How to develop an AI medical imaging platform
When thinking about the clinical validation of a medical system, one of the first factors that must be considered is how the system will be integrated into the clinical workflow.
In the initial years, software systems were mostly embedded in hardware medical devices, and thus the primary concern was guarding against the possibility of physical harm, with attention to aspects such as the transmission of energy and/or substances to or from the body, the degree of invasiveness, the closeness to sensitive organs, etc.
This was reflected in many of the regulatory directives and guidelines, which often did not offer specific indications for software developed as a standalone clinical aid. As the use of such applications steadily grew, the need for specific guidance was felt and several contributions were developed.