A Guide to FMEA for Medical Devices: Including Cybersecurity Failure Modes

In this guide, we’ll cover what FMEA is, why it matters, the core components, how to conduct one, the different types (DFMEA, PFMEA, SFMEA), and how to incorporate cybersecurity in a way that feels natural—not bolted on.

Understanding FMEA: An Overview

What is Failure Mode and Effects Analysis?

Failure Mode and Effects Analysis (FMEA) is a systematic, proactive method for identifying potential failure modes in a product, process, or system—and evaluating the effects of those failures. The goal is straightforward: find problems early, prioritize what matters most, and define actions that reduce risk before failures reach users.

FMEA typically breaks the product or process into components or steps, then evaluates how each could fail, what happens if it fails, how likely it is to occur, and how likely it is to be detected before causing harm.

The importance of FMEA in risk management

Risks exist in every design and every process. FMEA helps teams stop relying on gut feel by providing a structured way to prioritize risk and document decisions. Done well, it reduces rework, warranty issues, recalls, and unpleasant surprises—especially late in development.

FMEA also works best when it’s treated as a living artifact. Products change, processes evolve, suppliers swap, and new information emerges. Updating your FMEA as the device evolves is part of maintaining a mature program.

How Medical Device Teams Use FMEA for Cybersecurity

For connected medical devices, cybersecurity often shows up as “software risk,” “connectivity risk,” or “third-party component risk.” FMEA gives you a practical way to translate those concerns into the same format as other failure modes—so they can be prioritized, assigned owners, and tied to controls and verification evidence.

Here’s the mindset shift that makes Cyber FMEA work:

• Threats describe what an attacker might try.
• Failure modes describe what the device or system could do wrong as a result (accept unauthorized commands, expose sensitive data, lose availability, log incorrectly, update insecurely).
• Effects describe the real impact—especially in clinical workflow and patient safety terms.
• Controls and actions define how you prevent, detect, respond, and verify.

Cyber FMEA vs threat modeling

Threat modeling and FMEA are complementary. Threat modeling is great for identifying attack paths and misuse cases. FMEA is great for operationalizing those insights into a structured risk table with ratings, controls, and corrective actions that cross-functional teams can maintain.

If you want both working together (which is where most teams end up), start with threat modeling and feed the outcomes into DFMEA/PFMEA. Related: Medical Device Threat Modeling Services.

The Core Components of FMEA

Identifying failure modes

The first step is identifying how a product, process, or system could fail. This is where cross-functional input matters. Engineering sees design risks. Manufacturing sees process risks. QA/RA sees compliance and use-related risk. Service teams see what fails in the field.

For cybersecurity, “failure modes” often look like:

• unauthorized access is possible (weak authentication/authorization)
• device accepts untrusted input (lack of validation)
• update mechanism is not robust (integrity not enforced)
• logs/alerts don’t capture key events (detection gap)
• data is exposed at rest or in transit (confidentiality/integrity gap)

Analyzing potential effects

Once failure modes are identified, evaluate the effects. Effects can include safety impact, performance degradation, data exposure, downtime, or customer trust issues. In medical devices, it’s important to translate effects into terms stakeholders understand:

• impact to clinical workflow (delays, downtime, incorrect results)
• impact to essential performance
• impact to alarms/alerts and operator decision-making
• impact to confidentiality of patient or operational data

Assessing severity, occurrence, and detection

FMEA commonly uses three ratings:

• Severity (S): How bad is the effect if it happens?
• Occurrence (O): How likely is the failure mode to occur?
• Detection (D): How likely are you to detect it before it causes harm?

Teams often combine these into a priority score (e.g., RPN or another prioritization approach). The exact scoring method matters less than consistency and a clear rationale everyone can follow.

The Process of Conducting an FMEA

Assembling the FMEA team

A strong FMEA team includes people who actually understand the product and how it is built, used, serviced, and supported. For medical devices, that often means engineering, software, QA/RA, manufacturing, service, and (when applicable) clinical or human factors representation.

If cybersecurity is in scope, include someone who can speak to architecture, connectivity, and security controls—either internal product security or an external partner.

Reviewing the process or product

Before rating anything, make sure the team aligns on what’s being analyzed: boundaries, intended use, environment, and interfaces. For connected devices, include the ecosystem—not just the device hardware. Cloud portals, mobile apps, update services, and third-party dependencies can all introduce meaningful failure modes.

Prioritizing failure modes

Once failure modes and effects are identified, use your scoring approach to prioritize. This is where FMEA becomes practical: it helps you decide what gets fixed first, what needs additional controls, and what requires verification evidence.

Different Types of FMEA

Design FMEA (DFMEA)

DFMEA focuses on risks introduced by design choices. In MedTech, DFMEA is where cybersecurity failure modes often belong, because security is fundamentally a design property (identity, authorization, encryption decisions, update integrity, logging, secure defaults, etc.).

Process FMEA (PFMEA)

PFMEA focuses on manufacturing and production processes. For cybersecurity, PFMEA is relevant for provisioning steps and service workflows—for example: how keys are provisioned, how debug interfaces are controlled, how production images are handled, and what happens when devices are refurbished or repaired.

