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Glossary Term

Human Factors Engineering (HFE)

Definition

Human Factors Engineering (HFE) is a multidisciplinary approach that focuses on designing medical devices and systems to align with the capabilities, limitations, and needs of users. HFE aims to optimize usability, safety, and performance by understanding how humans interact with devices in real-world scenarios.

Relevance to the MedTech Industry

HFE ensures that medical devices are intuitive, reduce the risk of user error, and meet safety standards. By prioritizing user-centered design, HFE enhances patient outcomes, supports regulatory compliance, and builds trust in MedTech products.

Additional Information & Related Terms

Challenges or Considerations User Diversity Devices must accommodate a wide range of users, including clinicians, patients with disabilities, and non-professional caregivers.

Complex Workflows Healthcare environments often involve complex workflows and distractions, requiring designs that minimize cognitive load and errors.

Regulatory Compliance HFE must comply with stringent regulatory standards, such as FDA’s Human Factors Guidance and IEC 62366-1 for usability.

Iterative Process Effective HFE requires iterative testing and refinement, which can extend development timelines and increase costs.

Key HFE Processes

  1. User Needs Assessment: Identifying the target users and their specific needs, preferences, and limitations.

  2. Task Analysis: Mapping out tasks users will perform with the device to identify potential risks or barriers.

  3. Usability Testing: Conducting iterative testing with actual users to evaluate the device’s safety and effectiveness.

  4. Risk Mitigation: Addressing identified risks through design modifications or training improvements.

  5. Human Factors Validation: A final usability test to confirm that the device meets safety and usability requirements.

Related Terms

  • Usability Engineering: A component of HFE that focuses on ensuring devices are intuitive and error-resistant.

  • Risk Management (ISO 14971): HFE complements risk management by addressing user-related hazards.

  • Post-Market Surveillance (PMS): HFE principles help refine devices based on real-world usability feedback.

  • Regulatory Compliance: Ensuring adherence to guidelines like FDA’s Human Factors Guidance and IEC 62366-1.

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