Module 18 2021

09/02/2021

What is the Human Factors and Usability Engineering process?

The human factors engineering process is part of the development of the drug device combination product. It follows a traditional path – Research, Design, Develop, Verify and Validate.

Research

Design

Develop

Verify

Validate

The key elements are:

 User research.  Risk Management of use-based risks.

Abnormal Use

Typical Use Hazardous Use

Mis-Use

 Development and the design of User Interfaces.  Verification and Validation of the drug device combination product with intended users, in the intended use environments. Also the comparison between two drug device combination products.

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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What is the Human Factors and Usability Engineering process? The Human Factors Engineering and Usability Engineering processes vary dependent on the regulation compliance is required for. Very subtly. The differences are small but all have the same outcome: mitigation and evidence to support a

rationale of use safety, to ensure the clinical benefit of the drug device combination product outweighs the inherent risks of use. All standards link to ISO 14971 (2012) and not the 2019 version since it has recently been revised. All processes follow the same route – INPUTS, PROCESS and OUTPUTS.

Source: Human Factors and Usability Engineering – Guidance for medical devices including drug device combination products . The MHRA Human Factors and Usability method.

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

16

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