Connected medical devices and Software as a Medical Device collect real-time data from patients and relevant third party sources that can be used to continuously evolve the product. AI and Machine Learning algorithms transform these devices into powerful data engines that take in device performance, patient engagement and health marker metrics to rapidly enhance medical device functionality, device adherence and patient outcomes.
Due to its relatively newness and untapped power, the FDA has drafted regulations that place parameters around multiple areas of AI/ML algorithms. To take advantage of the power of AI/ML while staying compliant, it’s essential to understand these regulations. Orthogonal can help you build flexible and scalable AI/ML algorithms, deployed in the cloud or in edge computing environments, that meet the FDA’s requirements.
Orthogonal has architected an AI Factory pattern that is compliant with medical device regulations and develops at speed. Our AI Factory aids companies in discovering and deploying AI algorithms that accelerate the improvement of patient and business outcomes. We’ll help you harness data to speed discovery and continue evolution of FDA-compliant algorithms.