The medical device industry is among the largest industries in healthcare, and it is driven by new technologies and innovation. In the last 10 years, there has been a rapid growth in innovative technologies that have contributed to the development of quality high tech medical devices, such as surgical robots and high-tech nanotechnology applications. The advancements, have consequently led to the growth and further development of the healthcare industry. According to the US Government Accountability Office (GAO) 2014 statistics, in the US, the medical device industry records sales of around $136 billion, which accounts for roughly 45% of the global market.
As much as the future of the industry seems bright, one problem that some stakeholders are facing is the increasing regulatory requirements. Furthermore, the regulations also keep changing, which presents another challenge for the companies. These requirements make it harder for medical device companies to rapidly respond to opportunities and ensure that the products get to the market quickly. Increased regulatory scrutiny has made it necessary for medical device companies and manufactures to turn to technology, in an effort to identify methodologies that are cost-effective, assure safety, increase the effectiveness of devices, reduce non-compliance risks, and increase the speed to market.
Attention to regulatory requirements and quality are becoming critical in the industry and an increasing number of major players in the medical device industry are focusing on them in a bid to minimize legal costs and product recalls, while at the same time meeting the health goals of their patients.
Medical Language Translations and the Medical Device Industry
Medical devices are in demand all over the globe. The expansion of the medical device sector worldwide has created attractive economic opportunities for manufacturers of medical devices. In addition, millions of people also get the chance to benefit from the advancements in healthcare. However, the whole process of successfully launching a product or device in a foreign market can be daunting, due to the administrative and linguistic problems that are raised by the diverse and stringent regulatory requirements.
For example, the importation and distribution of medical devices in different countries is subject to strict approval processes, and compliance measures that are set by the regulatory body of a specific country. In many cases, one requirement is medical document translation in the official language of the country. Some of the materials that are normally required are packaging and labels, marketing materials, instructions for use, software, and user interface. All documents such as clinical trials, administrative documents, and quality management system certificates that will be used by the regulators to assess a device and approve whether it can be imported and distributed to the target market, also have to be translated. These requirements make healthcare language translation companies integral players in the medical device approval process.
Another factor that is important is that some countries have several official languages. This aspect necessitates that the content and materials that are accompanying a medical device, also have to be made available in the languages in order for a device to be approved. As a result, Medical device manufacturers should invest in a professional medical language translation company. According to Nabil Freij, President of GlobalVision International, “translation services are essential to meet medical regulatory directives in most countries for very good reasons, primarily, helping people lead healthier and happier lives! Global companies demonstrate their solid commitment to the safety of global communities by embarrassing these directives and adequately planning and budgeting to meet all of them.” This assertion is a clear indicator of why companies must opt to hire professional translators, who have knowledge of the regulations, requirements and who can translate medical terminology and procedures. Investing in medical translators helps make the whole approval process easier, faster, and more efficient.