Familiar but Mysterious: Understanding Software as a Medical Device

As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms.  In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when software is considered a medical device and what are the implications for manufacturers.