Human Factors and Usability Engineering Services Market Growth is anticipated at a CAGR of 6.9% till 2035 | Roots Analysis

Human factors and usability engineering process involve the study of user and user’s interaction with a medical device through human factors research, whereas the usability testing involves the evaluation of medical device through testing with real users in order to ensure the safety and efficacy of the device.

It involves the identification of potential hazards and risks (by taking into consideration of how users perceive information and make decisions), implementation of design controls and risk mitigation strategies, validation through usability testing (to ensure that the device can be used safely and effectively by the intended users in the actual use environment) and documentation (to exhibit to regulatory bodies that use-related risks have been adequately addressed). 

Notably, in order to develop easy-to-use and safe medical devices, it is essential to consider human factors and usability engineering throughout the product development lifecycle. However, it is important to note that the in-house human factors research and usability testing of medical devices is fraught with several challenges, including complex manufacturing process and stringent regulatory guidelines for the approval of medical devices. 

This has prompted the medical device companies to outsource human factors and usability engineering aspect to service providers, which further helps them to meet the evolving device requirements and expediate the launch of their medical devices to the market.

According to Roots Analysis, the global human factors and usability engineering services market size is expected to reach over USD 1.97 billion by 2035, growing at a CAGR of ~7% in the forecast period, 2024-2035.

Market Drivers 

Several factors are propelling the growth of the human factors and usability engineering services market. The regulatory bodies, such as the United States Food and Drug Administration (USFDA), and Medicines and Healthcare Products Regulatory Agency (MHRA) have established mandatory guidelines that require developers to integrate human factors and usability engineering into the design and development of medical devices.

Furthermore, the rise in research and development initiatives in MedTech industry is significantly driving the human factors and usability engineering services market by fostering innovations, promoting user-centered design and ensuring regulatory compliance. These factors collectively contribute to the growth of human factors and usability engineering services in the medical device industry.

Market Restraints 

While the human factors and usability engineering services market is experiencing substantial growth, it is not without its challenges. One of the primary restraints is the lack of awareness for applying human factors and usability engineering in medical device (especially, Class I medical devices) which may hinder the understanding and implementation of human factors research during their development.

Medical device developers often skip this aspect and overlook the long-term benefits of human factors and usability engineering. In addition, there are chances of miscommunication between medical device companies and international service providers, which can present communication challenges due to differences in time zones, language, and cultural nuances.

These factors may result in misunderstandings or delays, ultimately leading to project setbacks that require extra time and resources to address. Consequently, it poses a challenge for the human factors and usability engineering service providers.

Growth Factors

Despite the challenges, several growth factors continue to drive the human factors and usability engineering services market forward. One notable factor is the increasing advent of various advanced medical devices, including connected combination products, digital health solutions, Software as Medical Devices (SaMD), and wearables.

The innovative healthcare technologies introduced in these devices generate new complexities that require rigorous usability testing in order to ensure user’s safety and efficacy. Moreover, as medical devices are expanding into new markets and applications (including digital therapeutics, geriatric care, point-of-care diagnostics and veterinary medicine), there is a heightened demand for usability testing to understand the needs and behaviors of the target population.

Human Factors and Usability Engineering Services Market Segments 

Based on the Steps Involved, the market is segmented into Summative Study, Contextual Analysis, Formative Study, Known Use Error Analysis, Use Risk Analysis, Submission Preparation, Design Process and Task Analysis

The summative study segment led the human factors and usability engineering services market, capturing the largest revenue share (~40%) in 2024.

The summative study segment is anticipated to show an annual growth rate of 7.5%, during the forecast period.

Based on the Type of Research Method, the market is segmented into Evaluation Research and Generative Research

The evaluation research segment led the human factors and usability engineering services market, capturing the largest revenue share (more than 65%) in 2024.

The evaluation research segment is anticipated to show an annual growth rate of 7%, during the forecast period.

Based on the Class of Medical Device Tested, the market is segmented into Class I Medical Devices, Class II Medical Devices and Class III Medical Devices

The Class III medical devices segment led the human factors and usability engineering services market, capturing the largest revenue share (50%) in 2024.

The Class III medical devices segment is anticipated to show an annual growth rate of 7.3%, during the forecast period.

Based on the Regional Insights, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America

North America dominated the human factors and usability engineering services market and accounted for the largest revenue share (55%) in 2024.

In Asia-Pacific, the human factors and usability engineering services market is anticipated to demonstrate lucrative growth during the forecast period.

Key Companies Profiled 

The human factors and usability engineering services market report also includes profiles of key players (listed below) that are engaged in human factors and usability engineering domain:

Aptar Digital Health, AYES, Bayoomed, Bold Insight, ClariMed, Comate, D+I, Greenlight Guru, Hydrix, Invetech and Johari Digital

About Roots Analysis

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