Risk ManagementUsabilityUX & Human Factors

Elevating User Safety in Medical Devices with IEC 62366-1 and Related Standards

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IEC 623661 Essentials: Elevating User Safety in Medical Devices

When developing a medical device, user safety is an aspect that must not be overlooked. Usability engineering, also known as human factors engineering, plays a crucial role in mitigating the use-related risks.

IEC 62366-1 is an essential document for integrating this discipline into the medical device development process. It coexists with other standards that complement and reinforce the regulatory framework for developing and bringing medical products to market.

What is the regulatory framework for medical device development?

What are the standards and guidelines for usability engineering?

In a recent webinar in partnership with Greenlight Guru, Senior Human Factors Specialist Maude Leclerc-De Guire and Quality Assurance Manager Jean-Yves Pairet addressed these questions to help provide clearer insights.

At CLEIO, their teams collaborate closely to develop medical devices that not only meet user expectations but also comply with regulatory requirements.

The Regulatory Framework for Medical Device Development

A Regulatory Framework that Evolves with Medical Innovations

The regulatory landscape faces the challenge of keeping pace with the innovations that are transforming the healthcare sector. With the introduction of new technologies, medical devices have become more intelligent and autonomous, yet they also feature more complex interfaces.

Additionally, the rise of at-home care has placed patients as the primary users. Consequently, devices must be sufficiently intuitive for non-professional caregivers and patients managing their own care, thereby minimizing use-related risks.

That’s why current regulations require a meticulous design process and rigorous testing from medical device manufacturers. In particular, they are committed to conducting thorough evaluations of the safety, efficacy and usability of their products to meet the stringent requirements of these regulations.

Applicable Standards for Medical Device Development

Navigating the regulatory compliance landscape for medical device development is no easy task. As standards and regulations evolve rapidly, it’s understandable to feel overwhelmed by the volume and complexity of guidelines to consider.
To help you find your way, here are some essential standards:

ISO 13485

This standard forms the foundation of the quality management system (QMS) for organizations that develop medical devices. It guides operational processes and ensures that practices adhere to quality requirements throughout the development cycle.

21 CFR Part 820

This regulation outlines the FDA’s Quality Management System (QMS) requirements. It describes the best practices that medical device manufacturers in the USA must follow regarding their QMS.

ISO 14971

This standard provides a robust framework for identifying, analyzing, and controlling potential risks associated with medical devices. It enables the development of a comprehensive risk management strategy that meets the regulatory expectations of various target territories.

Depending on the specific characteristics of the medical device, a range of other standards and guidelines may come into play. 

For example, IEC 62304 is essential for defining software lifecycle processes, while standards such as IEC 60601 and ISO 10993-1 are crucial for ensuring safe design and mitigating risks associated with mechanical, electrical, and biocompatibility aspects, respectively.

Key Standards and Guidelines for Usability and Human Factors Engineering

Human Factors Engineering: What Is It?

Usability engineering, also known as human factors engineering, plays an essential role in the design and development of medical devices. This discipline evaluates the extent to which a product can be used by specific users to achieve specific objectives effectively, efficiently, and satisfactorily in real-life use scenarios.

This understanding forms the basis for integrating usability into the product development process, particularly from a regulatory perspective.
Early involvement of usability and human factors specialists enables the identification and mitigation of potential usability problems well before they become costly or complex. This proactive approach fosters the product’s commercial success and user acceptance.
“The quality of a medical device is not measured by its functionality alone. It must also be efficient, clinically effective, safe, reliable, and compliant with regulations. All without compromising user satisfaction through an optimized user experience.”

Maude Leclerc-De Guire
Senior Human Factors Specialist at CLEIO

Applicable Standards for Usability Engineering

Standards establish a robust regulatory pathway that guides manufacturers in creating medical devices that not only meet clinical needs but also enhance the overall user experience. This ensures that devices are accessible, safe, and effective for all intended users.

The IEC 62366-1 Standard

This standard is specifically designed for the application of usability engineering to medical devices. It provides key regulatory guidance and defines a framework for identifying and mitigating usability risks throughout the product life cycle.
Complementarily, the IEC 62366-2 technical report offers additional insights and guidance on how to effectively apply the principles of usability engineering.

The AAMI HE75 Standard

The AAMI HE75 standard offers a more in-depth exploration at the intricacies of human factors engineering. This comprehensive document extends beyond basic requirements, providing detailed information on the tools and methods needed to enhance the usability of medical devices.

FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)"

For medical devices intended for the US market, specific regulatory guidelines must be followed. The FDA’s final guidance from 2016 on applying human factors and usability engineering to medical devices is essential for manufacturers.
This guidance provides comprehensive information on integrating usability engineering throughout the design and development process.
Depending on the device and its intended environment of use, additional standards and guidelines may apply. This is particularly true for home-use devices or drug-device combination products.

Usability Engineering Focuses on Use-Related Risks

Usability engineering aims to minimize use-related risks, which are often at the heart of problems involving user interaction with medical devices. A primary concern of IEC 62366-1 is addressing use errors. As defined by the standard, “A use error is an incorrect or omitted action by the user that results in a different outcome than the manufacturer’s intent or the user’s expectation”.

There are three sources of use errors:
The user has difficulty seeing or interpreting the visual information on the medical device.
The user forgets how to perform specific operations or fails to understand instructions.
The user is physically unable to execute the necessary commands due to limitations in the device’s design (e.g., buttons too small).
Note that a single use incident may involve multiple sources of error. By identifying their underlying causes, it is possible to explore strategies aimed at mitigating the severity of the risks.
The regulatory framework for usability engineering emphasizes the importance of adopting a thorough and proactive approach to human factors in the development of medical devices to reduce use-related risks.

The key question is how to integrate the activities recommended by IEC 62366-1 into the development process. This is what our two experts discuss in the second part of the webinar, available soon.


10 things you need to know about IEC 62366-1 for Medical Device Development

Stop making costly Medical Device Development mistakes! 💥 Increased development times, improved sales, higher user satisfaction, those are just a few of the benefits of applying IEC 62366-1. Download our free guide made by experts.

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