North America Software as a Medical Device Market to Grow at a CAGR of 22.2% to reach US$ 39,854.20 Million from 2020 to 2027

North America Software as a Medical Device Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Device Type (PCs/Laptops, Smartphones/Tablets, Wearable Devices), Application (Screening and Diagnostics, Monitoring and Alerting, Disease Management), Deployment Type (Cloud, On-Premises), and Country

  • Report Code : TIPRE00010412
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 110
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The North America Software as Medical Device market is expected to reach US$ 39,854.20 Mn in 2027 from US$ 8,353.94 Mn in 2019. The market is estimated to grow with a CAGR of 22.2% from 2020-2027.

The growth of the market is driven by the factors such as, increasing adoption of IoT in healthcare and advantages of software as medical device (SaMD) .On the other hand, threat of data breach is likely to restraint the growth of market during the forecast years.

The North American Software as Medical Device market is expected to witness significant growth during the forecast period, due to factors such as the rising adoption of Internet of Things (IoT) in healthcare services for screening and monitoring of patient may offer vital growth opportunities for market growth. The US is among the top countries in the field of software as medical device. The presence of key players in the country and guidelines proposed by the US FDA for software as medical device are driving the growth of software as medical device in country.

The growth of the North American software as a medical device market is primarily driven by increasing adoption of smart health monitoring devices, transformation of digital healthcare, increasing number of chronic diseases, and support from the federal governments to implement digital tools in healthcare to cut down the costs and improve the quality of care. According to the US FDA, software has become an important part of all the products that are widely integrated into the digital healthcare platforms. The FDA also states that the use of software as medical device is continuously increasing in the US. The implementation of these devices is broadly seen across a range of digital platforms, including commercial off-shelf platforms, virtual networks, and medical device platforms. The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators that have come together to develop a harmonized regulation on medical devices. The US FDA specifies certain criteria to qualify software as medical devices.

North America Software as Medical Device Market Revenue and Forecast to 2027 (US$ Mn)

  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

North America Software as Medical Device – Market Segmentation

By Device Type

  • PCs/Laptops
  • Smartphones/Tablets
  • Wearable Devices

By Application

  • Screening and Diagnosis
  • Monitoring and Alerting
  • Disease Management

By Deployment Type

  • Cloud
  • On-Premises

By Country

  • US
  • Canada
  • Mexico

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 
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Device Type, Application, Deployment Type, and Country

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

US, Canada

The List of Companies - North America Software as a Medical Device Market

 

  1. Velentium LLC
  2. Tietronix Software, Inc.
  3. S3 Connected Health
  4. Zühlke Group
  5. Science Group
  6. Inzentiz
  7. Cambridge Consultants Inc
  8. BrightInsight, Inc.
  9. CompliancePath
  10. Jabil Inc.
  11. Phillips-Medisize
  12. Pro4People Sp. Z.o.o 

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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