The human factors engineering and usability testing services market for medical devices is projected to reach USD 1 Bill

London

Roots Analysis has announced the addition of “Human Factors Engineering 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.

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.

By 2030, the market is anticipated to be worth close to USD 1 billion, growing at an annualized rate of 14.2%.

Based on the revenues generated from different services for usability testing, currently, the maximum share is expected to be generated through evaluative testing methodologies (61%), followed by generative testing methodologies (39%).

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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?

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

The research covers profiles of key players (mentioned below) that offer human factors engineering and usability testing services for medical devices; each profile features an overview of the company, details related to its human factors engineering and usability testing portfolio, recent developments and an informed future outlook.