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PUBLISHER: Roots Analysis | PRODUCT CODE: 1568353

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PUBLISHER: Roots Analysis | PRODUCT CODE: 1568353

Human Factors and Usability Engineering Services Market, Industry Trends and Global Forecasts, till 2035 - Distribution by Steps Involved, Type of Research Method, Class of Medical Device Tested, Geographical Regions and Leading Players

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Description

Table of Contents

List of Tables

The global human factors and usability engineering services market is valued at USD 0.94 billion in 2024, growing at a CAGR of 6.9% during the forecast period till 2035.

There has been an alarming surge in the number of adverse events related to medical devices, in the medical device industry. As per the United States Food Drug and Administration (USFDA), most common user errors leading to medical device recalls stem from design and user interface related modifications in a medical device, insufficient user training, and improper use of devices outside their intended applications.

According to Sedgwick brand protection's US Recall Index report, medical device recalls in the US have surged by nearly 15% in the first quarter of 2024, marking the highest number of recalls in any quarter in over five years. To provide the solutions for the above-mentioned challenges, medical device manufacturers have implemented various proactive measures, including robust product design and risk management processes, maintaining meticulous documentation, and collaborating closely with regulatory authorities. One prominent example of such a process is the integration of human factors and usability engineering during product design and product development.

Human factors and usability engineering provides a comprehensive analysis of how users will interact with a medical device in the real-world setting, considering all the possible parameters / potential hazards related to product use, ensuring that a device is designed in such a way that the risk of use-related errors is minimal, by comprehending the impact of devices on different type of user groups.

Moreover, the human factors and usability engineering service providers offer specialized expertise (including FDA guidance), furnishing help to the medical device companies to navigate through the complex and evolving regulatory requirements. In order to avoid potential biasedness (which may potentially influence the participants they choose), a result of familiarity with the devices and a desire for favorable outcomes, it is often preferred by the manufacturers to outsource human factors and usability engineering. This has resulted in the development of an extensive contract services market that caters to the human factors and usability engineering needs of medical device manufacturers, ensuring adequacy and integrity of the study that aligns with regulatory requirements. The increasing demand for innovative and personalized medical devices, directly proportionate the outsourcing of human factors and usability engineering services operations. This trend presents burgeoning growth opportunities for experienced medical device CROs (contract research organizations).

Key Market Segments

Steps Involved

  • Summative Study
  • Contextual Analysis
  • Formative Study
  • Known Use Error Analysis
  • Use Risk Analysis
  • Submission Preparation
  • Design Process
  • Task Analysis

Type of Research Method

  • Evaluation Research
  • Generative Research

Class of Medical Device Tested

  • Class I Medical Devices
  • Class II Medical Devices
  • Class III Medical Devices

Geographical Regions

  • North America (US, Canada)
  • Europe (Germany, France, Italy, Switzerland, UK, Rest of Europe)
  • Asia-Pacific (China, Japan, Australia, India, Rest of Asia-Pacific)
  • Middle East and North Africa
  • Latin America

Research Coverage:

  • An in-depth assessment of the companies in human factors and usability engineering services market landscape, based on several parameters, such as, year of establishment, company size (in terms of employee count), location of headquarters, type of service offered (concept phase, design and development, verification and validation testing, documentation / file compilation, regulatory guidance, packaging and labeling, training, post market surveillance, and other services), concept phase (user research and use error risk analysis and management), design and development (prototype design and development , user interface design and development, and task analysis), verification and validation testing (summative study, formative study, usability inspection, and remote usability study), type of medical devices tested (diagnostic devices, drug delivery devices, therapeutic devices, surgical devices / equipment, clinical use / care devices, wearables, robotics, connected / digital devices, dental products, Software as Medical Devices (SaMD), and other medical / laboratory equipment), medical device users (hospital and clinics, and home settings) and software engineering offered.
  • A comprehensive assessment of service providers in the human factors and usability engineering market, based on several relevant parameters, which include, company strength (in terms of years of experience) and portfolio strength (type of service offered and type of medical device tested).
  • Elaborate profiles of prominent companies in the human factors and usability engineering service domain (shortlisted based on our proprietary criteria) based in North America, Europe and Asia-Pacific, wherein each company profile provides a brief overview of the company, along with information on location of headquarters, year of establishment, number of employees, business segments, management team, contact details, service portfolio, recent developments and an informed future outlook.
  • A detailed analysis of mergers and acquisitions that have taken place in the human factors and usability engineering services market, since 2019, based on several relevant parameters, such as year of agreement, type of agreement and geographical location of the companies.
  • An elaborate discussion on the cost implications across various steps of the human factors and usability engineering process, namely contextual inquiry, task analysis, design process, formative study, use risk analysis, known use error analysis, summative study, submission preparation, and the cost requirements across each of the aforementioned stages.
  • A comprehensive discussion on the medical device recalls, including information on the year-wise trend of device recalls and the possible underlying causes for the same. Further, the chapter provides information about the top five medical device recalls and strategies on applying human factors and usability engineering to medical devices to prevent errors and reduce the number of recalls.
  • A qualitative assessment of the various megatrends ongoing in the human factors and usability engineering market.
  • In-depth information about the factors that can impact the growth of human factors and usability engineering industry. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
  • In-depth details pertaining to the estimates of the current market size, future opportunity and the growth potential of the human factors and usability engineering services market over the next decade. Based on multiple parameters, likely adoption trends and through reliable secondary and primary validations, we have provided an informed estimate on the market evolution during the forecast period, till 2035. Further, to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.
  • A detailed projection of the current size and future opportunity within the human factors and usability engineering services industry across different steps involved, such as summative study, contextual analysis, formative study, known use error analysis, use risk analysis, submission preparation, design process, and task analysis.
  • A detailed projection of the current size and future opportunity for human factors and usability engineering service providers across different types of research methods, such as evaluation research and generative research.
  • An in-depth assessment of the current size and future opportunity in the human factors and usability engineering services market across class of medical devices tested, such as Class I medical devices, Class medical devices and Class III medical devices.
  • An in-depth analyzed projection of the current size and future opportunity in the human factors and usability engineering services industry across different geographical regions, such as North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America.
  • A detailed assessment of the leading players in the human factors and usability engineering services market based on relevant parameters.

