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Human Factors and Usability Engineering Services Market

Human Factors and Usability Engineering Services Market, Share & Trends Analysis Report, By Medical Devices (Therapeutic Devices, Diagnostic Devices, Wearable and Implantable Devices, Surgical and Interventional Devices, Home Healthcare Devices), By Type of Services, By Class of Medical Device Tested, By Application, By Services, By Region, and Segment Forecasts, 2024-2031

Report ID : 2765 | Published : 2024-11-05 | Pages: 170 | Format: PDF/EXCEL

The Human Factors and Usability Engineering Services Market Size is valued at USD 1.06 Bn in 2023 and is predicted to reach USD 1.7 Bn by the year 2031 at an 6.2% CAGR during the forecast period for 2024-2031.

human factors

Human factors and usability engineering focus on optimizing interactions between humans and devices, with the user-device interface being a key area of design. This interface encompasses all elements that users interact with when setting up, operating, or maintaining a device. The major goal of adding human factors and usability testing into the development of medical devices, software as medical devices, and combination products is to eliminate use-related hazards and dangers, allowing end users to use the product safely and effectively. Applying these principles to medical devices offers significant advantages, such as safer connections between device components and accessories, improved interaction between controls and displays, better user understanding of device functionality and status, and enhanced comprehension of a patient's health condition.

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. The worldwide medical device design landscape has seen a transformation due to the growing influence of medical devices in emerging economies, which has resulted in a shift towards more accessible and economical healthcare solutions.

Competitive Landscape

Some of the major key players in the human factors and usability engineering services market are

  •  

  • AptarGroup, Inc.
  • Mauro Usability Science
  • Bayoomed
  • Bold Insight Inc.
  • ClariMed
  • Comate
  • Delve
  • Gilero
  • Emergo by UL
  • Freyr Solutions
  • Gilero
  • Greenlight Guru
  • Human Factors Insight
  • Human Factors International (HFI)
  • Hydrix
  • Improvita
  • Johner Institute
  • Kapstone Medical
  • Kymanox
  • PDD Group Ltd
  • Planet Innovation
  • Tata Elxsi
  • Veranex, Inc.
  • Decos Software Engineering B.V.
  • Kaleidoscope Innovation
  • Eurofins Human Factors MD, LLC
  • Ipsos Healthcare
  • Battelle
  • Design Science
  • Other Prominent Players

Market Segmentation

The Global Human Factors and Usability Engineering Services Market for medical devices is segmented based on several key factors. By device type, the market is divided into categories such as therapeutic devices, diagnostic devices, wearable and implantable devices, surgical and interventional devices, and home healthcare devices. In terms of service types, offerings include user research and analysis, usability testing, human factors engineering (HFE) analysis, interface and interaction design, regulatory and compliance support, as well as training and education. Furthermore, the market can be segmented by the class of medical device tested, which includes Class I, Class II, and Class III devices. The applications for these services are diverse, spanning emergency care, chronic disease management, diagnostics and monitoring, and surgical and invasive procedures, addressing the comprehensive needs of healthcare providers and device manufacturers in ensuring usability, safety, and regulatory compliance across different medical settings.

The Class III Segment Is Anticipated To Maintain A Substantial Market Share During The Projection Period.

The Human Factors and Usability Engineering Services Market is classified into class I, class II, and class III based on the category of medical device evaluated. The class III segment is anticipated to maintain a substantial market share during the projection period. This dominance arises from the classification of Class III devices as high-risk, given their potential to cause significant harm or injury to people. To provide an improved interface, mitigate usage-related dangers, and get a high usability quotient, it is imperative to conduct human factors and usability engineering studies on these devices.

North America Has the Largest Market Share During the Forecast Period.

North America has a robust R&D ecosystem, with significant investments from both private companies and government agencies. These organizations rely heavily on human factors and usability engineering to ensure their products are both innovative and user-centered. The presence of top universities, research institutions, and companies engaged in human factors research also contributes to the market's strength.  The region has a highly educated workforce with expertise in human factors, ergonomics, psychology, and usability engineering. The rapid adoption of digital health solutions like telemedicine, mobile health apps, and wearable health devices requires rigorous usability testing to ensure ease of use.

Recent Developments:

  • In March 2024, Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE guidance. The Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) in China has published final guidelines on the use of usability engineering (UE) and human factors engineering (HFE) in medical device development.

