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Unlike machines, human-beings are unpredictable and prone to errors. There’s no doubt about it: To Err Is Human.
Acknowledging it is a good thing, but in high-risk sectors such as aviation or healthcare, errors can be problematic, even fatal. A study conducted by Johns Hopkins University in Baltimore, Maryland, revealed that medical errors cause over 250,000 deaths annually in the United States, making them the third leading cause of death in the country, following cancer and heart disease.
However, with the introduction of the IEC 62366-1 standard on usability engineering for medical devices in 2007, things have been moving in the right direction. This standard promotes an iterative, user-centered design process to minimize the use-related risk for a medical device, highlighting the importance of studying human factors.
CLEIO’s specialists explain why it’s important to consider human factors into medical device design, and how they can positively impact its development.
Studying Humans to Reduce Use-Related Risks
During the design process of a medical device, it is crucial to focus on the end user – the human being who will interact with it. This has given rise to a new discipline: human factors engineering, also known as usability engineering.
A New Discipline: Human Factors Engineering
Human factors engineering applied to medical devices encompasses various disciplines, including social sciences, biological sciences, design and engineering, neurosciences, biomedical engineering, cognitive engineering. Its primary focus is on mitigating use-related risks.
By incorporating and understanding of cognitive biases, human factors engineering allow us to comprehend how users behave and think while using a medical device. Its objective is to ensure that the product is safe for healthcare professionals, patients, and caregivers, and that it meets the criteria for an optimal user experience.
Considering the User Environment in a Holistic Manner
Human factors engineering differs from user experience (UX) in that it goes beyond the product-user interactions. It examines the entire user environment, looking for anything that can influence his behavior.
Let’s take the case of a nurse: human factors specialists will focus their attention on the noise she hears in an operating room, the lighting, the people she communicates with, the type of room she works in, or even her working schedule. They also analyze, at a higher level, the nurse’s professional life to address questions like: What is the user’s persona? Does the work environment induce stress? How can this stress negatively impact device use and lead to errors?
Studying all these elements provides essential insights for designing the medical device in a safer way.
Designing a High-Quality Medical Device Optimized for Use
Human factors engineering involves various activities aimed at gathering information about the final context of use. Observation sessions, user interviews, and formative evaluations help identify critical tasks in the use of the medical device, and ensure that use-related risks have been mitigated as much as possible before the product’s launch.
Adopting a user-centered, iterative process enables the development of a low-risk product that meets user needs, and that can be more easily adopted than another.
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A Compelling Argument for Buyers
Valuable and precise data on end-user behavior can be acquired by focusing on human factors in product design. Such data, obtained through recommended formative evaluations under the IEC 62366-1 standard, can be strategically important when convincing potential buyers.
For example, a test might reveal that nurses using the newly-designed medical device were able to complete a task in 43 seconds that previously took them 3 minutes. Such data serves as a powerful argument for obtaining approval from healthcare establishment decision-making committees, especially in settings with limited budgets for new technology.
Demonstrating that the medical device is user-friendly, effective, safe, and enjoyable to use can greatly influence purchasing decisions.
Facilitating Market Success
The IEC 62366-1 standard is not the only reference for usability engineering. In the US market, the Food Drug and Administration (FDA) recommends the inclusion of human factors activities to strengthen submission files. If conducted correctly, these activities enhance the chances of obtaining approval.
Moreover, investors find products designed with a user-centric approach and tailored to meet precise user needs more attractive. This demonstrates that the product has a viable market and can be easier to commercialize.
Integrating Human Factors into the Design and Engineering Process for Medical Devices
To ensure the success of human factors activities, proper integration within the medical device design and engineering process is essential. At CLEIO, our human factors team is involved from day zero of a new project to understand the context of use and user needs.
- risk identification: identifying potential risks associated with device use
- defining design requirements: establishing design specifications to mitigate identified risks
- formative evaluations: conducting evaluations to verify that the new design effectively mitigates risks
Moreover, right from the project’s beginning, our team informs them about critical elements to be tested, whether specific components or a particular use case scenarios. This provides a clearer understanding of key points to consider during formative evaluations to drive forward the medical device’s development.
Human Factors are Essential to Medical Devices Development
Human factors engineering is a relatively new discipline that contributes significantly to reducing the use-related risks in medical devices. But it’s not the only contributing factor.
