Accelerating Secure Innovation for Medical Devices with High Assurance Linux

A medical device manufacturer partnered with Lynx to address the challenges of moving to Linux, ensuring compliance, and securing their product lifecycle. By leveraging Lynx’s expertise in high-assurance boot and lifecycle maintenance, the client achieved 70% cost savings while accelerating time-to-market. Discover how Lynx helped them seize the edge in infection control.

Revolutionizing Infection Control with Cost-Efficient Security Solutions

A leading infection control specialist collaborated with Lynx to overcome technical hurdles and ensure their medical device met stringent regulatory and security standards. From addressing platform integration issues to enabling long-term security and maintenance, Lynx delivered results that saved time, reduced costs, and safeguarded patient safety.

About the Client: Innovating Medical Device Sterilization

The client is a specialist in infection control, providing sterilization solutions for medical instruments. With stringent industry standards and a mission-critical need for device security, they sought a partner who could address their Linux challenges and deliver a secure, market-ready solution.

Challenge

High-Stakes Challenges in a Time-Critical Industry

Medical device manufacturers face increasing pressures to innovate while adhering to strict security and compliance requirements. This client faced three critical challenges:

Transition to Linux: High development effort on their existing platform made moving to Linux essential. However, the engineering team lacked Linux expertise.
Hardware Integration Issues: During final testing, the device failed to boot, risking costly delays.
Lifecycle Maintenance: Maintaining an updated, secure Linux operating system for a connected medical device was vital to compliance and patient safety.

Solution

Delivering a Secure, Market-Ready Solution with Lynx

Lynx stepped in with tailored solutions at every stage of the development process, ensuring the client could launch a secure product on schedule.

Secure Boot Implementation: Enabled high-assurance boot (HAB), securing the kernel and root filesystem for a complete chain of trust. This ensured the device met the most stringent medical standards.
Hardware Troubleshooting Expertise: Resolved critical boot issues in hours by identifying and fixing a configuration problem, saving the client weeks of development time.
Lifecycle Security Maintenance: Integrated a meta-security layer into the client’s Yocto Linux BSP to streamline CVE fixes and root filesystem updates. Delivered a private Git repository, regular kernel updates, and tools like Vigiles Prime for proactive vulnerability monitoring.

Results

Measurable Outcomes That Exceed Expectations:

The client achieved tangible, business-critical results:

70% Cost Savings: Optimized security and maintenance for Linux-based devices.
Faster Time-to-Market: Critical boot issue resolved in hours instead of weeks.
Proactive Security: Initial vulnerability scan identified 557 issues, empowering the client to prioritize and address risks effectively.
Lifecycle Compliance: Ongoing updates and maintenance aligned with FDA cybersecurity guidance for postmarket management.