Capital Required to Develop and Commercialize AI in Medical Devices

How much capital is required to develop and commercialize medical devices with artificial intelligence in the United States? What expectation should medical technology (MedTech) executives and funders have for the time it takes to complete development and regulatory milestones, particularly FDA 510(k) clearance? How does this compare to competitive non-AIML medical devices? Does geography, medical specialty, or veteran FDA approval experience separate the hares from the tortoises in the race to deliver AI-enabled medical devices to patients and providers? What are the best practices for building digital ventures that develop and commercialize Artificial Intelligence and machine learning (AIML) medical devices? These questions and more will be explored as this session unveils, for the first time ever, an industry study that examines comprehensive data and generates novel insights into the timelines and private capital raised by MedTech innovators and ventures to develop, test and obtain FDA clearance or approval for more than 500 cutting-edge Artificial Intelligence and machine learning-enabled software as medical devices (AIML SaMD) in the United States over the last decade.