Software as a Medical Device (SaMD) is the regulated sub-segment of digital health solutions, including digital therapeutics (DTx).

Industry demands are accelerating convergence of digital health technologies, combining patient centric applications with telehealth and HCP dedicated apps as part of a holistic healthcare ecosystem, but also increasing complexity.

Accelerating technological change has created new ways for providers to engage with patients, creating a need to deliver SaMD solutions quickly to maintain market relevance thereby challenging the traditional business models.