From 2009 to 2019, around 2 million injuries were associated with faulty medical devices, according to the International Consortium of Investigative Journalists.
The investigation also showed that 80,000 deaths were caused by usability related of.
Around 36% of problems associated with faulty medical devices are attributed to poor usability design issues.
The average cost to bring a medical product from concept to market costs around $31 million.
Of that cost $24 million – 77% – is attributed to regulatory and FDA-related activities.
From 2009 to 2019, 2 million injuries were associated with faulty medical devices and 80 000 deaths were caused by medical device issues. Out of these injuries and deaths, around 36% are attributed to poor usability design issues. Poor usability design issues can be prevented early on during the development and manufacturing of a medical device.
Common usability testing of medical devices such as surveys, questionnaires and interviews are thus inefficient in ensuring patient safety.
CogniUse can be used to test:
- Learnability: First-time encounter: Is it easy to use your device?
- Memorability: Using the device after a period of abstinence: how easily can users reestablish proficiency?
- Satisfaction: How pleasant is it to use the device?
- User Acceptance: Are users willing to use the device longer-term?
- Summative testing
- Formative testing
- We expose users to the medical device
- We use Eye Tracking and EEG hardware while users are using your device
- Our Automated Analyses are carried out by AI-powered algorithms analysing the interaction of the medical device with the user
- We provide extracted features from brain signals in real-time and the possibility to interact and analyse the data
Compared to traditional usability testing methods, our tool can help medical device companies to derive objective, unbiased, automated and holistic data from brain analysis. By combining the analysing power of Artificial Intelligence and Neuroscience, CogniUse analyses the cognitive and emotional states of patients and medical personnel, as a way of improving the performance of medical devices and the safety of those that will use them.