Global Human Factors and Usability Engineering Services Market Insights Forecasts to 2033

• The Global Human Factors and Usability Engineering Services Market Size was Valued at USD 1.09 Billion in 2023
• The Market Size is Growing at a CAGR of 6.78% from 2023 to 2033
• The Worldwide Human Factors and Usability Engineering Services Market Size is Expected to Reach USD 2.10 Billion by 2033
• Asia Pacific is Expected to Grow the fastest during the forecast period.

The Human Factors and Usability Engineering Services Market Size is Anticipated to Exceed USD 2.10 Billion by 2033, Growing at a CAGR of 6.78% from 2023 to 2033. Human factors is a scientific discipline that studies the relationships between humans and other system elements, along with a profession that uses theory, concepts, data, and methodologies to design for human health and overall system performance.

Market Overview

Human factors and usability is a branch of medical device research and development that investigates and evaluates the interactions between individuals and medical devices. Medical device businesses use human factors and usability engineering to better recognize and mitigate possible causes of device risk, resulting in safer and more effective medical equipment for end users. Human factors engineers study how intended users of a technology will interact with it in order to create a user-device interface that supports proper, error-free use of the equipment while potentially endangering the user. Human factors and usability engineering offer an in-depth evaluation regarding how users will communicate with a medical device in a real-world setting, taking into account all of the probable potential hazards associated with product use, to make sure a device is designed in such a way that the risk of use-related errors is minimized, and understanding the impact of devices on various user groups. The market is anticipated to expand because to the variety of medical devices, the requirement for increased regulatory demands, and the need for risk administration for medical devices.

Opportunities

A number of opportunities are driving the expansion the regulatory agencies such as the United States Food and Drug Administration (USFDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have created mandatory guidelines requiring developers to incorporate human factors and usability engineering into medical device development and design. Furthermore, the surge in R&D activities in the MedTech industry is considerably fueling the market for Human Factors and Usability Engineering Services Market by stimulating developments, promoting user-centered design, and assuring regulatory compliance

Challenges

One significant challenge is the risk of miscommunication between medical device businesses and foreign service providers due to time zones, language, and cultural variations. Delays or misconceptions driven by these variables may ultimately result in project setbacks that take more time and money to resolve.

Report Coverage

This research report categorizes the market for the Human Factors and Usability Engineering Services Market based on various segments and regions forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the Human Factors and Usability Engineering Services Market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the Human Factors and Usability Engineering Services Market.

Driving Factors

The Human Factors and Usability Engineering Services Market is propelled by several key factors. The growing number of advanced medical equipment, such as wearables, digital health solutions, software as medical devices (SaMD), and connected combined products, is one important contributing element. To ensure user safety and effectiveness, these gadgets' cutting-edge healthcare technologies create new complications requiring for thorough usability assessment.

Restraining Factors

One of the main obstacles is a lack of knowledge about the application of usability engineering and human factors in medical devices, particularly Class I medical equipment. Developers of medical devices frequently neglect this component and the long-term advantages of usability engineering and human factors.

Market Segmentation

The Human Factors and Usability Engineering Services Market share is classified into steps involved, type of research method, and class of medical device tested.

• The formative study segment is expected to hold the largest share through the forecast period.

Based on the steps involved, the Human Factors and Usability Engineering Services Market is categorized into summative study, contextual analysis, formative study, known use error analysis, use risk analysis, submission preparation, design process, and task analysis. Among these, the formative study segment is expected to hold the largest share through the forecast period. Formative research is carried out iteratively during the course of the product development cycle. The formative study is popular because it guarantees regulatory compliance, decreases risks, promotes iterative design improvements, examines usability concerns early, and ultimately saves money.

• The generative research segment is predicted to grow at the fastest CAGR during the forecast period.

Based on the type of research method, the Human Factors and Usability Engineering Services Market is categorized into evaluation research and generative research. Among these, the generative research segment is predicted to grow at the fastest CAGR during the forecast period. The majority of human factors and usability engineering initiatives begin with generative research. To guarantee that the product is developed from the base up, businesses and designers make significant investments in learning about their users.

• The class III segment is expected to hold a significant market share through the forecast period.

Based on the class of medical device tested, the Human Factors and Usability Engineering Services Market is categorized into class I, class II and class III. Among these, the class III segment is expected to hold a significant market share through the forecast period. This dominance is due to the purpose for the Class III devices are regarded as high-risk devices since they have the potential to seriously harm or injure patients. To guarantee a better interface, reduce use-related risks, and achieve a high usability quotient, human factors and usability engineering studies must be carried out on these devices.

Regional Segment Analysis of the Human Factors and Usability Engineering Services Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the Human Factors and Usability Engineering Services Market over the predicted timeframe.

North America is projected to hold the largest share of the Human Factors and Usability Engineering Services Market over the forecast period. North America has an active R&D environment, with major investments from both corporate and public sectors. These firms depend substantially on human factors and usability engineering to ensure that their products are both innovative and user-friendly. The existence of renowned colleges, research organizations, and enterprises involved in human factors research adds to the market's strength.

Asia Pacific is expected to grow at the fastest CAGR growth in the Human Factors and Usability Engineering Services Market during the forecast period. This is because the main cause of this is the growing regulatory standards in this area for medical equipment approvals. High-risk devices (Class II and III medical devices) are subject to stricter regulations under risk-based classification systems that have been implemented in some Asian countries, including Australia, China, India, and Japan. As a result, medical device companies are required to perform usability and human factors engineering.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the Human Factors and Usability Engineering Services Market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Aptar Digital Health
• AYES
• Bayoomed
• Greenlight Guru
• Human Factors Insight
• Bold Insight Inc.
• ClariMed
• Comate
• Emergo by UL
• Freyr Solutions
• Human Factors International (HFI)
• Improvita
• Tata Elxsi
• Kymanox
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent Developments

• In March 2024, The NMPA released the "Medical Devices Usability Engineering Guideline." According to NMPA, producers are scheduled to be able to evaluate and lower the risks related to the use of medical devices by making improvements to the devices' usability and design that limit potential use errors and the harm that could occur.

• In February 2024, Tigermed-Jyton, a prominent medical device CRO in China, and NAMSA, a world-renowned MedTech Contract Research Organization (CRO) providing worldwide end-to-end expansion services, disclosed their exclusive regional partnership in China and their global cooperation. Tigermed-Jyton also acquired NAMSA China.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2033. Spherical Insights has segmented the Human Factors and Usability Engineering Services Market based on the below-mentioned segments: 

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

• Class I
• Class II
• Class III

Global Human Factors and Usability Engineering Services Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa