Human Factors
Human Factors for medical devices has been the focus of my work for the last 10 years. The main goal of this type of work is to ensure that a medical device is safe and effective. Knowing that I have made someone’s life easier because a product that they have to use at work has gone through usability testing methodology is very rewarding to me. Healthcare workers provide support for so many people. I want to help them in my own way to make sure that I support their heroic efforts. The other type of person I am proud to support through my work is the patient as they are going to an illness or prevention of illness.
My experience in Human Factors for medical devices spans many different functions. My favorite part of this role is talking to end-users and seeing how they react to using a device for the first time. I have been fortunate to be able to test many different types of devices such as web applications for monitoring infusion pumps in hospitals, respiratory systems, diagnostic devices, insulin pumps, web applications for field service technicians, cataract surgery planning applications, and many other types of devices, and applications.
My process begins with performing a Human Factors audit to review all the existing documentation for a particular device. Then depending on if the product will be used only in the United States, outside the United States, or both areas, helps me determine what type of regulations and standards the device needs to meet. Next thing that I pay attention to are the users of the device. We will need to recruit these exact types of people when we begin testing the device. It helps to see what types of environment they need to work in. This affects how they will be using the device or application. Next I review the device or application and understand how the users will need to interact with it.
Depending on the project, I may be brought in at the very beginning, or just at the very end, or somewhere in the middle. My favorite part is being able to understand the users at the very beginning and continuing to talk to them through the very end of the project and beyond. Throughout the whole process we learn what changes in the product and the process are needed for the end users to use the device or application safely and effectively.
My favorite part is testing. This is when we actually get to put the device in front of users and have them work with it directly. Deciding when to test and how to test a device is an important part of the process.
The actual testing and documenting what we learn is a large part of what I do in this role. This effort typically needs involvement from the entire team. They approve all the documentation and prepare materials that I use when testing the end users. Before, during, and after testing I am required to write a lot of documents. The results of the test are recorded very specifically and documented for scrutiny from the FDA (Food and Drug Administration) in the United States and the EU (European Union) outside the United States. These agencies use the Human Factors documentation as one of the determining factors to release the device for release to ensure that it is safe and effective. This work is very rewarding and I recommend it as it allows me to be part of a system that gives back to healthcare workers and help patients in their well-being and ensure patient safety. I also like knowing that my work makes a difference for healthcare workers.
