The Human Factors and Usability Engineering Services Market Size is valued at USD 1.11 Bn in 2024 and is predicted to reach USD 2.16 Bn by the year 2034 at an 7.0% CAGR during the forecast period for 2025-2034.
Human factors and usability engineering focus on optimizing interactions between humans and devices, with the user-device interface being a key area of design. This interface encompasses all elements that users interact with when setting up, operating, or maintaining a device. The major goal of adding human factors and usability testing into the development of medical devices, software as medical devices, and combination products is to eliminate use-related hazards and dangers, allowing end users to use the product safely and effectively. Applying these principles to medical devices offers significant advantages, such as safer connections between device components and accessories, improved interaction between controls and displays, better user understanding of device functionality and status, and enhanced comprehension of a patient's health condition.
The market is expected to grow as a result of the necessity for risk management for medical devices, the need for more stringent regulatory regulations, and the complexity of medical devices. The worldwide medical device design landscape has seen a transformation due to the growing influence of medical devices in emerging economies, which has resulted in a shift towards more accessible and economical healthcare solutions.
The Global Human Factors and Usability Engineering Services Market for medical devices is segmented based on several key factors. By device type, the market is divided into categories such as therapeutic devices, diagnostic devices, wearable and implantable devices, surgical and interventional devices, and home healthcare devices. In terms of service types, offerings include user research and analysis, usability testing, human factors engineering (HFE) analysis, interface and interaction design, regulatory and compliance support, as well as training and education. Furthermore, the market can be segmented by the class of medical device tested, which includes Class I, Class II, and Class III devices. The applications for these services are diverse, spanning emergency care, chronic disease management, diagnostics and monitoring, and surgical and invasive procedures, addressing the comprehensive needs of healthcare providers and device manufacturers in ensuring usability, safety, and regulatory compliance across different medical settings.
The Human Factors and Usability Engineering Services Market is classified into class I, class II, and class III based on the category of medical device evaluated. The class III segment is anticipated to maintain a substantial market share during the projection period. This dominance arises from the classification of Class III devices as high-risk, given their potential to cause significant harm or injury to people. To provide an improved interface, mitigate usage-related dangers, and get a high usability quotient, it is imperative to conduct human factors and usability engineering studies on these devices.
North America has a robust R&D ecosystem, with significant investments from both private companies and government agencies. These organizations rely heavily on human factors and usability engineering to ensure their products are both innovative and user-centered. The presence of top universities, research institutions, and companies engaged in human factors research also contributes to the market's strength. The region has a highly educated workforce with expertise in human factors, ergonomics, psychology, and usability engineering. The rapid adoption of digital health solutions like telemedicine, mobile health apps, and wearable health devices requires rigorous usability testing to ensure ease of use.
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Report Attribute |
Specifications |
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Market Size Value In 2024 |
USD 1.11 Bn |
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Revenue Forecast In 2034 |
USD 2.16 Bn |
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Growth Rate CAGR |
CAGR of 7.0% from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Medical Devices By Type of Services, Class Of Medical Device, Application, and Services |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
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Competitive Landscape |
AptarGroup, Inc., Mauro Usability Science, Bayoomed, Bold Insight Inc., ClariMed, Comate, Delve, Gilero, Emergo by UL, Freyr Solutions, Greenlight Guru, Human Factors Insight, Human Factors International (HFI), Hydrix, Improvita, Johner Institute, Kapstone Medical, Kymanox, PDD Group Ltd, Planet Innovation, Tata Elxsi, Veranex, Inc., Decos Software Engineering B.V., Kaleidoscope Innovation, Eurofins Human Factors MD, LLC, Ipsos Healthcare, Battelle, Design Science, and other prominent players. |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Human Factors and Usability Engineering Services Market Snapshot
Chapter 4. Global Human Factors and Usability Engineering Services Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2024-2031
4.8. Global Human Factors and Usability Engineering Services Market Penetration & Growth Prospect Mapping (US$ Mn), 2023-2031
4.9. Competitive Landscape & Market Share Analysis, By Key Player (2023)
4.10. Use/impact of AI on Human Factors And Usability Engineering Services Market Industry Trends
Chapter 5. Human Factors and Usability Engineering Services Market Segmentation 1: By Medical Device, Estimates & Trend Analysis
5.1. Market Share by Medical Device, 2024 & 2034
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Medical Device:
5.2.1. Therapeutic Devices
5.2.2. Diagnostic Devices
5.2.3. Wearable and Implantable Devices
5.2.4. Surgical and Interventional Devices
5.2.5. Home Healthcare Devices
Chapter 6. Human Factors and Usability Engineering Services Market Segmentation 2: By Type of services, Estimates & Trend Analysis
