Design with the end user in mind

1. Design with the end user in mind Whenever any new device is designed or design is revised, designer’s first focus usually goes towards its functionality and performance and is very conscious about this. Consider very high fashioned shoes which looks very attractive but fails if it hurts while wearing. Though user requirement is one of the important requirements some time it is ignored unknowingly. Presently during covid epidemic lot of masks came into market but discomfort while wearing on ears was not prime criteria even for users while buying though it was supposed to be worn for long time. With development of knowledge and experience of field event post marketing surveillance data design approach has changed. Keeping human factor in mind has now become best practices. That is why design engineer focuses on users who consider product as not only efficient but very user friendly while using. Its also a challenge as The medical device industry is vast, and products are often intended to be used by many various types of users like, healthcare professionals, elderly patients, adolescents. As such, it is essential that no matter the sort of user, a medical device must be intuitive and user friendly, and any technical difficulties must be easy to diagnose and resolve. an important step that manufacturers can take when designing a product for a spread of users is to implement an easy but effective rule: Design with the top in mind. A principle for “highly effective” medical device design This idea of “beginning” with the top in mind may be a notion taken from best-selling author Stephen Covey. In his self-help book, the 7 Habits of Highly Effective People, Covey states that if a private begins a task with the specified destination in mind, then that individual has defined a transparent direction which will lead them towards their goals. If this aspect is considered and applying this theory to medical device design, if a manufacturer focuses on design oriented towards their desired user using their product effectively and easily, they are going to have defined a transparent direction which will (hopefully) guide them towards creating a successful product that satisfies users’ needs. Considering the meaning of Designing with the top in mind (i.e., the most solution that the product is providing) while developing the medical device, in order that the user can intuitively use the product to meet their needs. a standard technique used within the HFE (Human Factor Engineering). As stated, earlier user research world is to conduct a Validated approach to verify that the product is meant to accommodate the user. Such an activity will allow device manufacturers to pinpoint specific areas where the user might struggle to use the device. While considering this aspect even risk assessment aspect can also be used considering user’s difficulty in use as one of the risk factors. Design engineer must put itself into user’s shoe while envisaging this risk. Medical device usability research reduces regulatory and patient risk. Design to accommodate and empower your users It is relatively easy to discern when a product has been designed with or without the top in mind. An example of this will be seen within a smartphone app that is related to a medical device. Suppose a diabetes patient begins using an app that is an insulin dose calculator. The patient is tasked with entering information regarding daily consumption so as for the app to supply a recommended dose to inject. Before the patient can begin using the app, specific health-related background information is required to make sure the recommended doses are valid and accurate. If data regarding the

2. patients’ health is missing (e.g., user did not add BMI information) thanks to oversight, then the straightforward act of highlighting a selected button on the app that guides users to require action to finish the required step is sort of effective. This feature is useful because users are often tasked with completing a spread of steps whenever they are working with a medical device and/or app. this will provide an in-depth mental burden on the user, especially if there is a looming diagnosis that also provides some level of stress and anxiety. When manufacturers inculcate features like highlighting a button to remind patients to enter their data, the user might find the app intuitive and, as a result, feel comfortable using the app. Please note that your user who is patient can be from an IT savvy, or a person very familiar with using various smartphone applications and a patient who is not used to such technology. In such event some function may look dumb to smartphone users but will become so useful for others who are not. Whether it is the medical device, the instructions to be used, or the smartphone app connected to the device, a manufacturer’s intended solution should aim to supply a user experience that is seamless and intuitive. this is often beneficial for the top user also because the manufacturer; by dedicating time and resources towards human factors studies and early user research at the start and throughout the product lifecycle, manufacturers can mitigate design issues which may arise down the road . How do we get design engineer get educated about user issues? 1.Observations in user environment. 2.User diary data (user reaction) By asking them proactively. This help knowing user behaviour and product usage. 3.One on one and group interviews. One can know individual need and his/her preferences. In group interviews one can also reach consensus requirement also. 4.Some benchmark tests (Should be part of validation strategy) It is also better to test competitor’s product for benchmark. One of the important aspects is Threshold Analysis which is basically a detailed comparisons between user interfaces to two products to identify and assess any potential impact of any differences. US FDA introduced this concept and released draft guidance document in 2017 through CDER. This idea is derived from drug delivery devices.