Regulatory Landscape in Software as a Medical Device Market: Understanding FDA, EMA, and Global Standards for SaMD Applications - UnivDatos

According to a new report by UnivDatos Market Insights, the Global Software as a Medical Device Market was valued at USD 5,588.56 Million in 2023 and is expected to grow at a CAGR of 10.71% during the forecast period (2024-2032). This is mainly due to the desire for rapid growth, more and more companies are making mergers and acquisitions as ways to boost their production capacities and shares and increase their knowledge and resources of new technologies to expand their global reach. With increasing global burden of diseases, the demand for SaMD solutions to provide quality healthcare delivery services has increased significantly, encouraging the market players to invest in collaboration activities. For instance, in 2024, GE HealthCare announced that it has signed an agreement to acquire MIM Software, which is a worldwide provider of medical imaging analysis and artificial intelligence solutions for applications such as radiation oncology, molecular radiotherapy, diagnostic imaging, and urology. These partnership agreements enable the companies to seek major funding from venture capitalist firms to fuel research and development activities for developing innovative SaMD solutions.

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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. 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.

Applications:

Software as a medical device have emerged as a pivotal solution for various applications such as diagnosis, disease monitoring and clinical management of the diseases. SaMD application for disease management dominate the market. However, diagnostics segment is growing significantly due to increased focus on preventive health measures such as early detection. With growing prevalence of infectious and chronic diseases, there is huge demand for rapid and accurate diagnosis that can improve the health outcomes of the patients. Additionally, more companies are investing and increasing research and development activities to enhance their diagnostics product portfolio. This is providing an added boost to the market.

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 the advantage 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:

In conclusion, the global software as a medical device market is poised for continued growth and innovation driven by economic expansion, increased healthcare expenditure, growing prevalence of chronic diseases and technological advancements in the healthcare industry. The increasing demand for SaMD solutions for timely diagnosis and effective disease management by the healthcare professionals is accelerating the growth of this market in the forecast period. Consistent collaboration activities, frequent product launches, investments and research and development in software as a medical device would also play a vital role in shaping the future of the global software as a medical device market, ensuring its resilience and contribution to the healthcare industry.