Software developers creating artificial intelligence/machine learning (AI/ML) medical products should move forward with the software development lifecycle (SDLC) models they are already familiar with to bring new products to market, according to experts.
Eric Henry, senior quality and regulatory compliance advisor at King & Spalding, and Kip Wolf, president of Thaumazo Bioscience Management, spoke about how to get AI/ML products to fit US Food and Drug Administration (FDA) requirements at the 2023 AI Summit held by the AFDO/RAPS Healthcare Products Collaborative.
They noted that while SDLC models have been around for a long time, software developers often seem stuck on which model to use when developing their product and on getting buy-in from their company executives. Despite the hesitation, they encouraged the audience to trust their abilities and take bold steps to push forward with their product development and not feel the need to reinvent the wheel…
