Human Factors and Usability Engineering Services Market (2nd Edition), Industry Trends and Global Forecasts, till 2035

Human Factors and Usability Engineering Services Market (2nd Edition), Industry Trends and Global Forecasts, till 2035

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