Human Factors and Usability Engineering Services Market CAGR To be ~7% During The Forecast Period, Due To The Increasing Number of Medical Device Recalls | Exclusive Report by Roots Analysis

The global human factors and usability engineering services market, valued at USD 1.01 billion in 2025, is projected to reach USD 1.09 billion in 2026 and USD 1.97 billion by 2035, with a 6.7% CAGR during the forecast period 2026 to 2035.

In recent years, there has been a noticeable rise in user awareness towards healthcare-related harm arising due to the error caused by the medical devices. The key strategy for preventing adverse events and patient harm is to design and develop medical devices that ensure both high performance and user-friendliness. In order to ensure the safety of medical devices, various advanced methods and technologies are being developed within the MedTech industry. One prominent example of such a process is the introduction of human factors and usability engineering during product design and product development. The primary aim of human factors and usability engineering is to identify and mitigate potential use errors that could cause harm to medical device users. Some of these errors include improper connection of device components, setting incorrect alarm limits or inability to control the initiation and termination of any therapeutic process. Further, the emergence of robust regulatory framework for the approval of medical devices, along with the growing focus on user-centric devices has led to a significant increase in the implementation of human factors and usability engineering during the medical device development.

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By steps involved, summative study segment is expected to account for the largest share of the global human factors and usability engineering services market in 2035

The large share of summative study within this market is mainly attributed to the fact that summative studies play a critical role in validating the safety and efficacy of medical devices and helps the service providers in identifying any potential use errors / difficulties that may arise during the use of medical devices.

By type of research method, evaluation research segment led the global human factors and usability engineering services market
Evaluation research hold a larger share within the human factors and usability engineering services market. This trend is unlikely to change in the near future. This can be attributed to the fact that evaluation research focuses on assessing the usability and effectiveness of medical devices through structured and comprehensive testing.

By class of medical device tested, class III medical devices hold a significant market share during the forecast period
The large share of class III medical devices within the human factors and usability engineering services market is likely due to the fact that they are considered as high-risk devices and have the potential to cause serious illness or injury to the patients.

Human Factors and Usability Engineering Services Market - Regional Analysis
North America is expected to dominate the human factors and usability engineering services market. This can be attributed to the presence of major market players, high healthcare expenditure, and a robust regulatory framework. Furthermore, in the coming years, owing to the growing geriatric population and rising demand for design-centric medical devices, Asia Pacific region is likely to grow at a higher CAGR as compared to other regions.

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Key Market Players
1. Aptar Digital Health
2. AYES
3. Bayoomed
4. Bold Insight
5. ClariMed
6. Comate
7. D+I
8. Greenlight Guru
9. Hydrix
10. Invetech
11. Johari Digital

Human Factors and Usability Engineering Services Market - Key Segments
Human Factors and Usability Engineering Services Market, by Steps Involved
1. Summative Study
2. Contextual Analysis
3. Formative Study
4. Known Use Error Analysis
5. Use Risk Analysis
6. Submission Preparation
7. Design Process
8. Task Analysis

Human Factors and Usability Engineering Services Market, by Type of Research Method
1. Evaluation Research
2. Generative Research

Human Factors and Usability Engineering Services Market, by Class of Medical Device Tested
1. Class I Medical Devices
2. Class II Medical Devices
3. Class III Medical Devices

Human Factors and Usability Engineering Services Market, by Geographical Regions
1. North America
2. Europe
3. Asia Pacific
4. Middle East and North Africa
5. Latin America

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Contact Details
Gaurav Chaudhary
Email: Gaurav.chaudhary@rootsanalysis.com or sales@rootsanalysis.com
Website: https://www.rootsanalysis.com

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