In an age where software permeates every aspect of our lives, it’s no surprise that the healthcare industry has also embraced the digital revolution. One remarkable development is the emergence of Software as a Medical Device (SaMD). This transformative concept has the potential to reshape the way healthcare is delivered, monitored, and managed.
The International Medical Device Regulators Forum (IMDRF), which the US Food and Drug Administration (FDA) is a member of, describes SaMD as software designed to perform medical functions without the need for additional hardware.
For software to be classified as a medical device, it needs to serve as such. These applications are developed to be used for medical purposes, such as diagnosing, monitoring, treating, or preventing diseases. They can range from apps that track your heart rate to more complex clinical decision support systems used by healthcare professionals.
SaMD brings forth a plethora of benefits that are reshaping the landscape of healthcare. Thanks to its versatility, it can be used to support and accelerate innovation in other healthcare domains such as medical treatment and medical devices. SaMD leverages artificial intelligence and machine learning to analyze vast datasets, enabling the development of tailored treatment plans. Additionally, SaMD supports remote monitoring, allowing healthcare providers to continuously collect and analyze patient data. The data-driven nature of SaMD empowers healthcare professionals by providing real-time insights. In turn, this enhances decision-making, reduces medical errors, and facilitates early disease detection. This contributes to a more efficient and effective healthcare system.
Automation and data-driven processes within SaMD could also reduce the risk of human error in healthcare. This can result in consistent and accurate data collection and analysis, enhancing patient safety.
Navigating the complex regulatory landscape of medical devices is no easy task, and with Software as a Medical Device comes the need for stricter regulations.
The FDA used to regulate SaMD the same way as hardware-based medical devices. However, this approach is not suited for software-based medical technologies, due to their iterative design, development, and the type of validation that they use. Most hardware-based medical devices stay untouched by the device maker after it’s been released, on the contrary with software based medical technologies. These technologies receive continuous post-launch changes and updates. This regulatory process emphasizes thorough evaluation before a product is released into the market, without much evaluation after.
Currently, the primary organization regulating Software as a Medical Device is the IMDRF, which is also responsible for presenting the classification of SaMD and labeling it on a global level. In addition, in the US, developers must follow the Quality System Regulations (QSR) from the FDA, and in Europe, SaMD is governed by the EU MDR. The most important part of each of these regulations is a risk classification framework for medical devices, including software.
The Software as a Medical Device risk categorization framework has four categories; I, II, III, IV. “These categories are based on the levels of impact on the patient or public health where accurate information provided by the SaMD to treat or diagnose, drive or inform clinical management is vital to avoid death, long-term disability or other serious deterioration of health, mitigating public health.” Level I category has the lowest impact, while the Level IV category SaMD is the one with the highest impact on the patient or public health.
Hanna Taller is a content creator for PTC’s ALM Marketing team. She is responsible for increasing brand awareness and driving thought leadership for Codebeamer. Hanna is passionate about creating insightful content centered around ALM, life sciences, automotive technology, and avionics.