Security Architecture as the Foundation of your Medical Device

A medical device built on a weak security architecture can cost a manufacturer a lot of money. Worse, it can put patients at risk.

Decisions made early in the design process have a way of coming back to haunt manufacturers. Poor medical device security architecture can lead to expensive redesigns, development delays, and security problems that follow a device throughout its lifecycle.

So, it's not surprising that the FDA's February 2026 premarket cybersecurity guidance emphasizes building security into a device from the beginning. What it doesn't want medical device manufacturers to do: Fold in protections after the design is finished.

And let's be real. For manufacturers, it's good business sense to design security architecinture into medical devices from the get-go. Jumping on cybersecurity from the start avoids expensive rework as well as protects those who depend on medical devices.

The hidden costs of not creating a security architecture

When manufacturers put off security decisions until later in development, they're taking on what the industry calls "security debt." And like financial debt, it tends to get more expensive the longer it goes unaddressed.

For medical device manufacturers, the consequences can be especially serious. A security flaw discovered after a device reaches patients isn't just an engineering headache. Depending on the vulnerability, it could affect patient safety.

The FDA says cybersecurity problems can be harder to address once a device is on the market. Manufacturers may find themselves dealing with several unexpected expenses:

• Emergency fixes: Developing and testing security patches under tight deadlines, sometimes with increased regulatory scrutiny.
• Field repairs: Sending technicians to hospitals to address vulnerabilities, potentially taking devices out of service and disrupting patient care.
• Regulatory filings: Preparing additional FDA submissions when security-related changes trigger regulatory requirements.
• Legal costs: Responding to enforcement actions or lawsuits that may follow a cybersecurity incident.

These costs can add up quickly. And some are avoidable.

Building security into the design process gives manufacturers a better chance of identifying weaknesses before they become expensive problems. It can also make future software updates and security fixes easier to manage without redesigning the device.

Security architecture: the foundation that matters

Medical device security architecture starts with understanding the entire system, not just the device itself. That means identifying its components, how they communicate, and every connection that could introduce a security risk.

FDA describes security architecture through design views that show how a system is divided into security domains and how its controls protect information based on sensitivity.

These aren't diagrams manufacturers should put together at the last minute for an FDA submission. They should reflect decisions made during development, including how security controls address the threats identified through risk assessment.

Key security views the FDA wants

FDA's premarket cybersecurity guidance recommends several architecture views, depending on the device's design and complexity. Each serves a different purpose, and together they help reviewers understand how the manufacturer has addressed cybersecurity risks.

Our book chapter on security architecture views explains how to develop them.

• Global System View: Shows the complete device system and its connections. For a networked device, that could include hospital networks, cloud services, home networks, and software update infrastructure. The goal is to make clear what connects to the device and how those connections work.
• Multi-Patient Harm View: Examines how the system could be attacked in ways that affect multiple patients. It also shows the security measures designed to prevent those attacks or limit their consequences.
• Updatability and Patchability View: Documents how software updates and security patches move from development through delivery and installation on the device.
• Security Use Case Views: Focus on individual security scenarios associated with device functions. These detailed views show how security controls work in situations where particular threats could arise.

Connecting Ssecurity to quality systems

Security architecture can't operate separately from a manufacturer's quality management system. Under FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820), which incorporates ISO 13485:2016 by reference, cybersecurity needs to be addressed through the applicable design and development processes.

Manufacturers can also use FDA's Q-Submission Program to discuss their security design approach with the agency before submitting a device for review.

There are three important areas where QMSR cybersecurity design controls and security architecture come together.

Design planning (ISO 13485 Subclause 7.3.2)

Manufacturers need documented plans for design and development. Cybersecurity should be part of that planning from day one, not something the engineering team addresses after the device is built.

Design inputs (ISO 13485 Subclause 7.3.3)

Security requirements belong alongside the device's functional requirements. FDA recommends establishing design requirements and acceptance criteria for built-in security features. That gives developers specific security objectives to work toward and a way to determine whether they've met them.

Design outputs (ISO 13485 Subclause 7.3.4)

Security architecture documentation is part of the design outputs. It shows how the manufacturer translated security requirements into the device's actual design and provides evidence that the architecture addresses those requirements.

Secure product development framework: how to do it

FDA recognizes a Secure Product Development Framework (SPDF) as one approach manufacturers can use to address cybersecurity within their quality management systems. The idea is to have processes in place that catch security weaknesses early and reduce their severity throughout the device's lifecycle.

An SPDF also helps manufacturers make security part of everyday development work rather than treating it as a separate task. Our book chapter on the secure development lifecycle explains how to establish these processes.

