Human Factors Usability Testing Market

Human Factors Usability Testing Market by Type of Tools, Steps Involved, Device Class and Key Geographical Regions: Industry Trends and Global Forecasts, 2020-2030

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Human Factors Usability Testing Market Overview

The human factors usability testing market is estimated to be worth $267 million in 2020 and is expected to grow at CAGR of 14.2% during the forecast period. Over the years, technological advancements have enabled the development of a variety of versatile medical devices, offering various specialized features, for various drug delivery and disease management applications. In fact, there are a number of devices that are designed for use by patients themselves. It is, therefore, crucial for device developers to ensure that their products are not only easy-to-use, but also safe, posing minimum risks to users who lack medical training. Errors in product design can lead to dosing inaccuracies, incorrect measurement of critical health parameters and, in the process, cause serious injuries (some of which may even prove to be fatal). It is estimated that every year, close to 400,000 hospitalized patients report having experienced some kind of preventable injury, a large proportion of which may be attributed to medical device related errors. A study conducted at John Hopkins University reported that 15% of fatalities caused due to medical errors in the US, are attributed to medical device user interface related concerns. Further, close to 17% of the medical devices are recalled on an annual basis, owing to concerns related to poor design. In this context, it is worth stating that a major device recall has been shown to severely impact the reputation of its developer, causing up to 10% decline in share value. Therefore, stakeholders in the medical device industry are known to undertake elaborate initiatives, across the various stages of development, in order to ensure product safety. This includes detailed assessment of key human factors and product usability.

Human factors engineering (HFE) and usability testing involves the evaluation of the potential applications of medical devices in the real-world setting, taking into account all possible influences / parameters related to product use. This approach has been demonstrated to provide a number of benefits when implemented at the appropriate stages of device development. The identification of critical design flaws and anticipated user interface-related concerns early during the prototype stage, allows developers to improve and optimize the product, as well as ensure the safety of end users. Given that medical devices are becoming increasingly complex, it is often hard for developers to stay up to date with evolving real-world parameters (human factors) and regulatory standards. Moreover, several stakeholders in this domain lack the required resources and capital to conduct detailed HFE and usability testing studies. This has led to the establishment of an elaborate contract services market catering to the HFE and usability testing needs of medical device developers. As the demand for novel and more personalized medical devices grows, outsourcing of HFE and usability testing operations is anticipated to increase as well. This trend is likely to present lucrative opportunities to the CROs that claim to have expertise in this field.

This image highlights the context of Human Factors Engineering Market report. Human factors and usability engineering has contributed to remarkable improvements in medical device design and quality; however, the complexities associated with the testing process have caused many innovator firms to outsource this operation This image highlights the geographical distribution of HFE and Usability Testing Service Providers. Over time, a number of medical devices have been recalled due to various reasons; therefore, presently, HFE and usability testing is being perceived as a fundamental necessity in order to drive product development efforts This image provides list of HFE and Usability Testing Service Providers for Medical Devices. Currently, more than 90 companies claim to offer human factors engineering and usability testing services, catering to needs across different stages of the medical device development process

Key Companies in Human Factors Usability Testing Market 

Examples of key companies engaged in human factors usability testing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Agilis, Human Factors Consulting Service, Human Factors MD, User wise, Ximedica, Austrian Center for Medical Innovation and Technology (ACMIT), Auxergo, THAY Medical, Ergotech and Jonathan Bar-Or Industrial Design. This market report includes an easily searchable excel database of all the companies providing human factors engineering and usability testing services, worldwide.