System FMEA (SFMEA)

SFMEA looks at the system as a whole and the interactions between components. This is especially useful for connected ecosystems where device, cloud, app, and integrations can create cascading effects.

Example: Adding Cybersecurity Failure Modes to an FMEA

Below is a simplified example (illustrative only) showing how cybersecurity can fit naturally into an FMEA format. Keep yours specific to your device, intended use, and architecture.

If you need help turning cybersecurity controls and test results into clean, submission-ready evidence, start here:
FDA Premarket Cybersecurity Services.

FMEA and Quality Management

FMEA in ISO 9001 and IATF 16949

FMEA is widely used in quality management and is commonly referenced in quality frameworks like ISO 9001 and IATF 16949. The underlying idea is risk-based thinking: don’t wait for failures—anticipate them.

FMEA in medical devices (where it fits)

Medical device manufacturers typically align risk management activities with medical-device-specific expectations and standards. FMEA is often used as one of the practical tools in that broader risk management approach—especially when you need a structured, team-based way to prioritize risks and document controls.

FMEA and Six Sigma

FMEA is also commonly paired with Six Sigma and continuous improvement programs because it helps teams identify high-impact failure modes and prioritize improvements based on risk.

Overcoming Common FMEA Challenges

Avoiding subjectivity in FMEA

One of the biggest FMEA problems is subjectivity: different people rate severity, occurrence, or detection differently. The fix is boring but effective—define clear scoring criteria, use examples, and keep calibration discussions short but consistent.

Ensuring effective communication in FMEA teams

FMEA works when teams communicate. Use structured meetings, document assumptions, and make sure the people who will implement actions are actually in the room. For cybersecurity-related failure modes, ensure the security control owners are included—otherwise the FMEA becomes aspirational instead of actionable.

Making FMEA Work Postmarket (Especially for Connected Devices)

For connected medical devices, postmarket reality matters. New vulnerabilities, new third-party component issues, and new deployment environments can change your risk picture. A practical approach is to treat FMEA as a living artifact that gets revisited when:

• you release a major software update or introduce new connectivity
• a vulnerability disclosure affects a key component
• you change a supplier or a critical library
• you see field issues that change occurrence or detection assumptions

This is also where postmarket cybersecurity management becomes critical for staying ahead of exposure and maintaining consistent documentation over the lifecycle:
FDA Postmarket Cybersecurity Management Services.

The Future of FMEA

Technological advancements and FMEA

As products become more software-driven, FMEA is increasingly useful for “system thinking” across software, cloud, and device components. Some teams also use automation and data to improve how occurrence and detection are estimated over time.

FMEA in an increasingly complex world

Modern products are interconnected, and failures can cascade. FMEA remains valuable because it forces teams to think about interdependencies and downstream effects—exactly the kind of thinking connected medical device ecosystems require.

FAQs

Is FMEA required for medical devices?

FMEA is a widely used risk analysis method in medical devices, but whether you “must” use FMEA depends on your internal procedures and how you satisfy broader risk management expectations. Many teams use FMEA because it’s practical, repeatable, and easy for cross-functional teams to maintain.

How do we include cybersecurity in a DFMEA?

Translate cybersecurity concerns into failure modes and effects. For example: “unauthorized access possible,” “update integrity not enforced,” “logging gaps prevent detection.” Then define controls (prevention and detection) and verification evidence that proves the controls work.

What’s the difference between FMEA and threat modeling?

Threat modeling identifies attacker paths and misuse cases. FMEA helps you turn that insight into a structured risk table with ratings, controls, and actions. Many medical device teams use both: threat modeling feeds the cyber-related rows in DFMEA/PFMEA.

How do we score severity when cybersecurity could affect patient safety?

Severity should reflect the worst credible impact in the context of intended use and clinical workflow. If a failure mode could affect essential performance, therapy delivery, alarms, or availability during critical use, that should be reflected in the severity rationale.

How often should we update a Cyber FMEA postmarket?

Update it when your risk picture changes: major software releases, new connectivity, supplier/library changes, vulnerability disclosures that affect your components, or field experience that changes occurrence/detection assumptions.

Conclusion

FMEA is popular for a reason: it’s a practical way to identify failure modes early, prioritize what matters most, and create a trackable plan to reduce risk. For medical devices—especially connected ones—adding cybersecurity failure modes to your FMEA is one of the simplest ways to make sure security is treated like a real engineering and quality concern, not an afterthought.

If you want help building an FDA-aligned cybersecurity story that ties together threat modeling, FMEA, testing evidence, and postmarket readiness, Blue Goat Cyber can help you make it defensible and maintainable across the lifecycle.

• FDA Premarket Cybersecurity Services
• Medical Device Threat Modeling
• Medical Device Penetration Testing
• FDA-Compliant SBOM Services for MedTech
• FDA Postmarket Cybersecurity Management
• Contact Blue Goat Cyber

Blue Goat Cyber focuses on practical cybersecurity work for medical device manufacturers—so your risk documentation is clear, your testing is credible, and your team can move faster with fewer surprises.