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Case study · April 30, 2025

CryptographyDevice AuthenticationFDA Cybersecurity ReadinessSecure Device Communication

Securing Communication for a Radiotherapy Treatment System

Secure Intradevice & Intra-system Communication

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The Challenge

Unprotected communication

A radiotherapy device manufacturer needed a secure, efficient way to protect communication between treatment planning software and the device itself. Key challenges included:

  • Manual & outdated provisioning – Security key management relied on labor-intensive, error-prone processes.
  • Performance constraints – Limited memory and processing power made integrating security features difficult.
  • Vulnerabilities to cyber threats – Outdated protocols left patient data and system communications exposed.
  • Complex infrastructure – Secure communication was required across two networks and 25 nodes without costly re-engineering.‍
  • Regulatory compliance – Meeting evolving FDA cybersecurity requirements without disrupting clinical operations was critical.

The Solution

Scalable security solution in Guardian

Guardian provided a seamless, scalable security solution that ensured compliance without impacting device performance.

  • Automated cryptographic key provisioning – Secure provisioning and reprovisioning of devices in the field.
  • Root of Trust (RoT) & component identities – Unique cryptographic keys assigned to each component, ensuring secure authentication.
  • Encrypted real-time communication – Protected messaging and treatment planning orders against tampering.‍
  • Seamless integration – Secured communication across a complex multi-node system without costly redesigns.

The Impact

Full FDA cybersecurity compliance

With Guardian, the manufacturer achieved:‍

  • Full FDA cybersecurity compliance while maintaining system performance.‍
  • Secure, encrypted communication across 25 nodes and two networks.‍
  • Streamlined in-field security updates without disruptions.‍
  • Confidence in device security through cryptographic authentication and RoT.

The Power of Guardian

See how medical device manufacturers avoided delays, simplified regulatory submissions, and ensured the highest level of cybersecurity for their life-saving radiotherapy system.

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