Securing a Legacy 3D Mapping System for Radiation Oncology

A medical device manufacturer faced mounting cybersecurity challenges with its 3D mapping system used during surgery. The system relied on manual cryptographic key provisioning via USB, had strict memory and processing constraints, and operated across multiple independent codebases that could not be modified due to FDA clearances. Additionally, communication protocols were outdated or unencrypted, leaving the system vulnerable to cyberattacks and noncompliant with evolving FDA expectations.

Medcrypt deployed Guardian Agent as a plug-and-play solution, enabling secure communication and certificate management without source code modifications:

• Field provisioning via USB for secure manual key updates in disconnected environments.

• Certificate and key management to establish a secure Root of Trust and enable authenticated communications.

• Performance-optimized implementation to work within limited memory and processing power.

• Compatibility across independent code bases without disrupting regulatory approvals.

• Modern protocol support to replace plaintext or deprecated TLS with strong encryption.

By integrating Guardian Agent, the manufacturer enhanced security across its deployed systems while maintaining regulatory compliance and device performance. No source code changes were required, preserving FDA approvals and avoiding costly re-engineering.

• Secured authentication and encrypted communication across all system components.

• Achieved compliance with FDA cybersecurity guidelines.

• Delivered seamless integration without altering clinical workflows or device functionality.