A medical device manufacturer uses the risk management process as part of their design controls to minimize and decrease any hazards connected with product use. However, anticipating usage faults before people start using the item can be difficult.
Difficulties are not necessarily tied to the item itself. Technology can be difficult to use at times, which can lead to human mistakes that cause injury. Human factors and usability engineering are very important for making sure that new products are safe and easy to use. This is because they examine how people interact with technology. Here’s an overview of human factors and usability testing for those in the medical device industry.
What is the human factor?
The human factor is how a user interacts with a medical device and the dangers that are created as a result of the human aspect. The FDA has suggested that sponsors plan and execute usability studies to identify and prevent or eliminate these hazards. The goal of these tests is to put their product through its paces in real-world scenarios, get user input, and make any required modifications to prevent patient adverse events and medication mistakes caused by use-related errors. This is commonly referred to as “human factors engineering.”
According to the Agency, it is critical to understand how people receive information from medical devices, how they comprehend that information and arrive at decisions, and how they use the device, its components, and its controls. It is also critical to comprehend how the gadget collects user input and then responds and offers feedback to the user on the consequences of their actions.
Importance of human factors testing
As healthcare and medication delivery systems become more complicated, regulatory authorities place a greater focus on guaranteeing their safety and efficacy through human factors testing and user research. Anyone utilizing a medical device, whether a clinician or a patient, should be able to do so without making mistakes that jeopardize the end user’s safety.
It is costly and time-consuming to have your gadget returned due to faulty testing, yet it happens very often. This problem is solved by conducting proper human factors testing at the outset. Human factors research looks at how a person interacts with a gadget in a simulated environment. The purpose of user testing and human factors in the medical device sector is to discover and eliminate any preventable mistakes that may occur by taking into account the product interface, environment, and user.
These simulated situations can attempt to mimic a nurse in a clinical environment, a surgeon inside an operating room, or a patient at home with connected medical equipment. Usability testing and human factors for medical and medication delivery devices are critical to ensuring that the product design is easily accepted by users and that it may be operated securely in real-world settings.
Benefits of human factors testing
Sponsors can create a medical gadget with a variety of useful features. On top of legal requirements and regulatory compliance, there are many benefits to human factors testing, also known as human factors engineering. They include:
- Easier to interpret devices (interfaces, controls)
- Easy-to-use and safer devices
- More secure connections between device accessories and components (cartridges, tubing, leads, and power cords)
- More powerful warning signals
- Improved user comprehension of the device’s state and operation
- Simpler controls, displays, device repair, and maintenance
- Improved user comprehension of a patient’s present medical state
- Reduced risk of usage mistakes
- Decreased user dependence on user manuals
- Reduced likelihood of undesirable events
- Reduced user retraining and training requirements
- Reduced likelihood of recalls
Special considerations in human factors testing
When doing human factors testing, medical device makers must take certain questions into consideration. These include:
Who are the device users?
Determine the product’s prospective consumers, including both intended and inadvertent users. Think about people who might use the product without realizing how dangerous it is or who are less able to protect themselves from the risks. A user’s ability to use medical equipment is determined by personal traits such as
- Physical size, stamina, and strength
- Physical dexterity, coordination, and flexibility
- Sensory abilities (tactile sensitivity, hearing, vision)
- Memory and other cognitive abilities
- The health issue for which the equipment is utilized
- Comorbidities (numerous ailments or diseases)
- Literacy and linguistic abilities
- General health condition
- Mental and emotional condition
- Level of health and education literacy in relation to the medical condition under consideration
- General knowledge of comparable types of equipment
What environment will the device be used in?
Any project that wants to test and validate human aspects needs to model real-world situations. When a test requires participants to be trained in the appropriate use of a technology, consider imitating the real setting in which they will use it.
If the product or equipment will be used in a home kitchen or bathroom, the sterile, overly-bright light found in a hospital setting will not be an accurate representation of the genuine usage environment. Take into account all characteristics of the environment in which the product may be employed. A few examples are vibration, noise, temperature, and lighting.
What is the user interface?
The product-user interface includes all points of interactions between the product and the user throughout setup (unpacking, assembly), usage, disposal, and maintenance, such as:
- Weight, shape, and size of the product
- Displays, indicator lights, and visual and auditory alerts are examples of elements that offer information to the user
- Product software components’ graphical user interfaces
- The format in which information is delivered to the user, including feedback
- Packaging and labeling, which may include training materials, operating instructions, and other information
Steps in human factors testing
A human factors validation study is an activity designed to demonstrate the safety and usability of a market-ready product in the presence of representative end users.
The three essential steps are:
Preparation and planning
Begin by collaborating with a business that focuses on medical device usability testing to keep your human factors validation research on track. Alternatively, consult with your company’s own human factors team. In either event, this is not a task for one of your marketers. It necessitates a highly specialized skill set as well as a testing method.
In addition to the human factors specialists, be sure to designate the correct core team of internal individuals to help with study preparation. We propose that at least one person from training, regulatory affairs, marketing, and engineering be included, as well as a point person to oversee the project.
Usability testing is something we’ve done at Improvita in a number of different locations and types of facilities. A specialized setting is sometimes required. Other times, you may need to take the tests to a place with a greater population of a particular surgeon. Whatever you do, make sure you leave enough time for orientation and setup.
Analysis and reporting
The human factors moderator is generally in charge of data analysis. If data was logged by a second observer, the two will discuss and compare notes. You can’t always rely on a single observer’s constant monitoring; that individual needs breaks. Having several sets of eyes on users is thus a smart practice. If there is a disagreement or the mission doesn’t go as planned, you can also use the opinions of other people to come to a more well-rounded conclusion.
Why is human factors testing so difficult?
Usability testing as a scientific process is limited by its reliance on subjective, qualitative judgments.The data gathered during the testing procedure is heavily influenced by the experimenter’s experience, how the researcher interacts with the participants, and the individuals participating in the study. If testing is not carried out in accordance with recognized qualitative research guidelines, the procedure may yield incorrect results.
What is reliable human factors testing?
Reliable human factors testing is the kind of testing done to show that the product can be used by the expected or planned users without major mistakes or problems and in the expected or planned conditions of use. The testing should be extensive, sensitive enough to identify faults allowed by user interface design, and the results should be generally applicable to real-world consumer use.
Who has to do human factors testing?
With the purpose of minimizing usage-related hazards and risks and ensuring users can use the device effectively and safely, the best time to integrate human factors engineering is as soon as possible in the product development cycle to affect the user interface and product design to minimize use-related risks.
Improvita human factors and usability testing for medical devices
The incorrect use of medical equipment can cause significant damage or even death. Focusing on human factors during the development and design process can assist in identifying possible problems and lowering the risk of a product being used incorrectly before it is released to the public. Human-centered design is central to the Improvita method.
We provide a comprehensive range of medical device development and design services, including human factors. We provide products that are both safe and effective in the real world. Human factors testing is a vital investment when human lives are at stake. Feel free to reach out to us today!