Our last blog in the series of Usability Engineering for Medical Devices highlighted mandatory steps of the usability process. It is now time to take a step further to START applying usability engineering to medical devices.
The very first step is to define Use Specifications.
First of all, what does it mean? Use Specifications is the summary of characteristics of the use of the medical device. Simply put, it is an elaborated version of the device’s intended use. One might argue that the intended use is already available. Then why need an elaborated version of it? Well, use specification is the foundation for specifying your device design and developing the design. The use characteristics help in identifying hazards, hazardous situations as well as use errors that are bound to occur during device-user interactions.
So, what use characteristics does it cover? See below:
Figure 1: Characteristics of Use Specifications
To define use specifications, one needs user research. This can be done through interviews (e.g. focus groups), surveys, and observation (e.g. contextual inquiry).
You may not get a ‘perfect picture’ initially, but use specifications can always be built on once you have gathered sufficient information about all the characteristics. The initial level of use specification can be as good as a high level intended use statement, but it still needs to be elaborated for safe and effective device design.
Once you agree that use specifications need to be documented in addition to a high-level intended use, it’s time to think about what information to gather. See Figure 2 below:
Once you agree that use specifications need to be documented in addition to a high-level intended use, it’s time to think about what information to gather. See Figure 2 below:
Figure 2: Elements of Use Specifications
Facts about use specifications:
FACT 1: Use specifications are NOT the same as user-interface specifications
FACT 2: Use specifications will be the basis for formative testing and summative studies.
Alceon Medtech Consulting can help you apply human factors concepts to your product portfolio. Reach us to evaluate the existing status of your usability process and allow us to map the right directions for you. We can also help you train your resources or prepare relevant documentation. Inquire today at contact@alceonconsulting.com.
Because we are passionate about what we do, we would love to offer a FREE one-time consultancy on use specifications for one of your products. AVAIL TODAY!
The next blog in the series of Usability Engineering for Devices will be about writing an intended use for a medical device
