Since we are a language service provider (LSP), we obviously approach our interaction with medical device companies based on our perception of what they need. Every LSP should be trying to offer a service that really satisfies the needs of its clients. Unfortunately, the reality is, what we as service providers consider important for these companies is not always critical, while we sometimes miss identifying needs that are truly crucial.
In June of this year, however, Nadège Young joined our LSP after having worked most recently for Boston Scientific, a large medical device company, and we compared notes on how our perception of what these companies need compares to reality. What we found interesting was that in some cases, as an LSP, we had a good understanding about medical device firms and their needs, but in other cases we didn’t have it quite right.
The first question we asked ourselves was how important quality systems and traceability are. Since the medical device industry is so heavily regulated, we were quite sure that medical device companies needed their vendors to have quality systems in place and would require full traceability through each step in their projects in order to conform to their own quality standards. When talking to such companies, we often emphasized that we had systems in place that would allow them to know who touched their files during each phase. We definitely felt that it was important as a translation vendor to have quality standards that were similar to our medical device clients and that is why we were certified not only for the EN 15038 translation standard, but, additionally, for the ISO 13485 standard, which is specifically for the medical device industry.
It is indeed becoming key for LSPs to have ISO certifications, and it is now a common line item on request for proposals. Some life sciences companies will not even consider a supplier without ISO certifications. Quality systems also play a big role in the supplier selection process, and a review of these systems is often performed at the supplier site. More and more, medical device companies are also auditing their LSPs on a regular basis to ensure that their quality systems are maintained and continue to improve. The gap here is that many companies do not adapt their audits to the specific service of translation unless they have the expertise in the service itself. Having spent time on the client side, we can testify that it is very reassuring to a client when a supplier can spell out each task in a workflow, along with the resource that performed it, for any project given to the supplier. The system has to be able to demonstrate that the right workflow and the right resources were utilized for each specific project.
The second question we asked ourselves involved the importance of training linguists on the products they are translating. In our experience, one of the biggest challenges when translating highly specific content for the medical device industry is the need to work closely with our clients. We believe that the more training we can provide our linguists to help them understand the products they are working on, the better. In some cases we even request that our clients do YouTube video product demonstrations that our linguists can access anywhere, at any time. From our perspective, we feel that we need to have a partnership relationship with these clients and that they invest the time to share product knowledge with the linguists. On the one hand, we are aware that this is time consuming on the client side, and on the other hand, true linguistic quality comes when translators understand all the intricacies of what they are translating and can see them in context.
Now, it would be absolutely great if all linguists could be trained on all products they are translating, but the reality is that it does not happen much. Very large companies have so many products that it would be logistically and financially impossible. Of course, there are ways to minimize the effort and concentrate on the most important products or the products with the greatest sales. We have personally seen and been part of several product training sessions on site at clients’ facilities, and the benefits can be priceless.
A couple of decades ago, information was not readily available on the internet, and there was a field trip to Harley-Davidson with fellow translators to spend time in the company’s shop with mechanics. We had a chance to identify parts and see how they work, take components apart and put them back together, working with real product experts. Another beneficial exposure to the product, which we recommend whenever possible, is a client site tour of the manufacturing plant, be it Boston Scientific or John Deere. Being able to follow an assembly line and see the products being created firsthand, whether you’re talking about a stent or a tractor, gives the translators valuable experience.
Unfortunately, in our modern world, this type of training and physical exposure to the products does not happen very often. The global make-up of translation agencies tends to make such events challenging and costly. The upside is that with so much information available through the internet, there are ways to help our linguists understand the products. Asking clients to participate via videos is asking a lot, but they may have other training materials they might be willing to share. The LSP project manager can always do a little research and send relevant links to the translators. We personally know some dedicated linguists who will take the time to research products not familiar to them. However, the client’s collaboration is needed when products are new and not yet launched.
The next best thing after product training is glossary creation, approval and usage. It cannot be stressed enough that this is the first step to quality. Product training or no product training, glossary creation should be part of every project. Whether the client pays for it or not, it will be beneficial for the supplier at every linguistic step. If clients can approve glossary terms with their own subject matter experts in country, it is a huge advantage. The only thing left, of course, is to ensure that the linguists will use these glossaries.
Thirdly, we looked at the importance of translations for medical device companies about to enter new markets. Whether medical device companies are entering new markets for the first time or whether they are expanding into additional foreign markets, the perception we had was that translation was not the foremost thing on these companies’ minds. This is particularly true when you talk to companies that are expanding globally for the first time. There are many other things they need to consider apart from actual translations. First and foremost, they are going to be trying to understand the regulatory requirements of the countries they are entering. They are going to be thinking about costs and how having a multilingual manual might change their needs with respect to packaging devices. For example, when you have your instructions in English, everything might fit nicely into your package, but once you have a multilingual instruction manual, which is obviously going to be thicker than the English one you suddenly realize that because of translation and going global, you need to rethink your packaging strategy as well.
In addition, companies entering new markets are going to be thinking about support and whether there should be local country support or regional support. Will they use a local distributor network? Whose budget will the translation belong to? These are just a few issues, but they illustrate that companies entering new markets — and particularly medical device companies due to regulatory requirements — have a lot of issues to tackle and translation is only one of them. As a result, it is not surprising that the question of how to actually do the translations and what the needs are for a translation supplier are not high on the client’s priority list. Thus, we need to have patience. Medical device companies will get to the “translation problem” in due course.
However, since some of our client side experience with medical device companies was directly connected to translation and localization, we would say that for sure, at least at some companies, translation is taken very seriously. Translation can be one of the key factors considered when entering new markets. In the last few years, translation and localization even became an integral part of planning. In our experience on the vendor side, though, we definitely have noticed different levels of importance placed on translation and localization based on the size of the company in question. The smaller the company, the more likely it is that there is one department, and sometimes one person, managing all aspects of the international expansion. As a result, the translation component may be only one piece to the larger puzzle of how to move into new markets, and it becomes an afterthought.
The fourth thing we considered was how important having your own translation management system (TMS) is. Translation companies love to talk about their translation systems. We work in a translation company and we know it’s true. We do it ourselves. We often want to differentiate ourselves by pointing out that our system does this and that, while our competitor’s systems have certain limitations. We spend a lot of time on positioning ourselves in terms of TMSs. The reason we do that is we believe that medical device companies, and other companies as well, assume that such systems are absolutely critical.
The reality is that medical device companies are getting familiar with TMSs because they are given elaborate presentations about these systems. Some clients are talked into purchasing the TMS for themselves and end up managing the translations in-house. These clients have to be ready for the effort and cost associated with the new process. New resources will be needed to manage the system and maintenance will be required. Most clients, however, believe that the TMS is the supplier’s responsibility, part of the core service being offered.
Medical device companies that have been around for a long time have become familiar with TMSs as their suppliers (and their competitors) are keeping them aware of improvements, new functionalities and features of their systems. As the clients are getting savvier about the systems, if they have someone or a department who owns the translation process, the LSPs will need to open up and expose these magic systems to be audited. In the United States, it is becoming standard practice, as mentioned earlier, to audit translation suppliers. These clients know it is crucial that the suppliers operate from a system linked to their quality system and they understand that such a system is a benefit to them from both a cost and quality perspective.
