Advancing the need for cultural localisation of medical device software tools
Article by Associate Consultant Mark Gibson
Software localisation of medical devices is not a universal regulatory requirement. However, software localisation is vital as a competitive tool to gain a foothold in foreign markets. This potential advantage is not only the case for medical device manufacturers, but also for all software applications that aim to be used outside their native language regions.
Take, for example, a medical device that incorporates a software program that relies on date expression for safe and effective use. The software originates in the USA, whose developers programmed date to be expressed as follows:
02.12.2010 (for 12th February 2010)
The device and software in question is to be marketed in the UK, Spain, Sweden and South Korea. However, date expression differs from country to country, as is illustrated with the example of 12th February 2010 below:
| USA |
UK |
Spain |
Sweden |
South Korea |
| 02.12.2010 |
12.02.2010 |
12/02/2010 |
2010-02-12 |
2010.02.12 |
However, the software, in its current iteration, cannot accommodate these cultural date conventions. From this example, it is possible to see at a glance the potential confusion this could bring to a user in each country if the original US format is not localised to the respective countries’ usual formulations of date expression. Another common example is how units of measurement are expressed, such as the UK Imperial system, the US Customary system and the more internationally recognised metric system.
Product localisation and cultural adaptation can help address safety issues related to human factors, such as the risks outlined above with the improper interpretation of date/time information or unit of measurement. Safety issues in medical device development can be identified in trials and resolved in the development process in the initial locale, i.e. where the device was created, before it goes to market. However, the impact of faulty translation and localisation issues that affect safety are not as carefully controlled, verified or validated and many such issues are not identified until after the product has been licensed and marketed. This can often lead to product recalls in the countries in question, which naturally has a direct and negative impact on the manufacturer’s revenues.
Issues also worth considering are
Software localisation and cultural adaptation
Customising software application for use in different target locales will help users in different countries gain maximum benefit from your device. Typically, this would include the translation of accompanying documentation, help files, user interface components, such as screen/display text, buttons, error messages, and so on, as well as ensuring the adaptation of software to the target locale to specific local conventions and requirements, such as date/time formats. The adaptation aspect of the service would involve aspects of user-centred design or human factor testing.
Software verification and validation
The objectives of software verification and validation is to provide evidence that the design outputs of a particular phase in the software development life-cycle meets all the specified requirements for that phase, such as FDA’s General Principles of Software Validation Guidance [1]. Software validation provides insights into the usability of the tool through the provision of objective evidence from a user-centred process that the software specifications conform to user needs and intended uses of the device in question.
The business case for undertaking localisation and cultural adaptation services is supported by legislation. For instance, FDA’s Medical Device Quality System Regulation Part 820:30 (21 Code of Federal Regulations 820:30)[2] states that labelling, whether electronic, paper-based or both, is considered part of the medical device and subject to design control. In Europe, the Medical Devices Directive (MDD) [3], as well as ISO 13485:2003 also requires design control and software validation for medical devices as part of the application for Marketing Authorisation within the EU. Accordingly, as with traditional labelling, the User Interface of medical device software tool can carry vital information about the product in question for safe and effective use. For many products, the User Interface provides the medium for the user’s interaction with device. In some cases, the software is the only way to interact with the device, or with stand-alone tools, the software is the device. Furthermore, ISO14971: Medical Device Risk Management identifies a lack of product localisation as a possible cause for hazards and recommends, as standard practice, the involvement of an expert in localisation risk for both the labelling of the product and its User Interface.
In addition to the regulatory framework currently in place, the advantages of these are to:
- Provide medical device developers with a tool to mitigate risk
- Help to gain an advantage in foreign markets
Help to support a global user base for the product.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