Scope of the Report

The “Human Factors Usability Testing Market for Medical Devices, 2020-2030” market report features an extensive study on the current market landscape, market size, market share, market growth, market forecast, market outlook and future opportunities of the human factors usability testing market. The market research report also includes an in-depth analysis, highlighting the capabilities of various service providers engaged in human factors usability testing market. Amongst other elements, the market research report includes:

  • A detailed assessment of the current market landscape of companies offering HFE and usability testing services based on several relevant parameters, including developer information (year of establishment, company size and location of headquarters), types of certifications obtained, types of HFE services offered in the concept phase (user research and use error risk analysis and management), design and development phase (prototype development and designing and interface development and designing),  verification and validation phase (usability inspection, formative studies / usability verification, pre-validation testing / clinical trial, and summative studies / usability validation) and documentation / file compilation phase, types of other services offered (regulatory guidance, packaging and labeling, training and post market surveillance) and types of medical devices designed by the company (drug delivery devices, clinical use / care devices, diagnostic devices, therapeutic devices, home use medical devices and different laboratory and surgical equipment). 
  • A detailed company competitiveness analysis of HFE and usability testing service providers, taking into consideration the supplier power (based on the year of establishment of developer) and other key specifications (such as core services offered, other services offered and types of medical devices designed) of players.
  • An elaborate discussion on the various guidelines established by major regulatory bodies, governing medical device HFE and usability testing services, across different regions. 
  • A detailed discussion on the cost implications across various steps of the HFE and usability testing process.
  • Profiles of HFE and usability testing service providers (shortlisted on the basis of the number of services offered), featuring an overview of the company, details related to their HFE and usability testing service portfolio and an informed future outlook.
  • A discussion on important industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall HFE and usability testing services market. 

The key objective of human factors usability testing market report is to provide a detailed market analysis in order to estimate the existing market size, market trends, market value, statistics and future opportunity for human factors usability testing market during the forecast period. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, for the forecast period 2020-2030. The market report also provides details on the likely distribution of the current and forecasted opportunity across [A] different types of tools used for HFE and usability testing (generative and evaluative tools),  [B] types of steps involved in the usability testing process (contextual analysis, task analysis, design analysis, formative studies, use risk analysis, known use error analysis, summative study and submission preparation), [C] device class (class I, class II and class III), [D] company size (small, mid-sized and large) and [E] key geographical regions (North America, Europe, and Asia Pacific and rest of the world). In order 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 evolution. In addition, the market research report discusses the impact of the recent COVID-19 pandemic on the global HFE and usability testing services market for medical devices, along with providing details related to the future market opportunity for service providers engaged in human factors usability testing market. 

This image presents current market landscape of HFE and Usability Testing Service Providers. The market landscape is highly fragmented, featuring the presence of several well-established players and new entrants, many of which have varied service portfolios, focused on different types of medical devices This image highlights competitive analysis of players engaged in the domain of Human Factors Engineering. Players involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and gain an advantage over competitor firms This image highlights the market segments of HFE and Usability Testing Service Providers. As device developers continue to rely on specialty service providers for critical inputs on device design, the HFE and usability testing services market is anticipated to register double digit growth in the long term

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order):

  • Daniel Jenkins (Research Lead of Human Factors and Usability, DCA Design International)
  • Greg Thay (Manager, THAY Medical)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is human factors engineering?

Answer: Human factors engineering (HFE) involves the evaluation of the potential applications of medical devices in the real-world setting, taking into account all possible influences / parameters related to product use.

Question 2: How big is the human factors usability testing market?

Answer: The human factors usability testing market size is estimated to be worth $267 million in 2020.

Question 3: What is the projected market growth of the human factors usability testing market?

Answer: The human factors usability testing market is expected to grow at compounded annual growth rate (CAGR) of 14.2% during the forecast period 2020 – 2030.

Question 4: Who are the leading companies in the human factors usability testing market?

Answer: Examples of key companies engaged in human factors usability testing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Agilis, Human Factors Consulting Service, Human Factors MD, User wise, Ximedica, Austrian Center for Medical Innovation and Technology (ACMIT), Auxergo, THAY Medical, Ergotech and Jonathan Bar-Or Industrial Design.

Question 5: What are the advantages of human factors engineering?

Answer: Human factors engineering has been demonstrated to provide a number of benefits when implemented at the appropriate stages of device development. The identification of critical design flaws and anticipated user interface-related concerns early during the prototype stage allows developers to improve and optimize the product, as well as ensure the safety of end users.

Question 6: How many companies are currently engaged in the human factors usability testing market?

Answer: More than 90 companies are currently engaged in the human factors usability testing market, offering human factors engineering and usability testing services for a range of medical devices.

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