How much fidelity should be included in Human factors studies?

Before a medical device can be launched it is recommended that it go through a number of human factors and usability studies to ensure it is safe to use. These studies are used to develop safe medical devices and to ensure that they are usable by the intended users (patients, carers and healthcare professionals ect). Studies include; comparative, pre-formative, formative and summative human factors and usability studies. During pre-formative and formative studies, the test team are testing with pre-production level devices. These often are still at prototype stage and changes to the device can still be made. A summative human factors or usability study will hopefully use production-level devices. This study is the final study in development, hopefully proving that the medical device is safe to use.A study should ideally be conducted in the intended use environment that the device will be used within. For example, if a device is for home use, the study should ideally take place within a home. If it is for surgical use, the study should take place in an operating theatre and so on. If this is not possible, a simulated-use environment should be created. This can sometimes be difficult to achieve so an alternative location is used. Often a meeting room within a hotel will be used to simulate a home or a nurse’s office environment.Comparing a meeting room to someone's home should be recorded in the test protocol. A meeting room is rarely welcoming, and has no personal touches. A home is welcoming and has a number of personal attributes. The furniture in a meeting room will have a large table, multiple upright chairs, a flipchart and a projector possibly. Where as your home is likely to also have a table, but it may be laid ready for dinner, have a vase of flowers and comfortable chairs. It would be very easy to change the environment of a meeting room simply with a number of portable props such as a home phone, a vase of flowers, some magazines and cook books. Requesting a comfortable chair or a sofa into the meeting room would also give a friendlier welcome to test participants. Ensuring lighting and temperature is represented of the real use environment is also important. Meeting rooms can often feel cold and unwelcoming. This is easily changed by adding warm lighting and changing the temperature of the room. If the real use environment should have a window, the simulated one should also. A windowless room can feel claustrophobic and uncomfortable for many. When simulating a home environment within a meeting room, requesting a room with a window is recommended. In addition to simulating the real use environment, it will also allow natural light into the room. Another positive.Why is it important to make a participant feel welcome, at ease and comfortable? To put it simply, we would not want to create a hostile, unwelcoming or stressful test environment. We want a true representation of how the test participant would act in the intended use environment with the device. By allowing participants to feel comfortable in their environments, they are more likely to act and talk without reservation. This allows the device to be tested with less bias. On occasions when a participant does not feel relaxed, they are likely to give responses and answers that they think the test team are looking for. This is not necessary what they think of the device, but what they think the test team want to hear.Small things can make a big difference.If you would like to hear more about how THAY Medical conduct human factors and usability testing and the number of other elements we take in consideration during human factors and usability testing, please do get in touch.Llinos James, Human Factors Engineer