Human Factors and Usability Engineering Services Market Report Scope

Report Attribute

Specifications

Market Size Value In 2023

USD 1.06 Bn

Revenue Forecast In 2031

USD 1.7 Bn

Growth Rate CAGR

CAGR of 6.2% from 2024 to 2031

Quantitative Units

Representation of revenue in US$ Bn and CAGR from 2024 to 2031

Historic Year

2019 to 2023

Forecast Year

2024-2031

Report Coverage

The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends

Segments Covered

By Medical Devices By Type of Services, Class Of Medical Device, Application, and Services

Regional Scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country Scope

U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia

Competitive Landscape

AptarGroup, Inc., Mauro Usability Science, Bayoomed, Bold Insight Inc., ClariMed, Comate, Delve, Gilero, Emergo by UL, Freyr Solutions, Greenlight Guru, Human Factors Insight, Human Factors International (HFI), Hydrix, Improvita, Johner Institute, Kapstone Medical, Kymanox, PDD Group Ltd, Planet Innovation, Tata Elxsi, Veranex, Inc., Decos Software Engineering B.V., Kaleidoscope Innovation, Eurofins Human Factors MD, LLC, Ipsos Healthcare, Battelle, Design Science, and other prominent players.

Customization Scope

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Chapter 1.          Methodology and Scope

1.1.        Research Methodology

1.2.        Research Scope & Assumptions

Chapter 2.          Executive Summary

Chapter 3.          Global Human Factors and Usability Engineering Services Market Snapshot

Chapter 4.          Global Human Factors and Usability Engineering Services Market Variables, Trends & Scope

4.1.        Market Segmentation & Scope

4.2.        Drivers

4.3.        Challenges

4.4.        Trends

4.5.        Investment and Funding Analysis

4.6.        Porter's Five Forces Analysis

4.7.        Incremental Opportunity Analysis (US$ MN), 2024-2031

4.8.        Global Human Factors and Usability Engineering Services Market Penetration & Growth Prospect Mapping (US$ Mn), 2023-2031

4.9.        Competitive Landscape & Market Share Analysis, By Key Player (2023)

4.10.     Use/impact of AI on Human Factors And Usability Engineering Services Market Industry Trends

Chapter 5.          Human Factors and Usability Engineering Services Market Segmentation 1: By Medical Device, Estimates & Trend Analysis

5.1.        Market Share by Medical Device, 2023 & 2031

5.2.        Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Medical Device:

5.2.1.    Therapeutic Devices

5.2.2.    Diagnostic Devices

5.2.3.    Wearable and Implantable Devices

5.2.4.    Surgical and Interventional Devices

5.2.5.    Home Healthcare Devices

Chapter 6.          Human Factors and Usability Engineering Services Market Segmentation 2: By Type of services, Estimates & Trend Analysis

6.1.        Market Share by Type of services, 2023 & 2031

6.2.        Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Type of services:

6.2.1.    User Research and Analysis

6.2.2.    Usability Testing

6.2.3.    Human Factors Engineering (HFE) analysis

6.2.4.    Interface and Interaction Design

6.2.5.    Regulatory and Compliance Support

6.2.6.    Training and Education

Chapter 7.          Human Factors and Usability Engineering Services Market Segmentation 3: By Class of Medical Device, Estimates & Trend Analysis

7.1.        Market Share by Class of Medical Device, 2023 & 2031

7.2.        Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Class of Medical Device:

7.2.1.    Class I

7.2.2.    Class II

7.2.3.    Class III

Chapter 8.          Human Factors and Usability Engineering Services Market Segmentation 4: By Application, Estimates & Trend Analysis

8.1.        Market Share by Application, 2023 & 2031

8.2.        Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Application:

8.2.1.    Emergency Care

8.2.2.    Chronic Disease Management

8.2.3.    Diagnostics and Monitoring

8.2.4.    Surgical and Invasive Procedures

Chapter 9.          Human Factors and Usability Engineering Services Market Segmentation 5: By Services, Estimates & Trend Analysis

9.1.        Market Share by Services, 2023 & 2031

9.2.        Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2019 to 2031 for the following Services:

9.2.1.    User Research and Contextual Inquiry

9.2.2.    Usability Testing

9.2.3.    Human Factors Engineering (HFE) Analysis

9.2.4.    Risk Management and Safety Analysis

9.2.5.    Regulatory and Compliance Support

9.2.6.    User Interface (UI) and Interaction Design

9.2.7.    Post-Market Usability Evaluation and Feedback Analysis

Chapter 10.        Human Factors and Usability Engineering Services Market Segmentation 6: Regional Estimates & Trend Analysis

10.1.     Global Human Factors and Usability Engineering Services Market, Regional Snapshot 2023 & 2031

10.2.     North America

10.2.1.  North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2019-2031

10.2.1.1.             US

10.2.1.2.             Canada

10.2.2.  North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2019-2031

10.2.3.  North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2019-2031

10.2.4.  North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2019-2031

10.2.5.  North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2019-2031

10.2.6.  North America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2019-2031

10.3.     Europe

10.3.1.  Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2019-2031

10.3.1.1.             Germany

10.3.1.2.             U.K.

10.3.1.3.             France

10.3.1.4.             Italy

10.3.1.5.             Spain

10.3.1.6.             Rest of Europe

10.3.2.  Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2019-2031

10.3.3.  Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2019-2031

10.3.4.  Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2019-2031

10.3.5.  Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2019-2031

10.3.6.  Europe Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2019-2031

10.4.     Asia Pacific

10.4.1.  Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2019-2031

10.4.1.1.             India

10.4.1.2.             China

10.4.1.3.             Japan

10.4.1.4.             Australia

10.4.1.5.             South Korea

10.4.1.6.             Hong Kong

10.4.1.7.             Southeast Asia

10.4.1.8.             Rest of Asia Pacific

10.4.2.  Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2019-2031

10.4.3.  Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2019-2031

10.4.4.  Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2019-2031

10.4.5.  Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts By Application, 2019-2031

