With the ongoing development of medical devices, more and more are becoming available for patient’s at home. There are numerous benefits to the patient of a home-use medical device. For example, the patient will be at home surrounded by their home comforts, friends and family. With this in mind when testing a home-use medical device for a usability or human factors study consideration of the test venue is important. We often hear that many will choose to test a home-use medical device at a testing facility, for example one with an observation window. While allowing the client to observe is beneficial to them, is it right to compromise the test participants experience of a home-use device out-side the home?
There are a number of factors that need consideration when arranging the test venue for a usability or human factors study on a home-use medical device. The first and most obvious is the environment in which the medical device is intended to be used within. A home-use medical device could mean a device that should only be used in one room for example, a home dialysis machine or one that can be carried from room to room for example an insulin pen. This would be specific to the medical device in question. With this in mind, is the intention of the medical device to be used once a day in a living space or would it be used multiple times a day in a bedroom? Once the room or rooms have been decided how they are set up for an evaluation is equally important to the study and to the safety of the test participants and the test team. What other obstacles could occur?
- Does the device need power?
- Does it need to have access to plumbing or waste?
- What tasks are required by the user?
- Do they need to assemble and disassemble the device or maintain the device?
- What is required to ensure the maintenance of the device?
- Should it be cleaned in a specific way?
- Does it require access to a sink? Or some other area?
Understanding the detail of the device and its tasks will paint a clearer picture of what the intended use environment is.
In addition to how the device will work, a consideration needs to be made in relation to the intended user. Can they easily move from one location to another? Do they require the use of a walking aid or wheelchair and therefore is there room to accommodate this at the test venue? Understanding the user before the evaluation of the medical device, allows the test team to ensure that the test venue is appropriate to the device and the user.
A hazard assessment should always be completed on the test venue before any testing should begin. If a number of risks become apparent with little or no mitigation, then the chosen test venue is unsuitable. To ensure safety of the test participants and the test team the test venue should have the required health and safety procedures in place. These can be as simple as fire and smoke alarms and emergency first aid to name a few.
In theory a home-use medical device can be used by more than just the intended users. Therefore, a consideration of who the population of the device is important to understand. In addition, understanding where the home-use medical device is intended to be launched should be known. Knowing this information will give a clear understanding of where the test venue for the usability and human factors study should be. If this information is misunderstood there is a possibility of a culture clash between testing and launching the home-use medical device. For example, practices in Europe may differ to those in the USA. As would a home set up in Taiwan be different to a home set up in the UK. Understanding the differences in cultures and how they will affect the home-use of a medical device is imperative to usability and human factors evaluations. If the demographic of the intended user varies in age, ethnicity or sex (to name a few variations), then this variation is required in the recruitment of the test participants. It would be advised that without the recruitment of the correct test participants there would be no usability or human factors study. Therefore, understanding where the demographic population of a device live, affects the location of the test venue. The test venue is required to be in a location where the recruiter is confident that they will be able to recruit the correct test participants. If the intended users range in ethnicity for example, then testing in a predominantly white community will result in an unfulfilled recruitment for the usability or human factors evaluation.
Location! Location! Location!
- Can the device be simulated at the location?
- Can the recruiters confidently recruit?
- Is the location safe?
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For any questions on this blog post, please do not hesitate to contact us.
The Staff at THAY Medical