By Liat Laufer
Digital tools and applications have become integral parts of our daily lives. With their increasing prevalence, came an inevitable spread in the healthcare industry. One category of these tools is the software as a medical device (SaMD).
The global SaMD market size was estimated to be USD 847.5 million in 2021[i].
Software that is embedded in or is part of a hardware-based medical device has been in use for a long time. However, the past decade saw an emergence of a new class- software which, on its own, is a medical device. The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to accelerate international medical device regulatory harmonization and convergence. In 2013, the IMDRF established SaMD key definitions as a common framework for regulators to incorporate converged controls into their regulatory approaches for SaMD[ii].
According to IMDRF, 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”. It is important to note that SaMD may be regarded as either a medical device or an in-vitro diagnostic medical device.
Examples of SaMD include apps which allow remote collection of patient data for clinicians to analyze, image processing software used for medical purposes, software used to program and collect data from implantable devices, computer aided diagnosis that performs image post-processing to help detect certain types of cancer, software using AI for analyzing test results and detecting pathologies; and the list goes on…
From the regulator’s point of view, SaMD should not only accomplish analytical validity, as most software not considered medical devices would aim to achieve. For a software to be a medical device, it needs to demonstrate clinical validity.
Analytical validation examines whether the SaMD correctly process input data to generate accurate, reliable, and precise output data.
Clinical validation assesses whether the accurate, reliable, and precise output data achieves the manufacturer’s intended purpose in the target population in the context of clinical care.
The clinical validation process measures the ability of a SaMD to yield a clinically meaningful output. Clinically meaningful means the positive impact of a SaMD on the health of an individual or population. To be considered “meaningful”, the positive impact needs to be measurable, and provide with patient-relevant clinical outcome(s), related to the function of the SaMD[iii]. This may include screening, monitoring, determination of predisposition, diagnosis, treatment, prediction of risk or prediction of treatment response and prognosis.
[ii] IMDRF SaMD Working Group, Software as a Medical Device (SaMD): Key Definitions
[iii] Software as a Medical Device (SAMD): Clinical Evaluation, Guidance for Industry and Food and Drug Administration Staff, December 8, 2017