Key Benefits of Buying this Report

  • The report provides valuable insights to market leaders and newcomers regarding the revenue estimations of the overall market and its sub-segments.
  • Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
  • The report provides stakeholders with a pulse on the Human Factors and Usability Engineering Services Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Key Companies Profiled

  • Aptar Digital Health

AYES

  • Bayoomed
  • Bold Insight
  • ClariMed
  • Comate

D+I

  • Greenlight Guru
  • Hydrix
  • Invetech
  • Johari Digital
Show more
Product Code: RA100511

TABLE OF CONTENTS

1. PREFACE

  • 1.1. Introduction
  • 1.2. Market Share Insights
  • 1.3. Key Market Insights
  • 1.4. Report Coverage
  • 1.5. Frequently Asked Questions
  • 1.6. Chapter Outlines

2. RESEARCH METHODOLOGY

  • 2.1. Chapter Overview
  • 2.2. Research Assumptions
    • 2.2.1. Market Landscape and Market Trends
    • 2.2.2. Market Forecast and Opportunity Analysis
    • 2.2.3. Comparative Analysis
  • 2.3. Database Building
    • 2.3.1. Data Collection
    • 2.3.2. Data Validation
    • 2.3.3. Data Analysis
  • 2.4. Project Methodology
    • 2.4.1. Secondary Research
      • 2.4.1.1. Annual Reports
      • 2.4.1.2. Academic Research Papers
      • 2.4.1.3. Company Websites
      • 2.4.1.4. Investor Presentations
      • 2.4.1.5. Regulatory Filings
      • 2.4.1.6. White Papers
      • 2.4.1.7. Industry Publications
      • 2.4.1.8. Conferences and Seminars
      • 2.4.1.9. Government Portals
      • 2.4.1.10. Media and Press Releases
      • 2.4.1.11. Newsletters
      • 2.4.1.12. Industry Databases
      • 2.4.1.13. Roots Proprietary Databases
      • 2.4.1.14. Paid Databases and Sources
      • 2.4.1.15. Social Media Portals
      • 2.4.1.16. Other Secondary Sources
    • 2.4.2. Primary Research
      • 2.4.2.1. Types of Primary Research
        • 2.4.2.1.1. Qualitative Research
        • 2.4.2.1.2. Quantitative Research
        • 2.4.2.1.3. Hybrid Approach
      • 2.4.2.2. Advantages of Primary Research
      • 2.4.2.3. Techniques for Primary Research
        • 2.4.2.3.1. Interviews
        • 2.4.2.3.2. Surveys
        • 2.4.2.3.3. Focus Groups
        • 2.4.2.3.4. Observational Research
        • 2.4.2.3.5. Social Media Interactions
      • 2.4.2.4. Key Opinion Leaders Considered in Primary Research
        • 2.4.2.4.1. Company Executives (CXOs)
        • 2.4.2.4.2. Board of Directors
        • 2.4.2.4.3. Company Presidents and Vice Presidents
        • 2.4.2.4.4. Research and Development Heads
        • 2.4.2.4.5. Technical Experts
        • 2.4.2.4.6. Subject Matter Experts
        • 2.4.2.4.7. Scientists
        • 2.4.2.4.8. Doctors and Other Healthcare Providers
      • 2.4.2.5. Ethics and Integrity
        • 2.4.2.5.1. Research Ethics
        • 2.4.2.5.2. Data Integrity
    • 2.4.3. Analytical Tools and Databases

3. MARKET DYNAMICS

  • 3.1. Chapter Overview
  • 3.2. Forecast Methodology
    • 3.2.1. Top-down Approach
    • 3.2.2. Bottom-up Approach
    • 3.2.3. Hybrid Approach
  • 3.3. Market Assessment Framework
    • 3.3.1. Total Addressable Market (TAM)
    • 3.3.2. Serviceable Addressable Market (SAM)
    • 3.3.3. Serviceable Obtainable Market (SOM)
    • 3.3.4. Currently Acquired Market (CAM)
  • 3.4. Forecasting Tools and Techniques
    • 3.4.1. Qualitative Forecasting
    • 3.4.2. Correlation
    • 3.4.3. Regression
    • 3.4.4. Extrapolation
    • 3.4.5. Convergence
    • 3.4.6. Sensitivity Analysis
    • 3.4.7. Scenario Planning
    • 3.4.8. Data Visualization
    • 3.4.9. Time Series Analysis
    • 3.4.10. Forecast Error Analysis
  • 3.5. Key Considerations
    • 3.5.1. Demographics
    • 3.5.2. Government Regulations
    • 3.5.3. Reimbursement Scenarios
    • 3.5.4. Market Access
    • 3.5.5. Supply Chain
    • 3.5.6. Industry Consolidation
    • 3.5.7. Pandemic / Unforeseen Disruptions Impact
  • 3.6. Key Market Segmentation
  • 3.7. Robust Quality Control
  • 3.8. Limitations

4. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

  • 4.1. Chapter Overview
  • 4.2. Market Dynamics
    • 4.2.1. Time Period
      • 4.2.1.1. Historical Trends
      • 4.2.1.2. Current and Future Estimates
    • 4.2.2. Currency Coverage and Foreign Exchange Rate
      • 4.2.2.1. Major Currencies Affecting the Market
      • 4.2.2.2. Factors Affecting Currency Fluctuations and Foreign Exchange Rates
      • 4.2.2.3. Impact of Foreign Exchange Rate Volatility on the Market
      • 4.2.2.4. Strategies for Mitigating Foreign Exchange Risk
    • 4.2.3. Trade Policies
      • 4.2.3.1. Impact of Trade Barriers on the Market
      • 4.2.3.2. Strategies for Mitigating the Risks Associated with Trade Barriers
    • 4.2.4. Recession
      • 4.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
      • 4.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
    • 4.2.5. Inflation
      • 4.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
      • 4.2.5.2. Potential Impact of Inflation on the Market Evolution

5. EXECUTIVE SUMMARY

  • 5.1. Chapter Overview
  • 5.2. Executive Summary: Market Landscape
  • 5.3. Executive Summary: Mergers and Acquisitions
  • 5.4. Executive Summary: Market Forecast and Opportunity Analysis

6. INTRODUCTION

  • 6.1. Chapter Overview
  • 6.2. Overview of Human Factors and Usability Engineering
  • 6.3. Human Factors Influencing Medical Device Design
    • 6.3.1. End Users
    • 6.3.2. User Environment
    • 6.3.3. Device-User Interface
  • 6.4. Key Steps Involved in Human Factors and Usability Engineering
  • 6.5. Outsourcing of Human Factors and Usability Engineering
  • 6.6. Advantages of Outsourcing Human Factors and Usability Engineering
  • 6.7. Risks and Challenges Associated with Outsourcing Human Factors and Usability Engineering
  • 6.8. Key Considerations while Selecting a Human Factors and Usability Engineering Service Provider
  • 6.9. Conclusion

7. REGULATORY GUIDELINES FOR HUMAN FACTORS AND USABILITY ENGINEERING

  • 7.1. Chapter Overview
  • 7.2. Key Regulatory Authorities for Human Factors and Usability Engineering
  • 7.3. Regulatory Landscape in North America
    • 7.3.1. The USFDA Recognized Standards on Human Factors and Usability Engineering
    • 7.3.2. The USFDA Guidance Documents Related to Human Factors and Usability Engineering
    • 7.3.3. Human Factors and Usability Engineering Process by the USFDA
  • 7.4. Regulatory Landscape in Europe
    • 7.4.1. EU Recognized Standards for Human Factors and Usability Engineering
    • 7.4.2. Human Factors and Usability Engineering Process by European Union
  • 7.5. Comparison between the USFDA and EU Guidelines
    • 7.5.1. Common Approach to Make the USFDA and EU Submissions
    • 7.5.2. Human Factors and Usability Engineering Process for Other Devices
  • 7.6. Recent Activity of Regulatory Bodies Involved
  • 7.7. Concluding Remarks

8. MARKET LANDSCAPE

  • 8.1. Chapter Overview
  • 8.2. Human Factors and Usability Engineering Service Providers: Overall Market Landscape
    • 8.2.1. Analysis by Year of Establishment
    • 8.2.2. Analysis by Company Size
    • 8.2.3. Analysis by Location of Headquarters
    • 8.2.4. Analysis by Company Size and Location of Headquarters
    • 8.2.5. Analysis by Type of Service Offered
      • 8.2.5.1. Analysis by Concept Phase
      • 8.2.5.2. Analysis by Design and Development
      • 8.2.5.3. Analysis by Verification and Validation
    • 8.2.6. Analysis by Type of Medical Device Tested
    • 8.2.7. Analysis by End User of Medical Device Tested
    • 8.2.8. Analysis by Software Engineering Offered

9. COMPANY COMPETITIVENESS ANALYSIS

  • 9.1. Chapter Overview
  • 9.2. Assumptions and Key Parameters
  • 9.3. Methodology
  • 9.4. Company Competitiveness Analysis: Human Factors and Usability Engineering Service Providers
    • 9.4.1. Human Factors and Usability Engineering Service Providers based in North America (Peer Group I)
    • 9.4.2. Human Factors and Usability Engineering Service Providers based in Europe (Peer Group II)
    • 9.4.3. Human Factors and Usability Engineering Service Providers based in Asia-Pacific, Middle East and North Africa, and Latin America (Peer Group III)

10. COMPANY PROFILES: SERVICE PROVIDERS IN NORTH AMERICA

  • 10.1. Chapter Overview
  • 10.2. ClariMed
    • 10.2.1. Company Overview
    • 10.2.2. Service Portfolio
    • 10.2.3. Recent Developments and Future Outlook
  • 10.3. Aptar Digital Health
    • 10.3.1. Company Overview
    • 10.3.2. Service Portfolio
    • 10.3.3. Recent Developments and Future Outlook
  • 10.4. Bold Insight
    • 10.4.1. Company Overview
    • 10.4.2. Service Portfolio
    • 10.4.3. Recent Developments and Future Outlook
  • 10.5. Greenlight Guru
    • 10.5.1. Company Overview
    • 10.5.2. Service Portfolio
    • 10.5.3. Recent Developments and Future Outlook
  • 10.6. Key Winning Strategies

11. COMPANY PROFILES: SERVICE PROVIDERS IN EUROPE

  • 11.1. Chapter Overview
  • 11.2. Bayoomed
    • 11.2.1. Company Overview
    • 11.2.2. Service Portfolio
    • 11.2.3. Recent Developments and Future Outlook
  • 11.3. AYES
    • 11.3.1. Company Overview
    • 11.3.2. Service Portfolio
    • 11.3.3. Recent Developments and Future Outlook
  • 11.4. Comate
    • 11.4.1. Company Overview
    • 11.4.2. Service Portfolio
    • 11.4.3. Recent Developments and Future Outlook
  • 11.5. Key Winning Strategies

