Human Factors and Usability Engineering Services Market Key Players Analysis - AptarGroup, Inc., Mauro Usability Science, Bayoomed, Bold Insight Inc.

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 the year 2034 exhibiting a CAGR of 7.0% during the forecast period.

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Human Factors and Usability Engineering (HF/UE) services play a vital role in ensuring that products-particularly within the healthcare and medical device industries-are developed with a user-centric approach. These services aim to align product design with real-world user interactions, thereby enhancing usability, safety, and overall performance. In highly regulated sectors such as medical device manufacturing, HF/UE is essential for minimizing the risk of human error and ensuring that devices are both effective and intuitive. This requires a deep understanding of user behavior, ergonomic design principles, and the cognitive and physical limitations of end users.

In October 2023, the U.S. Food and Drug Administration (FDA) issued guidance titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, offering specific recommendations for integrating HF/UE considerations into the design and development of combination medical products. This regulatory direction underscores the importance of incorporating human factors early in the product development lifecycle.

Professionals in this field include Usability Engineers, who conduct user research, usability testing, and heuristic evaluations to ensure product designs align with user expectations and operational needs. Concurrently, Human Factors Specialists focus on the cognitive and ergonomic aspects of human interaction with technology, conducting risk assessments and behavioral analyses to identify potential safety issues and enhance product usability.

As medical devices evolve to accommodate increasingly diverse user groups, manufacturers are prioritizing usability from the initial design stages. This shift toward user-centered design is fostering the development of more inclusive, efficient, and accessible healthcare technologies that are tailored to the varying capabilities and needs of end users.

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
• Kymanox
• PDD Group Ltd
• Planet Innovation
• Tata Elxsi
• Veranex, Inc.
• Other Prominent Players

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Market Dynamics
Drivers:
The Human Factors and Usability Engineering (HF/UE) services market is experiencing significant growth, driven by the increasing focus on risk mitigation during medical device development, the enforcement of stringent regulatory requirements, and the rising complexity of healthcare technologies. The widespread adoption of patient-managed healthcare tools-such as self-administration devices and digital health platforms-has reinforced the importance of user-centered design. This shift is particularly evident in the development of advanced medical technologies, including combination diagnostic products, implantable devices, surgical robotics, Software as a Medical Device (SaMD), and mobile health applications. As a result, comprehensive usability assessments have become essential to ensure the safety, effectiveness, and reliability of these innovations. Additionally, rising global healthcare expenditures are contributing to the demand for high-quality, intuitive, and user-friendly medical devices, further propelling the HF/UE services market.

Challenges:
Despite the growing recognition of HF/UE's value, integrating these practices early in the product development lifecycle poses several challenges. Effective implementation often requires significant organizational changes, including the adaptation of internal processes and the alignment of cross-functional teams, which can face operational or cultural resistance. Moreover, conducting user research and usability testing involves managing sensitive personal data, necessitating strict adherence to data privacy and security regulations to maintain compliance and user confidence.

Regional Trends:
North America currently leads the global HF/UE services market, supported by its strong presence in the development of cutting-edge medical technologies, such as artificial intelligence-enabled devices, wearable health monitors, and robotic surgical systems. The region's emphasis on human-centered design is further reinforced by the need to accommodate the aging population and address related cognitive and physical limitations. Meanwhile, the Asia-Pacific region is emerging as a high-growth market, driven by expanding healthcare infrastructure, increased investment in medical technology innovation, and a heightened focus on improving patient safety and user satisfaction. These factors collectively support the growing adoption of HF/UE practices across the region.

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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.

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

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This release was published on openPR.