The increasing adoption of Internet of Things (IoT) and connected devices in the health sector for in-patient treatment and health monitoring is driving the market for Software as a  Medical device and is expected to grow exponentially

At a compound annual growth rate of ~16.7%, the size of the worldwide Software as a Medical Device market is projected to reach US$ 5.4 Billion in 2032.

Covid-19 Impact & Market Status

The report offers an exhaustive overview of the business dynamics and new investment strategies that are being adopted by business leaders across countries and regions to overcome the acute challenges and financial instabilities that have emerged in the post pandemic times.

The report highlights some of the best industry strategies and practices that are adopted by the players across local and global markets. Ever since the Covid-19 broke out in 2019, it has spread aggressively, resulting in rapid declaration by the WHO affirming Covid-19 as a global pandemic and an emergency.

The Covid-19 pandemic resulted in a worldwide lack of available hospital beds. Patients with chronic illnesses were urged not to visit hospitals physically for treatment for fear of becoming infected. This trend fostered the aggressive adoption of software as a medical device around the world, ensuring that patients do not suffer as a result of a lack of healthcare infrastructure. As a result, the pandemic boosted the rise of the software sector as a medical device.

Ever since the outbreak of the global crisis, impact on upstream, downstream, and midstream industries have been appalling. The report delivers a quick ready-to-deploy approach to counter such crisis and steer the global Software as a medical device market towards steady growth and systematic progression.

In this report, inquisitive business players would be provided with sufficient guidelines regarding business transformation, integral to sustain stiffening competition in the pandemic and beyond pandemic era.

Cloud-based service is anticipated to grow at a significant rate in the forecast period

Cloud-based deployment solutions accounted for the highest share of the SaMD market in 2019 because of its support for predictive maintenance, which enables hospitals, clinics, and other healthcare institutions to provide medical device maintenance services. The introduction of new cloud solutions for medical devices and pharmaceutical companies, as well as the increased deployment of cloud solutions to ensure hospital security, are expected to boost demand for cloud-based solutions for the Software as a Medical Device market in the coming years. Laptops and computers are evolving into complicated hardware systems capable of acting as integrating tools as well as performing various monitoring and advanced healthcare diagnostics via new in-built functions. On the other hand, increased smartphone adoption and software developers' interest in developing smartphone-compatible healthcare apps that operate as a medical device are predicted to propel the smartphones/tablets sectors to the greatest CAGR throughout the projection period.

Cloud-based SaMD is predicted to have a considerable market share due to its growing popularity and improved capability and scope as compared to on-premises-based devices. It is also expected to present numerous growth prospects in the coming years as IoT adoption in healthcare increases. For example, Zoll Medical introduced Zoll HFAMS, a patch-based wearable heart management system, in June 2019. Cloud-based software enables great performance on lower-tier hardware, which many healthcare technology behemoths are using to produce high-performance devices through innovations and research and development. Biofourmis, based in Singapore, just acquired FDA approval for its cloud-based AI software RhythmAnalytics, which is part of its digital medicines programme.

Healthcare segment to drive the market for Software as a Medical Device

According on end user, the hospital segment is expected to acquire a foothold in the Global Software as a Medical Device market during the forecast period, owing to the increasing adoption of medical devices to aid medical health experts and professionals with diagnosis and tracking patient characteristics. The extensive use of medical equipment such as PCs/laptops, smartphones/tablets, and so on by professionals to continually monitor, diagnose, and treat any ailment is increasing the demand for SaMD in the approaching years.Other healthcare clinics are also leaning toward using SaMD to treat, diagnose, or detect early indicators of disease in patients.

For patients with more complex disorders, SaMD can help give tailored treatment regimens and shorten the time between diagnosis and treatment. Lung cancer, for example, is exceedingly difficult to detect, and most lung tumours are advanced when discovered. Smart algorithms in SaMD devices can detect anomalies that would otherwise go undiscovered, such as blood vessel problems or pleural illnesses, enhancing patient survival rates.

