Usability evaluations are connected to the risk management and is an important part of the technical documentation. Performing formative and summative evaluations will make sure that the user of the medical device can use it safely. Usability evaluations are not only important for the sake of meeting regulatory standards, but they are also very valuable for the design of medical devices. The evaluations are guiding the manufacturers in the development of a device that is easy and satisfying to use, as well as preventing any future misuse or errors. Usability engineering activities are an efficient way to make sure the medical device will be safe to use, preventing costly and time consuming activities once marketed.
Malin Truvé is one of the experts at Key2Compliance who is helping our clients with usability evaluation. Here she will guide you through usability evaluations, its importance, and what the process could look like.
Malin Truvé is one of the talented Regulatory Affairs consultants here at Key2Compliance. She has years of experience performing evaluations of medical devices and has a vast knowledge of what the usability engineering process looks like and why it is essential for manufacturers of medical devices.
“I have worked with performing evaluations of medical devices used in hospitals, specialized clinics, and other healthcare settings. I have performed safety testing and process review toward several standards, including IEC 62366-1:2015/A1:2020, that specifies a process for a manufacturer to analyse, specify, develop, and evaluate the usability of a medical device as it relates to safety. At Key2Compliance, I can be involved with the clients, not just with the reports, but to guide them and help them in different ways. One of the best parts of my job is to help our clients fulfil regulatory requirements and thereby put safer and better products on the market” says Malin.
Usability is not only important for user safety, but also highly valuable to the design process, making sure that the medical device is truly designed with the user in mind, as well as finding opportunities to help improve the design. Malin explains the process of usability evaluations like this: “First of all, we help the client with a plan for how the evaluations should be performed. Is this a new medical device being designed, or is it an existing device that was placed on the market prior to current standard version? Existing devices usually need less-extensive evaluations. The next step in the process for a new device is to do a formative evaluation, which serves as a verification of the device, filter-out design shortcomings and indicate changes that would need to be made to the user interface.”
Then follows the summative evaluation, described in the IEC 62366-1:2015/A1:2020 as a user interface evaluation with the intent to obtain objective evidence that the user interface can be used safely. This testing is one of the most important parts of the usability evaluation, and Malin describes it as follows: “The test participants get to perform various real user tasks, based on selected hazard-related use scenarios. The test participants correspond to the intended users (for examples nurses) and the test environment corresponds to real use (for example a hospital). Test protocols are prepared and used throughout this testing. Any use errors, close calls, missuse or mistakes are documented. If the test results are satisfying and fulfil the acceptance criteria, no further testing needs to be done. The results from formative and summative evaluations are summed up in a report, showing the results. While this description sums up some of the major parts, there are of course several other documents and details that need to be written and documented as part of the Usability Engineering File. Proving fulfilment of IEC 62366-1:2015/A1:2020 can, in turn, be used to fulfill some of the general safety and performance requirements of MDR.”
According to Malin, usability evaluations have two important benefits. One is, of course, to meet regulatory requirements. But it can also make the development process more efficient and cost-effective. “Testing if the medical device really is safe and user-friendly before it reaches the market means that it is easy to use in the right way and that more people will buy it. If it turns out that the users have difficulty using the product, it can lead to complaints and having to redesign the product later. Making sure that the medical device is designed as user-friendly as possible is a big win both for the user and the manufacturer” says Malin.
As always with Key2Compliance, the extent of our usability services depends on the needs of the client. “We can set up a Usability Standard Operating Procedure (SOP) for the client, describing the actual process of how they will carry out the evaluations,” says Malin, “We can help them write a use specification and user interface evaluation. We can also set up both the formative and summative evaluations, produce test protocols, and help the client carry out the evaluations. We can be on site during the process or have training with the client before the evaluations and then summarize the results of the studies. This is all depending on the needs of the client.”
The usability engineering process is a valuable aid for clients from idea to market, but also for manufacturers that already have a medical device on the market prior to the latest standard edition. “Usability has always been important, although I believe it is more important than ever in today’s fast paced work environment. Users in hospitals can be surrounded by numerous medical devices and benefit from intuitive and easily understandable medical devices. While health care professionals are trained, there are also non-trained users, for example in a home healthcare setting. Following the usability engineering process will ensure usability of the device as well as understanding of the accompanying documents,” says Malin.
It is important to evaluate changes to the product and keep the technical documentation up to date. Malin describes how she and her colleagues help these manufacturers with products on the market: “We can help clients with performing a GAP analysis if they already have a usability documentation for a previous edition. This is valuable if certain parts of the product or accompanying documentation have been changed. If our client is uncertain if the documentation that they have written meets the requirements, or if something is missing, then we can review it. This will help them meet the requirements, and it will also function as a quality mark that the device really is user friendly, combining compliance with better design.”
