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

The global human factors and usability engineering services market is estimated to grow from USD 0.94 billion in the current year to USD 1.97 billion by 2035, at a CAGR of 6.8% during the forecast period, till 2035.

Human Factors and Usability Engineering Services Market Overview

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

Key Geographical Regions

North America (US, Canada)
Europe (Germany, France, Italy, Switzerland, UK, Rest of

the Europe)

Asia-Pacific (China, Japan, Australia, India, Rest of Asia-Pacific)
Middle East and North Africa
Latin America

HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: GROWTH AND TRENDS

Over the years, human factors and usability engineering have evolved into a crucial component of the development for all types of medical devices. Consequently, developers have established a dependency on service providers for performing human factors research on their devices to improve device safety, effectiveness, and user experience. With the increasing complexity of medical devices, it is essential to concentrate on prototype and user interface design to reduce any possible risks linked to their use. Additionally, regulatory agencies (notably, the USFDA) progressively require the integration of human factors into the design and assessment of medical devices. These organizations have begun using a structured approach to evaluate manufacturers' compliance with usability engineering standards.

The focus on human factors and usability engineering in the medical device industry highlights a wider dedication to patient safety and the functionality of devices. This emphasizes the necessity of performing human factors and usability engineering on the devices during the product lifecycle (instead of doing it in later phases of development). This will assist the developers in promptly making adjustments in the device development process to enhance user satisfaction and minimize risks. The growth of the market can be attributed to the rapid progress in medical devices, such as wearables, connected products, software as medical devices (SaMD), and digital health solutions, necessitating comprehensive usability evaluations to tackle new interaction issues and ensure safe user experiences. Further, the growing focus on reducing use-related risks via analysis of actual interactions between users and devices, particularly for varied user demographics, increases the need for services that improve safety and efficiency. Therefore, we are led to believe as the need for innovative and customized medical devices increases, the outsourcing of human factors and usability engineering services is expected to grow in the short-term.

HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: KEY INSIGHTS

The report delves into the current state of the human factors and usability engineering services market and identifies potential growth opportunities within the industry. Some key findings from the report include:

Presently, over 210 companies claim to have the required expertise to offer human factors and usability engineering services for various medical devices; notably, most of the start-ups are based in Europe.

More than 95% of the service providers offer product design and development related services; of these, majority of service providers support the testing of diagnostic devices.
In order to gain an edge in this competitive industry, companies are continuously upgrading their capabilities to enhance their respective human factor engineering service portfolios.
The rising interest in this domain is reflected by the wide array of mergers and acquisitions occurred in the recent past; in fact, close to 50% of the deals were inked in the last three years.

Owing to the benefits offered by outsourcing human factors and usability engineering services, the market is anticipated to grow at an annualized rate of over 6.8% in the coming decade.

HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: KEY SEGMENTS

Currently, Summative Study Market Segment Occupies the Largest Share of the Human Factors and Usability Engineering Services Market

Based on the steps involved, the market is segmented into summative study, contextual analysis, formative study, known use error analysis, use risk analysis, submission preparation, design process and task analysis. Currently, summative study holds the largest market share and is poised for the highest growth during the forecast period. This can be attributed to the fact that summative studies play a critical role in validating the safety and effectiveness of medical devices. Further, contextual analysis captures a significant share of the human factors and usability engineering services market. It is worth highlighting that contextual analysis offers various advantages, such as decreased chance of device recall, high return on investments (ROI) and expedition in the market launch of the medical device.

Evaluation Research is Likely to Dominate the Human Factors and Usability Engineering Services Market During the Forecast Period

Based on the type of research method, the market is segmented into evaluation research and generative research. At present, evaluation research segment occupies the highest market share of the human factors and usability engineering services market. This trend is unlikely to change in the near future.

Currently, Class III Medical Devices Testing Segment Occupies the Largest Share of the Human Factors and Usability Engineering Services Market

Based on the class of medical device tested, the market is segmented into class I, class II and class III. At present, class III medical device testing holds the maximum share of the human factors and usability engineering services market. This can be attributed to the fact that class III devices are considered high-risk devices and have the potential to cause serious illness or injury to the patients. Moreover, class II medical devices (including the IVD and injectors) require careful consideration of human factors engineering to ensure safe and effective use.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. Majority share is expected to be captured by players based in North America and Europe. This can be attributed to the stringent regulatory guidelines for medical device approvals in this region. It is worth highlighting that, over the years, the market in the rest of the world is expected to grow at a higher CAGR.

