It is important to analyze the target market well before putting money into advanced technologies. One can make a product highly advanced and functionally equipped but what if the market doesn’t need it. The language, interface, and aesthetics all play a crucial role in determining success of the device. Missing out on any of the aspects can lead to product failure. The developers must design the product in a way that it offers all three. The device should have intuitive interfaceĪccessibility covers a wide range of factors including cost, ease-of-use (interactive & comprehensible interface), and handling ease. It’s highly recommended to evaluate the end-user environment before moving on to next steps. For example a device meant for home-use must be compact and easy to carry, a device meant for OT should offer low interference and it would be better if it is wireless and battery operated. The industrial design of the device must be done in a way that fits the end-user environment. The product must adapt to the user-environment Things to consider while incorporating human factors in medical device: 1. The use environment for which the device has been created should also be kept the same during validation.In case the end-users won’t be given any training before using the device, the validation testing should also be done with untrained individuals.The device developers must ensure that all types of users are validated for the safety.Different kinds of users will have a different experience with the medical device.Human factors validation testing ensures that the device is used by its intended users without any serious use errors.User Validation : Each of these together contribute in making a device more user-centric. User Evaluation: User evaluation includes studying the user demographics to get an idea about which area will be the primary user of the device.Ĭ. The primary motive of research is to analyze the market, intent for production and safety of the end-user.ī. User Research :User research includes testing the relevance of device for the user on multiple dimensions. Once you have clarity on these aspects, you can proceed to next steps including:Ī. What kind of safety will be required by the end-user for a specific type of device?.Is the device meant for primary users or clinicians?.In which environment will the device be used?.What is the exact use of the medical device?.Incorporating human factors in medical devices requires a few basic pre-requisites: How to incorporate human factors during Medical Device Development? Usability Quotient: When the device is made keeping the above aspects in mind then it’s said to have a higher usability quotient. The interface, handling ease, safety and rhythm of the device with the use-environment are key aspects of human factors in medical devices. Human factors: Human factors involve focusing on the interactions between people and devices. Human Factor Considerations (Source : FDA) What are Human Factors & Usability in Medical Devices? Let’s dig deeper to understand what exactly do we mean by human factors and usability in medical devices. The PMA report also requires a human factors engineering report to be submitted along with other documents. Regulatory bodies have made it mandatory to consider human factors in their design and risk management plans. It is due to this it has become imperative to ensure compliance to FDA’s Human Factors guidelines compliance of medical devices. Functionality and aesthetics both play a crucial role in making a device user-friendly.Ī J ohn Hopkins study reveals medical errors account for 2,50,000 deaths and out of those approximately 45000 deaths are due to complicated device user interface. An intuitive interface and safety are the top priorities for today’s Medical device designers.
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