Today, the increasing application of AI-enabled solutions has been part of the fabric of our daily lives. The rapidly evolving landscape of digital healthcare has also seen a remarkable surge in utilising Artificial Intelligence and Machine Learning (AIML) software as a medical device (SaMD). This innovative field represents a transformative convergence of computer science, engineering, analytics, software development, and medical science. It promises to revolutionise patient care and diagnostic capabilities.
The talk aims to give participants an overview of the emerging SaMD commercialisation pathway through the development lifecycle, clinical evaluation, validation and certification considerations, all essential for commercialisation. The commercialisation risks can be reduced with the use of the Commercialisation Readiness Diagnostic Tool, which enhances the likelihood of commercialisation success. The speaker will also share the Digital Health Malaysia (DHM) platform where healthcare professionals, researchers and industry can collaborate to pilot digital health solutions.