Medical devices and healthcare companies are embracing digital technologies and are moving headfirst into an era where innovation is powered by new technologies that catalyze change. In the last 20 years, technological innovation – both within and around medical devices – have accelerated thanks to the IoT, wireless connectivity, cloud computing, AI and analytics, and more. These advancements are shifting the treatment-centric approach to a patient-centric and collaborative care.
These apps or software, or Software as a Medical Device (SaMD) which are medical devices on their own – that are fast becoming an inherent part of users’ lives in terms of both diagnosis and the monitoring and treatment process.
SaMD brings new opportunities and challenges for both medical device companies and regulators to enable innovation while ensuring patient safety and clinical effectiveness.
What is Software as a Medical Device (SaMD)?
As per The International Medical Device Regulators Forum (IMDRF) document (IMDRF/SaMD WG/N10 FINAL:2013), Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Risk categorization for SAMD
Seeing the growing inclusion of SaMD in everyday healthcare, the IMDRF has described the concept and SaMD risk categories in detail for the medical app development industry to follow. (IMDRF/SaMD WG/N12 FINAL:2014)
It also considers the accuracy of information provided by the SaMD to treat or diagnose, drive or inform clinical management, this is vital to avoid death, long-term disability or other serious deterioration of health, mitigating public health.
In general, the makers of SaMD products intend to gather specific information/health parameters of users, analyze the data, and deliver it along with software that has been designed for safety and effectiveness. The software should be fully documented to identify its role and its place within the clinical environment.
Failure in software functionality can have fatal consequences or cause serious injury to patients. Therefore, the software development and testing process is of vital importance, and regulating this across medical devices is a fundamental core element of medical device manufacturing. The verification and validation (V&V) activities should be targeted towards the criticality and impact on patient safety of the SaMD.
In our next blog we will explain the critical aspects of verification and validation of SaMD.