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As the healthcare industry continues to embrace digital transformation, connected medical devices are becoming more common—and more vulnerable. From insulin pumps and pacemakers to remote monitoring systems and diagnostic tools, these devices are increasingly exposed to cyber threats that can compromise patient safety, data integrity, and regulatory compliance.
In this blog, we explore the top cybersecurity risks facing connected medical devices and share expert insights on how manufacturers can stay ahead of evolving threats and meet global regulatory expectations.
Listen to this podcast where we take a deeper dive into the Cybersecurity risks associated with Connected Medical Devices
Late Integration of Cybersecurity in Product Development
One of the most frequent mistakes medical device manufacturers make is waiting too long to address cybersecurity. Cybersecurity should be embedded early in the medical device development lifecycle, not added as an afterthought. Delayed integration can lead to vulnerabilities that are costly to fix and may result in regulatory delays or denials.
Tip: Begin threat modeling immediately after defining device features to ensure secure design specifications and reduce remediation costs.
Incomplete Software Bill of Materials (SBOM)
A comprehensive Software Bill of Materials (SBOM) is now a regulatory requirement in both the U.S. and EU. Many companies still submit SBOMs that lack depth, omitting nested components or failing to meet machine-readable format standards. This can lead to compliance issues and increased risk exposure.
Tip: Include all software layers—components of components—and ensure your SBOM is both human- and machine-readable.
Legacy Devices with Outdated Security
Legacy medical devices often lack modern cybersecurity features such as patching capabilities, logging, and threat detection. These devices pose a significant risk, especially when integrated into hospital networks.
Tip: Conduct a full cybersecurity assessment of legacy devices and plan for updates or redesigns that meet current FDA cybersecurity guidance and EU MDR requirements.
Lack of Threat Modeling and Vulnerability Management
Without proper threat modeling, manufacturers may overlook critical vulnerabilities. Additionally, failing to maintain a coordinated vulnerability disclosure program can result in non-compliance and reputational damage.
Tip: Implement a secure product development framework that includes threat modeling, penetration testing, and vulnerability traceability.
Overexposed Physical and Network Interfaces
Ports like USB, Bluetooth, and Wi-Fi can be exploited if not properly secured. Devices with exposed service ports or debug features are particularly vulnerable to unauthorized access.
Tip: Use physical controls (e.g., security screws, access doors) to limit exposure. Disable unnecessary ports and implement strong authentication protocols.
Misalignment with Global Regulatory Requirements
With evolving guidance from the FDA, EU MDR, UK MHRA, and the Cyber Resilience Act, companies must ensure their cybersecurity practices align across markets. Misalignment can lead to costly redesigns and delayed market access.
Tip: Stay informed on global cybersecurity regulations and work with experts who understand regional differences and harmonization efforts.
Final Thoughts
Cybersecurity in connected medical devices is no longer optional—it’s a regulatory and ethical imperative. By addressing these risks early and thoroughly, manufacturers can protect patients, ensure compliance, and maintain trust in their products.
Ready to Strengthen Your Cybersecurity Strategy?
Regulatory Compliance Associates® (RCA) specializes in helping medical device companies navigate the complex world of cybersecurity compliance, from SBOM development and threat modeling to FDA submissions and global market access. Contact RCA today to schedule a consultation with our cybersecurity experts and ensure your device is secure, compliant, and ready for market.
