Human Factors and Usability Engineering Services Market Top Companies Study - 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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The primary objective of Human Factors and Usability Engineering (HF/UE) services is to ensure that products-particularly in the healthcare and medical device sectors-are designed with a strong emphasis on the end user. By aligning product design with real-world user interactions, HF/UE contributes significantly to enhancing usability, safety, and overall performance. These services are especially critical in highly regulated industries such as medical device manufacturing, where optimizing user experience and minimizing the potential for human error require a comprehensive understanding of user behavior, ergonomic principles, and human limitations.

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, providing detailed recommendations for incorporating human factors and usability considerations into the design and development of medical devices, with a specific focus on combination products.
Within this discipline, Usability Engineers conduct user research, usability testing, and heuristic evaluations to assess and refine product design, ensuring it meets user expectations and needs. Meanwhile, Human Factors Specialists concentrate on the cognitive and physical aspects of human-machine interaction, performing ergonomic assessments and analyzing user behavior to identify and mitigate safety risks. Both roles are essential to creating solutions that are not only functionally effective but also intuitive and safe to use.

As medical devices become increasingly adaptable to a broad spectrum of user demographics, manufacturers are placing greater emphasis on usability from the initial stages of product development. This shift toward user-centered design is leading to more accessible and efficient healthcare technologies that better accommodate the needs and capabilities of diverse user populations.

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 poised for growth, primarily due to the increasing emphasis on risk mitigation in medical device development, the implementation of more rigorous regulatory standards, and the rising complexity of medical technologies. The growing adoption of self-administration tools and digital health solutions has empowered patients to take a more active role in managing their healthcare, prompting a shift toward user-centric product development. This evolution has led to the emergence of advanced technologies such as combination diagnostic tools, implantable devices, surgical robotics, digital health applications, and Software as a Medical Device (SaMD). Consequently, comprehensive usability testing has become a critical component in ensuring the safety, efficacy, and reliability of these solutions. Furthermore, the global rise in healthcare expenditure continues to drive the demand for high-quality, user-friendly medical equipment, thereby supporting the expansion of the HF/UE services market.

Challenges:
Despite its growing importance, integrating HF/UE practices early in the product development cycle can be challenging. This integration often requires significant adjustments to organizational workflows and mindsets, which may encounter internal resistance or logistical hurdles. Additionally, maintaining data privacy and security during user research and usability testing presents further complexities that must be addressed to ensure regulatory compliance and user trust.

Regional Trends:
North America currently dominates the HF/UE services market, attributed to its leadership in developing advanced technologies-including artificial intelligence, robotics, and wearable medical devices-that necessitate user-centered design to maximize usability and safety. The demand for intuitive design solutions is further supported by the need to address age-related cognitive and physical limitations within the patient population. Meanwhile, the Asia-Pacific region is witnessing substantial growth in this market segment, fueled by expanding healthcare infrastructure, rapid technological innovation, and a growing focus on enhancing patient safety and user experience.

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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.