6.1. Market Share by Type of services, 2024 & 2034
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Type of services:
6.2.1. User Research and Analysis
6.2.2. Usability Testing
6.2.3. Human Factors Engineering (HFE) analysis
6.2.4. Interface and Interaction Design
6.2.5. Regulatory and Compliance Support
6.2.6. Training and Education
Chapter 7. Human Factors and Usability Engineering Services Market Segmentation 3: By Class of Medical Device, Estimates & Trend Analysis
7.1. Market Share by Class of Medical Device, 2024 & 2034
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Class of Medical Device:
7.2.1. Class I
7.2.2. Class II
7.2.3. Class III
Chapter 8. Human Factors and Usability Engineering Services Market Segmentation 4: By Application, Estimates & Trend Analysis
8.1. Market Share by Application, 2024 & 2034
8.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application:
8.2.1. Emergency Care
8.2.2. Chronic Disease Management
8.2.3. Diagnostics and Monitoring
8.2.4. Surgical and Invasive Procedures
Chapter 9. Human Factors and Usability Engineering Services Market Segmentation 5: By Services, Estimates & Trend Analysis
9.1. Market Share by Services, 2024 & 2034
9.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Services:
9.2.1. User Research and Contextual Inquiry
9.2.2. Usability Testing
9.2.3. Human Factors Engineering (HFE) Analysis
9.2.4. Risk Management and Safety Analysis
9.2.5. Regulatory and Compliance Support
9.2.6. User Interface (UI) and Interaction Design
9.2.7. Post-Market Usability Evaluation and Feedback Analysis
Chapter 10. Human Factors and Usability Engineering Services Market Segmentation 6: Regional Estimates & Trend Analysis
10.1. Global Human Factors and Usability Engineering Services Market, Regional Snapshot 2024 & 2034
10.2. North America
10.2.1. North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021 to 2034
10.2.1.1. US
10.2.1.2. Canada
10.2.2. North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2021-2034
10.2.3. North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2021-2034
10.2.4. North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2021-2034
10.2.5. North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.2.6. North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2021-2034
10.3. Europe
10.3.1. Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.3.1.1. Germany
10.3.1.2. U.K.
10.3.1.3. France
10.3.1.4. Italy
10.3.1.5. Spain
10.3.1.6. Rest of Europe
10.3.2. Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2021-2034
10.3.3. Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2021-2034
10.3.4. Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2021-2034
10.3.5. Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.3.6. Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2021-2034
10.4. Asia Pacific
10.4.1. Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.4.1.1. India
10.4.1.2. China
10.4.1.3. Japan
10.4.1.4. Australia
10.4.1.5. South Korea
10.4.1.6. Hong Kong
10.4.1.7. Southeast Asia
10.4.1.8. Rest of Asia Pacific
10.4.2. Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2021-2034
10.4.3. Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2021-2034
10.4.4. Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2021-2034
10.4.5. Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts By Application, 2021-2034
10.4.6. Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2021-2034
10.5. Latin America
10.5.1. Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.5.1.1. Brazil
10.5.1.2. Mexico
10.5.1.3. Rest of Latin America
10.5.2. Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2021-2034
10.5.3. Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2021-2034
10.5.4. Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2021-2034
10.5.5. Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.5.6. Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2021-2034
10.6. Middle East & Africa
10.6.1. Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
10.6.1.1. GCC Countries
10.6.1.2. Israel
10.6.1.3. South Africa
10.6.1.4. Rest of Middle East and Africa
10.6.2. Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2021-2034
10.6.3. Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2021-2034
10.6.4. Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2021-2034
10.6.5. Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.6.6. Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2021-2034
Chapter 11. Competitive Landscape
11.1. Major Mergers and Acquisitions/Strategic Alliances
11.2. Company Profiles
11.2.1. AptarGroup, Inc.
11.2.1.1. Business Overview
11.2.1.2. Key Product/Service
11.2.1.3. Financial Performance
11.2.1.4. Geographical Presence
11.2.1.5. Recent Developments with Business Strategy
11.2.2. Mauro Usability Science
11.2.3. Bayoomed
11.2.4. Bold Insight Inc.
11.2.5. ClariMed
11.2.6. Comate
11.2.7. Delve
11.2.8. Gilero
11.2.9. Emergo by UL
11.2.10. Freyr Solutions
11.2.11. Gilero
11.2.12. Greenlight Guru
11.2.13. Human Factors Insight
11.2.14. Human Factors International (HFI)
11.2.15. Hydrix
11.2.16. Improvita
11.2.17. Johner Institute
11.2.18. Kapstone Medical
11.2.19. Kymanox
11.2.20. PDD Group Ltd
11.2.21. Planet Innovation
11.2.22. Tata Elxsi
11.2.23. Veranex, Inc.
11.2.24. Decos Software Engineering B.V.
11.2.25. Kaleidoscope Innovation
11.2.26. Eurofins Human Factors MD, LLC
11.2.27. Ipsos Healthcare
11.2.28. Battelle
11.2.29. Design Science
11.2.30. Other Prominent Players
Global Human Factors and Usability Engineering Services Market- By Medical Devices
Global Human Factors and Usability Engineering Services Market – By Type Services
Global Human Factors and Usability Engineering Services Market – By Class of Medical Device Tested
Global Human Factors and Usability Engineering Services Market – By Application
Global Human Factors and Usability Engineering Services Market – By Services
Global Human Factors and Usability Engineering Services Market – By Region
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
