In design and engineering, we are progressing quite rapidly in creating masterpieces in medical devices, as in every sector. However, we encounter problems when we do not sufficiently consider the usage environment, the characteristics of the targeted user group, and the user requirements of the medical device we design. Especially in terms of usability, the increase in negative incidents due to errors in the use of medical devices, which we have recently put a great deal of energy into R&D studies, is a cause for concern. The basis of this problem stems from the lack of an effective usability engineering study.
The main goal of usability engineering is to identify and minimize usage errors. The most effective way to do this is to comply with the EN 62366-1 standard with a competent team. Investing in usability engineering can benefit manufacturers in numerous ways, including optimizing development programs, increasing sales, simplifying product support and reducing legal risks.
One of the most valuable recommendations of the EN 62366-1 standard is usability testing. Usability testing is an important way to determine whether a particular medical device will meet the needs and preferences of its target users. Usability testing can focus on early design concept models, more advanced prototypes and even production units. Getting the most out of testing is possible by preparing a detailed Usability Test Plan and Report that can be included in a device's design history file.
Although usability testing can be performed by the manufacturers themselves, it is usually performed in a special purpose facility (preferably a usability testing laboratory), with a representative number of users using the medical device.
Whether a dedicated usability testing laboratory is required depends on the intended use of the product. For example, if it is a medical device that needs to be used in an operating room or emergency room, usability testing can be performed in an environment that simulates the actual use.
As test participants perform tasks, a test manager (e.g., data logger, data analyst, usability expert) observes intensively to determine how the medical device facilitates or hinders task completion. Testing personnel document observed use failures, recording data such as task durations, test participant comments, and various subjective design feature ratings such as ease and speed of use.
Usability engineering is an integral part of risk management. It helps to determine whether a device poses risks during its use that need to be reduced or eliminated before it goes to market. Simply put, the work done during the design phase and can be repeated on a continuous basis is called Formative Usability Evaluation. Summative Usability Evaluation is the work done on the finished product when you do not foresee any additional risks.