12. COMPANY PROFILES: SERVICE PROVIDERS IN ASIA-PACIFIC

  • 12.1. Chapter Overview
  • 12.2. Hydrix
    • 12.2.1. Company Overview
    • 12.2.2. Service Portfolio
    • 12.2.3. Recent Developments and Future Outlook
  • 12.3. D+I
    • 12.3.1. Company Overview
    • 12.3.2. Service Portfolio
    • 12.3.3. Recent Developments and Future Outlook
  • 12.4. Invetech
    • 12.4.1. Company Overview
    • 12.4.2. Service Portfolio
    • 12.4.3. Recent Developments and Future Outlook
  • 12.5. Johari Digital
    • 12.5.1. Company Overview
    • 12.5.2. Service Portfolio
    • 12.5.3. Recent Developments and Future Outlook
  • 12.6. Key Winning Strategies

13. MERGERS AND ACQUISITIONS

  • 13.1. Chapter Overview
  • 13.2. Type of Mergers and Acquisitions
  • 13.3. Mergers and Acquisitions: Human Factors and Usability Engineering Service Providers
    • 13.3.1. Analysis by Year of Agreement
    • 13.3.2. Analysis by Type of Agreement
    • 13.3.3. Analysis by Geography
      • 13.3.3.1. Intracontinental and Intercontinental Agreements
      • 13.3.3.2. International and Local Agreements
  • 13.4. Most Active Players: Analysis by Number of Agreements

14. COST IMPLICATIONS RELATED TO HUMAN FACTORS AND USABILITY ENGINEERING PROCESS

  • 14.1. Chapter Overview
  • 14.2. Key Steps involved in Human Factors and Usability Engineering Process
  • 14.3. Cost Distribution across the Different Steps of Human Factors and Usability Engineering
    • 14.3.1. Costs Associated with Contextual Inquiry
    • 14.3.2. Costs Associated with Task Analysis
    • 14.3.3. Costs Associated with Design Analysis
    • 14.3.4. Costs Associated with Formative Study
    • 14.3.5. Costs Associated with Use Risk Analysis
    • 14.3.6. Costs Associated with Known Use Error Analysis
    • 14.3.7. Costs Associated with Summative Study
    • 14.3.8. Costs Associated with Submission Preparation

15. CASE STUDY: MEDICAL DEVICE RECALLS AND ROLE OF HUMAN FACTORS AND USABILITY ENGINEERING

  • 15.1. Chapter Overview
  • 15.2. Medical Device Recalls
  • 15.3. Major Medical Device Recalls
    • 15.3.1. Philips: Recall of Sense XL Torso Coil
    • 15.3.2. Inspire Medical Systems: Recall of Inspire IV Implantable Pulse Generator (IPG) Model 3028
    • 15.3.3. Hamilton Medical: Recall of HAMILTON-C6 Intensive Care Ventilator
    • 15.3.4. Zoll Medical: Recall of ZOLL 731 Ventilator
    • 15.3.5. Elekta Instrument: Recall of Disposable Biopsy Needle Kit
  • 15.4. Medical Device Recalls: Role Of Human Factors and Usability Engineering
  • 15.5. Conclusion

16. HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: ONGOING MEGATRENDS

  • 16.1. Chapter Overview
  • 16.2. Key Megatrends

17. MARKET IMPACT ANALYSIS

  • 17.1. Chapter Overview
  • 17.2. Market Drivers
  • 17.3. Market Restraints
  • 17.4. Market Opportunities
  • 17.5. Market Challenges
  • 17.6. Conclusion

18. GLOBAL HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET

  • 18.1. Chapter Overview
  • 18.2. Assumptions and Methodology
  • 18.3. Global Human Factors and Usability Engineering Services Market, till 2035
    • 18.3.1. Roots Analysis Perspective on Market Growth
    • 18.3.2. Scenario Analysis
      • 18.3.2.1. Conservative Scenario
      • 18.3.2.2. Optimistic Scenario
  • 18.4. Key Market Segmentations

19. HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET, BY STEPS INVOLVED

  • 19.1. Chapter Overview
  • 19.2. Assumptions and Methodology
  • 19.3. Human Factors and Usability Engineering Services Market: Distribution by Steps Involved, Current Year and 2035
    • 19.3.1. Human Factors and Usability Engineering Services Market for Summative Study, till 2035
    • 19.3.2. Human Factors and Usability Engineering Services Market for Contextual Analysis, till 2035
    • 19.3.3. Human Factors and Usability Engineering Services Market for Formative Study, till 2035
    • 19.3.4. Human Factors and Usability Engineering Services Market for Known Use Error Analysis, till 2035
    • 19.3.5. Human Factors and Usability Engineering Services Market for Use Risk Analysis, till 2035
    • 19.3.6. Human Factors and Usability Engineering Services Market for Submission Preparation, till 2035
    • 19.3.7. Human Factors and Usability Engineering Services Market for Design Analysis, till 2035
    • 19.3.8. Human Factors and Usability Engineering Services Market for Task Analysis, till 2035
  • 19.4. Penetration-Growth (P-G) Matrix
  • 19.5. Data Triangulation and Validation

20. HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET, BY TYPE OF RESEARCH METHOD

  • 20.1. Chapter Overview
  • 20.2. Assumptions and Methodology
  • 20.3. Human Factors and Usability Engineering Services Market: Distribution by Type of Research Method, Current Year and 2035
    • 20.3.1. Human Factors and Usability Engineering Services Market for Evaluation Research, till 2035
    • 20.3.2. Human Factors and Usability Engineering Services Market for Generative Research, till 2035
  • 20.4. Penetration-Growth (P-G) Matrix
  • 20.5. Data Triangulation and Validation

21. HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET, BY CLASS OF MEDICAL DEVICE TESTED

  • 21.1. Chapter Overview
  • 21.2. Assumptions and Methodology
  • 21.3. Human Factors and Usability Engineering Services Market: Distribution by Class of Medical Device Tested, 2024 and 2035
    • 21.3.1. Human Factors and Usability Engineering Services Market for Class I Medical Devices, till 2035
    • 21.3.2. Human Factors and Usability Engineering Services Market for Class II Medical Devices, till 2035
    • 21.3.3. Human Factors and Usability Engineering Services Market for Class III Medical Devices, till 2035
  • 21.4. Penetration-Growth (P-G) Matrix
  • 21.5. Data Triangulation and Validation

22. HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET, BY GEOGRAPHICAL REGIONS

  • 22.1. Chapter Overview
  • 22.2. Assumptions and Methodology
  • 22.3. Human Factors and Usability Engineering Services Market: Distribution by Geographical Regions, Current Year and 2035
    • 22.3.1. Human Factors and Usability Engineering Services Market in North America, till 2035
      • 22.3.1.1. Human Factors and Usability Engineering Services Market in the US, till 2035
      • 22.3.1.2. Human Factors and Usability Engineering Services Market in Canada, till 2035
    • 22.3.2. Human Factors and Usability Engineering Services Market in Europe, till 2035
      • 22.3.2.1. Human Factors and Usability Engineering Services Market in Germany, till 2035
      • 22.3.2.2. Human Factors and Usability Engineering Services Market in France, till 2035
      • 22.3.2.3. Human Factors and Usability Engineering Services Market in Italy, till 2035
      • 22.3.2.4. Human Factors and Usability Engineering Services Market in the UK, till 2035
      • 22.3.2.5. Human Factors and Usability Engineering Services Market in Switzerland, till 2035
      • 22.3.2.6. Human Factors and Usability Engineering Services Market in Rest of Europe, till 2035
    • 22.3.3. Human Factors and Usability Engineering Services Market in Asia-Pacific, till 2035
      • 22.3.3.1. Human Factors and Usability Engineering Services Market in China, till 2035
      • 22.3.3.2. Human Factors and Usability Engineering Services Market in Japan, till 2035
      • 22.3.3.3. Human Factors and Usability Engineering Services Market in Australia, till 2035
      • 22.3.3.4. Human Factors and Usability Engineering Services Market in India, till 2035
      • 22.3.3.5. Human Factors and Usability Engineering Services Market in Rest of Asia-Pacific, till 2035
    • 22.3.4. Human Factors and Usability Engineering Services Market in Middle East and North Africa, till 2035
    • 22.3.5. Human Factors and Usability Engineering Services Market in Latin America, till 2035
  • 22.4. Market Movement Analysis
  • 22.5. Penetration-Growth (P-G) Matrix
  • 22.6. Data Triangulation and Validation

23. HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET, BY LEADING PLAYERS

  • 23.1. Chapter Overview
  • 23.2. Leading Industry Players

24. CONCLUSION

25. EXECUTIVE INSIGHTS

  • 25.1. Chapter Overview
  • 25.2. Interview Transcript, Chief Executive Officer and Chair, Mid-sized Company, US
  • 25.3. Interview Transcript, Managing Director and Human Factors Consultant, Small Company, UK
  • 25.4. Interview Transcript, Head of Human Factors, Mid-sized Company, UK
  • 25.5. Interview Transcript, Head of Research (Human Factors and Interaction), Mid-sized Company, UK
  • 25.6. Interview Transcript, UX Director and Team Manager, Mid-sized Company, Germany

26. APPENDIX I: TABULATED DATA

27. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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Product Code: RA100511