Three parts of an SPDF are especially important to security architecture.

Threat modeling

FDA recommends including threat modeling documentation in premarket submissions. This gives reviewers a picture of how the manufacturer examined the medical device system, identified potential threats, and evaluated which ones could affect patient safety.

Security controls

FDA identifies eight security control categories in Section V.B.1 of its premarket cybersecurity guidance, with additional recommendations in Appendix 1. Manufacturers should consider how each applies to their device and its architecture.

• Authentication
• Authorization
• Cryptography
• Code, Data, and Execution Integrity
• Confidentiality
• Event Detection and Logging
• Resiliency and Recovery
• Updatability and Patchability

Lifecycle risk management

Cybersecurity risks don't stay the same once a device reaches the market. New vulnerabilities emerge, software changes, and threats evolve.

That's why a premarket security risk assessment may look different from one performed after the device is in use. Manufacturers need an architecture that supports ongoing risk management, including the ability to address new vulnerabilities without compromising device safety.

The money side: why built-in security pays off

Security problems are generally easier and less expensive to address during development than after a device reaches patients. FDA's cybersecurity guidance makes a similar point, noting that vulnerabilities can become harder to mitigate once a device is on the market.

For medical device manufacturers, several factors can make those fixes particularly expensive:

• Regulatory oversight: Some security-related changes require additional documentation or regulatory submissions.
• Clinical environment limits: Hospitals can't always take devices out of service whenever a patch becomes available.
• Patient safety needs: Manufacturers must make sure a security fix doesn't interfere with the device's intended clinical functions.
• Legal liability: A cybersecurity incident that causes harm can expose manufacturers to lawsuits and other legal expenses.

FDA also recommends tracking three cybersecurity measures in Section V.A.6 of its premarket guidance:

• The percentage of identified vulnerabilities that have been updated or patched.
• The time between discovering a vulnerability and making a fix available.
• The time between making a fix available and deploying it to affected devices in the field.

These measures can tell manufacturers a lot about how well their security processes work. They can also reveal where delays are driving up costs.

A device designed with secure update mechanisms and effective vulnerability management processes may be easier to maintain than one that requires extensive modifications whenever a new threat appears.

Planning for the future: making architecture last

Nobody can predict every cybersecurity threat a medical device will face over its lifetime. Manufacturers can, however, make design decisions today that leave room for changes tomorrow.

That means building an architecture that can accommodate new capabilities, connections, and security requirements without forcing engineers to start over.

Planning for more connections

A medical device that operates independently today may eventually need to connect to a hospital network, mobile application, or cloud service.

Manufacturers should consider those possibilities during initial development. Otherwise, adding connectivity later could introduce vulnerabilities that the original architecture wasn't designed to handle.

Planning for changing rules

FDA's cybersecurity expectations have evolved, and manufacturers should expect further changes as technology advances.

A well-documented security architecture makes it easier to evaluate new regulatory expectations, identify gaps, and determine what changes are needed.

Supporting growing security operations

FDA recommends that manufacturers monitor and document cybersecurity measures throughout a device's lifecycle.

Devices designed with logging, monitoring, and secure update capabilities can make that work more manageable. Manufacturers can track vulnerabilities, investigate incidents, and verify whether security fixes have reached devices in the field.

Bottom line: security architecture as business advantage

Building security into a medical device from the beginning isn't just about satisfying FDA expectations. It's also about avoiding problems that can become expensive and difficult to fix later.

Manufacturers that invest in security architecture during development may see several business benefits:

• Faster time-to-market: Clear security documentation can help reduce questions and rework during regulatory review.
• Lower total costs: Addressing vulnerabilities during development may reduce the need for expensive postmarket fixes.
• Better market position: Healthcare organizations increasingly consider cybersecurity when evaluating connected medical devices.
• Regulatory efficiency: A documented security-by-design approach can make it easier to demonstrate how cybersecurity risks have been addressed.

As medical devices become more connected, manufacturers have more potential vulnerabilities to consider. A security weakness in one component can affect other parts of the system and, in some cases, patient safety.

That's why medical device security architecture deserves attention long before a product reaches FDA review.

The decisions manufacturers make during design can influence how easily they maintain, update, and secure their devices for years. Getting those decisions right early can save money, reduce risk, and make life easier for everyone responsible for keeping the device secure.

Need help with your medical device security architecture? Email us at info@cybermed.ai.

Sources

• FDA. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions. Final guidance, February 3, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions
• FDA. Quality Management System Regulation, 21 CFR Part 820 (incorporating ISO 13485:2016), effective February 2, 2026.
• ISO 13485:2016. Medical devices, Quality management systems, Requirements for regulatory purposes.