Without a doubt, the medical device industry is on an ever-increasing transformation and evolution both in the complexity of the manufacturing of medical devices and in the different methods of testing usability problems that are required to gain acceptance for entering the market. With about 1.7 million injuries and nearly 83,000 deaths reported within the last decade due to usability issues and failures, the demand for more reliable and effective usability testing is on the rise. As such, BCI (Brain-Computer Interface) applications are rapidly transforming the medical device industry and will continue to do so in the following years, due to the benefits they provide.
What are BCI applications?
Brain-Computer Interface applications refer to devices that allow users to interact with computers, measuring the brain activity of the user. The electrical activity is measured with EEG, recognising energy and frequency patterns of the brain. Over the years, Artificial Intelligence and Machine Learning have become a vital tool in aiding the accuracy and reliability of BCI applications. In order for BCI applications to work, the user and the BCI have to work together in a process of encoding and decoding.
No, they don’t read your mind. Instead, with the use of AI and Machine learning, BCI applications can decode the cognitive behavior of the user, extracting information such as joy, frustration, concentration, mental load, and engagement providing objective and reliable information.
For more information about the development of BCI applications:The Brief History of Brain-Computer Interfaces.
The Medical Device Industry and BCI
The rise of the BCI market is directly related to the rise in demand for better manufacturing of medical devices, as a way of accelerating the process for approval and for providing safer and easy to use devices. Usability testing is a prerequisite that is required by governmental laws to gain approval and enter the medical market.
- Bringing a medical device to the market takes an average of 3-7 years, entering a cycle of testing and redesign that typically takes 2-3 years and costs between $10 – $20 million.
- On average in one year, 400,000 hospitalized patients experience some kind of preventable harm that can be detected early during the usability testing process.
- Common errors that can cause harm or even death include issues with manufacturing and design, not enough information on how to use the equipment, complexity in using and low quality.
With BCI applications the user’s emotions and responses towards a product can be detected early on and optimised to provide a better experience.
Traditional methods vs BCI applications
Have you ever tried to explain a vivid experience to a friend? If you have done so, how accurately could you describe the intensity of what you felt at that moment? Were words sufficient? What if that person could actually feel what you felt, without you having to describe it?
- Traditional methods for testing the manufacturing of medical devices include users filling questionnaires or reports after they have used the product. This can often be biased and subjective, and cannot be as accurate as real-time analysis.
- By using a BCI application such as EEG, the cognitive load and certain emotions can be directly extracted from the user in real-time, leading to better decisions in the manufacturing and design of a product. The device can be optimised early during the usability testing process, avoiding extra costs and long waiting time for approval.
- Verbal and written questionnaires are not as reliable as a BCI application. This is because users have to interpret their emotions and their actions and often can report what the interviewer wants to hear or sometimes, they cannot describe their emotions well enough. A BCI application does not rely on human interpretation but rather derives information directly from the source of information: the brain.
- A BCI application reveals even the subconscious responses of users, which are often left out in a traditional method report.
- GSR applications measure the sweat on the pores of the user’s skin to giving information about feelings of discomfort, stress, relaxation, engagement and the different levels of complexity when using a device. This is something that cannot be effectively measured with a questionnaire or during an interview.
- Face Response Analysis is another BCI method that can provide information about different facial expressions when using a device, providing data about the user’s emotions and responses. These can be often missed out or misinterpreted by a person carrying out an interview as interpretations by humans can be subjective.
A combination of BCI applications can help to derive reliable, accurate and objective data, helping to reduce errors, increase patient safety, improve patient care, improve staff performance, lower training course because of the ease of using the device, and increase the possibilities of using a specific device because of its ease. In this sense, not only patient safety is improved, but also healthcare professionals can work more efficiently and the manufacturers of medical devices reduce the risk of heavy fines, problems with their devices, extra costs and long approval time.