Health & Safety Industry Today

Human Factors and Usability Engineering Services Market Report Latest Trends and Future Opportunities Analysis

The Human Factors and Usability Engineering (HF/UE) services market is growing rapidly, driven by the need for user-centered, safe, and effective medical devices and healthcare technologies. Services enhance usability, reduce errors, and ensure compliance with regulatory guidelines. North America leads the market, while Europe and Asia-Pacific are expanding due to increasing adoption of usability practices and regulatory support. High costs and limited expertise remain key challenges.
Published 07 November 2025

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the “Human Factors and Usability Engineering Services Market”-, By Steps Involved (Summative Study, Contextual Analysis, Formative Study, Known Use Error Analysis, Use Risk Analysis, Submission Preparation, Design Process and Task Analysis), By Type of Research Method (Evaluation Research and Generative Research), Class of Medical Device Tested (Class I, Class II and Class III ), Industry Trends, and Global Forecasts, 2024-2031 And Segment Revenue and Forecast To 2034.”

The Human Factors and Usability Engineering Services Market is estimated to reach over USD 2.16 Bn by 2034, exhibiting a CAGR of 7.00% during the forecast period. 

 

Request For Free Sample Pages:

https://www.insightaceanalytic.com/request-sample/2765

 

 

The primary goal of Human Factors and Usability Engineering (HF/UE) services is to ensure that products, particularly medical devices and healthcare technologies, are designed with the end user in mind. By aligning product design with how users naturally interact with a device, HF/UE enhances usability, safety, and overall effectiveness. These services are especially critical in highly regulated sectors, such as medical device manufacturing, where performance improvement and the reduction of user errors depend on a thorough understanding of human behavior, limitations, and ergonomics.

In October 2023, the U.S. Food and Drug Administration (USFDA) issued the guideline “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers”, offering detailed recommendations for incorporating usability and human factors principles into medical devices, with particular emphasis on combination products.

List of Prominent Players in the Human Factors and Usability Engineering Services Market:

·      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

Market Dynamics:

Drivers:

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. Users are now more equipped to actively manage their own healthcare demands due to the growing usage of self-administration tools and digital health solutions. The development of complex devices, such as combination diagnostic tools, digital health solutions, implantable devices, surgical robots, and Software as Medical Devices (SaMD), has increased as a result of this shift in preference towards patient-centric solutions. This has ultimately made extensive human factors testing necessary to guarantee the performance, safety, and dependability of such products. Moreover, the increase in worldwide healthcare spending has increased the need for medical equipment with quality assurance, which is fueling the expansion of the human factors and usability engineering services markets.

 

Curious about this latest version of the report? @

https://www.insightaceanalytic.com/enquiry-before-buying/2765

 

Challenges:

Incorporating human factors and usability engineering early in the design process can be challenging. Integrating these practices from the outset requires a shift in mindset and processes within organizations, which can be met with resistance or logistical hurdles. Ensuring data privacy and security while conducting research and testing is crucial and can present additional challenges.

Regional Trends:

North America has the largest market share during the forecast period, due to the forefront of developing cutting-edge technologies like artificial intelligence, robotics, and wearable medical devices, all of which require human-centered design to ensure usability and safety. This drives the need for user-friendly designs that accommodate age-related physical and cognitive limitations, further fueling the demand for usability engineering services. However, the Asia-Pacific region is experiencing rapid growth in the human factors and usability engineering market due to increasing investments in healthcare infrastructure, technological advancements, and a growing emphasis on user safety.

Recent Developments:

·      In Jan 2023, ClariMed, declared the acquisition of UserWise, a San Jose-based company, to advance its integrated, human-centered approach to the creation of medical products. UserWise is a self-contained human factors company that provides IRB services, market research and simulation facilities, recruitment for usability studies, and usability engineering services.

·      In March 2022, Emergo by UL, introduced Optimal Product Usability SuiteTM (OPUS), a web-based platform. Manufacturers of technology and medical devices now have easy access to human factors engineering (HFE) skills to assist commercial and regulatory endeavors thanks to this software as a service (SaaS) offering.

·      In Sept 2022, Aptar Pharma, declared the acquisition of Metaphase Design Group, Inc., a pioneer in the application of ergonomics and human factors engineering science to product design.

 

Get Specific Chapter/Information From The Report:

https://www.insightaceanalytic.com/customisation/2765

 

Segmentation of Human Factors and Usability Engineering Services Market.

Global Human Factors and Usability Engineering Services Market- By Steps Involved         

·      Summative Study

·      Contextual Analysis

·      Formative Study

·      Known Use Error Analysis

·      Use Risk Analysis

·      Submission Preparation

·      Design Process

·      Task Analysis

Global Human Factors and Usability Engineering Services Market – By Type of Research Method              

·      Evaluation Research

·      Generative Research

Global Human Factors and Usability Engineering Services Market – By Class of Medical Device Tested  

·      Class I Medical Devices

·      Class II Medical Devices

·      Class III Medical Devices

Global Human Factors and Usability Engineering Services Market – By Region

North America-

·      The US

·      Canada

·      Mexico

Europe-

·      Germany

·      The UK

·      France

·      Italy

·      Spain

·      Rest of Europe

Asia-Pacific-

·      China

·      Japan

·      India

·      South Korea

·      Southeast Asia

·      Rest of Asia Pacific

Latin America-

·      Brazil

·      Argentina

·      Rest of Latin America

 Middle East & Africa-

·      GCC Countries

·      South Africa

·      Rest of the Middle East and Africa

 

Get More Information @

https://www.insightaceanalytic.com/report/human-factors-and-usability-engineering-services-market/2765


About Us:

InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain a competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets, and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.https://www.insightaceanalytic.com/images_data/148861653.

Contact Us:

info@insightaceanalytic.com

InsightAce Analytic Pvt. Ltd.

Visit: www.insightaceanalytic.com

Tel : +1 607 400-7072

Asia: +91 79 72967118

Follow Us on LinkedIn @ bit.ly/2tBXsgS

Follow Us On Facebook @ bit.ly/2H9jnDZ

Twitter: https://twitter.com/Insightace

Other Industry News

Ready to start publishing

Sign Up today!