Healthcare use cases
Neuromuscular Transmission for muscle relaxation measurements
This use case corresponds to a very innovative device for Neuromuscular Transmission (NMT) for muscle relaxation measurements. This device is aimed at simplifying the protocol to be followed by the Anaesthetists to monitor, in the operating room, the level of ”Muscle Relaxation”, i.e the deliberate paralysis of the totality of skeletal muscles of a patient under general anaesthesia. In VALU3S, we want to turn this device into an automated system that will be able to control the infusion pumps in order to keep the patient at a desired level of relaxation. This device uses a modified blood pressure cuff with stimulation electrodes to perform monitoring. The device has been a great success and highly appreciated by anaesthesiologists for its extreme simplicity of use, and has been certified for Europe and Japan. The 510 (k) process has been completed with the FDA, while China’s regulation is in progress.
Total Knee Arthroplasty navigation system
Total Knee Arthroplasty (TKA) is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint. P3D is developing a “marker-less” navigation system that does not rely on any attachments to the patient. Instead, video from a cell-phone camera is used to automatically segment the bone regions of the image and match the reconstructed 3D surfaces to the pre-operative CT-scan or MRI of the patient. This marker-less registration process uses Machine Learning computer vision techniques to learn the anatomy of the patient and recover the structure needed to guide the surgeon throughout the procedure. V&V activities in medical devices that contain AI softwares pose an added challenge for the manufacturer, and regulators are currently discussing strategies to ensure safety of medical devices that use such non-deterministic software modules. Upon entry in the market of an AI-based medical device, its performance is likely to be improved. Such modification could potentially require a re-submission of the medical device for the competent authorities for recertification of the device, even if the intended use would remain the same. The VALU3S technology can facilitate and automate the thorough V&V activities that will be required by regulators for this type of technology by providing a validated platform for the systematic testing of complex software systems.