The True Importance of Medical Device Human Factors Engineering
While medical device human factors engineering (HFE) is critical to product development, some teams struggle to integrate HFE principles throughout their product lifecycles. Noble International, LLC President Jeff Baker will answer common questions about HFE, address challenges, and discuss potential solutions. He will also provide case studies for both the pros and cons of incorporating HFE into medical device development.
Before a medical device is released to the market, it must undergo a usability assessment. The objective of usability testing is to identify any errors that might hurt the user’s experience. The final version of the device is then evaluated, and any remaining errors are analyzed for risk-benefit ratio. Unfortunately, the current decision rule for sample size is not always practical due to statistical limitations and the lack of a clear decision-making perspective.
The guidance document published by the FDA guides conducting usability tests on medical devices. The paper discusses risk analysis methods, the characteristics of users and their environments, and the planning of usability testing. It also refers to the IEC 62366 standard. This standard is widely used in the medical device industry and meets the regulatory requirements for developing medical devices. In addition, the book discusses the various government regulations and industry standards related to usability testing of medical devices.
A medical device’s user interface is one of a product’s most critical features. Unlike most other products, it isn’t easy to move from one location to another, making it crucial. Ergonomics should be considered during design, from the ergonomics of a surgical instrument to the layout of the laboratory apparatus. Experts at Noble take the time to consider user function early in the development process.
It is essential to understand that the user interface of medical devices involves all physical components of the product, including the physical appearance and the way it interacts with the user. This interface is how the user and the medical device communicate. This includes visual, auditory, and tactile displays. But the user interface doesn’t just refer to the software interface. It is as important as the actual design of the device itself.
Interactions with other devices
Human factors refer to the variables that influence a product’s performance and can affect the safety of its use. For example, the user interface for medical devices, which includes the features with which healthcare practitioners interact, often influences how people use them. If the user interface is challenging or poorly designed, medical device use mistakes can cause severe patient problems. Because these mistakes can have fatal consequences, developing medical devices with human factors in mind is essential.
The concept of human factors in product design goes beyond ensuring usability. In addition to product usability, a human factors perspective considers how the device fits within a healthcare system. For example, how does the technology fit in with the patient? The goal is to make the entire experience as pleasant as possible for the patient. The Human Factors in Device Design Guide guides the design process. In addition, the human factors in healthcare also consider the impact of the device on the patient’s environment.
Training of users
There are many benefits to a comprehensive training program for medical device users, including increased patient satisfaction and safety. Practical training should emphasize patient outcomes and usability and should be tailored to the background and experience of the trainees. The program should include hands-on activities and ample time to ensure absorption and comprehension. A comprehensive training program can also help reduce adverse events and device recalls. Here are three ways to design a training program that meets the needs of all trainees.
First, determine the purpose of training the end users. It would help if you established how many users your medical device will have and what their learning styles are. Based on the objectives of the training, you should choose an e-learning course that best meets those needs. Next, consider the training program’s purpose and your trainees’ language and learning styles. In addition, consider the availability of support for any questions or concerns. Finally, consider the number of resources you need to train medical device users.
Impact of unique features
Medical devices have numerous unique features that can influence their use. Many of these devices are portable and may be used in places other than the clinic, such as homes or workplaces. Portability affects not only the appearance of the device but also its discretion. For example, some people may use medical devices to measure the levels of certain chemicals in their blood or when traveling. Other features affect their portability, including battery life and durability.
Human factors research is increasingly applied to commercial products, including automobiles, furniture, and computers. Many manufacturers incorporate human factors principles into the design process of their medical devices. This approach is necessary because design-induced errors in the use of medical devices can lead to patient harm or death. In addition, the characteristics of equipment affect user behavior and can even cause errors in the hands of a highly skilled user. These factors are fundamental to the understanding of human factors.