Product development in medical technology has its own laws. As specialists in medical technology, our task is to design and develop the products in terms of optimal handling and safe use. For example, a device that is to be used in a hospital environment must be primarily functional. When designing, hygiene standards for instance play an important role - surfaces without corners or edges, and easy to clean materials such as stainless steel or plastic that are easy to sterilize. The trend here is increasingly towards disposable products that enhance both compliance and convenience.
To ensure this balance, we work closely with practitioners, nurses and doctors. Wherever possible, we look at the work environment and processes in detail. In an emergency, it should not take long or be difficult to see which button to press - it must be obvious at first glance. In order to standardize the operation of the various devices and systems, guidelines exist for their design and labeling. A modified operating logic would disrupt the workflow and lead to errors. To ensure optimal usability, we work to the DIN EN 62366 standard. This approach is a central, although still very new, part of the development of medical devices that indicates that ease of use is being taken ever more seriously. These guidelines and requirements by legislators (CE, FDA or SFDA) are the ones that make the difference between product design and medical design. We must, however, never lose sight of the trends in medical technology toward the adjacent fields of homecare, wellness and rehabilitation.
As part of the development process for drug delivery devices, and diagnostic, therapeutic and surgical systems for CE or FDA, we take responsibility for mechanical solutions, enclosure functions and usability.
For several years now, usability has become one of the priority tasks in medical design. We offer the complete user-centered process-inclusive Usability Engineering File, according to DIN EN 62366.
What is the effect for example of the trends towards more autonomy, telemedicine and remote monitoring on the design of medical products? With regular updates, we give you a view of the most important vogues.
From development to approved medical device takes much longer than in other comparable industries. Early on in the development process, we visualize ideas to accelerate project development.
Medical Design requires a systematic approach and high level of documentation from design engineers. We integrate our work results into the design history file and create guidelines for the risk management file.
The usability of a product is critically dependent on its usage context. Medical designers go out to practices and organizations to ask questions and investigate in order to understand and optimize.