Why Cybersecurity Is Non-Negotiable for Medical Devices

What happens when a medical device is hacked? For someone relying on a connected insulin pump, cardiac monitor, or implantable defibrillator, the consequences are not just digital—they’re deeply personal and potentially life-threatening. But it doesn’t stop there. One compromised device can open the door to an entire hospital network, jeopardizing adjacent systems and critical care delivery across the board. 

The Bigger Picture: What’s at Stake  

Cybersecurity has become a cornerstone of safety, compliance, and patient trust in the development of connected medical technologies. Regulatory bodies now expect manufacturers to proactively address cybersecurity risks across the entire device lifecycle. And for people using these technologies, the expectation is simple: that the systems keeping them healthy will also keep them safe. 

The Challenge: Growing Connectivity, Expanding Risk  

As medical devices grow smarter and more interconnected via cloud platforms, mobile apps, hospital networks, and wearable sensors, their attack surface increases exponentially. And with that, so does the potential blast radius of a single breach.
A hacked device isn’t just a safety concern for the individual. It’s an access point. From there, attackers can pivot laterally across the network, compromise other medical systems, and even hold the entire healthcare infrastructure hostage through ransomware.  

The Path Forward: Cybersecurity by Design  

1.      Secure by Design Starts Early

• Apply threat modeling and cybersecurity risk analysis at the concept phase

• Use secure design principles like least privilege, fail-safe defaults, and defense in depth

• Integrate cybersecurity requirements directly into the Design Development Plan

Example: A client developing a wearable device for remote patient monitoring engaged us to run a threat model before hardware selection, helping them avoid costly redesigns down the line.

2.      Navigating Regulatory Expectations with Confidence

• Develop and maintain a Software Bill of Materials (SBOM)

• Include documentation for secure boot, authentication protocols, and data encryption

• Create and test a patch and update mechanism before market release

• Prepare a vulnerability disclosure and response plan in line with FDA expectations

Example: For a connected infusion pump, we helped draft and implement a patch strategy that met both FDA premarket and postmarket cybersecurity guidance, ensuring the client’s 510(k) submission was successful on first pass. 

3.      Beyond the Device: Safeguarding the Entire Ecosystem

Not all medical devices are classified as high risk, but in a connected hospital environment, even a seemingly benign system can become a conduit for a catastrophic cyber event.

Example: The Low-Risk Monitor with High-Risk Consequences

Imagine a basic vitals monitoring system used in a step-down recovery unit. It’s a low-risk device with no therapeutic function, intended only to track heart rate and blood pressure post-operatively. Because of its classification, it may not receive the same cybersecurity scrutiny as higher-risk systems. But it's connected to the hospital network for remote monitoring, EMR integration, and software updates.

Now imagine it’s compromised through an unpatched software component. That foothold enables a threat actor to move laterally through the hospital’s internal systems, gaining access to infusion pumps in the ICU or the pharmacy’s medication dispensing system. Within hours, the entire infrastructure could be held ransom, jeopardizing surgeries, ER admissions, and continuity of care for every patient in the building. 

4.      Building Trust Through Transparency and Monitoring

• Secure devices with multi-factor authentication and encrypted communication protocols

• Enable real-time monitoring and logging to detect unusual behavior

• Keep users informed with clear, understandable security updates and disclosures

Why it matters: For people living with chronic conditions, devices are not optional; they are essential. Demonstrating security builds trust, loyalty, and ultimately better health outcomes.

What the Regulators Say  

The FDA’s final 2023 guidance makes clear that “the exploitation of one system can compromise other interconnected systems, even if those systems individually pose lower risks” (Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, FDA, 2023).

Key regulatory expectations include:

• Evaluating system-level risks, including downstream effects of a breach

• Incorporating network segmentation, secure defaults, and access control

• Designing for resilience, including timely patching and recovery

Manufacturers are expected to demonstrate not only that their device is secure but that it doesn’t pose a risk to the broader healthcare ecosystem in which it operates. 

What You Can Do Today  

Cybersecurity isn’t a one-time checkbox. It is a continuous practice woven into every stage of the medical device lifecycle. By taking a proactive, human-centered approach to security, organizations can reduce risk, accelerate approvals, and protect not only individual patients but entire care delivery systems.

Whether you’re at the start of your development journey or assessing an existing product, now is the time to elevate your cybersecurity strategy.  

Partnering for Secure, Compliant, and Trusted Devices

Cybersecurity is a shared responsibility across the medical device ecosystem, and navigating it effectively requires experience, strategic foresight, and cross-functional expertise. At ClariMed, we help companies design and deliver safer, smarter, and more resilient digital health technologies without compromising speed or compliance. 

Whether you're developing a connected device from the ground up, preparing for regulatory submission, or addressing postmarket cybersecurity expectations, our team can guide you every step of the way. 

We bring a lifecycle approach that integrates secure design principles, risk mitigation strategies, and regulatory know-how, helping you meet FDA and global requirements while building trust with end users and care providers. 

Explore our Cybersecurity Solutions for Medical Devices here: clarimed.com/services/digital-health#cyber-security-solutions

Looking to strengthen the cybersecurity of your medical devices? Contact ClariMed today to learn how we can help you navigate these challenges and build resilient, trusted products.