List of Tables

  • Table 7.1 The USFDA Recognized Standards for Human Factors and Usability Engineering Services
  • Table 8.1 Human Factors and Usability Engineering: List of Service Providers
  • Table 8.2 Human Factors and Usability Engineering Service Providers: Information on Type of Service Offered
  • Table 8.3 Human Factors and Usability Engineering Service Providers: Information on Concept Phase, and Design and Development
  • Table 8.4 Human Factors and Usability Engineering Service Providers: Information on Verification and Validation
  • Table 8.5 Human Factors and Usability Engineering Service Providers: Information on Type of Medical Device Tested
  • Table 8.6 Human Factors and Usability Engineering Service Providers: Information on End User of Medical Device Tested
  • Table 8.7 Human Factors and Usability Engineering Service Providers: Information on Software Engineering Offered
  • Table 10.1 Human Factors and Usability Engineering Service Providers: List of Companies Profiled (North America)
  • Table 10.2 ClariMed: Company Overview
  • Table 10.3 ClariMed: Service Portfolio
  • Table 10.4 ClariMed: Recent Developments and Future Outlook
  • Table 10.5 Aptar Digital Health: Company Overview
  • Table 10.6 Aptar Digital Health: Service Portfolio
  • Table 10.7 Aptar Digital Health: Recent Developments and Future Outlook
  • Table 10.8 Bold Insight: Company Overview
  • Table 10.9 Bold Insight: Service Portfolio
  • Table 10.10 Bold Insight: Recent Developments and Future Outlook
  • Table 10.11 Greenlight Guru: Company Overview
  • Table 10.12 Greenlight Guru: Service Portfolio
  • Table 10.13 Greenlight Guru: Recent Developments and Future Outlook
  • Table 11.1 Human Factors and Usability Engineering Service Providers: List of Companies Profiled (Europe)
  • Table 11.2 Bayoomed: Company Overview
  • Table 11.3 Bayoomed: Service Portfolio
  • Table 11.4 Bayoomed: Recent Developments and Future Outlook
  • Table 11.5 AYES: Company Overview
  • Table 11.6 AYES: Service Portfolio
  • Table 11.7 Comate: Company Overview
  • Table 11.8 Comate: Service Portfolio
  • Table 11.9 Comate: Recent Developments and Future Outlook
  • Table 12.1 Human Factors and Usability Engineering Service Providers: List of Companies Profiled (Asia-Pacific)
  • Table 12.2 Hydrix: Company Overview
  • Table 12.3 Hydrix: Service Portfolio
  • Table 12.4 Hydrix: Recent Developments and Future Outlook
  • Table 12.5 D+I: Company Overview
  • Table 12.6 D+I: Service Portfolio
  • Table 12.7 D+I: Recent Developments and Future Outlook
  • Table 12.8 Invetech: Company Overview
  • Table 12.9 Invetech: Service Portfolio
  • Table 12.10 Invetech: Recent Developments and Future Outlook
  • Table 12.11 Johari Digital: Company Overview
  • Table 12.12 Johari Digital: Service Portfolio
  • Table 12.13 Johari Digital: Recent Developments and Future Outlook
  • Table 13.1 Human Factors and Usability Engineering Service Providers: List of Mergers and Acquisitions, since 2019
  • Table 15.1 Philips: Recall of Sense XL Torso Coil
  • Table 15.2 Inspire Medical Systems: Recall of Inspire IV Implantable Pulse Generator Model 3028
  • Table 15.3 Hamilton Medical: Recall of HAMILTON-C6 Intensive Care Ventilator
  • Table 15.4 Zoll Medical: Recall of ZOLL 731 Ventilator
  • Table 15.5 Elekta Instrument: Recall of Disposable Biopsy Needle Kit
  • Table 15.6 Approached for Mitigating the Risks Associated with Use Errors
  • Table 23.1 Leading Industry Players: Based on General Market Understanding
  • Table 23.2 Leading Industry Players: Based on Number of Services Offered
  • Table 23.3 Leading Industry Players: Based on Number of Mergers and Acquisitions
  • Table 25.1 Mid-sized Company, US: Company Overview
  • Table 25.2 Small Company, UK: Company Overview
  • Table 25.3 Mid-sized Company, UK: Company Overview
  • Table 25.4 Mid-sized Company, UK: Company Overview
  • Table 25.5 Mid-sized Company, Germany: Company Overview
  • Table 26.1 Human Factors and Usability Engineering Service Providers: Distribution by Year of Establishment
  • Table 26.2 Human Factors and Usability Engineering Service Providers: Distribution by Company Size
  • Table 26.3 Human Factors and Usability Engineering Service Providers: Distribution by Location of Headquarters
  • Table 26.4 Human Factors and Usability Engineering Service Providers: Distribution by Company Size and Location of Headquarters
  • Table 26.5 Human Factors and Usability Engineering Service Providers: Distribution by Type of Service Offered
  • Table 26.6 Human Factors and Usability Engineering Service Providers: Distribution by Concept Phase
  • Table 26.7 Human Factors and Usability Engineering Service Providers: Distribution by Design and Development
  • Table 26.8 Human Factors and Usability Engineering Service Providers: Distribution by Verification and Validation
  • Table 26.9 Human Factors and Usability Engineering Service Providers: Distribution by Type of Medical Device Tested
  • Table 26.10 Human Factors and Usability Engineering Service Providers: Distribution by End User of Medical Device Tested
  • Table 26.11 Human Factors and Usability Engineering Service Providers: Distribution by Software Engineering Offered
  • Table 26.12 Mergers and Acquisitions: Cumulative Year-Wise Trend, since 2019
  • Table 26.13 Mergers and Acquisitions: Distribution by Type of Agreement
  • Table 26.14 Mergers and Acquisitions: Distribution by Year and Type of Agreement
  • Table 26.15 Most Active Players: Analysis by Number of Agreements
  • Table 26.16 Mergers and Acquisitions: Intracontinental Agreement and Intercontinental Agreement
  • Table 26.17 Mergers and Acquisitions: International Agreements and Local Agreements
  • Table 26.18 Global Human Factors and Usability Engineering Services Market, till 2035: Base Scenario (USD Billion)
  • Table 26.19 Global Human Factors and Usability Engineering Services Market, till 2035: Conservative Scenario (USD Billion)
  • Table 26.20 Global Human Factors and Usability Engineering Services Market, till 2035: Optimistic Scenario (USD Billion)
  • Table 26.21 Human Factors and Usability Engineering Services Market: Distribution by Steps Involved, Current Year and 2035 (USD Billion)
  • Table 26.22 Human Factors and Usability Engineering Services Market for Summative Study, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.23 Human Factors and Usability Engineering Services Market for Contextual Analysis, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.24 Human Factors and Usability Engineering Services Market for Formative Study, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.25 Human Factors and Usability Engineering Services Market for Known Use Error Analysis, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.26 Human Factors and Usability Engineering Services Market for Use Risk Analysis, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.27 Human Factors and Usability Engineering Services Market for Submission Preparation, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.28 Human Factors and Usability Engineering Services Market for Design Analysis, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.29 Human Factors and Usability Engineering Services Market for Task Analysis, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.30 Human Factors and Usability Engineering Services Market: Distribution by Type of Research Method, Current Year and 2035 (USD Billion)
  • Table 26.31 Human Factors and Usability Engineering Services Market for Evaluation Research, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.32 Human Factors and Usability Engineering Services Market for Generative Research, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.33 Human Factors and Usability Engineering Services Market: Distribution by Class of Medical Device Tested, 2024 and 2035 (USD Billion)
  • Table 26.34 Human Factors and Usability Engineering Services Market for Class I Medical Devices, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.35 Human Factors and Usability Engineering Services Market for Class II Medical Devices, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.36 Human Factors and Usability Engineering Services Market for Class III Medical Devices, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.37 Human Factors and Usability Engineering Services Market: Distribution by Geographical Regions, Current Year and 2035 (USD Billion)
  • Table 26.38 Human Factors and Usability Engineering Services Market in North America, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.39 Human Factors and Usability Engineering Services Market in the US, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.40 Human Factors and Usability Engineering Services Market in Canada, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.41 Human Factors and Usability Engineering Services Market in Europe, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.42 Human Factors and Usability Engineering Services Market in Germany, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.43 Human Factors and Usability Engineering Services Market in France, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.44 Human Factors and Usability Engineering Services Market in Italy, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.45 Human Factors and Usability Engineering Services Market in the UK, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.46 Human Factors and Usability Engineering Services Market in Switzerland, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.47 Human Factors and Usability Engineering Services Market in Rest of Europe, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.48 Human Factors and Usability Engineering Services Market in Asia-Pacific, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.49 Human Factors and Usability Engineering Services Market in China, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.50 Human Factors and Usability Engineering Services Market in Japan, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.51 Human Factors and Usability Engineering Services Market in Australia, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.52 Human Factors and Usability Engineering Services Market in India, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.53 Human Factors and Usability Engineering Services Market in Rest of Asia-Pacific, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.54 Human Factors and Usability Engineering Services Market in Middle East and North Africa, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)
  • Table 26.55 Human Factors and Usability Engineering Services Market in Latin America, till 2035, Conservative, Base and Optimistic Scenarios (USD Billion)

