The Swedish regulatory and quality assurance consultancy firm Symbioteq assists in the development of medical technology products with higher usability. Relying on decades of hands-on experience and well-established collaboration networks, Symbioteq offers a wide range of services to help secure and improve usability in medical devices.
Medical device developers are among the most regulated businesses in the world, with ever increasing requirements. For individual innovators or small companies it can be difficult to keep track of changes in the legislation and new requirements concerning their activities. Symbioteq facilitates the process by keeping track of what applies to each client's business as well as their products, and has helped a large number of medical technology companies to achieve success over the years through guidance in the complex process of quality assurance and certification.
By engineers for engineers? Usability is a recurring concept of concern to all companies actively developing, manufacturing and distributing some kind of medical device. “The medical technology industry is characterised by high technical expertise where cutting-edge technology is developed by engineers for engineers. Medical devices are often complex and based on high technology, which sometimes results in misuse. Multiple studies have shown that misuse account for about a third of all accidents in health care”, explains Jakob Dumky, Senior Quality & Regulatory Consultant at Symbioteq. “Usability defines the characteristics regarding ease of use, which in turn results in the desired effect, and satisfaction with the product. Without appropriate usability a product is simply not desirable or even suitable for the general user”, Dumky continues. Jacob Dumky is currently participating in the Swedish committee for the development of a new version of medical quality standard TK355, where usability is included. This standard was introduced in 2006 in response to the high number of identified incidents related to medical devices. The aim is to increase the usability by increasing awareness of the end user’s needs, abilities and demands.
An important concept of quality So why are medical devices not user-friendly? Usability is a new concept that may seem alien even though the principles behind the concept are based on common sense. Usability has long played a central role in for example industrial design, where the design is just as important as function. “Usability in itself is not new, but the standardisation and application to medical technology products are. The industry must realise that usability is an important concept of quality, just like safety and performance and that authorities at present time have listed usability as a “hot topic”.”, says Senior Quality & Regulatory Consultant Micael Johansson, who has over 20 years of experience working with regulatory affairs related to product development.
Increasing awareness Symbioteq helps customers interpret the regulations concerning usability and apply the right level of usability for their products. The company is also working actively to disseminate knowledge about usability and will therefore organise a seminar in the fall to raise awareness in the area. More information about the event can be obtained from Micael or Jakob at Symbioteq. “Usability permeates all of our service areas. We strive for greater patient safety by helping to develop our clients’ products with higher usability. Although much is based on common sense, the aspect of usability is very difficult to implement in reality, and therefore we are offering our combined expertise”, Micael Johansson concludes.