$1.97 Bn Human Factors and Usability Engineering Services Market Industry Trends and Global Forecasts, 2035 - Competitive Landscape Heats Up with Surge in Mergers and Acquisitions

Dublin, March 25, 2025 (GLOBE NEWSWIRE) -- The "Human Factors and Usability Engineering Services Market Industry Trends and Global Forecasts to 2035, 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 estimated to grow from USD 0.94 billion in the current year to USD 1.97 billion by 2035, at a CAGR of 6.9% during the forecast period, till 2035.

Over the years, human factors and usability engineering have become an integral part of the development of all classes of medical devices. As a result, the developers have actively started relying on the service providers for conducting human factors research for their devices (in development) in order to enhance device safety, efficacy and user experience.

As medical devices become more complex, it is imperative to focus on the prototype and user interface design so as to minimize any potential risk associated with the use. Further, regulatory bodies (especially, the USFDA) are increasingly mandating the incorporation of human factors into the design and evaluation of medical devices. These bodies have started to employ a systematic method to assess manufacturers' adherence to usability engineering standards.

The emphasis on human factors and usability engineering in the medical device sector reflects a broader commitment to patient safety and device usability. This potentiates the need to conduct human factors and usability engineering on the devices throughout the product lifecycle (rather than conducting at later stages of development). This will support the device developers in timely facilitating the tweaks in the device development process so as to enable user satisfaction and eliminate risks. With the growing demand for innovative and personalized medical devices, the outsourcing of human factors and usability engineering services is anticipated to rise in the near future.

Human Factors and Usability Engineering Services Market: Key Segments

Currently, Summative Studies Account for 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

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.

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 6.9% in the coming decade.

Some Key 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, ClariMed
• Managing Director and Human Factors Consultant, THAY Medical
• Head of Human Factors, Cambridge Design Partnership
• Head of Research (Human Factors and Interaction), DCA
• UX Director and Team Manager, Ergosign

Key Topics Covered:

1. Preface
2. Research Methodology
3. Market Dynamics
4. Economic And Other Project Specific Considerations
5. Executive Summary
6. Introduction
7. Regulatory Guidelines For Human Factors And Usability Engineering
8. Market Landscape
9. Company Competitiveness Analysis
10. Company Profiles: Service Providers In North America
11. Company Profiles: Service Providers In Europe
12. Company Profiles: Service Providers In Asia-Pacific
13. Mergers And Acquisitions
14. Cost Implications Related To Human Factors And Usability Engineering Process
15. Case Study: Medical Device Recalls And Role Of Human Factors And Usability Engineering
16. Human Factors And Usability Engineering Services Market: Ongoing Megatrends
17. Market Impact Analysis
18. Global Human Factors And Usability Engineering Services Market
19. Human Factors And Usability Engineering Services Market, By Steps Involved
20. Human Factors And Usability Engineering Services Market, By Type Of Research Method
21. Human Factors And Usability Engineering Services Market, By Class Of Medical Device Tested
22. Human Factors And Usability Engineering Services Market, By Geographical Regions
23. Human Factors And Usability Engineering Services Market, By Leading Players
24. Conclusion
25. Executive Insights
26. Appendix I: Tabulated Data
27. Appendix II: List Of Companies And Organizations

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 10% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older

For more information about this report visit https://www.researchandmarkets.com/r/ma4rw

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Attachments

• HF and Usability Engineering Market
• HF and Usability Engineering Providers

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