Who is the user of your medical device? We often design our products with either the end user or the major skilled user (such as a physician) in mind.
Medical devices are often touched by someone in addition to the final intended user. As medical device designers, we need to consider all the different users and incorporate their needs into the final device design. Below are some points to consider.
The first example is a wound care dressing where the dressing is stocked in the hospital, applied to the patient while at the hospital, but is required to be changed for a time once the person has been discharged. The person could be discharged to a skilled care facility or to their home. Once home, the person changing the dressing could be the patient, an unskilled caregiver, or a skilled caregiver. For this example, we now have 3 different environments and multiple skill sets for interacting with the dressing, plus the stockroom staff. The diagram below further details the requirements for the users in the hospital environment.
Figure 1: Example of user requirements for each user in the hospital environment for the wound dressing example
How might the requirements change in the different care settings or with the different user skills?
The second example is a power surgical instrument. In the US, this medical device will be used in a hospital or ambulatory surgical setting. However, in Europe the same device could be used in a physician’s office. In a surgical setting, the device is used by the surgeon during the surgery, handled by the OR nurse during setup and the surgery, will be cleaned and sterilized by either the hospital or a third party service, and stored for the next procedure. In a physician’s setting, the physician and a nurse would be responsible for all the activities handled by multiple groups in a hospital.
Through these examples, you see that the users of medical devices are often more diverse than the key targeted users and they have needs distinct from those of the target user. As designers of medical devices, you have the obligation to identify these requirements and translate them into design inputs.
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For more information or to speak with one of our consultants, please contact Mary Drotar at 312-212-3144 or [email protected]