Case Study
Cryptography

Case Study: Securing a Multi-Device Surgical Tool Suite: How Medcrypt’s Guardian Suite Unified Security Across Diverse Platforms

Multi-Device Surgical Tool
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Unified Security Across Diverse Platforms

The Challenge

A medical device manufacturer needed to secure a Surgical Tool Suite comprising three distinct devices - each with unique technology stacks, manufacturing environments, and connectivity limitations. Some devices were built in-house, others by third parties, and all operated in disconnected environments with minimal field connectivity. Challenges included:

  • Provisioning in low/no connectivity environments
  • Maintaining FDA clearances across diverse subsystems
  • Preventing unauthorized or gray-market attachments
  • Meeting corporate security goals while respecting device-specific constraints
  • Operating within strict performance limitations

The Solution: Medcrypt’s Guardian

Medcrypt’s Guardian Suite offered a unified yet flexible security architecture that worked across all three devices:

  • Secure provisioning and reprovisioning in disconnected environments, both in the field and during manufacturing.
  • Tailored Root of Trust (RoT) for each device, supporting unique tech stacks without affecting performance.
  • Unified security architecture aligning corporate policies with individual device needs.
  • Optimized cryptographic implementation that respected memory and processing limitations.
  • Authentication to block unauthorized accessories, maintaining safety and reliability.

The Impact

Guardian Suite unified the security infrastructure across a highly diverse surgical tool portfolio, enabling secure operation while meeting regulatory expectations and performance demands.

  • Prevented gray-market and counterfeit attachments.
  • Maintained device-specific configurations within a consistent enterprise security model.
  • Achieved cybersecurity readiness without redesign or revalidation.
  • Preserved high performance in critical surgical environments.

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.