Abstract:
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Digital health technologies including AI/ML is revolutionizing medical device development and is being leveraged in applications ranging from wellness products to in vitro diagnostics to sophisticated robotic surgery devices. Although it is expected that the number of digital health products will increase exponentially in the future, the global regulatory framework is still evolving. For example, currently no suitable regulatory framework for addressing the iterative improvements that can occur post-launch for AI/ML-enabled medical devices, while ensuring their safety and effectiveness for their intended use. Such a framework would need to take into account numerous factors, such as the potential use of Real World Data (RWD), and the appropriate metrics to use to address the unique challenges posed by AI/ML applications used as software in a medical device (SiMD) and/or software as a medical device (SaMD). In this session we will highlight how the Medical Device innovation Consortium (MDIC), a public-private partnership is bringing stakeholders together through pre-competitive regulatory science initiatives to provide solutions to challenges faced in digital health technologies
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