Understanding the World of Software as Medical Device (SaMD)

Software as Medical Device (SaMD), according to the definition by the International Medical Device Regulators Forum (IMDRF) is a “software intended to be used for one or more medical purposes and perform given purposes without being part of a hardware medical device”. The popularity of SaMD is continuing to increase owing to the growing adoption of IoT in healthcare, developments in regulations for software as a medical device, and concerns regarding misdiagnosis in healthcare, further driving the growth of the global software as a medical device (SaMD) market during the forecast period. However, strict regulatory procedures for the development and approval of medical devices and concerns regarding data security and privacy may pose a threat in restraining market growth during the forecast period.

Rising Adoption of IoT in Healthcare

The market is expected to grow during the forecast period with the growing adoption of IoT in healthcare. Some of the applications of IoT in healthcare include continuous monitoring of the blood pressure, heartbeat, respiration rate, body temperature, and providing remote assistance among other applications. The growing adoption of these IoT devices is being driven by the growing prevalence of chronic diseases worldwide and also with the growing geriatric population suffering from various age-associated diseases, especially in remote monitoring of patients, fueling the market growth as well. Additionally, the growing investments in IoT are continuing to fuel the innovations in the field of healthcare which include innovations such as AI and big data analytics and thus are having a significant impact on fueling the growth of the global software as a medical device market in the forecast period. Furthermore, with the growing consumer preferences for sophisticated wearables, the popularity of the connected devices in healthcare is increasing with the rise in the disposable income of the customers worldwide during the forecast period.


software as a medical device market


SaMD is a niche area experiencing a rapid increase in use and, therefore, is receiving attention from the various regulatory bodies. Regulations and guidelines are also being updated to keep up with the new technology. Recently in February 2019, Health Canada proposed the regulatory requirements for software as a medical device (SaMD) based on International Medical Device Regulators Forum (IMDRF) guidelines. Similarly, in April 2018, The US Food and Drug Administration proposed to pre-certify vendors of certain medical device software allowing the companies to skip the agency's much more rigorous pre-market approval process for hardware-based medical devices. The proposed program is for the review of "software-as-a-medical-device" products. Thus, the standard guidelines and streamlined regulatory pathway will help promote technology innovation keeping in view the patient’s safety, thereby favoring the software as a medical device (SaMD) market trend during the given time frame.

Investment Trend

Several investments in the form of collaborations and partnerships by many market players are being observed in the field of digital therapeutics, resulting in providing effective treatment and diagnosis possible in the real-time scenario. Such investments will continue to fuel the market growth in the forecast period and the coming years. One of the examples includes the recent collaborative agreement between Click Therapeutics and Otsuka America, Inc. for the development, advancement, and commercialization of prescription digital therapeutics in the treatment of MDD. Following the collaboration, the focus lies on leveraging the Click Therapeutics ability to discover and validate a software application and its deployment commercially utilizing Otsuka’s expertise in the development of approved prescription therapies for patients suffering from severe mental illnesses. The app will be classified as the Software as a Medical Device and will fall under the FDA regulatory framework which is known to support the innovation and commercialization of digital tools while protecting the health of the patient. The company, Otsuka is geared to provide full funding to Click’s mobile application namely Ct-152 for MDD in addition to commercializing the application on a global level after gaining the regulatory approvals.

Segment Overview

By device type, the software as a medical device (SaMD) market is segmented based on PCs/laptops, smartphones/tablets, and wearable devices. Software as a medical device is widely used across a broad range of technology platforms including PCs and Laptops. Increasing accessible healthcare and growing demand for personalized treatment is expected to be the prime drivers for the growth of the market for PCs and Laptop segment during the forecast period. Today new smart sensor laptops are changing the way users can work, in simple words, the combination of sensing technology and laptops/PCs can handle the computing capabilities of advanced healthcare applications and software to monitor the daily activities of patients. The increasing number of product launches couple with favoring regulatory policies increases the competition in the market which is anticipated to positively impact the overall healthcare industry in the coming years.

Regional Analysis

In the Asia Pacific region, the concept of SaMD is in its niche stage and is slowly gaining traction with regulatory bodies in countries like Japan, China, and Australia working towards creating a framework for the SaMD adoption. Japan has regulated the software as a medical device under the Japanese Pharmaceutical and Medical Device (PMD) Act that regulated the SaMD for diagnosis, treatment, and prevention of diseases. As a result, companies are involved in getting approvals from the regulatory body to make their product available to the healthcare facilities in the country. In China, the National Medical Products Administration (NMPA) has issued a draft “Appendix of Medical Device Good Manufacturing Practice for Standalone Software” in February 2019 that specifies the requirement of SaMD production quality management and is used as a reference for the software component of the medical devices.


Rajat Sudan is a Market Research Analyst at Knowledge Sourcing Intelligence, working on estimates and global/regional specific reports on multiple industries ranging from Healthcare to food and beverages, with a special knack for automotive and healthcare. With the addition of his formal education in Economics, Commerce, and Finance, he can provide more light on the macro aspects of the story. To read more articles by him, and for more information regarding multiple global markets, visit www.knowledge-sourcing.com.