the OS image as a baseline ensures consistency in deployment and reduces the attack surface at the earliest stages of development.

By eliminating a certain level of risk early in the design process, manufacturers gain a long-term advantage for products and systems with extended life-cycles. For example, a costly and sophisticated device like an MRI or X-ray machine is intended to be in the field for many years, and engineers need to address evolving security threats. This becomes increasingly complex as more devices are connected.

While every device is different, the ideal is to incorporate greater controls within the operating system (OS). One method to achieve this is to move toward an embedded OS, providing a longer lifecycle and additional security features for an optimized OS image or software stack. Other hardening techniques, such as blending hardware- and software-based security, whitelisting, and freezing configurations, give engineers a broader array of security strategies to reduce the attack surface from the start. (See Figure 1)

Gaining an Embedded OS Advantage

Customizing an OS can be costly, considering the effort required to meet existing FDA and National Institute of Standards & Technology (NIST) security standards; integrate existing applications; and account for custom development, testing, and validation. Choosing the right operating system requires additional thought. For example, a Microsoft Windows® Embedded platform not only enables manufacturers to make those customizations, but it securely improves their customer’s experience and workforce productivity, particularly when working with a partner experienced in Windows Embedded and knowledgeable about their business. Depending on the application, an embedded Linux operating system may be a better alternative, and is traditionally stable, efficient, and less costly. There are also several different distributions of Linux, so choosing what is ideal for the business could be cumbersome.

Beyond productivity and potential cost savings, the configuration options available within an OS create more control. For example, Microsoft Windows 7 is designed for the consumer. It includes features and functionality to improve a consumer computing experience. Internet browsers or email are inherently accessible and ready to use. In an application-specific device, an engineer may turn off various functions, essentially eliminating them from the playlist. In contrast, Windows 10 Internet of Things (IoT) is designed for the manufacturer, and comes with its features and functionality restricted at the start. The engineer selectively turns on applications rather than turning them off. This greater level of control reduces the footprint for security risks.

Ensuring Competitive Value by Optimizing, Validating, and Scanning the Stack

By enabling only features that add value to the application or system itself, engineers create a smart baseline OS image, consistent for all customers using a particular device. By establishing this baseline as an initial standard of deployment, an extra layer of security is established at the product management level. Engineers can then enable corresponding product groups with access to that secure image to easily customize their business unit’s application. It is this customized, yet consistent, approach that helps medical device manufacturers maintain customer satisfaction, meet specific deployment and performance requirements, and simplify compliance and certification processes.