Software as a Medical Device Market Size, Trends 2027

The software as a medical device market is expected to reach USD 86,451.62 million by 2027 from US$ 18,488.00 Mn in 2019; it is estimated to grow at a CAGR of 21.9% during 2020–2027.

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.

Lucrative Regional Software as a Medical Device Markets

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Market Insights

Advantages of Software as a Medical Device

The number of technological innovations in the healthcare information technology has dramatically increased over the past few years. Wireless connectivity, artificial intelligence and cloud computing and artificial intelligence are some of the prominent advancements that have helped to transform healthcare. In addition, development of software solutions that now act as medical devices have been categorized and approved by FDA as well as European Commission are now likely to take over as leading edge technologies continuing to a source of seismic shift in healthcare modernization.

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.

The SaMD has particularly witnessed a fast growth within the recent years, as there is no hardware involved and the applications have very few constraints for using fast feedback loops for improvement. These solutions are also being piloted constantly to better enable innovation and ensure patient safety as well improve clinical significance at the same time.

There are various advantages associated with the use of these solutions. For instance, software as medical device helps to amplify the effectiveness of medical devices and existing treatment plans thereby offering fast and high-quality data collection leading to better health outcomes. Furthermore, these solutions helps to enhance the builds on existing builds as these are faster and cheaper to update than the hardware solutions. The easy solicitation of user feedback on host devices also assists in shortening market time, quicker product iterations and faster innovations. Thus, the advantages offered by these solutions are expected to drive the market for software as a medical device market over the coming years.

Device Type-Based Market Insights

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.. Further, the laptops and computers are now being evolved into complex hardware systems that can act as integrating tools as well as can conduct various monitoring and advanced healthcare diagnostics through new in-built features. On the other hand, the growing adoption of smartphones and the interest of software developers toward building smartphone-compatible healthcare apps acting as a medical device are expected to lead the smartphones/tablets segments toward the highest CAGR during the forecast period.

Software as a Medical Device Market, by Device Type – 2019 and 2027

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Application-Based Market Insights

The software as 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.

Deployment-Based Market Insights

The software as medical device market, by deployment type, is segmented into cloud and on-premises. The cloud segment held a larger share of the market in 2019, and is anticipated to register a greater CAGR during the forecast period.

Strategic Insights

Partnership is the most commonly adopted strategy by the software as medical devices market companies to expand their footprint worldwide and meet the growing demand. This strategy also helps them broaden their product portfolios. The players adopt the strategies of partnerships and collaborations to enlarge customer base across the world, which also permits them to maintain their brand name globally. For instance, in April 2020, CompliancePath and Ideagen entered into a product validation partnership to extend their ongoing validation accelerator program for the inclusion of all life science-related software products.

Global Software as a Medical Device Market – By Device Type

• PCs/Laptops
• Smartphone/Tablets
• Wearable Devices

Global Software as a Medical Device Market – By Application

• Screening and Diagnostics
• Monitoring and alerting
• Disease management

Global Software as a Medical Device Market – By Deployment Type

• Cloud
• On-Premise

Global Software as a Medical Device Market – By Geography

• North America
  • US
  • Canada
  • Mexico
• Europe
  • France
  • Germany
  • Italy
  • UK
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • South Korea
  • Japan
  • Australia
  • Rest of Asia Pacific
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa
• South America
  • Brazil
  • Argentina
  • Rest of South America

Company Profiles

• Velentium LLC
• Tietronix Software, Inc.
• S3 Connected Health
• Zühlke Group
• Science Group
• Inzentiz
• Cambridge Consultants Inc
• BrightInsight, Inc.
• CompliancePath
• Jabil Inc.
• Phillips-Medisize
• Pro4People Sp. Z.o.o