Producers of medical devices of the future need to pay close attention to the plethora of "human factors" which influence who will use a device, and how, and where it may be used.
From apps which act as our personal assistants, play our favourite music, and do our shopping, to those which heat our houses remotely, call us a taxi, and record how well we sleep, technology is already delivering a personalised service. But it doesn’t end in the domestic setting, the use of technology in medicine is rapidly developing to allow clinicians to work with patients in monitoring their health wherever they are.
In September this year the Medicines and Healthcare products Regulatory Agency ("MHRA") published its "Human Factors and Usability Engineering" guidance for manufacturers of medical devices (including drug-device combination products), and notified bodies.
The guidance looks at the importance of considering "human factors". By "human factors" in the development of medical devices it means how a person interacts with systems surrounding them, including the technology they use. The guidance applies to the future design of products as well as changes in how users interface with existing products, and aims to clarify regulatory expectations in relation to medical devices that are to be made available on the UK market. The guidance is intended to be in line with international standards and with guidance on the same topic from the FDA (the US Food and Drug Administration).
A central theme in the guidance is that producers of medical devices should be considering human factors as integral to their design, development, and evaluation process, particularly given that more and more medical devices are being used in increasingly diverse settings, including in patients' own homes. The guidance sets out ways in which producers can apply human factors and usability engineering to medical devices to optimise safety and performance. Key points include:
The Medical Devices Directive (93/42/EC) sets out (in Annex I) a number of requirements, including the need to reduce the risk of error due to the ergonomic features of the device, design of measurement, monitoring, and display scales in line with ergonomic principles, and providing information needed to use the device safely, taking into account the training and knowledge of the potential user.
Human factors studies can be used to address regulatory requirements, but where they involve clinical use of the device on humans, MHRA ethics committee approval may be required.
Device users should not have to read, understand and remember complex instructions for use. A well designed device should be easy to use correctly.
Application of human factors to product design results in devices which are more pleasing to use and therefore likely to be used correctly, in accordance with their intended purpose.
Manufacturers should engage in pro-active post-market surveillance, reviewing all feedback and acting on that feedback where appropriate to improve current and future designs.
Manufacturers should seek out feedback from users and should review complaints data for potential user error in relation to their own device, and for similar devices where available. Where adverse event reports and product recall data for such devices are available for public review, those reports should also form part of manufacturers' active post market surveillance strategy. The new regulations will require manufacturers of certain classes of device to submit a periodic product safety report, setting out a summary of the results and conclusions of analyses of post-market surveillance data
Whilst the guidance was produced with the current EU regulations on medical devices in mind, and is a not a mandatory compliance requirement, it is intended that the guidance will be of assistance to producers seeking to demonstrate compliance with the new EU regulations which will fully apply from 26 May 2020.