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Human Factors

The successful interaction between patient and product is crucial for safe and effective device use. Empowering patients, within both healthcare and home environments, is critical for future drug programs and treatments with patient centricity key to the R&D process.

We apply our expertise in usability, human factors, design, and engineering to create innovative and intuitive devices that enhance the patient experience.
Person using a gloves that simulates arthritis as parts of a usability engineering evaluation

Usability Engineering

Failing to consider the user-device interaction and lacking an intuitive design can risk patient and user safety for devices.

We work to the international standard for usability engineering, IEC 62366. This ensures that human factors and user interface is considered at every step of device development. Users will be able to quickly understand how to interact with a product in the most efficient and error-free manner. 

people conducting user study for a Shore designed medical device

Human Factors Testing

User research to generate valuable insights is critical for inclusive design.

We provide comprehensive and informative early-stage human factors testing improving confidence on which concept to take forward into engineering.

We involve our engineers at the concept design phase to create prototypes that can replicate the key device characteristics of every individual project, such as button activation forces, audible clicks or functional elements.

human factors study taking place with people being observed from a room

Human Factors Studies

Our expert Human Factors team can facilitate formative usability tests, or we collaborate with our external partners on summative studies for device validation.

We focus on the interaction between the individual and the product, and the usability of the device to enable safe, effective and reliable administration of a treatment.

We apply proven methodologies and detailed analysis to validate every design solution, working to IEC 62366, usability standards, and FDA regulations.

user guide and packaging for insulin patch pump system

Patient Information Design

Clear, considered and engaging information accompanying a device enables the user to feel fully informed, able to make appropriate decisions and facilitate effective treatment administration.

With this in mind, we will work closely with you to ensure that the information necessary to your device is presented in a clear and structured manner, in accordance with relevant standards, to instil solid user and patient confidence.
a user risk analysis spreadsheet used to identify potential risks with an autoinjector

User Risk Analysis

It’s essential to identify, analyse and evaluate all possible risks that a user could face when using a device. Carrying out a comprehensive user risk analysis, we investigate not just the risk itself, but the consequences it may have on patients and/or the healthcare professionals.

View our human factors and usability engineering capabilities in action: