Strategies For Accommodating User Diversity in Medical Device Design

17-Jan-2025

The FDA has developed this guidance document in order to guide the industry in performing appropriate human factors engineering and usability engineering processes and thereby maximize the likelihood that the new devices will be both safe and effective for the proposed users, uses, and use environments. The intent of this draft guidance is for manufacturers to do better design regarding devices so they can reduce risks of potential usage errors and eventual harm. The FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with the use of medical devices.

This guidance advises the use of human factors engineering or usability engineering processes when developing new medical devices, paying particular attention to the user interface, which the user interface encompasses all points of interaction between the product and the user(s), including, for example, displays, controls, packaging, product labels, instructions for use, etc. While following these processes may be helpful to optimize user interfaces in other respects (e.g., maximizing ease of use, efficiency, and user satisfaction), the FDA is primarily concerned that devices are safe and effective for the intended users, uses, and use environments. The goal is to ensure that the device user interface has been designed such that use errors that occur during the use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible.

This has been one of the findings from studies into the healthcare sector where it emerged that most of the medical errors came from bad design of systems and not mistakes made by human beings. This led to applying human factors engineering and usability engineering into the design of medical devices such that products created can inherently minimise risks of error occurrences. Consequently, patient health will be guaranteed. This approach is essential in any system where human interaction with machines or software is involved, with the ultimate goal of enhancing functionality by aligning with human capabilities and limitations.

Human factors and usability engineering form an essential basis when applied to medical devices in the development of medical software. This procedure, based on FDA usability guidance, integrates with medical device software and ultimately dictates the outcomes in terms of patient safety and financial performance. In the following, we discuss several reasons for the importance of human factors and usability engineering in software as medical devices.

Improve user experience.

Usability becomes a cornerstone of the development process for SaMD. Human factors and usability engineering principles are applied to enhance the user-friendliness, efficiency, and error minimization of the medical software. This approach follows user-centered design through ongoing user feedback, iterative testing, and continuous refinement. Intuitive interfaces and clear instructions leading to streamlined workflows result in the final product as an enhanced user experience.

Improving patient safety

Human factors and usability engineering in the development of medical devices, particularly in software as a medical device (SaMD), are key factors in patient safety. The process includes the design and development of medical software based on knowledge of the end-users' needs, capabilities, and limitations. Focusing on human factors such as cognitive ability and physical limitation, designing intuitive interfaces and workflows, and therefore optimising SaMD for safe and effective use would prevent adverse events and improve patient outcomes.

Minimizing user error

Human error is the leading cause of healthcare-related adverse events. The application of human factors and usability engineering to medical devices is aimed at identifying potential user errors in SaMD and designing the software in a way that minimises the risks. Such strategies include intuitive navigation, clear visual cues, and effective feedback mechanisms, helping users make decisions and reduce the chances of error.

Regulatory compliance

Regulatory compliance, especially FDA standards, plays a critical role in the application of human factors and usability engineering to medical devices. Following the FDA's guidance on this subject is necessary for market access. Compliance ensures that developers of SaMD take into account human factors from the very early stages of development and carry out deep usability evaluations in keeping with regulatory expectations and enhancing the quality of the overall device.

In the Software as a Medical Device (SaMD) sector, the integration of human factors and usability engineering is essential for ensuring that medical software is both safe and effective. By comprehensively understanding user needs and capabilities, streamlining workflows, and reducing usage errors, developers can significantly improve patient safety, enhance user efficiency, and boost overall user satisfaction.