About Usability Engineering

THAY Medical can assist the development of medical devices by providing evidence of use safety to the global standard IEC 62366-1:2015

THAY Medical focus on the human elements of how medical devices are used. We only focus on medical devices, diagnostic technologies and healthcare systems. One focus is the specialist area of Usability Engineering. This science looks at the role of the user in the life of a medical device and how they would be expected to use it. Its core objective is to provide evidence of use safety by researching and evaluating how usable, effective and efficient it is to use. We offer the service of fully providing documentation and evidence of safe use of a medical device using a usability engineering methodology compliant to IEC-62366-1:2015. We are able to perform all aspects required for regulatory compliance, from user research through to formative and summative usability (user) studies.

The Usability Engineering standard (IEC-62366-1:2015) is a structured method of researching, specifying, evaluating and reporting all elements of usability of a medical device. It requires initiation at the beginning of a development or post-market change, which is different to the previous version of the standard. The primary goal of applying this Usability Engineering method is to have enough evidence that the medical device is acceptable in its level of use safety. This is performed in combination with the medical device risk management standard ISO 14971. This includes the following elements:

  • User Research
  • Contextual Enquiry
  • Task Analysis
  • Heuristic Analysis
  • Usability Risk Management
  • User Interfaces Research and Specification
  • Concept Design Usability Assessments
  • Formative Usability Testing
  • Summative Usability Testing
  • Usability Engineering Reporting

If you wish to read more details about the Usability Engineering methodology, please click here.

Want to know more information?

Do you want to find out more information?

Have you got a question for THAY Medical?

Please contact us! We would love to hear from you.

Send message

More on Usability Engineering to IEC 62366-1

IEC 62366-1 is a regulatory standard that aims to guide medical device developers to incorporate a level of usability into a device development. It is a globally recognised standard that applies a usability engineering process and a risk management strategy compliant to ISO 14971 to the development of medical devices.

It focuses on four parts – user research, usability specification, usability verification and usability validation. It describes a best practice method for performing these four parts in a logical sequence, focused on use safety and usability – efficiency, effectiveness, ease of use and user learning and user satisfaction.

More on Understanding IEC 62366-1

What is IEC 62366-1?

Compliance to this regulatory standard involves focusing on the four parts – user research, usability specification, usability verification and usability validation within the device development.

User research is the investigation of your devices intended user(s). Who are they? How will they interact with your device?

Usability specification is the definition of how your device interacts with its intended user(s) and how safe the interaction is expected to be.

Usability verification is the iterative evaluation of your device with the intended user(s) to enable safe use through the device development.

Usability validation is the final evaluation of your device with the intended user(s) proving that use of the device is safe, usable and meets the user needs.

More on User Research

Understanding device users

The process involved in developing a device to be safe and usable includes an element of user research. Typically this involves generating documentation about the intended device users. Who they are, what they are expected to do with the device, where they may use the device and how long for.

IEC 62366-1 requests the device intended users to be documented. THAY Medical can perform user research so that these users can be determined, understood, and to a level, predicted, based upon the device intended use. By completing these research activities, the devices intended users can be understood further.

More on User Specification

Defining intended use and user interfaces

The process involved in developing a device to be safe and usable includes defining the results of the user research into requirements and specifications. In IEC 62366-1, this starts with defining the intended users (Use Specification document – Section 5.1 of IEC 62366-1) and initiating the use-based risk management activities. The risk management activities include defining the characteristics related to use safety and potential use errors (Section 5.2 of IEC 62366-1) and the identification of hazards and hazardous situations (Section 5.3 of IEC 62366-1). With these defined, the hazard related use scenarios are documented (Section 5.4 of IEC 62366-1) and through use of  user research, understood and defined in detail. Section 5.4 of IEC 62366-1 then requires these hazard related use scenarios to be determined for the usability validation activities that involve a summative evaluation.

IEC 62366-1 also requires a focus on the user interface. To do this, a User Interface Specification is often generated (Section 5.6 of IEC 62366-1) and methods of how the user interface will be evaluated through formative and summative evaluations (Section 5.7 of IEC 62366-1). The user interface design (Section 5.8 of IEC 626366-1) is developed at this stage in combination with the device development (they are the same task), but based upon the User Interface Specification rather than any other method. The requirements of the User Interface Specification should define many of the device features, ergonomics and sizing, mechanics, electronics and software.

More on User Verification

Evaluating medical device use

The output of all this usability engineering process at this stage is to verify that the design of the medical device is safe, effective, learnable and satisfying to use, as well as meets the design inputs and User Interface Specification requirements. This is most frequently performed through Human Factors Testing, in what is called a formative evaluation (Section 5.8 of IEC 62366-1).

More on User Validation

Validating medical device use

The output of all this usability engineering process overall is to validate that the design of the medical device is safe, effective, learnable and satisfying to use, as well as meets the user needs of the medical device. This is most frequently performed through Human Factors Testing, in what is called a summative evaluation (Section 5.9 of IEC 62366-1).