human factors usability testing medical devices

FORMATIVE USABILITY STUDIES

 

For compliance to the US-based FDA Human Factors guidance, the UK MHRA Human Factors and Usability Engineering guidance and IEC 62366-1:2015, performing a Formative Usability study is essential, and it has to be performed well.

A Formative Usability study is an exploratory test of the design of the medical device, using representatives of the intended users to guide the design further. Focus on use safety and hazards, user interface design, efficiency and time, the expected use experience and the simulated effectiveness of the medical device are elements of a Formative Usability study. Where user research on a new design of medical device is theoretical, a Formative Usability study is practical.

For compliance to the European MDR, a Formative Usability study is a verification test of the design and its use safety. Where usability and human factors were subjective requirements in the 93/42/EEC MDD ‘Essential Requirements’, the new 2017/45/EC MDR Annex I ‘Essential Requirements’ list requires documented evidence of acceptable human factors and usability of the designed product.

We are currently able to perform Formative Usability studies in many countries globally including Australia, Austria, France, Germany, Ireland, Lithuania, Netherlands, Spain, Switzerland, USA and the UK.

Usability Testing

SUMMATIVE TESTING

 

Summative Human Factors tests are performed to validate the usability of the medical device; the readability and comprehension of the instructional materials and labeling; the use safety of how it is intended to be used; and the training methods intended for use once launched. Summative Human Factors tests are performed at the end of the development process – once the medical device design is final, and is performed generally only once in the development process. 

It is a prediction tool – to determine how safe to use the device is likely to be when subjected to its real life human factors – use environments, use situations, use-based hazards, interacting systems and intended users once launched. This is because in many cases, the fidelity of the test is much higher and more realistic than often used in a Formative Usability study. 

This type of Human Factors test requires a lot of planning, often requires ethical inputs, production-level devices, requires significant sample sizes of intended users as test participants, and can take a few months to perform in some cases. All of this has to be performed compliantly since all of the Human Factors and Usability guidances and regulations have strict requirements this test type has to meet to generate believable test data. 

COMPLIANCE

THAY Medical have the expertise to fully perform human factors studies to ensure the optimum outcomes are achieved. We as a minimum achieve compliance to the current regulations and best industry standards such as UK MHRA, ISO & FDA. Please click the below links to the guidance on applying human factors to medical devices .

human factors usability testing medical devices

FORMATIVE STUDIES

 

For compliance to the US-based FDA human factors guidance, the UK MHRA human factors guidance and IEC 62366-1:2015, performing a formative human factors test is essential, and has to be performed well.

For compliance to the European MDR, a formative human factors test is evidence of use safety during the development. Where usability and human factors were variable requirements in the 93/42/EEC Essential Requirements, the new 2017/45/EC Essential Requirements requires evidence of acceptable human factors and usability

Usability Testing

SUMMATIVE TESTING

 

Summative tests are performed at the end of the design process – once the device design is final, and is performed using production-level devices.

This testing requires a larger sample size than often used in formative testing. In addition, it is a prediction tool – to determine how safe to use the device is likely to be when subjected to its real life human factors – use environments, use situations, use-based hazards, interacting systems and intended users.

Summative tests are performed to validate many elements of the design of a medical device – the usability of the device; the readability and comprehension of the instructional materials and labelling; the use safety of how it is intended to be used; and the training methods

COMPLIANCE

THAY Medical have the expertise to fully perform human factors studies to ensure the optimum outcomes are achieved. We as a minimum achieve compliance to the current regulations and best industry standards such as UK MHRA, ISO & FDA. Please click the below links to the guidance on applying human factors to medical devices .