Software as a Medical Device

Software as a Medical Device

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.

The Software as a Medical Device Market is expected to grow at a significant rate of around 10.71% during the forecast period (2024-2032). With the increasing global prevalence and incidence of chronic diseases year by year, there is a huge need to increase the application of innovative medical solutions such as SaMD to cater to the need of this growing diseased population. SaMD facilitates early diagnosis and enhances disease monitoring process, which further assists the healthcare professionals in providing appropriate disease management. For instance, as per the World Health Organization (WHO), around 41 million people die each year due to chronic diseases. Metabolic risk factors such as increased blood pressure, obesity and hyperglycemia are the leading cause of death among this major population. To combat the growing chronic diseases, WHO has also suggested emphasis on preventive measures such as early detection, timely screening and effective treatment measures.

SaMD has the potential to provide accurate and rapid diagnosis, which is an important factor for efficient disease management process. This has increased the demand for SaMD solutions among healthcare providers as well as patients, leading to the tremendous growth of the software as a medical device market.

• Based on deployment, the market is segmented into cloud and on-premises. Of these, cloud segment holds the major market share due to its cost-effectiveness, efficient data storage capacity and provision of accessibility from any location with internet facility.
• Based on the application, the market is segmented into diagnostics, monitoring and clinical management. Of these, disease management has held the major market share across the globe. Some of the factors that have attributed to growth are growing aging population and increasing prevalence of chronic diseases such as diabetes, cardiovascular diseases and cancer. SaMD has huge potential in providing rapid and quality data collection and improved healthcare delivery services, leading to higher demand for software as a medical device solution for the clinical management of the diseases.
• Based on therapeutic area, the market is segmented into metabolic, oncology, respiratory, cardiovascular, neuroscience, hematology and others. Of these, the oncology segment has exhibited the highest CAGR, fueled by growing incidence of cancer and increased awareness regarding importance of early diagnosis in the cancer management plan.
• For a better understanding of the market adoption of the software as a medical device, the market is analyzed based on its worldwide presence in countries such as North America (U.S., Canada, and the Rest of North America), Europe (Germany, France, U.K., Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. North America holds a significant share of the software as a medical device market and is anticipated to maintain a steady growth rate over the forecast period. North America, with a robust healthcare infrastructure, allows adoption of new technologies that leads to substantial investments and innovation in the SaMD market. Additionally, the region is home to some of the largest manufacturers, such as Imagen Technologies, Inc. and Digital Diagnostics Inc. Considering the vast volume of production, and the high demand for healthcare solutions, the region is further anticipated to dominate the demand for software as a medical device market in the forecast period.
• Some of the major players operating in the market include Siemens Healthineers, GE HealthCare Technologies Inc., Koninklijke Philips N.V., Aptar Digital Health, Qure.ai Technologies Private Limited, Imagen Technologies, Inc., Digital Diagnostics Inc., Viz.ai, HeartFlow, Inc., Hologic, Inc.