HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: OVERVIEW
As per Roots Analysis, 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.
The market sizing and opportunity analysis has been segmented across the following parameters:
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
Key Geographical Regions
- North America (US, Canada)
- Europe (Germany, France, Italy, Switzerland, UK, Rest of
the Europe)
- Asia-Pacific (China, Japan, Australia, India, Rest of Asia-Pacific)
- Middle East and North Africa Latin America
HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: GROWTH AND TRENDS
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 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.
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
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. 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.
Example 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
HUMAN FACTORS AND USABILITY ENGINEERING SERVICES MARKET: RESEARCH COVERAGE
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the human factors and usability engineering services market, focusing on key market segments, including [A] steps involved, [B] type of research method, [C] class of medical device tested, and [D] geographical regions.
- Market Landscape: A comprehensive evaluation of human factors and usability engineering service providers, considering various parameters, such as [A] year of establishment, [B] company size (in terms of employee count), [C] location of headquarters, [D] type of service offered, [E] concept phase, [F] design and development, [G] verification and validation testing, [H] type of medical devices tested, [I] medical device users and [J] software engineering offered.
- Regulatory Landscape Analysis: A discussion on general regulatory guidelines established and issued by major regulatory bodies for medical device approval. In addition, it features a brief description of human factors and usability engineering process followed by regulatory bodies in the US and the EU, their comparison and a common approach that can be adopted to satisfy guidelines issued by authorities of the aforementioned regions.
- Company Competitiveness Analysis: A comprehensive competitive analysis of service providers engaged in the human factors and usability engineering market, examining factors such as [A] company strength and [B] portfolio strength.
- Company Profiles: In-depth profiles of key human factors and usability engineering service providers based in North America, Europe and Asia-Pacific, focusing on [A] company overviews, [B] service portfolio, [C] recent developments and [D] an informed future outlook.
- Mergers and Acquisitions: A comprehensive examination of the various mergers and acquisitions, focusing on multiple relevant parameters, including [A] year of agreement, [B] type of agreement and [C] geographical location of the companies.
- Case Study: The chapter discusses medical device recalls, focusing on the yearly trends in recalls and the potential underlying causes. It also highlights the top five medical device recalls and suggests strategies for incorporating human factors and usability engineering into medical devices to minimize errors and decrease the frequency of recalls.
- Mega Trends: A qualitative assessment of the various megatrends ongoing in the human factors and usability engineering market.
- Additional Insight: A detailed 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.
- Market Impact Analysis: The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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