Genourob design, manufacture and market medical devices and specifically for helping Medical Practitioners to detect ACL (Anterior Cruciate Ligament) tears (complete and mostly partial are very difficult to observe with only manual exams). ACL is very important for knee stability and when you get a torn ACL you must very often operate it with an ACL graft. The last ten years expertise have shown that ACL is not alone for the knee stability and several other peripherical ligaments as ALL (Antero Lateral Ligament) are important too and has torn with ACL injury very frequently. If you can detect ACL tears with tibial translation tests (like Lachman test in clinical exam), you must assess tibial rotation movements (specifically medial rotation) for ALL tears. The specific test for detecting rotatory instability is the jerk (pivot) test but it’s very difficult to realize when the patient is not under anesthesia. Lots of manual devices exist but just for reproducing the Lachman test only.
That’s why in the last decade Genourob has produced a new medical device (the first motorized device, the GNRB, for the Lachman test and then another, the Rotam, for tibial rotation assessments. But it was two independent motorized devices and to be more efficient we decided to design an all-in-one device the Dyneelax for both tibial translation and rotation assessments.
It was spread all over the world for surgeons first. They now have validated these motorized devices and we can offer this exam for GPs (General Practitioners) who are the first concerned medical practitioners when patient get an ACL tear. Unfortunatly GPs usually used MRI now because they think that it’s the only device to confirm an ACL rupture. So we must try to warn them (GPs) that there’s a new device to get a good complementary exam and less expensive than MRI for detecting ACL tears.
The goal for us is now to introduce in GPs practices this ADL test (Automated Dynamic Laximetry test) with motorized devices when they suspect ACL tears from a patient with a knee sprain. It is not necessarily the GPs who must carry out this ADL test but in Medical Centers with assistants or perharps in radiologists or physiotherapists offices.
Validate the Dyneelax device as the reference and easy access for General Practitioners (GPs) to detect ACL tears instead of using MRI exploration (because of delays and costs for communities).
Dyneelax is the combination of GNRB and ROTAM devices which could analyze tibial translation and rotation assessments.
The first step to design this new device was to elaborate a specific work plan with several items.
This part of specifications presents an analysis of the conceptual, functional and technical requirements of the client *, in order to produce the conceptual architecture, an analysis of the data domain (risk management, compliance with ISO standards, etc.), and the different stages of software development for the product Dyneelax.
Architecture according with the standard EN 62304
Genourob medical devices are developed according to EN 62304 standards. The development follows the V-model, definition of production and maintenance processes and activities : presented in processing layers and separate interfaces.
