Cybersecurity for Connected Medical Device Manufacturers

Health information remains a valuable target for malicious actors, with connected medical devices expanding the potential attack surface. Many manufacturers rely on legacy systems lacking modern security protections. Governments across the United States, Canada, European Union, and other jurisdictions have established cybersecurity regulations protecting patients and mandating vulnerability remediation throughout device lifecycles.
Cybersecurity testing and regulatory compliance for medical manufacturers is not a one-size-fits-all process, and depends on company maturity, product development stage, existing measures, and other variables.
6 Areas of Cybersecurity Focus for Connected Medical Device Manufacturers
1. Compliance and Security Landscaping
Mapping security infrastructure represents the foundational step. This involves situating endpoints and network devices and extends beyond mere compliance checkbox completion to achieving true protection against cyber threats.
2. Managed Detection and Response
MDR involves outsourcing cybersecurity services. Rather than building internal capabilities, outsourcing detection and response to experienced professionals ensures that your system is running correctly, updated regularly.
3. Endpoint Security
Each device endpoint presents potential breach risks for Protected Health Information (PHI), resulting in fines and reputational damage. CrowdStrike is a cloud-native endpoint security platform validated for HIPAA compliance, and has partnered with CISA to protect critical endpoints and workloads, as well as expanded its technical integrations for healthcare device manufacturers like Nihon Kohden.
4. Vulnerability Assessment
Vulnerability assessments provide a snapshot of the vulnerabilities that exist within your security environment, such as unpatched or misconfigured network services. Assessments should be conducted regularly, particularly after configuration changes, updates, integration of new technology, and migration of existing data.
5. Penetration Testing
Penetration testing involves a simulated attack on your devices to see if there are any vulnerabilities that could be exploited by malicious actors. Third-party contractors bring a different outlook on your devices than internal testing can provide.
6. Ongoing Security Information and Event Management
SIEM and Security Operations Centers function as your command center, where you monitor your network and devices, and your defense center, which logs and combats any security events that arise, providing real-time monitoring and intrusion prevention.
NaviSec: Security Testing Tailored to Your Needs
Each company's cybersecurity needs differ, depending on where you are in developing your product and building your company. NaviSec offers either comprehensive packages addressing all six areas above or focused services like penetration testing or vulnerability assessment alone, including management of third-party platforms like CrowdStrike.
Contact us for a free consultation to assess your cybersecurity needs.