Cyber Threats on Medical Devices: A Case Study

Introduction

Medical devices are increasingly networked and software-driven, expanding the clinical benefits of connectivity while enlarging the attack surface for cyber threats. This convergence of healthcare and information technology creates patient-safety, operational, and regulatory risks that require coordinated technical, clinical, and procurement responses (Proofpoint & Ponemon Institute, 2024; HIMSS, 2024).

The threat landscape

Medical devices span implantable, bedside monitors, infusion pumps, imaging systems, and remote monitoring platforms. Many devices combine legacy hardware, proprietary firmware, and modern connectivity (Wi-Fi, Bluetooth, Ethernet), producing a heterogeneous environment that is difficult to secure (Cybellum, 2024; NIST, 2021). Common threat vectors include ransomware and malware that disrupt device availability, remote code execution against unpatched firmware, network attacks enabled by weak segmentation, supply-chain compromises, and insider or misconfiguration risks (CISA, 2024; Proofpoint & Ponemon Institute, 2024). Empirical reports show frequent incidents that can delay care and increase clinical workload, while breach-cost analyses highlight substantial financial exposure for healthcare organizations (IBM Security & Ponemon Institute, 2024).

Case study summary

A representative incident involved malicious firmware delivered via a compromised vendor update channel that affected infusion pumps and an imaging system. The malicious update propagated across a poorly segmented clinical network, causing intermittent device failures and operational disruption over a 48-hour period. The organization isolated affected segments, reverted devices to validated firmware where possible, and coordinated with vendors and regulators to contain the event (FDA, 2025; CISA, 2024).

Impact and technical root causes

Clinical and operational impact

The incident produced delayed infusions, rescheduled imaging appointments, increased manual monitoring, and exposure of device logs containing patient identifiers—outcomes consistent with sector surveys and breach reports that document patient-care disruptions and high remediation costs (Proofpoint & Ponemon Institute, 2024; IBM Security & Ponemon Institute, 2024).

Technical root causes

Key failures included acceptance of unsigned or insufficiently validated firmware updates, default or shared credentials on devices, inadequate network segmentation between clinical and administrative systems, incomplete asset inventories, and procurement contracts that lacked security requirements for secure development and timely vulnerability disclosure (NIST, 2021; UL Solutions, n.d.; Cybellum, 2024). These gaps enabled the initial compromise and facilitated lateral movement across the clinical network.

Response, lessons learned, and recommendations

Immediate response priorities

Contain and triage by isolating affected network segments, preserve forensic evidence, revert to known-good firmware or validated configurations, and implement safe manual clinical workflows with checklists to reduce error (CISA, 2024; FDA, 2025).

Strategic lessons and prioritized actions

• Secure update mechanisms: Require cryptographic signing and validation of firmware and software updates; verify vendor update channels (NIST, 2021; FDA,2023/2025).

• Credential and access hardening: Eliminate default accounts, enforce unique strong credentials, and apply role-based access controls (Cybellum, 2024).

• Network segmentation and micro segmentation: Separate clinical devices from administrative and guest networks to limit lateral movement (HIMSS, 2024).

• Authoritative asset inventory and monitoring: Maintain device inventories with firmware versions and support status; deploy device-aware monitoring and detection (IBM Security & Ponemon Institute, 2024).

• Procurement and vendor management: Include security requirements, SBOMs, signed updates, and vulnerability disclosure SLAs in contracts (UL Solutions, n.d.; Cybellum, 2024).

• Training and exercises: Conduct tabletop exercises that include device compromise scenarios and ensure clinical staff are trained on safe manual fallbacks (HIMSS, 2024).

Phased roadmap

• 30 days: Inventory critical devices, change default credentials, and apply segmentation for highest-risk systems.

• 90 days: Implement signed update verification for new devices, deploy basic device monitoring, and update procurement templates.

• 180 days: Roll out continuous monitoring, vendor SLAs for security support, and regular tabletop exercises.

Conclusion

Medical device cybersecurity is a patient-safety and organizational resilience imperative. The case study demonstrates how technical vulnerabilities, supply-chain weaknesses, and operational gaps can converge to create clinical harm. Implementing standards-based device requirements, secure update mechanisms, robust procurement practices, and continuous monitoring will materially reduce risk and align providers and manufacturers with evolving regulatory expectations (FDA, 2023/2025; NIST, 2021; UL Solutions, n.d.).

References:

Cybellum. (2024). 2024 medical device security survey report (Oct. 2024). https://cybellum.com/resourcesfiles/L_2024_Medical_Device_Security_Survey_Report_Letter_Print_Final.pdf

Freyer, O., Jahed, F., Ostermann, M., Rosenzweig, C., Werner, P., & Gilbert, S. (2024). Consideration of cybersecurity risks in the benefit-risk analysis of medical devices: Scoping review. Journal of Medical Internet Research, 26, e65528. https://www.jmir.org/2024/1/e65528

Healthcare Information and Management Systems Society. (2024). 2024 HIMSS healthcare cybersecurity survey (Survey report). https://www.himss.org/sites/hde/files/media/file/2025/02/20/2024-himss-cybersecuritysurvey.pdf

IBM Security & Ponemon Institute. (2024). Cost of a data breach: The healthcare industry (Industry analysis). https://www.ibm.com/think/insights/cost-of-a-data-breach-healthcareindustry

National Institute of Standards and Technology. (2021). SP 800-213: IoT device cybersecurity guidance for the federal government: Establishing IoT device cybersecurity requirements (NIST Special Publication). https://doi.org/10.6028/NIST.SP.800-213

Proofpoint & Ponemon Institute. (2024). The 2024 study on cyber insecurity in healthcare: The cost and impact on patient safety and care. https://assets.turtl.co/customerassets/tenant%3Dteam/pfpt-us-tr-cyber-insecurity-healthcare-ponemon-report-2024%20%281%29.pdf

U.S. Food and Drug Administration. (2025, January 30). Cybersecurity vulnerabilities with certain patient monitors from Contec and Epsimed: FDA safety communication. https://www.fda.gov/medical-devices/safety-communications/cybersecurity-vulnerabilitiescertain-patient-monitors-contec-and-epsimed-fda-safety-communication

U.S. Food and Drug Administration. (2023; updated 2025). Cybersecurity in medical devices: Quality system considerations and content of premarket submissions (Guidance for industry). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecuritymedical-devices-quality-system-considerations-and-content-premarket-submissions/

UL Solutions. (n.d.). Medical device cybersecurity standards and services (UL 2900, UL CAP overview). https://www.ul.com/insights/medical-device-cybersecurity-standards-and-services

Cybersecurity and Infrastructure Security Agency. (2024). Cybersecurity alerts & advisories (sector advisories and mitigations). https://www.cisa.gov/news-events/cybersecurity-advisories