Example Players in the Human Factors and Usability Engineering Services Market

Aptar Digital Health
AYES
Bayoomed
Bold Insight
ClariMed
Comate
D+I
Greenlight Guru
Hydrix
Invetech
Johari Digital

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Chief Executive Officer and Chair, Company A
Founder and Principal, Company B
Managing Director and Human Factors Consultant, Company C
Head of Human Factors, Company D
Head of Research (Human Factors and Interaction), Company E
UX Director and Team Manager, Company F

HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the human factors and usability engineering services market, focusing on key market segments, including [A] steps involved, [B] type of research method, [C] class of medical device tested, and [D] geographical regions.
Market Landscape: A comprehensive evaluation of human factors and usability engineering service providers, considering various parameters, such as [A] year of establishment, [B] company size (in terms of employee count), [C] location of headquarters, [D] type of service offered, [E] concept phase, [F] design and development, [G] verification and validation testing, [H] type of medical devices tested, [I] medical device users and [J] software engineering offered.
Regulatory Landscape Analysis: A discussion on general regulatory guidelines established and issued by major regulatory bodies for medical device approval. In addition, it features a brief description of human factors and usability engineering process followed by regulatory bodies in the US and the EU, their comparison and a common approach that can be adopted to satisfy guidelines issued by authorities of the aforementioned regions.
Company Competitiveness Analysis: A comprehensive competitive analysis of service providers engaged in the human factors and usability engineering market, examining factors such as [A] company strength and [B] portfolio strength.
Company Profiles: In-depth profiles of key human factors and usability engineering service providers based in North America, Europe and Asia-Pacific, focusing on [A] company overviews, [B] service portfolio, [C] recent developments and [D] an informed future outlook.
Merger and Acquisitions: A comprehensive examination of the various mergers and acquisitions, focusing on multiple relevant parameters, including [A] year of agreement, [B] type of agreement and [C] geographical location of the companies.
Case Study: The chapter discusses medical device recalls, focusing on the yearly trends in recalls and the potential underlying causes. It also highlights the top five medical device recalls and suggests strategies for incorporating human factors and usability engineering into medical devices to minimize errors and decrease the frequency of recalls.
Mega Trends: A qualitative assessment of the various megatrends ongoing in the human factors and usability engineering market.
Additional Insight: A detailed 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.
Market Impact Analysis: The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?
Which are the leading companies in this market?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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1. PREFACE

1.1. Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
1.5. Key Questions Answered
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 COMPETITIVENSS 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. Company A
25.2.1. Company Snapshot
25.2.2. Interview Transcript: Chief Executive Officer and Chair
25.3. Company B
25.3.1. Company Snapshot
25.3.2. Interview Transcript: Founder and Principal
25.4. Company C
25.4.1. Company Snapshot
25.4.2. Interview Transcript: Head of Human Factors
25.5. Company D
25.5.1. Company Snapshot
25.5.2. Interview Transcript: UX Director and Principal UX Designer
25.6. Company E
25.6.1. Company Snapshot
25.6.2. Interview Transcript: Head of Research (Human Factors and Interaction)
25.7. Company F
25.7.1. Company Snapshot
25.7.2. Interview Transcript: Managing Director and Human Factors Consultant

26. APPENDIX I: TABULATED DATA27. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

Accelerate Design
AcKnowledge Regulatory Strategies (acquired by RQM+)
ACMIT
ACMP (acquired by MEDIcept)
Advandes
aesco SOLUTIONS
Agile Medical Device Design
Agilis Consulting (acquired by Kynamox)
altr
American Preclinical Services (acquired by NAMSA)
AnswerLab
Aproio
Aptar Digital Health
ARAC
Aran R&D
Arrotek
Auxergo
Avanti Europe
AYES
Battelle
BAYOOMED
Bergo
Bioexcel
Biotex
BlackHagen Design
BlueBridge Technologies
Blur Product Development
Bold Insight
Boston Engineering
Boston Systems Consulting
Boulder iQ
Bresslergroup (acquired by Delve)
Cambridge Consultants
Cambridge Design Partnership
Capgemini
Carjes Soluciones
Cito Medical
ClariMed
Clinlogix (acquired by NAMSA)
Clinres Farmacija
Cobalt
Cognit
Comate
Concise Engineering
confinis
Consonance
Core Human Factors
Cormica
Creanova
CRI (a part of NAMSA)
Critical Innovations
CRO Kottmann
Crux
CSDmed
Custom Interactions
Custom Medical
D+I
Daedalus
Datum3D
DCA
DDSTUDIO
Delve
Design Psychology
Design Science
Diamond Pharma Services (acquired by ProPharma)
Digital Lab Consulting (acquired by ProPharma)
eg technology
embeX
Emergo (acquired by UL)
Emphysys
End To End User Research
EnMasse Industrial Design
Ergonomics Factory
Ergonomie
Ergosign
ERGOTECH
Eurofins
Eurofins Human Factors MD
Evo Design
Evolution Engineering
Exponent
FactorsNY
Farm, a Flex Company
FITS
Fluortek (acquired by Nordson)
Freudenberg Medical
Frontend.com
Gallant Capital
Garrett Technologies
Gentian Health
Gilero
Giotto.ai
Goddard
Goldschnitt
Greenleaf Health
Greenlight Guru
Harald Quandt (HQIB)
Harvey Medical
Haughton Design
HE Consulting
Healint
Healthcare Human Factors
Healthy Buildings International
Helios Technologies
Human-Factors-Consult (HFC)
HFUX Research
HIGHPOWER Validation Testing & Lab
HirLan
House of HR
HS Design
Human Ability Designs
Human Centred Research
Human design
Human Factors Centre
Human Factors Consulting Services (HFCSI)
Human Factors Engineering
Human Factors International
Human Systems Integration
Hydrix
i3 Product Development
i4 Product Design
ID8 Studio
ihm.gba
Improvita
Indesign

