5 Reasons to Use Medical Graphical User Interface Design Specialists Instead of Generalists

Should any digital design agency develop your medical device user interface?

In a single word, no!

That may seem too definite a statement to make, yet it is the correct answer.

For several decades, the medical and healthcare industry has undergone a transformation in its adoption of digitally enabled tools. Whether it’s an embedded user interface within a device or a mobile application that is part of a connected ecosystem of devices, this adoption will continue to grow, especially with the onset of augmented reality (AR) and artificial intelligence (AI) technologies.

This increase in digital adoption can place a greater demand on a medical device company’s internal design resources – or resources the company does not have. This situation usually leads to hiring an outside design partner. With a wide variety of excellent digital design agencies to choose from, that seems as if it won’t be challenging. You will simply select one for your needs. Be careful, though; not all agencies can provide the required methodology and process to undertake a medical graphical user interface development.

Even the terminology differences can confuse an agency that is not familiar with the medical industry and its regulatory pathway. You’ll note I used the term graphical user interface (GUI) above. This may seem like an outdated term from the ’70s, but there is an important distinction in how the FDA perceives the use of this term instead of the more common user interface (UI).

In FDA speak, user interface denotes every interaction point a user has with a medical device, both digital and physical. Graphical user interface refers to what we typically associate with a display or touchscreen and is a sub-part of the User Interface. This distinction may seem trivial, but regulatory standards are very particular about definitions. Using them correctly only benefits your device’s submission. To avoid any further confusion, I will use the term Medical GUI in reference to the digital design that appears on a display or touchscreen.

Why Medical Graphical User Interfaces Require a Specific Design Agency

• There is more to medical GUI design than just applying best practices of user experience (UX) and user interface (UI) design. It involves a different mindset than most digital design agencies possess. After all, if an eCommerce website makes it difficult to place an order, the outcome may result in a disappointed or lost customer. If a similar difficulty presents itself by a medical GUI user, the effect can seriously harm a patient or the user.

Safety and effectiveness are vital considerations when designing Medical GUI; they are not always a prime concern within other industries. A regulatory review of your device submission will demand your design is safe and effective, so if your design agency doesn’t take this into account, you will hit a bump in the regulatory road to market approval.

• Medical GUI can contain complex content and tasks that a user may have to perform under highly stressful situations. Those demanding circumstances require designers to have a deeper understanding of the user, intended and indications of use, and the use environment(s) – not just the technology in the device.

Also, multiple users or a care team are commonly involved in using a single medical device, with each one expecting to perform tasks and receive information pertinent to their specific needs. An intensive care nurse may only want to focus on four readings on a device’s display, but a physician may need to evaluate more data on the same display. A design agency must be knowledgeable about this multi-headed user scenario to accommodate their specific needs. This variety of users, conditions, and environments require developing a use specification document to indicate you have accounted for all use scenarios.

• When designing a medical GUI, one must determine what can go wrong, how the device can fail the user’s objective, and the outcome of that failure. The FDA will require documenting Graphical User Interface characteristics relating to safety and potential use errors are well documented and contained in your usability engineering file. Granted, this may seem like a very negative approach to start any design project, but it is a critical step in the process and needs to be done at the beginning to ensure your medical GUI design can prevent these failures.

Use error and the overall usability of a device are a definite focus of the FDA in device clearance and approval. Your design agency must have a process in place to evaluate and identify use errors and mitigation for each.

• Medical devices are migrating into the home as we experience the consumerism of healthcare. This transition incorporates a new set of end-users; patients and caregivers. Unlike their clinical counterparts, these end-users are not as knowledgeable about using medical devices to help monitor or treat their condition. Some of these medical devices can be relatively complex in their setup and operation, such as hemodialysis, and, more importantly, possess significant use error situations. The GUI of such a device will play an essential role in mitigating these potential use errors.

This consumerism of healthcare is where you may have a tendency to use an agency that lacks medical GUI experience. Without existing experience designing medical GUI for clinical staff, a design agency will not effectively translate the content and operation to a patient- or caregiver-level to aid in comprehension and usage. There is also a good chance you may not comply with FDA standards if you choose a design agency without medical expertise, which will cause potential issues with your submission – resulting in delays of your market release.

• Finally, like all medical device designs, a medical UI design must conform to the rigor of the regulatory process. For the most part, this means the documentation of why you did what you did. Since documentation is not the most appealing part of the design process, most design agencies do not address this critical task.

Risk analysis, use specification, formative and summative reports, user interface specification Packages, etc., are integral to the documentation process. If your design agency cannot provide the documentation, then the burden to develop it will be on your internal resources. Ideally, a design agency should have a Quality Management System (QMS) in place and have ISO 13485 certification to ensure their documentation process complies with the FDA’s expectations.

These five reasons are certainly not an exhaustive list to consider in your selection of a digital design agency, but if any are lacking, it may prove to be an issue at the most inconvenient time in your development schedule.