Medical devices play a vital role in modern healthcare, aiding in the diagnosis, treatment, and management of various medical conditions. However, the effectiveness and safety of these devices rely not only on technological advancements but also on their usability and compatibility with human factors.

Designers, engineers, usability specialists, and researchers seek to understand human behavior, cognitive processes, physical capabilities, and preferences to create products and systems that are intuitive, efficient, and safe.

Patients and healthcare professionals come from diverse backgrounds and possess varying levels of technological literacy that must be considered in user profiles and how user needs are traced.

While AI is a powerful tool with a wide range of capabilities such as optimizing medical treatment outcomes, it also has certain limitations.

Without even realizing it, you are processing the facial expressions and body language of the people you interact with. This is human perception.

It’s why you might experience:

• stage fright or love being in the spotlight;
• an instinct to fight or flight;
• a super reflex (#dadreflex) or “The Freeze[1]”

Humans can perceive when to change the tone of their voice; a topic of conversation or their behaviour, based on the physical and emotional feedback signals they interpret from other people.

AI can not.

AI does not have interpersonal skills. AI can not understand the emotional and psychological factors that influence human decision-making.

AI lacks real-world context and does not possess personal experiences or an understanding of current events beyond its knowledge.

Yes, it can analyze vast amounts of medical data or make predictions based on patterns for early disease detection, but it cannot understand the emotional needs of a patient or the desires of a surgeon.

It can’t “read the room” and adapt on the fly, and it can’t react to expressions or body language with a shift in tone or language, or information. AI operates based on patterns and associations learned from the algorithms it has been trained on but can not imagine. AI lacks human qualities.

This is why usability testing with targeted user groups (actual humans) is crucial for medical device development. Here are 5 reasons why we think including the human factor remains so important to creating medical products and systems that are safe, efficient, and intuitive:

Ensure Safety: By evaluating how users interact with the device, designers can uncover usability issues that may lead to user errors, misuse, or adverse events. Addressing these issues early in the device workflow and the development process, device safety can be improved.

Improve Efficiency: Usability testing enables identification and mitigation of design issues that may contribute to inefficiencies. By observing users interacting with the device in realistic scenarios, designers can uncover usability issues such as unclear instructions, confusing workflows, or complex user interfaces. Addressing these issues improves the device’s efficiency, reduces the likelihood of errors, and enhances user productivity.

Enhance User Experience: Usability is a key competitive factor in the medical device market. Devices that prioritize usability and offer an exceptional user experience have a higher chance of standing out from competitors. A user-friendly and intuitive interface promotes ease of learning, efficiency, and user satisfaction, ultimately leading to improved adoption and acceptance of the device.

Meet Regulatory Requirements: Regulatory bodies, such as the FDA, require usability testing as part of the submission process for medical device approval. Usability data and evidence are required to demonstrate that the device has been designed and tested with the intended users in mind and meets the necessary usability standards. Compliance with regulatory requirements is essential to gain market approval and ensure patient safety.

Reduce Training and Support Needs: Usability testing helps identify areas where the device’s design can be simplified and made more intuitive, reducing the need for extensive user training and support. A well-designed device that aligns with user mental models and expectations minimizes the learning curve, allowing users to quickly and effectively operate the device. This can lead to cost savings in training resources and ongoing support requirements.

A user-centred design process provides a competitive advantage, by creating intuitive, efficient, and safe devices that empower healthcare professionals, facilitate patient care, and ultimately improve health outcomes.

AI is a wonderful tool, but it lacks many of the essential human traits required for informing the user requirements of a medical device design. Human Factors plays a vital role in medical device development by identifying usability issues, improving user safety, enhancing the user experience, meeting regulatory requirements, and reducing training needs. Seeking user feedback and conducting usability tests early, iteratively enhances device usability, reliability, and overall performance.