List of Figures

  • Figure 2.1 Research Methodology: Project Methodology
  • Figure 2.2 Research Methodology: Data Sources for Secondary Research
  • Figure 3.1 Market Dynamics: Forecast Methodology
  • Figure 3.2 Market Dynamics: Key Market Segmentation
  • Figure 3.3 Market Dynamics: Robust Quality Control
  • Figure 4.1 Lessons Learnt from Past Recessions
  • Figure 5.1 Executive Summary: Market Landscape
  • Figure 5.2 Executive Summary: Mergers and Acquisitions
  • Figure 5.3 Executive Summary: Market Forecast and Opportunity Analysis
  • Figure 6.1 Role of Human Factors and Usability Engineering in Medical Device Development
  • Figure 6.2 Human Factor Influencing Medical Device Design
  • Figure 6.3 End user Related Factors for Designing Medical Devices for Users
  • Figure 6.4 Basic Components of Device-User Interface
  • Figure 6.5 Key Steps Involved in Human Factors and Usability Engineering
  • Figure 7.1 Key Regulatory Authorities for Human Factors and Usability Engineering
  • Figure 7.2 Human Factors and Usability Engineering Process by the USFDA
  • Figure 7.3 Human Factors and Usability Engineering Process by the European Union
  • Figure 7.4 Comparison between the USFDA and EU Guidelines
  • Figure 7.5 Common Approach to Make the USFDA and EU Submissions
  • Figure 7.6 Human Factors and Usability Engineering Process for Other Devices
  • Figure 8.1 Human Factors and Usability Engineering Service Providers: Distribution by Year of Establishment
  • Figure 8.2 Human Factors and Usability Engineering Service Providers: Distribution by Company Size
  • Figure 8.3 Human Factors and Usability Engineering Service Providers: Distribution by Location of Headquarters
  • Figure 8.4 Human Factors and Usability Engineering Service Providers: Distribution by Company Size and Location of Headquarters
  • Figure 8.5 Human Factors and Usability Engineering Service Providers: Distribution by Type of Service Offered
  • Figure 8.6 Human Factors and Usability Engineering Service Providers: Distribution by Concept Phase
  • Figure 8.7 Human Factors and Usability Engineering Service Providers: Distribution by Design and Development
  • Figure 8.8 Human Factors and Usability Engineering Service Providers: Distribution by Verification and Validation
  • Figure 8.9 Human Factors and Usability Engineering Service Providers: Distribution by Type of Medical Device Tested
  • Figure 8.10 Human Factors and Usability Engineering Service Providers: Distribution by End User of Medical Device Tested
  • Figure 8.11 Human Factors and Usability Engineering Service Providers: Distribution by Software Engineering Offered
  • Figure 9.1 Company Competitiveness Analysis: Human Factors and Usability Engineering Service Providers based in North America (Peer Group I)
  • Figure 9.2 Company Competitiveness Analysis: Human Factors and Usability Engineering Service Providers based in Europe (Peer Group II)
  • Figure 9.3 Company Competitiveness Analysis: Human Factors and Usability Engineering Service Providers based in Asia-Pacific, Middle East and North Africa, and Latin America (Peer Group III)
  • Figure 10.1 Key Winning Strategies: Distribution of Prominent Players in North America
  • Figure 11.1 Key Winning Strategies: Distribution of Prominent Players in Europe
  • Figure 12.1 Key Winning Strategies: Distribution of Prominent Players in Asia-Pacific
  • Figure 13.1 Mergers and Acquisitions: Cumulative Year-Wise Trend, since 2019
  • Figure 13.2 Mergers and Acquisitions: Distribution by Type of Agreement
  • Figure 13.3 Mergers and Acquisitions: Distribution by Year and Type of Agreement
  • Figure 13.4 Mergers and Acquisitions: Intracontinental and Intercontinental Agreements
  • Figure 13.5 Mergers and Acquisitions: International and Local Agreements
  • Figure 13.6 Most Active Players: Analysis by Number of Agreements
  • Figure 14.1 Key Steps Involved in Human Factors and Usability Engineering
  • Figure 14.2 Cost Distribution Across the Different Steps of Human Factors and Usability Engineering
  • Figure 14.3 Costs Associated with Contextual Inquiry
  • Figure 14.4 Costs Associated with Task Analysis
  • Figure 14.5 Costs Associated with Design Analysis
  • Figure 14.6 Costs Associated with Formative Study
  • Figure 14.7 Costs Associated with Use Risk Analysis
  • Figure 14.8 Costs Associated with Known Use Error Analysis
  • Figure 14.9 Costs Associated with Summative Study
  • Figure 14.10 Costs Associated with Submission Preparation
  • Figure 15.1 Types of Medical Devices Use Errors
  • Figure 16.1 Key Megatrends
  • Figure 18.1 Global Human Factors and Usability Engineering Services Market, till 2035 (USD Billion)
  • Figure 18.2 Global Human Factors and Usability Engineering Services Market, till 2035: Conservative Scenario (USD Billion)
