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What is Human Factor Study FDA Guidance? See Top 12 Outcomes of HF Application to Medical Devices

    Can you tell us how you determine whether your product is a “hit or miss” in the market? Do you look at the sales figure? The popularity among your target audience? Or your end-user satisfaction? Whatever you prefer, you can’t guarantee the success of your medical device without ensuring its extreme usability. Do you know why? Because unless and until your customers don’t know how to use your healthcare device to maximum efficiency and that too without compromising on safety, it won’t perform well in your sales chart. So, an obvious query arises here, how to make sure that the medical appliance you are producing will be easy to use for your potential customers? Well, that’s where human factors or usability engineering comes in. The expert HF professionals adhere to the “Human Factor Study FDA Guidance” to “come up” with the improvement recommendations that will make your healthcare machine handier for the target users, like doctors, patients, nurses, and caretakers. 

    If you don’t know what does Human Factor Study FDA Guidance means, let’s have a look at its definition:

    What is Human Factor Study FDA Guidance?

    Just so that you know, FDA has developed this guide to assist medical machine manufacturers in following the relevant human factors and usability processes and maximize the possibilities of new devices to be safe and effective. The primary purpose of the recommendations specified in the Human Factor Study FDA Guidance is to support healthcare device manufacturers in improving the design of their product, so it minimizes the chances of “use errors” or causing any harm to the patients. Thus, if you fabricate any equipment for the medical industry, you must sift through FDA’s suggestions to assess the instructions and lower the risks related to the use of the device. 

    With that covered, it’s time to learn about the relation between human factors and medical devices. So, let’s see:

    How do humans interact with medical devices in real-world conditions?

    Before we go any further, you must understand that human factors or usability engineering is “all about” establishing a smooth communication system between patients and medical devices. In the “next section,” we will see how people interact with devices, what processes they perform, and how the machine’s user interface responds to the user’s command. 

    Keep in mind that to interpret the user-device system, you must understand first the way the people:

    1. Comprehends information from the machine 

    2. Process it and then decide what to do next

    3. And, finally perform some tasks using its controls, like modifying its setting, stopping its functioning, or replacing a specific component 

    In addition to that, it is also instrumental to “interpret” the way most medical devices:

    1. Receives input from the people

    2. Process the data or given command 

    3. Responds to user’s request by delivering the outcome 

    4. Provide feedback about the effects of their actions 

    With this, you would have got an idea that the “main” purpose of the human factors or usability engineering is to design the user-device interface correctly. Here, the UI involves all elements people interact with while preparing the machine for use or performing maintenance down the line. The former task includes unpacking, setting up, and calibration, while the “latter” cleaning, repairing, and battery replacement. 

    What are the various beneficial outcomes of applying human factors to medical devices?

    Your users:

    1. Get easy to use devices

    2. Leverage easier-to-read controls and displays 

    3. Ensure easier device maintenance and repairs 

    4. Better understand your device’s status and operation

    5. Better understand the patient’s current medical condition

    6. Take advantage of more effective alarm signals

    7. Stay assured of reduced risk of use error

    8. Remain informed about the reduced risk of adverse events

    9. Rely less on medical device’s user manuals

    10. You can opt less for product recall options 

    11. Require lesser training and retraining 

    12. Could establish safer connections between “device components” and accessories, like leads, tubing, power cords, and cartridges. 

    Why is human factor engineering essential for medical devices?

    As discussed above, the end goal of passing your medical equipment through human factors or usability engineering processes is to lessen the use-related hazards and risks that the machine could develop. And once this process completes, the human factor engineers ensure that the machine enhancement efforts are successful and ready for patient use.

    In a nutshell

    We hope you learned everything discussed in this article, such as the definition of Human Factor FDA Guidance, the processing of user-device interaction, and the benefits of HF application to medical devices. So, if you liked this content and want to get HF engineering services, please talk to the service experts of the most renowned human factor engineering firm in Arizona.