Failure to build your medical device on a secure architecture costs millions and puts patients at risk
Poor security architecture choices early in device design create problems that last for years. When companies try to add security features after they finish designing a device, they face much higher costs, delays, and safety risks. The FDA’s 2023 guidance makes this clear: good cybersecurity must be “built in” to a device, not “bolted on” after the device is designed.
This rule isn’t just about following regulations. It’s about smart business choices that can save companies millions while keeping patients safe.
The Hidden Costs of Not Creating a Security Architecture
When security is an afterthought, companies build up what experts call “security debt.” This is the hidden cost of poor choices that get worse over time. For medical devices, security debt can mean life-or-death problems.
Think about what happens when companies find security flaws in devices already being used by patients. The FDA says it’s much harder to fix cybersecurity problems once a device is on the market. This creates big costs for:
- Emergency fixes: Rushing security patches through testing while regulators watch closely
- Field repairs: Sending technicians to hospitals where device downtime hurts patient care
- Regulatory filings: Submitting new paperwork to FDA when security changes affect safety
- Legal costs: Handling enforcement actions and lawsuits from security incidents
The FDA points out that using good security processes during design can prevent the need to rebuild devices later. This saves time and money when adding new features or fixing security holes.
Security Architecture: The Foundation That Matters
Good security architecture supports safety throughout a device’s life. Security architecture defines the system and all connections going in and out of it.
The FDA defines security architecture as views of system design that show how the system splits into security areas. These views show how security features protect data based on how sensitive that data is.
This foundation must be built during design. It gets documented through specific views that show how security controls handle identified threats.
Key Security Views the FDA Wants
The FDA asks for specific architectural views that match device complexity:
- Overall System View: This describes the whole medical device system. It includes the device and all internal and external connections. For networked devices, this shows all connected parts like update systems, hospital networks, cloud connections, and home networks.
- Multi-Patient Risk View: The FDA wants manufacturers to show how their devices protect against attacks that could harm many patients at once.
- Update View: This shows the complete process for getting software updates and patches to the device.
- Security Use Case Views: Detailed views that address specific security scenarios for device functions.
Connecting Security to Quality Systems
Good security architecture must work with the company’s Quality System under 21 CFR Part 820. The FDA recommends that device makers use the Q-submission process to discuss security design with the agency early.
Key connection points include:
Design Planning (21 CFR 820.30(b))
Companies must create plans that describe design activities. These plans must include cybersecurity from the start.
Design Requirements (21 CFR 820.30(c))
Security requirements must be set up alongside functional requirements. The FDA recommends that procedures include design requirements for security features built into the device.
Design Outputs (21 CFR 820.30(d))
Security architecture documentation becomes part of design outputs that prove the design meets requirements.
Secure Product Development Framework: How to Do It
The FDA recommends using a Secure Product Development Framework (SPDF) to meet Quality System requirements. An SPDF is a set of processes that reduce the number and severity of security flaws throughout the device lifecycle.
Key SPDF parts that support architectural security include:
Threat Modeling
The FDA recommends that premarket submissions include threat modeling documentation. This shows how the medical device system was analyzed to find potential security risks that could impact safety.
Security Controls
The FDA identifies eight essential security control types:
- Authentication
- Authorization
- Cryptography
- Code, Data, and Execution Integrity
- Confidentiality
- Event Detection and Logging
- Resiliency and Recovery
- Updatability and Patchability
Lifecycle Risk Management
Security risk assessment before market may differ from assessment after market. Architecture choices must account for how risks change over the device lifecycle.
The Money Side: Why Built-In Security Pays Off
Industry data shows that fixing security issues after market costs 10-100 times more than fixing them during design. For medical devices, these costs are even higher because of:
- Regulatory oversight requirements
- Clinical environment limits
- Patient safety needs
- Legal liability
The FDA recommends tracking key numbers: How many found security flaws get updated or patched; How long from finding a flaw to fixing it; How long from having a fix available to putting it in all field devices.
These numbers directly show business costs. A device with strong built-in security will do better than bolt-on approaches on all three measures.
Planning for the Future: Making Architecture Last
Security architecture must be designed for current threats and future growth. The security architecture should be broad and open-ended. Not all future parts need to be understood today, but the security architecture should support growth toward the desired future state.
This forward-thinking approach includes:
Planning for More Connections
Many devices that start standalone eventually need network connections. Early architecture choices determine whether such expansion can be done securely or needs complete redesign.
Planning for Changing Rules
As cybersecurity requirements keep evolving, devices with strong foundations can adapt more easily to new regulatory expectations.
Supporting Growing Security Operations
The FDA recommends that manufacturers track and record key measures. Devices with built-in security monitoring can provide these numbers efficiently.
Bottom Line: Security Architecture as Business Advantage
The choice between built-in and bolt-on security isn’t just about following rules or managing risk. It’s about basic business strategy. Companies that invest in strong security architecture from the design phase get:
- Faster time-to-market: Shorter regulatory review cycles through clear security documentation
- Lower total costs: Fewer post-market security fix costs
- Better market position: Stronger competitive positioning as cybersecurity becomes a buying factor
- Regulatory efficiency: Smoother submission processes through proven security by design
The growing connections between medical devices show the importance of addressing cybersecurity risks in device design because of the effects on safety and effectiveness.
The message is clear: security architecture isn’t a technical detail to hand off. It’s a strategic business decision that affects the entire device lifecycle. Companies that understand this early will benefit for years to come. Those who treat security as an afterthought will pay the price in both money and patient safety.
This blog post is based on FDA guidance documents including “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (2023) and related industry standards. For specific regulatory guidance, consult current FDA publications and seek qualified regulatory advice.