  • Figure 18.3 Global Human Factors and Usability Engineering Services Market, till 2035: Optimistic Scenario (USD Billion)
  • Figure 19.1 Human Factors and Usability Engineering Services Market: Distribution by Steps Involved, Current Year and 2035
  • Figure 19.2 Human Factors and Usability Engineering Services Market for Summative Study, till 2035 (USD Billion)
  • Figure 19.3 Human Factors and Usability Engineering Services Market for Contextual Analysis, till 2035 (USD Billion)
  • Figure 19.4 Human Factors and Usability Engineering Services Market for Formative Study, till 2035 (USD Billion)
  • Figure 19.5 Human Factors and Usability Engineering Services Market for Known Use Error Analysis, till 2035 (USD Billion)
  • Figure 19.6 Human Factors and Usability Engineering Services Market for Use Risk Analysis, till 2035 (USD Billion)
  • Figure 19.7 Human Factors and Usability Engineering Services Market for Submission Preparation, till 2035 (USD Billion)
  • Figure 19.8 Human Factors and Usability Engineering Services Market for Design Analysis, till 2035 (USD Billion)
  • Figure 19.9 Human Factors and Usability Engineering Services Market for Task Analysis, till 2035 (USD Billion)
  • Figure 19.10 Penetration-Growth (P-G) Matrix: Steps Involved
  • Figure 20.1 Human Factors and Usability Engineering Services Market: Distribution by Type of Research Method, Current Year and 2035
  • Figure 20.2 Human Factors and Usability Engineering Services Market for Evaluation Research, till 2035 (USD Billion)
  • Figure 20.3 Human Factors and Usability Engineering Services Market for Generative Research, till 2035 (USD Billion)
  • Figure 20.4 Penetration-Growth (P-G) Matrix: Type of Research Method
  • Figure 21.1 Human Factors and Usability Engineering Services Market: Distribution by Class of Medical Device Tested, Current Year and 2035
  • Figure 21.2 Human Factors and Usability Engineering Services Market for Class I Medical Devices, till 2035 (USD Billion)
  • Figure 21.3 Human Factors and Usability Engineering Services Market for Class II Medical Devices, till 2035 (USD Billion)
  • Figure 21.4 Human Factors and Usability Engineering Services Market for Class III Medical Devices, till 2035 (USD Billion)
  • Figure 21.5 Penetration-Growth (P-G) Matrix: Class of Medical Device Tested
  • Figure 22.1 Human Factors and Usability Engineering Services Market: Distribution by Geographical Regions, Current Year and 2035
  • Figure 22.2 Human Factors and Usability Engineering Services Market in North America, till 2035 (USD Billion)
  • Figure 22.3 Human Factors and Usability Engineering Services Market in the US, till 2035 (USD Billion)
  • Figure 22.4 Human Factors and Usability Engineering Services Market in Canada, till 2035 (USD Billion)
  • Figure 22.5 Human Factors and Usability Engineering Services Market in Europe, till 2035 (USD Billion)
  • Figure 22.6 Human Factors and Usability Engineering Services Market in Germany, till 2035 (USD Billion)
  • Figure 22.7 Human Factors and Usability Engineering Services Market in France, till 2035 (USD Billion)
  • Figure 22.8 Human Factors and Usability Engineering Services Market in Italy, till 2035 (USD Billion)
  • Figure 22.9 Human Factors and Usability Engineering Services Market in the UK, till 2035 (USD Billion)
  • Figure 22.10 Human Factors and Usability Engineering Services Market in Switzerland, till 2035 (USD Billion)
  • Figure 22.11 Human Factors and Usability Engineering Services Market in Rest of Europe, till 2035 (USD Billion)
  • Figure 22.12 Human Factors and Usability Engineering Services Market in Asia-Pacific, till 2035 (USD Billion)
  • Figure 22.13 Human Factors and Usability Engineering Services Market in China, till 2035 (USD Billion)
  • Figure 22.14 Human Factors and Usability Engineering Services Market in Japan, till 2035 (USD Billion)
  • Figure 22.15 Human Factors and Usability Engineering Services Market in Australia, till 2035 (USD Billion)
  • Figure 22.16 Human Factors and Usability Engineering Services Market in India, till 2035 (USD Billion)
  • Figure 22.17 Human Factors and Usability Engineering Services Market in Rest of Asia-Pacific, till 2035 (USD Billion)
  • Figure 22.18 Human Factors and Usability Engineering Services Market in Middle East and North Africa, till 2035 (USD Billion)
  • Figure 22.19 Human Factors and Usability Engineering Services Market in Latin America, till 2035 (USD Billion)
  • Figure 22.20 Market Movement Analysis
  • Figure 22.21 Penetration-Growth (P-G) Matrix: Geographical Regions
  • Figure 24.1 Conclusion: Human Factors and Usability Engineering Services Providers Market Landscape
  • Figure 24.2 Conclusion: Mergers and Acquisitions
  • Figure 24.3 Conclusion: Market Forecast and Opportunity Analysis
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