Medical device manufacturers use the risk management process as part of their design controls to minimize and decrease any hazards connected with product use. Human Factors considerations are an important and required part of that process. However, anticipating usability problems can be difficult in the early stages of development. The application of human factors testing, early and often, is critical to inform risk management.
Medical products can be difficult to use which can lead to human mistakes (use errors) that may cause injury to patients or users. Manufacturers need to demonstrate that new products can be used in a safe and effective manner through the application of Human Factors/Usability engineering process. Human Factors/Usability testing becomes the focal point of the process as development efforts advance towards completion. Here’s an overview of human factors and usability testing for those in the combination drug/device, medical device and software as a medical device industries.
What Are human factors?
In simple terms, human factors are attributes of the physical body, behavior, cognition and performance that impact how a user interacts with a product. A keen understanding of how a medical product is used is essential to evaluate the possibility that the user may make a mistake that can change how the product benefits them. The FDA has suggested that sponsors plan and execute usability studies to identify and prevent or eliminate these mistakes or “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.
According to the Agency, it is critical to understand how people receive information about medical devices, medication delivery systems and medical software, 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 product 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 are placing a greater focus on 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 or limit efficacy.
It is costly and time-consuming to have your product returned due to inadequate HF 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 device focusing on its user interface in a simulated environment. The purpose of user testing and human factors in the medical device sector is to discover and optimize the user interface, eliminating as many preventable mistakes as possible.
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 device 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, research and development teams 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?
The 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 company that specializes in human factors testing and engineering for medical devices to design and implement the key human factors validation research needed as part of the submission for regulatory approval. 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 test methods.
In addition to the human factors specialists, be sure to support the effort by designating a cross-functional team of internal individuals. We propose that at least one person from training, regulatory affairs, marketing, quality, and engineering be included.
Usability testing is something we’ve done at Improvita in at our own lab or but in numerous regions to ensure a diverse representation of the intended use population. A specialized setting is sometimes required.
Analysis and reporting
The human factors moderator is in charge of data analysis. If data was logged by a second observer, the two will discuss and compare and resolve any conflicts by watching the videos of the testing session. Each participant is scored following a framework that is prescribed by the FDA to allow for the assessment of user actions and knowledge. These scores help identify to characterize use errors and drive to required risk mitigations to improve the product.
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 intended users without major mistakes or problems and in the proper context of use. The testing should be extensive, sensitive enough to identify use errors allowed by user interface design, and the results should be generally applied to improve the product design to limit any risks that may impact the consumer in the real-world.
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!