Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030

NEW YORK, Oct. 8, 2020 /PRNewswire/ --

INTRODUCTION
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.

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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 op 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.

SCOPE OF THE REPORT
The "Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030" report features an extensive study on the current market landscape and future opportunities for service providers focused on human factor engineering and usability testing of medical devices. The study also includes an in-depth analysis, highlighting the capabilities of various service providers engaged in this market. Amongst other elements, the 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.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the HFE and usability testing services market for medical devices. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, for the period 2020-2030. The 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 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 this domain.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The 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 report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice, and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various technological and non-commercial trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED
- Who are the leading players providing human factors engineering and usability testing services to medical device developers?
- What is the cost associated with different steps of the human factors engineering and usability testing process for medical devices?
- What kind of cost savings can be achieved through the adoption of the human factors engineering and usability testing approach for medical device development?
- In the past, how has the adoption of human factors engineering and usability testing approaches impacted medical device recall rates?
- How do the guidelines for human factors engineering and usability testing for medical devices, differ across key global regions?
- What are the prevalent and emerging trends within the human factors engineering and usability testing service providers market?
- How is the recent COVID-19 pandemic likely to impact human factors engineering and usability testing services market?
- How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the HFE and usability testing service providers for medical devices and its likely evolution in the short-mid and long terms.

Chapter 3 provides a general overview of HFE and usability testing, along with information on ergonomics and hedonomics of medical devices. Further, it includes a detailed discussion on the overall HFE and usability testing process. The chapter also features a brief discussion on the benefits and risks associated with outsourcing HFE and usability testing operations to third-party service providers. In addition, it provides information related to the various factors that need to be considered while selecting a suitable HFE and usability testing service provider.

Chapter 4 provides a brief overview on the various regulatory guidelines that have been laid down by major regulatory bodies across different geographical regions, namely North America and Europe, for human factors and usability engineering. In addition, it features insightful and schematic representations with brief descriptions of HFE processes followed by regulatory bodies in the EU and the US, their comparison and a common approach that can be adopted to satisfy guidelines issued by authorities of the aforementioned regions.

Chapter 5 includes a detailed market landscape analysis of companies offering HFE and usability testing services. It includes information related to over 90 companies that are actively involved in providing HFE and usability testing services, presenting detailed analyses on the basis of the 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 provided (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). It further includes details on companies that offer HFE and usability testing services for medical device software.

Chapter 6 presents a company competitiveness analysis of the 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. The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups (region-wise) and identify opportunities to achieve a competitive edge in the industry.

Chapter 7 features detailed profiles of key players providers (shortlisted on the basis of the number of services offered) that specialize in providing services for HFE and usability testing to medical device developers. Each profile features an overview of the company, its service portfolio, and an informed future outlook.

Chapter 8 presents a detailed discussion on the cost implications across various steps of the HFE and usability testing process, namely contextual inquiry, task analysis, human factors in design, formative studies, risk analysis, use error analysis, summative studies, agency submission preparation, and the cost requirements across each of the aforementioned stages.

Chapter 9 presents a discussion on medical device recalls, including a year wise trend of device recalls and the possible underlying causes for the same. Further, the chapter provides details of the top ten medical device recalls (based on the number of units recalled) and strategies on how to implement HFE and usability testing so as to prevent those errors and reduce the number of recalls. Furthermore, it also presents an overview of the cost saving potential of human factors engineering and usability testing approach in the medical device development process.

Chapter 10 presents an insightful market forecast analysis, highlighting the growth of the HFE and usability testing service providers market till 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] type of tools used in HFE and usability testing (generative and evaluative tools), [B] type of steps involved in 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).

Chapter 11 highlights the effect of coronavirus outbreak on the human factors engineering and usability testing service providers industry. It includes a brief discussion on the short-term and long-term impact of COVID-19 upsurge on the market opportunity for device developers and usability testing service providers. In addition, it includes a brief section on strategies and action plans that these service providers are likely to adopt in the near future.

Chapter 12 provides a discussion on affiliated trends, key drivers, and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall human factor engineering and usability testing market for medical devices.

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of the HFE and usability testing service providers.

Chapter 14 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interview(s) held with Daniel Jenkins (Research Lead of Human Factors and Usability, DCA Design International) and Greg Thay (Managing Director, THAY Medical).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which contains a list of companies and organizations mentioned in this report.

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