Whatever the medical device is, the final aim of the development process is to provide user a product with an acceptable risk/benefit ratio. On one hand we seek to lower the medical device related risk. On the other hand, we try to reach the highest levels of efficacy.


A common and important point of both elements of this ratio that drives the development of medical devices is the usability.


First, regarding the risk, a recent FDA recall study shown that 44% of medical device recalls are due to design problems, and user errors are often linked to the poor user experience.


On the other side, treating a patient with a medical device frequently requires a more complex sequence of actions than the “simple” delivery of a drug. Consequently the efficacy of a medical device is closely linked to the product usability.


Usability and user experience are the key ingredients to get an acceptable risk/benefit ratio.


At Sophysa, we believe that usability and user experience of medical devices should never be a brake to patient management. That is why in every development we do, we keep challenging the status quo to provide you a unique user experience enabling you to be totally dedicated to your patient.


Over the last 40 years, in accordance with our vision, we put all our effort in developing ground-breaking solutions improving user experience for a better patient management in the fields of CSF Management and Neuro ICU.


Here are some concrete and well-known example of this dedication to usability :

  • The Sophy® valve which was the first adjustable valve in the World allowing non-invasive adjustment of pressure settings, to match an individual patient's changing clinical needs.
  • The Polaris® valve, the first adjustable valve with a magnetic lock, specifically designed to resist unintentional changes in pressure settings – a major milestone in adjustable valve safety. Polaris® offers the patient an unequalled security against the clinical risks associated with those dysadjustments.
  • The Pressio®2 monitoring system, a user-friendly Intra-Cranial Pressure and Intra Cranial Temperature monitoring system for neurosurgery and neurotrauma, bringing the continuous ICP and ICT monitoring to a new level of performance and ease of use.

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