Connected Medical Device
Networked medical devices such as infusion pumps, ventilators, and imaging systems. These devices are FDA-regulated, often run legacy software, and cannot support endpoint security agents.
What is Connected Medical Device?
Networked medical devices such as infusion pumps, ventilators, and imaging systems. These devices are FDA-regulated, often run legacy software, and cannot support endpoint security agents.
Connected medical devices are FDA-regulated devices that include network connectivity as part of their functionality — infusion pumps, patient monitors, ventilators, imaging systems, anesthesia machines, surgical robots, implantable cardiac devices with external monitoring, and thousands of other device types used in clinical care. They differ from general IoT devices in two critical ways: they are directly involved in patient care, and they are subject to FDA regulatory oversight.
The security challenges of connected medical devices are well-documented and severe. These devices often run Windows XP or Windows 7 operating systems past their Microsoft support dates. They cannot be patched without FDA clearance of the updated software. They use default credentials that clinical staff don't change. They communicate on flat hospital networks with no segmentation from general IT infrastructure. And they are managed by clinical engineering (biomed) teams whose primary mandate is device availability and patient safety, not security.
The convergence of these factors creates persistent risk. Ransomware attacks that encrypt clinical systems have directly delayed patient care and contributed to adverse outcomes. Device vulnerabilities with public exploits have been demonstrated in laboratory settings and in real healthcare incidents. The FDA's 2023 cybersecurity guidance represents a significant regulatory escalation — acknowledging that the status quo is inadequate and setting new expectations for device manufacturers and healthcare organizations alike.
Key Facts
- The FDA requires new medical device submissions to include cybersecurity documentation as of October 2023
- 53% of connected medical devices have at least one critical vulnerability according to industry research
- Ransomware attacks on healthcare systems have directly delayed patient care in documented incidents
- The average hospital has 10–15 networked medical devices per patient bed
How ORDR Addresses Connected Medical Device
ORDR provides specialized discovery and monitoring for connected medical devices, integrating UDI data, FDA recall databases, and manufacturer security advisories into the risk assessment. It operates passively to avoid any impact on clinical device function, integrates with clinical engineering workflows and CMMS platforms, and generates segmentation policies that protect medical devices without disrupting the clinical communication they depend on.
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ORDR gives healthcare security teams complete IoMT visibility, risk scoring, and automated segmentation—without disrupting care delivery.