legacy-medical-device-security-frameworks

Archetype 2 Scenario Library — Embedded RTOS Legacy

Reusable threat scenarios for medical devices built on real-time operating systems (VxWorks, QNX, ThreadX, INTEGRITY, FreeRTOS, eCos) or fully proprietary embedded firmware. Examples include large-volume infusion pumps, ventilators, anaesthesia machines, physiological monitors, point-of-care analysers, and many implantable device programmers.

The defining characteristic of Archetype 2 is the absence of a general-purpose OS shell and consequently the absence of host-based control surfaces. There is no place to install an EDR agent, no syslog daemon, often no per-user account model, and frequently no facility for cryptographic key storage. The dominant attack surface is the protocol parser itself, and compensating controls are exclusively network-adjacent and physical.

How to use this library

Draw scenarios from the relevant category and adapt to your specific device. The Archetype 2 mitigations are deliberately limited compared with Archetype 1 — accept that some risks must be addressed exclusively at the network or physical perimeter.

S — Spoofing

Network attacker

Physical / insider attacker

T — Tampering

Network attacker

Physical / insider attacker

R — Repudiation

Network attacker

Physical / insider attacker

I — Information Disclosure

Network attacker

Physical / insider attacker

D — Denial of Service

Network attacker

Physical / insider attacker

E — Elevation of Privilege

Network attacker

Physical / insider attacker

Cross-cutting compensating-control patterns

For Archetype 2, the following compensating controls have broad applicability:

When Archetype 2 protections are insufficient

Archetype 2 has structural limitations that compensating controls cannot fully overcome:

These structural limitations argue for defence-in-depth at the network and physical layers, behavioural monitoring as a first-class control rather than a backstop, and manufacturer engagement under FDA 524B postmarket cybersecurity obligations to drive longer-term improvements.