126. Infosys
127. Insight Product Development (acquired by Nemera)
128. Inspired Usability
129. INTAGE Healthcare
130. Interface Analysis Associates
131. Invetech
132. IoN Design

iSafety Systems (acquired by ProPharma)
Johari Digital
Johner Institute
Jonathan Bar-Or Industrial Design
Jordi Labs
Kaleidoscope Innovation
Kapstone Medical
Katalyst Engineering
Kateric (acquired by ProPharma)
KBW (acquired by UL Solutions)
KDA Marktforschung
KDS Medical Engineering
KeyMed Devices
Kickr Design
Kymanox
Libra Medical (acquired by RQM+)
Liv Systems
Loring Human Factors
M Squared Associates (acquired by ProPharma)
Maddison
Maetrics (acquired by RQM+)
MakroCare
Malsen Medical
Manta Product Development
Marble
MAURO Usability Science
Maven Profcon Services
Medanex (acquired by NAMSA)
Meddux
Medical Creative Partners
Medical Design

164. Medical Devices Design
165. Medical Engineering Technologies
166. Medical Human Factors (medHF)
167. Medical Systems Consult
168. MedicalRegs.com

MEDIcept
Medidee
Metaphase Design (acquired by Aptar Pharma)
Milfra (acquired by Nemera)
MindFlow Design (acquired by MPE)
Mixer Design
Movement Industrial Design
MPE
NAMSA
Nectar
Nemera
Noldus Information Technology
Nordson
Oconeo
Odyssey Medical Technologies
Omnica
OneSource Regulatory
Onion Design Studio
Optimum Technologies
Orthogonal
Paramit
Passio
PDD
PDR
PeepalDesign (a part of ReSight Global)
Perfectus Biomed (acquired by NAMSA)
Pharma4ever
Pharmica Consulting (acquired by ProPharma)
Product Creation Studio
Product Insight
ProPharma
Pacific Science & Engineering (PSE)
Psyma
QA/RA Consulting
Qserve
qtec
Quality Systems in Motion (acquired by MEDIcept)
Quasys Consult (acquired by Qserve)
Radius
RBC Medical Innovations (acquired by Vantage MedTech)
Rebus Medical
RED Group International
Red Seed Product Development
Reilly & Associates (acquired by MEDIcept)
Research Collective
ReSight
Rimkus
Root Cause Insights
RQM+
Saegert Solutions
Sage Research + Design
seleon
Sento Solutions
Shandong Weijing Medical
Shore
Sigma Design
SMART-TRIAL (acquired by Greenlight Guru)
Sophic Synergistics
Southwood Research (acquired by ProPharma)
SPEED
Springboard
StarFish Medical
SteriPack
Sterling Medical Devices (acquired by Vantage MedTech)
Strategic Design
Synergy MedTech
Syntactx (acquired by NAMSA)
Synthesize
Syrma SGS
Systems Ally
Tata Elxsi
TE Connectivity
Team Consulting
Team Human
Tecan
Technolution
Tensentric
THAY Medical
The Planet Group
Tigermed-Jyton
Toolbox Innovations (acquired by TE Connectivity)
TS Quality & Engineering
TWC Pharma Consulting
uintent
UL Solutions
Umbrella UX Healthcare
usability.de

USE-Ing.
Use-Lab
uSense
User Centric Design
User Research International
UserWise (a part of ClariMed)
UX Firm
Validant
Vantage MedTech
Velentium
Veranex
Vertex
Viena Medical
VISAMED
Voluntis (acquired by Aptar Pharma)
Warwick Design
Weaver Human Factors Engineering
Weinberg (acquired by ProPharma)
Wickham Micro
WILDDESIGN
Ximedica
XplusX
Ypsomed
zweigrad

Methodology

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