Mobile-based applications have infiltrated and proven to be an important element of healthcare for both medical and non-medical purposes. In a few situations, these software solutions have become an integral part of the patients' lives. SaMD applications are no longer restricted to diagnosis, but have expanded to include therapy and monitoring processes as well. These applications have gotten a lot of interest since they can be run on non-medical computing platforms like personal smartphones, tablets, and laptops, which are now highly prevalent and well-established in all nations.

Because there is no hardware involved and the applications have relatively few limits for employing fast feedback loops for improvement, the SaMD has seen particularly rapid growth in recent years. These solutions are also continually being piloted in order to better facilitate innovation, protect patient safety, and improve clinical significance all at the same time.

APAC to Sweep the Largest Revenue Streams Followed by North America

Asia Pacific is expected to grow at the fastest  rate (CAGR) during the forecast period, owing to rising demand for SaMD in light of Japan's high geriatric population, as well as rising health awareness among individuals, with educated individuals in emerging economies such as China and India keenly concerned about keeping track of their health. North America is expected to have the largest market share due to multiple businesses receiving FDA certifications for their software, as well as increased investment in the healthcare industry by key countries such as the United States and Canada. For example, Channel Medsystems announced in July 2020 that it had received FDA permission for its next-generation Cerenecryotherapy device to treat menstrual haemorrhage. In addition, Arterys Inc. raised $28 million in May 2020 to speed the delivery of artificial medical intelligence to practitioners around the world. The growth will be followed by Europe, the Middle East, and Africa during the forecast period.

The increased usage of linked devices and the advancement  in the healthcare sector due to increased usage of Internet Of Things (IoT) is expected to drive the growth market for Software as a Medical Device

Software as a medical device (SaMD) is a piece of software designed to be used for one or more medical duties that perform these functions without being part of a hardware medical device. It refers to software that is attached to a hardware medical device (rather than being an accessory) but is not required to achieve the medical device's intended medical function. SaMD solutions aid in the detection, management, and treatment of a wide range of medical concerns by automating certain aspects of care to save time. The programme is intended to be used to treat, diagnose, cure, alleviate, or prevent diseases. SaMD is most commonly utilised with non-medical computing platforms that are linked to virtual networks or other general-purpose devices. The unique qualities of these devices, which allow them to function more than a standard medical device, contribute to foster digital healthcare innovation and protect patient. Because of the quick product introductions and increased acceptance of the Internet of Things (IoT) and connected devices in the healthcare sector, the Software as a Medical Device market is expected to rise at a breakneck pace during the forecast period. Easing requirements for SaMD certification will enhance the market even further. Increased company investments in SaMD would provide numerous possibilities for market players to thrive during the projection period.

SaMD software packages perform a variety of functions, most of which are related to diagnosis, disease prevention, modernization of care, or treatment of an illness or injury. Other instances include software that allows a smartphone to see MRI pictures and computer-aided detection software that provides image post-processing to aid in the identification of breast cancer. Another example of SaMD is software with a medical purpose running on a general-purpose computing platform (one without a medical purpose). That is, software designed for diagnostics using a tri-axial accelerometer on a consumer digital camera.

SaMD can solicit user feedback through its availability on numerous devices by being able to collect vast amounts of data rapidly. Improved health outcomes from more precise data, as well as faster production and feedback leading to faster innovation, are two of the most significant benefits. Companies who use or develop SaMD can take advantage of this speedy feedback loop to enable faster product iterations, promote faster innovation, and get to market faster. It also makes data collection quick and easy, resulting in high-quality data and improved health outcomes.

The growing use of IoT in the healthcare industry is projected to have a substantial impact on the growth of the Software as a Medical Device market in the coming years. Sensors, cellphones, and wearables capture required data from the devices, which is then used to improve the consumer experience. Over the projected period, the increasing demand for data analysis and analytics integration is expected to push the Internet of Things market use. Among other applications, some IoT applications in healthcare include continuous monitoring of blood pressure, heartbeat, body temperature, and respiration rate, continuous collecting of particular metrics in cases of chronic illnesses, and offering remote support. For example, the FDA authorised the electroCore, Inc gammaCore Sapphire hand-held device for the acute treatment of migraine pain in 2018 and the electroCore, Inc gammaCore Sapphire hand-held device for the preventive treatment of migraine in 2020.

