What Are the Most Concerning Medical Device Cyber Threats?

Updated April 13, 2025

As with any connected device, cyber threats are simply part of the environment. There’s no way to remove all risk. However, some are more concerning than others. Here’s a quick guide on the most threatening cyber threats to medical devices.

Key Takeaways

• Ransomware disrupts healthcare operations and endangers patients.
• Data breaches target sensitive patient information for illicit gain.
• DDoS attacks can disable critical medical devices and networks.
• Insider threats pose risks through malice or accidental actions.
• Prevention requires secure design, testing, and employee education.
• The FDA's guidance mandates proactive cybersecurity measures.

Table of Contents

• Key Takeaways
• Ransomware Attacks Surge
• Hacking and Data Breaches Are Lucrative
• Distributed Denial of Service (DDoS) Can Shutter Networks and Services
• Insider Threats Can Be Malicious or Accidental
• Medical Device Cyber Threats Experts
• Medical Device Cybersecurity FAQs

Why this matters

The stakes for medical device cybersecurity are incredibly high, extending beyond financial costs to direct impacts on patient safety and continuity of care. Ransomware attacks, for example, can disable critical hospital systems, leading to delayed treatments or the inability to access patient records, potentially resulting in adverse patient outcomes. Data breaches compromise sensitive protected health information (PHI), exposing individuals to privacy violations and identity theft. The FDA, in its "Cybersecurity in Medical Devices" Final Guidance dated February 3, 2026, emphasizes that manufacturers must proactively address and manage cybersecurity risks throughout the total product lifecycle. This guidance underscores the necessity of designing secure devices, performing thorough risk assessments, and implementing postmarket surveillance strategies. Adherence to standards such as IEC 81001-5-1 for health software and health IT systems safety and security, ISO 27001 for information security management, and AAMI TIR57 for principles for medical device security, risk management are crucial for establishing a strong cybersecurity posture and protecting both patients and healthcare infrastructure.

Ransomware Attacks Surge

Ransomware has been growing in every industry. A state of ransomware report found that 58% of healthcare organizations had experienced a medical device cyberattack. The authors of the study defined why medical devices were such a target as the widespread use of legacy technology and infrastructure.

The consequences of ransomware aren’t just financial. They can interrupt care or even cause deaths. An analysis of the data estimated that ransomware attacks caused the deaths of 42 to 67 patients between 2016 and 2021.

From the manufacturer or organizational viewpoint, the most critical things to do to prevent ransomware include:

• Constant scanning for vulnerabilities
• Having a patching and updating protocol after vulnerability identification (which is also part of the Food and Drug Administration (FDA) requirements)
• Using a secure by design framework
• Regular penetration testing
• Limiting user access and creating strong controls
• Educating providers and patients about basic security measures (e.g., not connecting on unsecured networks)
• Firewalls, intrusion prevention system (IPS), and network segmentation

Hacking and Data Breaches Are Lucrative

These medical device cyber threats represent another angle for hackers. They could gain unauthorized access to a medical device, allowing them to infiltrate a whole network. Instead of seizing control, they are there to collect valuable PII and PHI, which they can sell on the dark web.

Opportunistic cybercriminals are typically motivated by greed and will use various tactics like phishing to breach systems. The best way to lower this risk is by having many of the same safeguards as noted above.

Additionally, manufacturers must create and keep their software bill of materials (SBOM) current. Doing so supports vulnerability management, supply chain transparency, and regulatory requirements.

Another best practice is cyber training for healthcare professionals who have access to the organization’s network.

Distributed Denial of Service (DDoS) Can Shutter Networks and Services

A DDoS is another threat that overwhelms networks and makes them inaccessible. The patient could be at serious risk if this occurs in a medical device scenario.

Preventing these attacks requires a multilayered approach to secure network infrastructure, which the study above cited as a leading cause of cyberattacks on medical devices.

Organizations should also implement DDoS protection systems to fend off attacks. These systems do this by analyzing traffic data and finding patterns that could be malicious, segregating them from legitimate traffic.

See also: When to Hire a Device Security Consultant vs. Build In-House, Cybersecurity Is Now a QMS Requirement, and Why Medical Device Cybersecurity Is Nothing Like Enterprise.

System audits and updates along with pen testing are proactive measures that can help you avoid a DDoS attack.

Insider Threats Can Be Malicious or Accidental

Much cybersecurity research points to people as the weakest link. Many cyberattacks start with their help, whether willingly or carelessly. Insider threats can compromise a device or network, leading to financial, reputational, or patient harm.

Prevention of these includes many of the same best practices listed above. The most important is a cybersecurity framework that involves security and access controls, encryption, and monitoring systems.

Employee training is vital here as well. It needs to be part of every employee’s curriculum, which they participate in regularly. It shouldn’t be a one-time thing that happens in onboarding.

Medical Device Cyber Threats Experts

Since we focus solely on medical device cybersecurity, you can use our expertise and experience. We work with manufacturers and organizations to set strategies, perform audits, conduct pen testing, and more.

Be ready for anything that comes next on the threat landscape.

Contact us today to get started.

How Blue Goat approaches this

Blue Goat Cyber addresses medical device cybersecurity threats through a structured, risk-based methodology. We apply deep technical expertise, including certifications like CISSP and OSCP, and use experience from former military red teams to identify and neutralize potential vulnerabilities. Our services start with a thorough threat modeling process, often followed by penetration testing to expose weaknesses before malicious actors can exploit them. We work closely with manufacturers to integrate security into the design phase, reducing the attack surface from the outset. Our approach includes rigorous documentation and alignment with regulatory requirements, ensuring that devices meet compliance standards. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost. Learn more about our proactive defense strategies at Medical Device Penetration Testing.

FAQ

What medical device cyber threats are most concerning?

The most concerning threats include ransomware, which can interrupt care; data breaches aimed at stealing PII/PHI; distributed denial of service (DDoS) attacks that make networks inaccessible; and insider threats, both malicious and accidental.

How does the FDA address medical device cybersecurity?

The FDA requires medical device manufacturers to implement a secure product development lifecycle, manage post-market vulnerabilities, provide a Software Bill of Materials (SBOM), and have processes for security updates and patches. These requirements ensure devices are resilient against cyber threats throughout their lifecycle.

What are the consequences of ransomware attacks on medical devices?

Ransomware attacks can have severe consequences, including financial losses, interrupted patient care, and, in critical cases, patient deaths. They can also damage an organization's reputation and lead to regulatory penalties.

How can medical device manufacturers prevent data breaches?

Manufacturers can prevent data breaches by implementing secure-by-design frameworks, conducting regular vulnerability scans and penetration tests, maintaining an up-to-date Software Bill of Materials (SBOM), limiting user access, and providing cybersecurity training to staff.

What is the role of employee training in mitigating cyber threats?

Employee training matters for mitigating cyber threats, especially insider threats. Regular and complete training helps staff recognize phishing attempts, understand secure practices, and avoid accidental actions that could compromise a device or network.

Does the FDA have specific requirements for medical device cybersecurity submissions?

Yes, the FDA's February 3, 2026 final guidance requires premarket submissions for 'cyber devices' to include detailed cybersecurity plans, a Software Bill of Materials (SBOM), and strong processes for vulnerability management and postmarket updates.

About the author

Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance. Read more about Christian.