When most industries think about intrusion detection (IDS) or intrusion prevention (IPS), they imagine installing agents directly on endpoints. But in the world of medical devices, that approach rarely works — and can even create risks for patient safety. Devices like infusion pumps, ventilators, imaging systems, and surgical robots don’t operate like corporate laptops or servers. They have strict performance constraints, regulatory requirements, and clinical safety considerations that make traditional endpoint security impractical.
In this blog, we’ll explain why agents don’t fit medical devices, the strategies that work, and how these align with FDA expectations for medical device cybersecurity.
Why Agents Aren’t Feasible on Medical Devices
Medical devices often run on constrained embedded operating systems (RTOS, embedded Linux) or legacy Windows builds. These systems are designed for reliability and performance, not for handling resource-heavy agents. Here’s why agents aren’t viable:
- Resource constraints: CPU, memory, and storage are limited; an agent could cause performance degradation.
- Regulatory and vendor support: Adding an agent may void FDA clearance or vendor warranties.
- Patient safety risks: An agent crash or false positive could disrupt care delivery in real time.
- Legacy designs: Many devices weren’t built with the ability to support third-party applications.
For these reasons, installing IDS/IPS or EDR-style agents directly on medical devices is generally not an option.
Practical Alternatives for Medical Devices
Since on-device agents aren’t feasible, healthcare organizations and manufacturers rely on network- and system-level protections that work around device limitations.
1. Network-Based IDS/IPS
- Passive IDS sensors monitor traffic from devices without touching the device itself.
- Inline IPS gateways enforce rules at the network edge, blocking malicious activity like command injection or ransomware traffic.
- Works well for protecting infusion pumps, imaging modalities, and monitoring systems without altering their configuration.
2. Micro-Segmentation and Allowlists
- Devices are grouped into role-based VLANs (e.g., imaging, monitoring, therapy).
- Least-privilege ACLs ensure devices only talk to PACS, EMR, or update servers.
- Prevents lateral movement and blocks Internet exposure by default.
3. Clinical Security Gateways and Proxies
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Gateways sit between devices and hospital networks, providing:
- Protocol validation (e.g., DICOM, HL7).
- Malware filtering and virtual patching.
- TLS termination and inspection when appropriate.
4. Using Device-Native Capabilities
- Secure logging: Forward syslog or export logs to SIEM if supported.
- Signed updates and secure boot: Ensure authenticity of firmware and updates.
- Audit trails: Use built-in logging to monitor clinical use and detect anomalies.
5. Passive Asset Discovery + SBOM Use
- Passive tools discover devices without active scanning.
- SBOMs (Software Bill of Materials) map known vulnerabilities to deployed assets.
- Risk-prioritized controls (segmentation, IPS rules) are applied when patching isn’t possible.
6. Network Access Control (NAC)
- Enforces that only approved medical devices connect to clinical VLANs.
- Rogue or noncompliant devices are quarantined automatically.
7. Change Control and Safety Testing
- Every segmentation or IPS rule change is validated in a clinical safety lab.
- Ensures new rules don’t disrupt patient care or critical device functionality.
When a Lightweight Agent Might Work
In rare cases, newer Windows-based devices may support vendor-approved lightweight monitoring agents. Even then, these should be used for visibility only (e.g., log forwarding, asset inventory), not prevention or enforcement. Safety and vendor approval must always come first.
Decision Guide for IDS/IPS in Medical Devices
Is the device vendor-supported for agents?
- No → Use network-based IDS/IPS + segmentation.
- Yes (documented) → Consider visibility-only agents, with network IPS for enforcement.
Can the device tolerate inline inspection?
- Yes → Place inline IPS at gateways; latency-test and allowlist.
- No/Unknown → Rely on passive IDS + ACLs/micro-segmentation.
Is patching unavailable?
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Apply virtual patching at IPS, restrict egress, monitor via passive IDS.
Alignment with FDA Guidance
The FDA emphasizes that cybersecurity is part of medical device safety throughout the Total Product Lifecycle (TPLC). While FDA does not require agents on devices, it does expect:
- Risk-based controls (threat modeling, secure updates, validated logging).
- Compensating controls when patching isn’t feasible (e.g., segmentation, IDS/IPS).
- Postmarket monitoring via secure logs and network visibility.
Healthcare providers and manufacturers can meet regulatory expectations while protecting patients by adopting layered network protections and leveraging existing device features.
Final Thoughts
Traditional endpoint security agents don’t fit the medical device environment. Instead, manufacturers and healthcare providers must rely on network-based defenses, segmentation, and secure processes to detect and prevent intrusions without compromising patient safety.
At Blue Goat Cyber, we help manufacturers and healthcare systems design practical, FDA-aligned cybersecurity strategies that integrate IDS and IPS effectively — without introducing unnecessary risk. The goal is always the same: protect patients, maintain trust, and ensure safe, reliable care.