The increasing acceptance of IoT in the healthcare sector, combined with recent regulatory developments in the healthcare industry, is projected to have a substantial impact on the growth of the Software as a Medical Device market in the coming years. In the healthcare industry, wearable technologies provide a handy way to monitor physiological variables. A plethora of medical solutions are not only available to customers, but also give up-to-date data for doctors to study patients in remote areas. From Apple Watch's glucose monitoring systems to its EKG capabilities, wearable medical technology have a wide range of uses in the healthcare sector.

COVID-19 has had a favourable impact on market growth. This is due to an increase in the number of patients, increasing pressure on doctors to provide advanced healthcare services, and governments developing apps based on connectivity technologies. The pandemic has resulted in new ways for patients to engage with clinicians. Telemedicine services are becoming more popular as governments around the world advise citizens to avoid leaving their homes. Because hospitals are solely focused on treating COVID-19 patients, people are developing innovative techniques to monitor their own health and only seek medical attention in crises. As a result, sales of smart wearables, particularly smartwatches, have soared in recent months.

Some of the prominent players in the market are Tietronix Software, Velentium LLC, S3 Connected Health, Inzentiz, BrightInsight, Jabil, Siemens, Zühlke Group, Pro4People Sp. Z.o.o, Phillips-Medisize, Velentium LLC, Tietronix Software, Inc.,S3 Connected Health,Zhlke Group,Science Group,Inzentiz,Cambridge,Consultants Inc,BrightIns

The market's expansion is primarily related to the increased usage of Internet of Things (IoT) and linked devices in the healthcare sector, as well as the benefits of software as a medical device (SaMD). . Among the uses of IoT in healthcare include continuous monitoring of blood pressure, heartbeat, body temperature, and respiration rate, continuous collecting of particular metrics in cases of chronic illnesses, and remote help. As a result, global adoption of IoT in healthcare will fuel market growth during the forecast period.

Latest Innovation in the Global Software as a Medical Device: A snapshot

• Qlarity Imaging and Blackford teamed on August 2, 2021, to deliver QuantX Diagnostic AI to more breast radiologists via the Blackford Platform in order to aid more patients in need.

• May 2021 – GE Healthcare launched Xeleris V, a revolutionary virtual precision health care solution that allows safe access to medical data from several places, removing the need for isolated nuclear medicine workstations. The system, which includes AI apps, simplifies and improves workflow by giving sophisticated data whenever and wherever it is needed for individualised care and treatment decisions.

• Royal Philips unveiled the Philips HealthSuite solutions, the Philips Acute Care Telehealth, and the Philips Patient Flow Capacity Suite in August 2021. These two new technologies are primarily intended to reduce barriers in patient care into a cost-effective and scalable paradigm. These solutions are cloud-based, secure, and enable health systems to integrate necessary informational applications that may scale up or down dependent on demand.

Software as a Medical Device Market Scope

Key Segments of the Global Software as a Medical Device Market

• Market By Device Overview, 2018-2028 (USD Billion)
  • Laptop/ PCs
  • Smartphone/ tablets
  • Wearable Device
  • Others

• Market by Application Overview, 2018-2028 (USD Billion)
  • Diagnostics
  • Clinical Management
  • Others

•  Market by Deployment Overview 2018-2028 (USD Billion)
  • On-Premise
  • Cloud Based
  • Others

• Regional Overview, 2018-2028 (USD Billion)
  • North America
    • U.S.
    • Canada
    • Mexico

• • Europe
    • UK
    • Germany
    • France
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • India
    • China
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific

• Middle East & Africa
  • • Turkey
    • Saudi Arabia
    • UAE
    • Rest of the Middle East & Africa