Expert advice from THAY Medical: CE marking usable medical devices
CE marking usable medical devices
It is now mandatory to show some form of evidence of use safety when CE Marking a medical device. Whether it is a mobile application with a clinical claim, an inhaler or ECG machine – when developing the next iteration or leap in technology or clinical practice, evidence of use safety will be required by the Notified Bodies, regulators and hopefully, internal Quality Management Systems.
The phrase “ease of use” relates to the practice of putting in a level of usability into a product – in this case medical devices. Having usable medical devices will prevent medical errors, will speed up healthcare and patient healing, and can reduce healthcare spend. Usability is a term that combines four different phrases – ease of use is one of them. Another is efficiency. A medical device should be efficient to use – timely, simple, quick and optimal. We all demand devices that are quick to use as we are all busy patients.
The process of incorporating usability into the development of a medical device is now prescribed by many regulators. An example of this is the guidance published by the US FDA, as well as the MHRA here in the UK. Internationally there has been an IEC/ISO standard that covers how to enhance the usability of a medical device during its development. IEC 62366 was released in 2007, and was updated in 2015 to become IEC 62366-1:2015. It describes the process of usability engineering and focuses the mindset of the developers on the user interfaces of the medical device – keeping it current with all the digital medical devices that are being developed.
The various usability engineering methods focus on a front-end approach. It’s pure R&D (Research and Development), in line with the US FDA’s waterfall design development methodology. Define the user needs, design, develop and then test (Verification and Validation), and then prove safety. All usability engineering methods align with the well-known ISO 14971 Risk Management process. The difference is that use safety is evaluated in addition to other common areas of medical device risk (design, production, clinical etc.).
For us at THAY Medical, we only focus on usability engineering – we help medical device developers and manufacturers to design and develop usable medical devices. Much of the work we do is front-end, in that we undertake user research before working with designers, engineers, developers to create the user interfaces of the medical device. Finally, we gather evidence of use safety by testing medical devices with users. This creates objective data that is very powerful if used correctly. Data from usability testing can be used as risk mitigation, can drive patient and user focused development decisions, and even provide data for a healthcare economic application.
It’s all very simple in our eyes. When you watch television adverts and you read at the bottom of the screen that “86% of people tested with this shampoo agreed it was better than their current shampoo”, you are reading data generated from usability testing. So, if you want to have evidence that your medical device is better than the last iteration, and is safe to use, then generating this type of data during its development is essential, and it may give that competitive edge required to make a good medical device into a great medical device.
For any queries on human factors and usability for medical devices, please contact Ann Watson.