The Human Factors and Usability Engineering Services Market Size is valued at USD 1.06 Bn in 2023 and is predicted to reach USD 1.7 Bn by the year 2031 at an 6.2% CAGR during the forecast period for 2024-2031.
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.
Competitive Landscape
Some of the major key players in the human factors and usability engineering services market are
- Aptar Digital Health
- AYES
- Bayoomed
- Bold Insight Inc.
- ClariMed
- Comate
- D+I
- Delve
- EG-Gilero
- Emergo by UL
- Freyr Solutions
- Gilero
- Greenlight Guru
- Human Factors Insight
- Human Factors International (HFI)
- Hydrix
- Improvita
- Invetech
- Johari Digital
- Johner Institute
- Kapstone Medical
- Kymanox
- PDD Group Ltd
- Planet Innovation
- Tata Elxsi
- Veranex, Inc.
- Other Prominent Players
Market Segmentation
The Human Factors and Usability Engineering Services Market is segmented based on the steps involved, and type of research method, class of medical device tested. Based on the type of steps, the market is divided into summative study, contextual analysis, formative study, known use error analysis, use risk analysis, submission preparation, design process, and task analysis. Based on the type of research method, the market is categorized into evaluation research and generative research. Based on the class of medical device tested, the market is segmented into Class I, Class II, and Class III.
The Formative Study Segment is Expected to Have the Highest Growth Rate During the Forecast Period
Based on the type of steps, the market is divided into summative study, contextual analysis, formative study, known use error analysis, use risk analysis, submission preparation, design process, and task analysis. Among these, the formative study segment is expected to have the highest growth rate during the forecast period. Formative studies are conducted iteratively throughout the product development cycle. These studies focus on identifying usability issues early in the design process, enabling continuous refinement before the product reaches final validation. The formative study is dominant because it addresses usability issues early, reduces risks, supports iterative design improvements, ensures regulatory compliance, and ultimately lowers costs. Its continuous nature throughout the design cycle makes it a cornerstone of the human factors and usability engineering market.
The Generative Research Segment Dominates the Market
Based on the type of research method, the market is categorized into evaluation research and generative research. Among these, the generative research segment dominates the market. Generative research is the starting point for most human factors and usability engineering projects. Companies and designers invest heavily in understanding their users to ensure the product is built right from the start. Generative research is crucial for setting the direction of development, making it a more dominant force in terms of effort, time, and market demand. Generative Research is more dominant in the human factors and usability engineering market because it drives innovation, defines user needs, and sets the foundation for the entire product development lifecycle.
North America Has the Largest Market Share During the Forecast Period.
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.
Recent Developments:
- In March 2024, Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE guidance. The Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) in China has published final guidelines on the use of usability engineering (UE) and human factors engineering (HFE) in medical device development.
Human Factors and Usability Engineering Services Market Report Scope
|
Report Attribute |
Specifications |
|
Market Size Value In 2023 |
USD 1.06 Bn |
|
Revenue Forecast In 2031 |
USD 1.7 Bn |
|
Growth Rate CAGR |
CAGR of 6.2% from 2024 to 2031 |
|
Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
|
Historic Year |
2019 to 2023 |
|
Forecast Year |
2024-2031 |
|
Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
|
Segments Covered |
By Steps Involved, and By Type of Research Method, Class Of Medical Device Tested. |
|
Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
|
Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
|
Competitive Landscape |
Aptar Digital Health, AYES, Bayoomed, Bold Insight, ClariMed, Comate, D+I, Greenlight Guru, Hydrix, Invetech, Johari Digital, Kymanox, Human Factors International (HFI), Emergo by UL, EG, Gilero, Johner Institute, UL Solutions |
|
Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
|
Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
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