Description

According to the Market Statsville Group (MSG), the global software as a medical device (SaMD) Market size is expected to grow from USD 117.46 million in 2021 to USD 429.64 million by 2030, at a CAGR of 15.6% from 2022 to 2030. Software as a medical device is a software solution used for one or more medical purposes. These solutions can be used across a vast range of technology platforms, including commercial off-the-shelf platforms, medical devices, virtual networks, and others. The growth of the market is augmented due to the increasing adoption of the Internet of Things (IoT) and connected devices in healthcare and the advantages of Software as a medical device, among others. However, the threat of data breach hinder the growth of the market to a particular extent. Asia Pacific is expected to register highest CAGR in the market during the forecast period owing to rising healthcare infrastructure and an increasing number of healthcare technology-based startups in the region.

COVID-19 Impact on the Global Software as a Medical Device (SaMD) Market

The COVID-19 pandemic resulted in a mass shortage of empty beds worldwide. The patients suffering from the chronic disease were advised against visiting hospitals physically for treatment due to the panic of being infected. This trend strengthens the aggressive use of Software as a medical device across the globe to make sure no patient suffers due to a lack of healthcare infrastructure. Thus, the pandemic highly accelerated the growth of the Software as a medical device market.

Global Software as a Medical Device (SaMD) Market Dynamics

The rising adoption of IoT in the healthcare sector and growing government initiatives for the same are expected to significantly power the growth of the software as a medical device market over the future years. Some of the operations of IoT in healthcare include monitoring of the blood pressure, heartbeat, body temperature, respiration rate, constant collection of certain parameters in case of chronic diseases, and providing remote assistance, among other applications. Hence, the adoption of IoT globally in the healthcare sector will propel the market growth during the forecast period. The privacy of the patients’ health data, such as their details, family history, sensitive medical history, confidential information, and others, maybe at stake as a data breach is greatly prevalent in the industry. There are no stringent laws for data privacy, which may make the users worried about adopting the Software as a medical device technology; this may, in turn, limit the overall growth of the market during the forecast period. 

Scope of the Global Software as a Medical Device (SaMD) Market

The study categorizes the Fuel Cell for Data Centers market based on device type, application, deployement at the regional and global levels.

By Device Type Outlook (Sales, USD Million, 2017-2030)

• PCs/Laptop
• Smartphone/tablets
• Wearable Device

By Application Outlook (Sales, USD Million, 2017-2030)

• Diagnostic
• Clinical Management

By Deployment Outlook (Sales, USD Million, 2017-2030)

• On-Premises
• Cloud

By Region Outlook (Sales, USD Million, 2017-2030)

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • Italy
  • France
  • UK
  • Spain
  • Poland
  • Russia
  • Slovenia
  • Slovakia
  • the Netherlands
  • Belgium
  • Norway
  • Denmark
  • Czech Republic
  • Sweden
  • Rest of Europe
• The Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Indonesia
  • Malaysia
  • Thailand
  • Vietnam
  • the Philippines
  • Singapore
  • Australia & New Zealand
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Colombia
  • Rest of South America
• The Middle East & Africa
  • Saudi Arabia
  • UAE
  • South Africa
  • Northern Africa
  • Rest of MEA

The PC/Laptop segment is projected to account for the largest market share by Device type

By device type, PCs and laptops dominate the market due to their advanced integration with advanced sensor technologies and computing capabilities to provide higher efficiency and better performance. The increasing number of product launches dual with favoring regulatory policies is increasing the competition in the market, which is anticipated to drive the market’s growth over the forecast period. 

Asia Pacific accounts for the highest CAGR during the forecast period

Based on Region, North America hold the larger portion in the Global Software as a Medical Device market share. The US dominated the North American SaMD market on account of the large number of aging populations and chronic diseases in people, proliferation in the use of wearable devices, and escalating healthcare expenses.

On the contrary, the APAC region is witnessing substantial growth in the coming years due to rapid regulatory changes in medical devices and populated countries like China and India. Moreover, proper regulations by the government for developers concerning the design of diagnostics and medical devices, including Software as a medical device (SaMD) is anticipated to promulgate the market growth of the Software as a Medical Device in the forthcoming period

Key Market Players in the Global Software as a Medical Device (SaMD) Market

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

Recent Developments

• In March 2022, Silicon Valley giant NVIDIA is enlarging its arsenal of products for healthcare with the launch of Clara Holoscan MGX, a type of tool designed to help medical device organizations develop artificial intelligence tools. The company said the new technology was produced to help industry players to meet regulatory standards.
• In August 2021, The Medical Device Innovation Consortium (MDIC) announced the launch of a Digital Health initiative. The scope of digital health-related efforts crosses several existing programs at MDIC, including Data Science and Technology, Health Economics and Patient Value, Clinical Science, and NESTcc. This launch of the new Digital Health initiative acknowledges the convergence of connectivity, information, and Software of these active programs and gives an opportunity to focus additional efforts on Software as a Medical Device.
•  In August 2021, Qualio introduced Design Controls for medical devices and software as a medical device (SaMD) company. Design Controls, a new product within Qualio's established electronic quality management software (eQMS), helps medical device companies expedite time to market by seamlessly integrating product development and quality management in one workstream and automatically generating detailed documentation to support compliance and regulatory approvals.

Key Issues Addressed

• What is the market size by various segmentation of the software as a medical device by region and its respective countries?
• What are the customer buying behavior, key takeaways, and Porter's 5 forces of the software as a medical device market?
• What are the key opportunities and trends for manufacturers involved in the software as a medical device supply chain?
• What are the fundamental dynamics (drivers, restraints, opportunities, and challenges) of the market?
• What and how regulations, schemes, patents, and policies are impacting the growth of the market?
• What are the upcoming technological solutions influencing market trends? How will existing companies adapt to the new change in technology?
• The market player positioning, top winning strategies by years, company product developments, and launches will be?
• How has COVID-19 impacted the demand and sales of software as a medical device in the global market? Also, the expected BPS drop or rise count of the market and market predicted recovery period.
• Detailed analysis of the competitors and their latest launch, and what are the prominent startups introduced in the target market? Also, detailed company profiling of 25+ leading and prominent companies in the market.