Improving Medical Device Cybersecurity Risk Strategies by Linking Lifecycle Stages
In the rapidly evolving world of healthcare technology, the importance of cybersecurity in medical devices cannot be overstated. The U.S. Food and Drug Administration (FDA) and international standards bodies like ISO have established guidelines to manage cybersecurity risks throughout a medical device's lifecycle.
Post-market medical device cybersecurity risk assessments are based on the FDA's Guidance on Postmarket Management of Cybersecurity in Medical Devices and ISO 14971:2019 Medical Devices - Application of Risk Management. These assessments are crucial at every stage, from design and development to decommissioning.
During the design and development phase, a tailored risk assessment ensures devices are built using secure software and firmware, threat vector identification, and appropriate traceability measures. Secure coding standards, protected development environments, and integrated security controls are essential components of this process.
In the production phase, risk assessments address cybersecurity risks within the supply chain, manufacturing processes, and the implementation of security measures within the device itself. The FDA's updated document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," provides comprehensive guidance on these matters.
At the end of a medical device's life, sensitive, protected, and health data must be securely erased before disposal or refurbishment, following NIST SP 800-88 Rev. 1 guidelines.
To effectively manage medical device cybersecurity risks, comprehensive security measures and risk assessments must be integrated at every stage of a medical device's lifecycle. Strict risk assessment and management processes must be adhered to by Original Equipment Manufacturers (OEMs), users, and stakeholders to ensure a device is as low risk as possible at every stage of its life.
Vantage MedTech, an ISO 13485-certified company, provides product development services incorporating cybersecurity consulting to ensure Class I, II, or III devices are safe from inception to decommissioning.
During the deployment phase, managing cybersecurity risks involves ensuring secure network and data system configurations, secure communication pathways, regular security assessments and testing schedules, network security, proper configuration, interoperability testing, physical security, continuous monitoring, regular updates, and incident response and recovery.
The Secure Product Development Framework (SPDF) and Software Bill of Materials (SBOM) are crucial components in achieving these goals during device development. These processes reflect the FDA’s final cybersecurity guidance effective June 2025 and broader industry best practices for medical device cybersecurity risk management, emphasizing a total product lifecycle approach to maintain patient safety, regulatory compliance, and secure device operation.
It's worth noting that 82% of healthcare organizations have experienced a cyberattack due to medical device (IoT) vulnerabilities. The production phase risk assessments ensure medical devices are resilient against cybersecurity threats, such as the event reported by LivaNova in late 2023.
Devices must meet security risk requirements depending on the region they will be used in, their medical class, the functions they are designed to perform, and other factors. Post-market cybersecurity risk assessments include continuous monitoring, regular updates and patch management, incident response and recovery, user training and awareness, and vulnerability reporting and management.
Regulatory bodies and standards that address cybersecurity risk assessment in medical devices include the U.S. Food and Drug Administration (FDA), ISO 14971, IEC 62304, and ANSI. The average FDA approval rating for medical devices is just 45%.
In conclusion, the key cybersecurity risk management processes that must be adhered to throughout a medical device's entire lifecycle include planning, risk assessment (including threat modeling), secure development practices, verification and validation, regulatory submission compliance, post-market surveillance, and ongoing vulnerability management. These processes ensure compliance with regulatory bodies like the FDA and minimize cyberattack risks. By following these guidelines, we can work towards a safer, more secure future for medical device users and patients alike.
- In the medical devices sector, news about cybersecurity risks can significantly impact health-and-wellness, especially in light of chronic diseases, cancer, and neurological-disorders.
- The period from design and development to decommissioning calls for rigorous bio-based research and product development to address cybersecurity concerns in medical devices.
- Cybersecurity in medical devices is not only about technology, but also about science, as it relates to medical-conditions and chronic-diseases.
- Post-market surveillance is essential to ensure the safety and security of medical devices, reviewing them using processes like ISO 14971:2019 for risk management.
- As medtech advances, so do the challenges in managing cybersecurity risks during the deployment phase, where secure network configurations and incident response plans play a crucial role.
- To combat cyberattacks, Original Equipment Manufacturers (OEMs) must integrate cybersecurity measures into each stage of product development, following guidelines such as the FDA's updated document and industry best practices like the Secure Product Development Framework (SPDF) and Software Bill of Materials (SBOM).
- With the increasing dependence on technology in healthcare, cybersecurity within medical devices will remain a pressing concern in the field of health-and-wellness, warranting continued attention and proactive intervention by all stakeholders.
