Improving the security management of medical devices by integrating their lifecycle
In the rapidly evolving world of healthcare technology, cybersecurity has become an essential concern for manufacturers and providers alike. Vantage MedTech is leading the charge with its product development services, incorporating cybersecurity consulting to ensure Class I, II, or III devices are as safe as possible and meet every security regulatory requirement from inception to decommissioning.
The value of a medical record on the black market ranges from $100 to $1000, making these devices prime targets for cybercriminals. As more medical devices become IoT-enabled for diagnostics and patient care, the risk of cyberattacks increases.
To combat this, Vantage MedTech employs a multi-faceted approach to cybersecurity risk management.
Design and Development
A secure-by-design approach is adopted, integrating security into early development stages. This includes formal threat modeling, secure coding standards, and penetration testing before market release. Strong technical controls such as encryption of data (at rest and in transit), authentication for user access, and safeguards against unauthorized firmware updates are implemented. A Software Bill of Materials (SBOM) is developed to list all software components (including third-party and open-source) to track and manage potential vulnerabilities throughout the product lifecycle.
Production
Controlled and secure software and hardware supply chains are established with validated components to minimize risks from malicious or vulnerable parts. Quality controls that incorporate cybersecurity checkpoints, ensuring secure firmware and software installation before deployment, are implemented.
Deployment
Comprehensive risk assessments are conducted for each device type, considering known vulnerabilities, exposure, and patchability. Network segmentation tailored to healthcare environments is applied to isolate devices and prevent threats from spreading if compromise occurs. Device isolation is validated through clinical workflow-aware penetration testing and passive monitoring to avoid interfering with patient care while ensuring security controls work.
Post-Market
Ongoing post-market surveillance, including continuous monitoring of device behavior and telemetry to detect anomalies early, is implemented. A robust patch management infrastructure is established, capable of secure, timely remote updates that maintain device uptime especially in clinical settings. Coordinated vulnerability disclosure programs are established to handle reported security issues responsibly and transparently, reinforcing regulatory compliance and stakeholder trust. Regular vulnerability assessments and updates to risk management practices are carried out to address emerging threats and maintain device safety.
Decommissioning
Secure end-of-life procedures, including data sanitization to protect sensitive information and prevent unauthorized data recovery, are ensured. Device retirement is documented and managed to prevent reuse of vulnerable devices in clinical environments.
By following these steps, aligned with FDA recommendations and healthcare-specific operational requirements, manufacturers and healthcare providers can effectively reduce cybersecurity risks across the entire medical device lifecycle while safeguarding patient safety and data integrity. Regulatory bodies require manufacturers to implement cybersecurity risk management processes at every stage of a device's lifecycle.
The Secure Product Development Framework (SPDF) helps Original Equipment Manufacturers (OEMs) ensure that security is a fundamental part of the design and development process. Cyber incidents involving medical devices are costly to hospitals, health organizations, and pose serious, life-threatening risks to patients. As cyber attacks targeting medical devices are on the rise due to their security vulnerabilities, continuous monitoring, regular updates and patch management, incident response and recovery, user training and awareness, vulnerability reporting and management, and secure erasure of sensitive data before disposal or refurbishment are key practices during post-market surveillance.
- The collaboration between Vantage MedTech and medical device manufacturers enhances product development, integrating cybersecurity as a fundamental aspect from inception to decommissioning.
- In the post-market phase, Vantage MedTech implements continuous monitoring and robust patch management to detect anomalies, update devices securely, and maintain uptime in clinical settings.
- With the Secure Product Development Framework (SPDF), Original Equipment Manufacturers (OEMs) prioritize cybersecurity throughout their design and development process to minimize risks and protect patient safety.
- As cybercriminals target medical devices for financial gain, medical devices, including those with IoT capabilities, are prime targets, making cybersecurity an essential concern in medtech and health-and-wellness industries.
- Post-market surveillance practices, such as vulnerability reporting and management, user training, and secure data erasure before disposal, are essential for reducing cybersecurity risks in medical devices and maintaining regulatory compliance.
- To combat the rise in cyber attacks on medical devices, technology solutions like network segmentation, penetration testing, and cybersecurity risk management at every stage of a device's lifecycle play a crucial role in safeguarding bio and medical devices, therapies, and treatments while ensuring medical-conditions data's integrity.
