Human Factors Engineering - HFE

A critical device design activity

Human Factors Engineering

Human Factors Engineering (HFE) is critical for medical device safety and regulatory compliance, especially for Class II and III devices, drug-delivery systems, and combination products. Following is a detailed breakdown of the regulatory expectations and functional components of HFE.

What is Human Factors Engineering?

Human Factors Engineering (HFE)—also called Usability Engineering (UE)—is the application of knowledge about human behavior, capabilities, and limitations to ensure that devices:

Are safe and effective for intended users,
Minimize use-related risks, and
Can be used without unintended harm or user error.

When a “Good Enough” Design May Not Be Sufficient

Many times, a solid basic design may not completely fulfill the needs of its users. Read about a common Class I device that standards and regulations would typically not require a risk/usability analysis may be insufficient for the needs of its users.

Regulatory Requirements and Guidance

FDA (U.S.)

The FDA regulates HFE under 21 CFR 820.30 (Design Controls) and defines it primarily through guidance documents.

Key FDA Guidance

“Applying Human Factors and Usability Engineering to Medical Devices” (2016)
“Human Factors Studies and Related Clinical Study Considerations” (2020)
Guidance for new devices, PMA submissions, 510(k)s (if new user interface), and De Novo devices.

FDA Expectations

Employ a risk-based approach to identify critical tasks. Human factors validation testing must demonstrate that intended users can use the device safely and effectively without prior training (unless training is part of the intended use).

Documentation

HFE/UE report with PMA or 510(k),
Validation testing protocols, results, and rationale for user groups.

Devices with user interfaces (buttons, displays, connectors, software, alarms, etc.) must undergo HFE validation.

International (Global)

ISO & IEC Standards

ISO 14971: Risk management (HFE is a mitigation tool).
IEC 62366-1: Application of usability engineering to medical devices (widely accepted globally, harmonized in the EU).
IEC/TR 62366-2: Guidance on application of usability engineering.

EU MDR

HFE is addressed under General Safety and Performance Requirements (GSPRs) in Annex I, including:

Minimization of use error,
Device usability under normal and fault conditions,
Consideration of ergonomic features.

Other regions

Health Canada, PMDA (Japan), and NMPA (China) expect similar alignment with IEC 62366-1 and ISO 14971.

When is an HFE Required?

Device Type	HFE Required?	Notes
Class I	Rarely	Unless has complex UI
Class II	Often	Especially for home-use, digital, or drug-delivery devices
Class III	Always	PMA requires robust HFE/UE documentation
Combination Products	Always	Especially drug-delivery (pens, pumps, injectors)
Digital Health Software	Yes	Apps, decision-support tools, UI-dependent devices

News

FDA Enforcement

Safety Alerts

Medical Devices

Pharma

New Drugs

Drug Shortages

Orthopedics Industry Consolidation

ISO 13485:2016 Clauses

1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
♦ 7.3 Design and development
♦ 7.4 Purchasing controls
8 Measurement, analysis & improvement

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Human Factors/Usability Report

FDA and global reviewers expect a report to contain the following documentation:

Summary of use-related hazards
User population analysis
Use environment details
Critical task identification
Formative test results
Final validation protocol & results
Labeling/instructions of use impact

Critical Tasks = tasks that, if performed incorrectly or not performed at all, could result in serious harm to the user or patient.

HFE Validation Testing Best Practices

Conduct in a realistic simulated-use environment
Use representative users (e.g., patients, caregivers, clinicians)
No training immediately before testing unless training is part of actual use
Collect both success/failure and behavioral data (e.g., hesitations, workarounds)
Capture root cause analysis for any errors or difficulties

Stage	Description	Activities
1. User & Use Environment Analysis	Identify intended users, use scenarios, and use environments	Interviews, surveys, user profiles, task analysis
2. Hazard Identification (Use Errors)	Identify potential use errors and hazards	Link to risk management (ISO 14971)
3. Preliminary Usability Testing	Early testing with prototypes	Formative studies, heuristic evaluations
4. Design Iteration	Refine UI and device based on feedback	UI redesign, labeling adjustments, feedback loops
5. Validation (Summative Testing)	Demonstrate users can safely use the device	Simulated-use testing (≥15 representative users per group)
6. Documentation & Submission	Report HFE findings and validation	Submit HFE/UE report with regulatory submission