Presentation
Opportunities for the Digitalization of Human Factors Engineering in Medical Product Development
SessionDigital Design
Event Type
Oral Presentations
TimeThursday, June 9th3:00pm - 3:30pm EDT
Location
DescriptionPlease summarize your topic, application, background, and overview of presentation, etc. You should focus on the importance of message and take away points.
Since computers were introduced into the mainstream, they have helped human factors specialists do their work. The simplest example is the computer-based literature search. Several computer-based mannequins have facilitated anthropometric analyses. Other models have been used to predict human performance or physical and cognitive tasks. So, computer-assisted human factors is nothing new. However, how have they assisted the application of human factors in the development of safe, effective, and usable medical products?
This presentation will cite examples where computers, and more specifically software applications, have contributed to the work of HF specialists working in the medical industry. However, the examples will be few in number because the work has remained quite dependent on the knowledge of the specialists and largely manual execution of tasks, such as known problems analysis and root cause analysis. On this basis, the presenters will declare that there is large, unmet need within the HF/Medical community.
To be clear, we will not suggest that a software application that helps with the application of HF can or should replace the HF specialists. Rather, we will spotlight a future that is almost certain to see HF specialists using software tools to structure their work in a manner that drives higher quality, efficiency, and reliability that suits working in a regulated industry.
The presenters will disclose their continuing role in the development of such software, which was recently released by UL under the tradename OPUS™. With care not to make their presentation a commercial pitch for OPUS, they will describe the application’s basic capabilities, but then speak about opportunities for OPUS and applications developed by other sources to take things further in the spirit of digitalization for the benefit of HFE specialists and their important work, not to undermine the need for the specialist.
Regarding OPUS™ and other applications of its kind, the presenters will spotlight the current and future value of software features including the following ones:
• User-paced, online training to apply HF to medical products in a manner that satisfies regulatory bodies around the world.
• Consolidated set of regulatory requirements from various government sources.
• Creation of an HF project plan that includes all necessary HFE activities and scales them appropriately to the product under development.
• Access to a library of user profiles, use environment descriptions, and user interface requirements (aka user requirements)
• Assistance with use-related risk analysis, including task analysis, hazard analysis, and known problems analysis.
• Assistance with planning a comprehensive usability test and determining the root cause(s) of use errors that occur during testing.
• Guidance on the structure and content of various HF reports.
• Tools that facilitate and evaluate user interface design, such as one that helps size text and evaluates its contrast against a given background to ensure its legibility.
The presenters will conclude by describing a future when HF specialists have the kind of digital tools that have advanced the work of professionals working in other fields. They will describe a future that enables HF specialists to focus on the creative and generative aspects of HF, and not struggle with strictly manual approaches to tasks that produce arguably flawed results, a good example being a manual review of known problems reported in the FDA’s MAUDE database.
Disclosure: UL plans to launch the first version of OPUS™ in the fourth quarter of 2021, with updated versions to follow. OPUS™ has been a 2-year development effort to digitalize aspects of HF as it is applied in the development of medical products. HF professionals have already had access to software products, such as IHF-SaaS and UsabilityHub for years.
Since computers were introduced into the mainstream, they have helped human factors specialists do their work. The simplest example is the computer-based literature search. Several computer-based mannequins have facilitated anthropometric analyses. Other models have been used to predict human performance or physical and cognitive tasks. So, computer-assisted human factors is nothing new. However, how have they assisted the application of human factors in the development of safe, effective, and usable medical products?
This presentation will cite examples where computers, and more specifically software applications, have contributed to the work of HF specialists working in the medical industry. However, the examples will be few in number because the work has remained quite dependent on the knowledge of the specialists and largely manual execution of tasks, such as known problems analysis and root cause analysis. On this basis, the presenters will declare that there is large, unmet need within the HF/Medical community.
To be clear, we will not suggest that a software application that helps with the application of HF can or should replace the HF specialists. Rather, we will spotlight a future that is almost certain to see HF specialists using software tools to structure their work in a manner that drives higher quality, efficiency, and reliability that suits working in a regulated industry.
The presenters will disclose their continuing role in the development of such software, which was recently released by UL under the tradename OPUS™. With care not to make their presentation a commercial pitch for OPUS, they will describe the application’s basic capabilities, but then speak about opportunities for OPUS and applications developed by other sources to take things further in the spirit of digitalization for the benefit of HFE specialists and their important work, not to undermine the need for the specialist.
Regarding OPUS™ and other applications of its kind, the presenters will spotlight the current and future value of software features including the following ones:
• User-paced, online training to apply HF to medical products in a manner that satisfies regulatory bodies around the world.
• Consolidated set of regulatory requirements from various government sources.
• Creation of an HF project plan that includes all necessary HFE activities and scales them appropriately to the product under development.
• Access to a library of user profiles, use environment descriptions, and user interface requirements (aka user requirements)
• Assistance with use-related risk analysis, including task analysis, hazard analysis, and known problems analysis.
• Assistance with planning a comprehensive usability test and determining the root cause(s) of use errors that occur during testing.
• Guidance on the structure and content of various HF reports.
• Tools that facilitate and evaluate user interface design, such as one that helps size text and evaluates its contrast against a given background to ensure its legibility.
The presenters will conclude by describing a future when HF specialists have the kind of digital tools that have advanced the work of professionals working in other fields. They will describe a future that enables HF specialists to focus on the creative and generative aspects of HF, and not struggle with strictly manual approaches to tasks that produce arguably flawed results, a good example being a manual review of known problems reported in the FDA’s MAUDE database.
Disclosure: UL plans to launch the first version of OPUS™ in the fourth quarter of 2021, with updated versions to follow. OPUS™ has been a 2-year development effort to digitalize aspects of HF as it is applied in the development of medical products. HF professionals have already had access to software products, such as IHF-SaaS and UsabilityHub for years.