Software as a Medical Device (SaMD) refers to software designed for one or more medical purposes to operate independently, without being a part of any hardware medical device.

According to the UnivDatos Market Insights Analysis, growing demand of SaMD for diagnostic purpose will drive the growth scenario of SaMD and as per their “Software as a Medical Device Market” report, the global market was valued at USD 5,588.56 million in 2023, growing at a CAGR of 10.71% during the forecast period from 2024 - 2032 to reach USD million by 2032.  

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SaMD applications include diagnosis, monitoring or management of health conditions. It operates on general-purpose computing platforms, which means it does not need to be integrated into a physical medical device to fulfill its medical role. It can run on various platforms, such as mobile applications and cloud-based systems, that further enhance accessibility and usability in healthcare settings.

Rising Demand for AI-based SaMD:

·       Technological advancements such as Artificial Intelligence (AI) have played a major role in driving the growth of SaMD market in the healthcare sector. Integration of AI in the medical software industry such as in SaMD, ease the disease management process by providing early and accurate diagnosis and efficient disease treatment plans in short duration of time. These potential benefits of AI-based SaMD solution assist healthcare professionals in quick data gathering and data interpretation and save time. This leads to huge demand for AI-based SaMD products among healthcare professionals. Moreover, AI-based SaMD helps the patients with remote disease monitoring, which has further enabled the patients to self-monitor their diseases using their digital devices such as smartphones or wearables.

·       Food and Drug Administration (FDA) emphasis on integrating AI with SaMD to enhance the potential of these medical software in improving the healthcare delivery service quality. For instance, in March 2024, FDA published an article on how artificial intelligence and medical products are working together efficiently and contributing to elevating the overall healthcare industry. This article focuses on the importance and benefits of developing AI-based SaMD action plans to provide improved patient care.

Rising adoption of digital healthcare system to Fuel the Demand:

One of the key factors that have promoted the demand for software as a medical device market is growing adoption of digital healthcare system across the globe. With growing internet connection and digitalization, more people are using smartphones and wearables to self-monitor their diseases with the help of SaMD installed in their digital devices. Additionally, SaMD applications by healthcare professionals in the healthcare settings provide them with ease of remote monitoring, which is rising demand for SaMD solutions.

Government initiatives such as increased emphasis on developing strong digital health action plans is essential for enhancing healthcare access and quality. For instance, according to WHO “Global Strategy on Digital Health 2020-2025” report, each country needs to have a strong digital health action plan to bring access to quality health services. It is of prime importance to strengthen digital health action plans by focusing on implementation of AI and machine learning within the healthcare system. This would enhance accuracy in diagnosis and ensure quality and improved medical treatment. Such initiatives can further drive demand for software as a medical device in the healthcare sector.

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Conclusion:

The global software as a medical device market is experiencing significant growth, driven by the increase prevalence of chronic diseases, technological advancements, digital healthcare system adoption, favorable government initiatives and policies and increasing collaboration activities. Stakeholders across the industry are embracing these trends to enhance their operational efficiency, etc.

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