Human factors engineering and usability testing have now become an essential part of product design across almost all industries, offering developers the chance to optimize proprietary products in alignment to the preferences of consumers


Roots Analysis has announced the addition of “Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030” report to its list of offerings.

Given the growing regulatory stringency, there are a number of medical devices recalls reported each year. Moreover, as such solutions are gradually becoming increasingly complex, it is imperative to identify potential risks / hazards, in order to guarantee safety to end users post product launch. This has led many device developers to resort to human factors engineering and usability testing. However, the aforementioned processes require specialized resources and expertise. Therefore, outsourcing this aspect of product design and development, has become common among industry stakeholders.

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Key Market Insights

Around 105 companies / organizations claim to be engaged in offering human factors engineering and usability testing services for medical devices
It is worth noting that this market is currently dominated by the presence of small players (2 to 50 employees), which represent more than 67% of the players. Further, more than 50% of the firms engaged in providing human factors engineering and usability testing services were established post 2000.

Majority (57%) of the players engaged in this domain offer services for hospital / laboratory equipment and instruments
Various companies (53%) engaged in this domain claim to offer human factors engineering and usability testing services for diagnostic devices, followed by those providing support for drug delivery devices (44%), home use medical devices (36%), clinical use devices (26%) and therapeutic devices (25%).

More than 90% companies provide design and development services for medical devices
Currently, over 80 players provide services for prototype design and development, while almost 70 firms offer services for interface development. In addition, 83% service providers offer verification and validation services; of these 65% players provide services for both formative testing and summative testing.

Implementation of human factors engineering and usability testing, at initial stages of device design and development, has been demonstrated to enable significant cost savings
We believe that, by 2030, an increase in adoption (up to 41%) of human factors engineering and usability testing services for medical devices is likely to be observed, resulting in savings worth USD 1.4 billion. Incorporation of such novel approaches is also anticipated to help developers in achieving high return on investments, in the range between 5:1 to 9:1.

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The USD 1 Billion (by 2030) financial opportunity within the human factors engineering and usability testing service providers market has been analysed across the following segments:
 Type of tools used
 Generative tools
 Evaluative tools

 Steps involved
 Contextual analysis
 Task analysis
 Design analysis
 Formative studies
 Use risk analysis
 Known use error analysis
 Summative studies
 Regulatory document preparation

 Device class
 Class I
 Class II
 Class III

 Key geographical regions
 North America
 Europe
 Asia Pacific

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About Roots Analysis
Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at [email protected]

Contact Information
Roots Analysis Private Limited
Gaurav Chaudhary
+1 (415) 800 3415
[email protected]
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