Software as a medical device is defined as a software solution used for one or more medical purposes without the software actually being a part of any medical hardware. These solutions can be used across a large range of technology platforms, including medical device, commercial “off-the-shelf” platforms, virtual networks, and others. The unique features of these devices that help them act more than a traditional medical device helps to promote innovation in digital healthcare and protect patient safety. The growth of the market is attributed to the increasing adoption of Internet of Things (IoT) and connected devices in healthcare sector, and advantages of software as a medical device, among others. However, the threat of data breach obstructs the growth of the market to a certain extent. Asia Pacific is expected to register highest CAGR in the market during the forecast period owing to rising healthcare infrastructure and increasing number of healthcare technology-based startups in the region.
The software as a medical device market, by application, is segmented into screening and diagnosis, monitoring and alerting, and disease management. The screening and diagnostics segment held the largest share of the market in 2019, whereas the monitoring and alerting segment is anticipated to register the highest CAGR during the forecast period.
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The software as a medical device market majorly consists of the players such as Velentium LLC, Tietronix Software, Inc., S3 Connected Health, Zühlke Group, Science Group, Inzentiz, Cambridge Consultants Inc, BrightInsight, Inc., CompliancePath, Jabil Inc., Phillips-Medisize, and Pro4People Sp. Z.o.o. The companies are focused on adopting inorganic strategies, such as partnerships and collaborations, to sustain their position in the dynamic global market. For instance, in April 2020, CompliancePath and Ideagen entered into a Product Validation partnership to extend their ongoing validation accelerator program to include all life science-related software products.
The early detection of diseases is vital and various people struggle to access basic and simple tests that can be helpful to trace the symptoms and signs of a disease. Various software companies these days are focused on developing applications that are compatible with smartphones and computers, and are able to convert these devices into disease diagnostic systems. For instance, in February 2020, the researchers at the University of Cincinnati developed a lab chip that can be plugged into smartphones and has ability to detect various infectious diseases such as malaria, Lyme, HIV, and coronavirus. Significant progress in the display, sensor, and battery technologies together have paved the way for modern mobile devices such as smartphones, tablets, and laptops enabling seamless Internet connectivity, and operations that helps in efficient monitoring of health and fitness. The advancements in software technologies for the diagnosis of various diseases are expected to drive the growth of the market in the coming years.
The growth of the market is mainly attributed to the factors such as increasing adoption of Internet of Things (IoT) and connected devices in healthcare sector, and advantages of software as a medical device (SaMD). However, threat of data breach is obstructing the growth of the market to a certain extent.
The mobile-based applications have seeped in and proved to be an important part of the healthcare for medical as well as non-medical purposes. These software solutions have become an inherent part of the patients’ life in few cases. The applications of SaMD are now not only limited to diagnosis and have widened to make their place in treatment as well as monitoring processes. These software have gained a significant attention as these are able to be run on non-medical computing platforms including personal smartphones, tablets and laptops whose use is now very common and penetrated deep in all the countries.
In 2019, the PCs/laptops segment accounted for the largest market share of the global software as a medical device market, by device type. The segment is expected to continue its dominance, in terms of market share, over the forecast period owing to consistent developments in the laptop designs, enabling the incorporation of smart sensors that is transforming the compatibility between these devices and the SaMD.
The report analyzes the software as a medical device market segmented on the basis of the following segments:
Software as a Medical Device Market – By Device Type
- Wearable Devices
Software as a Medical Device Market – By Application
- Screening and Diagnosis
- Monitoring and Alerting
- Disease Management
Software as a Medical Device Market – By Deployment Type
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