Usability Engineering

User research encompasses a range of activities to help understand and identify the factors influencing the user interactions as they relate to a safe, usable and reliable product. Factors include target users, demographics, use environment, product functions, user interactions and user training. Insights gained from these activities are used to formalise the product and user requirements and drive user-centred design solutions.

Cobalt can provide a wide range of user research activities including:

• User observations
• User interviews
• Predicate device review including benchmark testing and analysis
• Standards and regulatory review

Using outcomes of the User Research activities, Cobalt can assist clients in definition and preparation of requirements and risk management documentation. This process is focussed on developing a product and development strategy and specification that ensures your product is on a path to address the identified opportunity and ensure ease of use while minimising risk.

This documentation will comply with the requirements of FDA, and IEC 62366, and forms a key part of your ISO 13485 compliant medical device development. These documents include User Needs, Product Requirements, Risk management plan and risk and hazard analysis report.

Testing and validation are critical parts of an ISO 13485 compliant development program. When applied to usability engineering, there are two major testing steps that are required. Both are aimed at real world evaluation of your product in the hands of real users to ensure your development is addressing the requirements and product risk is being properly mitigated.

• Formative Testing – testing and evaluation of the product during the design process. This is used at multiple times during the development program to inform design decisions and help improve user interactions.
• Summative Testing – also known as human factors validation is usually performed once the design, development and verification steps are complete and is used to prove that a product can be used safely and effectively by the intended users. Often requiring large user groups and done with assistance of clinical partners, these tests require production or equivalent product.

Preparation of all documentation to meet the requirements for usability engineering as part your ISO 13485 compliant medical device development. This documentation, also known as Usability Engineering File (UEF), forms part of the overall design documentation (design history file) - a major part of the regulatory compliance requirements and submission.