10.4.6.  Asia Pacific Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2019-2031

10.5.     Latin America

10.5.1.  Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Country, 2019-2031

10.5.1.1.             Brazil

10.5.1.2.             Mexico

10.5.1.3.             Rest of Latin America

10.5.2.  Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2019-2031

10.5.3.  Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2019-2031

10.5.4.  Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2019-2031

10.5.5.  Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2019-2031

10.5.6.  Latin America Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2019-2031

10.6.     Middle East & Africa

10.6.1.  Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by country, 2019-2031

10.6.1.1.             GCC Countries

10.6.1.2.             Israel

10.6.1.3.             South Africa

10.6.1.4.             Rest of Middle East and Africa

10.6.2.  Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Medical Device, 2019-2031

10.6.3.  Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Type of services, 2019-2031

10.6.4.  Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Class of Medical Device, 2019-2031

10.6.5.  Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Application, 2019-2031

10.6.6.  Middle East & Africa Human Factors and Usability Engineering Services Market Revenue (US$ Million) Estimates and Forecasts by Services, 2019-2031

Chapter 11.        Competitive Landscape

11.1.     Major Mergers and Acquisitions/Strategic Alliances

11.2.     Company Profiles

 

11.2.1.  AptarGroup, Inc.

11.2.1.1.             Business Overview

11.2.1.2.             Key Product/Service

11.2.1.3.             Financial Performance

11.2.1.4.             Geographical Presence

11.2.1.5.             Recent Developments with Business Strategy

11.2.2.  Mauro Usability Science

11.2.3.  Bayoomed

11.2.4.  Bold Insight Inc.

11.2.5.  ClariMed

11.2.6.  Comate

11.2.7.  Delve

11.2.8.  Gilero

11.2.9.  Emergo by UL

11.2.10.              Freyr Solutions

11.2.11.              Gilero

11.2.12.              Greenlight Guru

11.2.13.              Human Factors Insight

11.2.14.              Human Factors International (HFI)

11.2.15.              Hydrix

11.2.16.              Improvita

11.2.17.              Johner Institute

11.2.18.              Kapstone Medical

11.2.19.              Kymanox

11.2.20.              PDD Group Ltd

11.2.21.              Planet Innovation

11.2.22.              Tata Elxsi

11.2.23.              Veranex, Inc.

11.2.24.              Decos Software Engineering B.V.

11.2.25.              Kaleidoscope Innovation

11.2.26.              Eurofins Human Factors MD, LLC

11.2.27.              Ipsos Healthcare

11.2.28.              Battelle

11.2.29.              Design Science

11.2.30.              Other Prominent Players

Segmentation of Human Factors and Usability Engineering Services Market

Global Human Factors and Usability Engineering Services Market- By Medical Devices         

  • Therapeutic Devices
  • Diagnostic Devices
  • Wearable and Implantable Devices
  • Surgical and Interventional Devices
  • Home Healthcare Devices

humna factors

Global Human Factors and Usability Engineering Services Market – By Type Services

  • User Research and Analysis
  • Usability Testing
  • Human Factors Engineering (HFE) analysis
  • Interface and Interaction Design
  • Regulatory and Compliance Support
  • Training and Education

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

  • Class I 
  • Class II 
  • Class III 

Global Human Factors and Usability Engineering Services Market – By Application 

  • Emergency Care
  • Chronic Disease Management
  • Diagnostics and Monitoring
  • Surgical and Invasive Procedures

Global Human Factors and Usability Engineering Services Market – By Services

  • Emergency Care
  • Chronic Disease Management
  • Diagnostics and Monitoring
  • Surgical and Invasive Procedures

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

 

InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.

Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.

Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.

Secondary research

The secondary research sources that are typically mentioned to include, but are not limited to:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista

Primary Research:

Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies

The contributors who typically take part in such a course include, but are not limited to: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

Data Modeling and Analysis:

In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.

The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.

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Frequently Asked Questions

How big is the Human Factors and Usability Engineering Services Market Size?

The Human Factors and Usability Engineering Services Market is expected to grow at an 6.2% CAGR during the forecast period for 2024-2031.

AptarGroup, Inc., Mauro Usability Science, Bayoomed, Bold Insight Inc., ClariMed, Comate, Delve, Gilero, Emergo by UL, Freyr Solutions, Greenlight Gur

By Medical Devices By Type of Services, Class Of Medical Device, Application, and Services are the key segments of the Human Factors and Usability Eng

North American region is leading the Human Factors and Usability Engineering Services Market.

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