The "Human Factors and Usability Engineering Services Market Industry Trends and Global Forecasts to 2035: Distribution by Steps Involved, Type of Research Method, Class of Medical Device Tested, Geographical Region and Leading Players" report has been added to ResearchAndMarkets.com's offering.

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, 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.

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, location of headquarters, type of service offered, concept phase, design and development, verification and validation testing, type of medical devices tested, medical device users 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 and portfolio strength.
• Elaborate profiles of prominent companies in the human factors and usability engineering service domain 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 Companies Profiled

Key companies in the Human Factors and Usability Engineering Services Market include:

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

Key Topics Covered:

1. PREFACE

2. RESEARCH METHODOLOGY

3. MARKET DYNAMICS

4. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

4.1. Chapter Overview

4.2. Market Dynamics

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

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

10. COMPANY PROFILES: SERVICE PROVIDERS IN NORTH AMERICA

• ClariMed
• Aptar Digital Health
• Bold Insight
• Greenlight Guru

11. COMPANY PROFILES: SERVICE PROVIDERS IN EUROPE

• Bayoomed
• AYES
• Comate

12. COMPANY PROFILES: SERVICE PROVIDERS IN ASIA-PACIFIC

• Hydrix
• D+I
• Invetech
• Johari Digital

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

13.4. 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

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

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

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

19.4. Penetration-Growth (P-G) Matrix

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

20.4. Penetration-Growth (P-G) Matrix

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

21.4. Penetration-Growth (P-G) Matrix

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

22.4. Market Movement Analysis

22.5. Penetration-Growth (P-G) Matrix

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

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