Device labelling is exceedingly difficult for manufacturers for many reasons, including:
- Increased regulations from government bodies to ensure compliance
- Increased Competent Authority Surveillance
- Increased audits
The process is exacerbated by the language requirements each country imposes on the industry. Local-language labelling is a requirement for devices and diagnostics that are to be sold across the EU, and poor translation on any documentation can expose companies to litigation.
A key practice that is assisting the process of writing the labels and translating them more effectively is the use of Electronic Labelling systems. Typically, there are text and symbols for each label which are used by several products in various media formats. This practice removes the need to re-label and re-translate slightly modified products and allows reuse of content from previously produced labels. It modularises content so that labels and other information can be assembled using a template.
For example, diagnostics with a sampling kit, testing kit, test materials, electronic data and help systems can all share content. Companies such as Johnson & Johnson are beginning to introduce this process to its individual businesses that need to go through a labelling process for their own products.
The nature of electronic labelling separates the text from the coding, typically in XML type files. This makes layout and typesetting much simpler and cost effective for companies that previously had to assemble 17 language versions by hand, comments Greg Rosner, US Vice President of thebigword. In addition, Electronic Labelling allows companies to re-use text that is the same or similar for updates and product revisions. Mr. Rosner continues: For some clients where there are frequent changes, we can integrate our SOAP Web Services directly into Electronic Labelling systems, which allows any changes or updates to be automatically detected and distributed for translation. With respect to Translation Memory, for a number of our clients, we see approximately 60% re-use of their content which increases the level of consistency, speeds up the turnaround and ultimately lowers the cost.
If navigating all these issues is not enough, you will also have to deal with placing multilingual text and symbols into the confined space of several labels. It is not until after this stage that translation is considered. If the information is not translated by a professional translator who understands the product and your industry, you may receive literal translations. For example, reverse-pipetting could be translated into German as use the pipette upside down. With regards to quality, Mr. Rosner adds, Translators must be industry accredited and have at least 3 years as a professional translator if they are going to work on our client's projects.
With a number of additional countries joining the EU, many medical device companies are struggling to find qualified resources in countries such as Sweden, Poland, Denmark and Turkey. In the care of acquiring the right resources in-country, Mr. Rosner says, Unlike many of our competitors who may claim to have these resources, thebigword has already spent the last 10 years sourcing these people and working with them on past projects.
Once the translation is complete, medical device organisations must have the translation approved and certified for its accuracy. Whilst many companies offer this type of certification, it is at this point that their quality guarantee comes to a halt. If the translation is found to be incorrect, and the medical device company is confronted with a lawsuit, most translation companies will limit their liability to the cost of the project which in many cases is less than $1,000. This limited liability can damage a companys confidence with respect to public exposure. Many organisations will acknowledge that after their translation company has completed a certification of accuracy there is no additional review prior to publishing. However, thebigword has a guaranteed accuracy policy, For a period of time after we deliver the acceptance of the translation, we will guarantee the accuracy and quality with a $3.5 million per claim insurance policy and no limit for death. There has never been a claim to date but we have this policy because we take quality seriously its our business.
On the subject of managing the translation process for medical device companies, Mr. Rosner states, If they are not supported by a proven process and the secure technology, their translations will not meet your accuracy and timing requirements.