Medical Device Hardware Consolidation on i.MX95 Using a Container-Based Mixed-Criticality Architecture

OEM Value at a Glance

Consolidate legacy medical device hardware onto a single i.MX95 platform, maintain deterministic real-time behavior, and introduce Android-based UI using a container-based mixed-criticality architecture designed for regulated environments.

Executive Summary

A medical device OEM sought to consolidate multiple legacy hardware platforms – built on different processors – into a single system-on-chip in order to reduce hardware complexity, streamline software maintenance, and create a scalable foundation for future products.

L4B Software supported this effort using NXP i.MX95, with MediTUX OS providing a real-time Linux kernel as the system host. Safety-relevant workloads execute directly on the host OS, while MedicDroid (Android 15 for medical devices) runs as a secure container, isolated using L4B’s secure real-time container platform.

This architecture enabled the OEM to modernize its platform while maintaining deterministic behavior and supporting regulated development practices.

OEM Context

For medical device OEMs, long-lived platforms often result in:

• Multiple hardware variants across product lines
• High BOM and manufacturing complexity
• Fragmented software stacks tied to specific processors
• Increasing effort to introduce modern UI, connectivity, and cybersecurity updates
• High cost of change due to regulatory impact analysis

The objective was to consolidate hardware and software while maintaining control over risk, lifecycle, and future scalability.

Challenges

• Multiple legacy hardware platforms with different processor architectures
• Requirement for deterministic, real-time behavior for safety-relevant functions
• Introduction of a modern Android-based user interface without disrupting critical workloads
• Mixed-criticality software running on shared hardware
• Support for software lifecycle processes aligned with IEC 62304

Solution Architecture

L4B Software supported the design of a container-based mixed-criticality architecture using NXP i.MX95.

Architectural components:

• MediTUX OS as the system host, based on a real-time Linux kernel
• Safety-critical and real-time workloads executed directly on the host OS
• MedicDroid (currently Android 15) deployed as a secure container on the same kernel
• Isolation enforced through L4B’s secure real-time container platform
• Resource control implemented via scheduling policies, cgroups, namespaces, and capability restrictions

This architecture allows the OEM to consolidate multiple software domains onto a single SoC while maintaining predictable behavior and controlled interference.

Key Benefits for Medical Device OEMs

Hardware and Cost Efficiency

• Consolidation of multiple boards into a single i.MX95-based platform
• Reduced BOM, manufacturing complexity, and supply-chain exposure
• Simplified hardware qualification across product variants

Software Lifecycle and Maintainability

• Clear separation between safety-relevant and non-critical software domains
• Easier impact analysis and controlled updates aligned with IEC 62304
• Reduced coupling between UI, connectivity, and real-time control software

Faster Innovation with Controlled Risk

• Ability to introduce modern Android-based UI and connectivity features
• Isolation limits the impact of changes to non-safety software
• Shorter development cycles for feature updates

Platform Scalability

• Reusable architecture across multiple device generations
• Easier migration of legacy software onto a unified platform
• Long-term roadmap support without reintroducing hardware fragmentation

Mixed-Criticality and Regulatory Considerations

The architecture was designed to support regulated medical device development by:

• Clearly defining software items of different criticality, even when sharing a kernel
• Treating Android as a non-safety-related software item, isolated through container mechanisms
• Supporting IEC 62304-aligned software lifecycle activities, including classification, maintenance, and impact analysis
• Limiting resource contention through controlled allocation and scheduling

Regulatory compliance and certification remain the responsibility of the medical device manufacturer.

Outcome

• Consolidation of multiple legacy hardware platforms onto a single i.MX95-based system
• Reduced hardware and software complexity
• Maintained deterministic real-time behavior for safety-relevant functions
• A scalable, future-ready platform for OEM product roadmaps

Conclusion

By combining MediTUX OS, a real-time Linux kernel, and secure container-based isolation, L4B Software enables medical device OEMs to consolidate legacy platforms, reduce lifecycle cost, and accelerate innovation – while maintaining the architectural discipline required for mixed-criticality and regulated environments.