Reasons why medical devices fail are numerous. Design flaws, lack of good manufacturing practices, not involving doctors, inadequate cleaning/sterilization of the unit, and reusing devices that should not be reused are all common culprits of medical device failure and should be mitigated before they lead to disastrous patient outcomes. But what about the myriad other reasons that may be avoided by simply involving a strong language service provider in the process? Below we list a few ways a fastidious global translation partner can help.
Startups with Limited Knowledge
Many companies entering the medical device field lack the technical expertise, project management, material know-how and research knowledge necessary to create safe medical devices. Startups need to recognize their shortcomings and hire experienced personnel to help in these areas. They need people who can research and build medical devices, but they also need others with experience in marketing and launching products. They need sufficient and timely financing as well. With an eye towards the future, smart startups will want to go global. An experienced translation vendor can not only help with global marketing, they can also act as a project manager to help establish cross-cultural information sharing and ensure a seamless transition into the global economy.
Improper Labeling, Packaging and Product Marking
Mislabeling of device shipments can cause a lot of problems in the end. Apparently, 90% of products have incorrectly marked shipping packaging. This number is huge when you think about what is inside. Ways in which the packages are inappropriately marked may include incorrect or missing model numbers, box orientation, weight, and CE markings.
Also, the symbols and labels marking the device need to be concise, readable and correct. Not only will an experienced translation partner be able to produce consistent and accurate labeling, they will also understand the specific country requirements and help to ensure compliance.
Missing or Confusing Instructions
When it comes to the instructions, many things can go wrong. These can all lead to devices being misused and possibly cause patient injury. Maybe the Operation Manual is missing sections. Perhaps the instructions are poorly worded, overly complicated or do not match the model they accompany. The language can be too technical or unclear. We have all had the experience of dealing with instructions that don’t make any sense. Perhaps the instructions were not translated well. Sometimes the process of translation can actually improve the source document – forcing the writers to be clear and concise. Why have an untrained person with a dictionary translate high science documentation? To help avoid confusion and problems, medical device manufacturers should use a qualified and experienced medical device translator.
Not Employing Human Factors Research
Every company that is planning on developing medical devices must do so with the aid of human factors studies. This reduces defects and failures in medical devices. Human factors research takes into account diverse fields such as industrial design, psychology and engineering. It uses focus groups and surveys when developing new products. In other words, it determines how the machine and the human interact. It also helps reduce the risk of error.
This can be as simple as the colors of the push buttons and indicator lights. According the Handbook of Human Factors in Medical Device Design, edited by Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau, different cultures interpret the same stimulus differently. In the United States, the color red means STOP, but in China, it means good luck. This can make a difference when going global with a medical device. Because of cultural and national differences, standardized color coding in the medical domain has yet to be achieved, so it is vital that colors and symbols used on medical devices be tested in all target markets in order to fend off costly and painful outcomes.
Also, the challenge in designing for international markets includes things not everyone would think at first glance: typeface, font, word layout in a document. For example, Chinese is read vertically, so all menus should be vertical. In contrast, Arabic and Hebrew are read from right to left so all menus must reflect this. Translators should be used to translate the document into the native language of the device’s users and also adjust the language style to the reading habits of the target user. A cultural sensitive translator should be used and rigorous user testing should be a minimum requirement.
Not Keeping Other Cultures in Mind
Medical device manufacturers need to consider the new markets they enter when they sell their devices worldwide. Here translators are key to bridging cultural and linguistic gaps by considering other countries local norms. Not complying to these norms could create misuse in the form of incorrect labels and confusing products, to name a few.
In order to more easily work with overseas colleagues, management should also have cross-cultural training, something a full-service language company can provide.
Not Noticing a System Failure is Looming
It starts somewhere. A surgeon didn’t read the instructions. The device was improperly labeled and stored. A nurse input the wrong settings. The device was improperly cleaned. A clinician installed a tube incorrectly. A standard operating procedure (SOP), manual or label was poorly translated or misunderstood. In the end, someone got hurt. The failure lies at the end of a series of events that lead to that moment. One way to better ensure that these failures do not happen is to have a language translation partner that understands the importance of accuracy and precision, and who works with you to consistently ensure the success of your device.
By Ilona Knudson