Human Factors in the QMS: Integrating Usability into Your Quality Design Controls

IN COLLABORATION WITH: NIKHIL MANGALE: VP OF QUALITY and RYAN LEWIS: HUMAN FACTORS SPECIALIST

Introduction

For medical device startups, the path to market is often managed through a phase-gate approach: engineering the prototype, securing funding, and navigating the regulatory requirements. However, there is a critical intersection where these paths meet. This is the point where your device meets its human user.

Integrating Human Factors Engineering (HFE), also called Usability Engineering (UE), into your Quality Management System (QMS) is no longer just a "nice-to-have". With the FDA’s transition to the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016, the expectation is clear: safety and effectiveness must be proven through the lens of human interaction.

Key Takeaways:

• Human Factors (HF) is a Regulatory Requirement: Under the new FDA Quality Management System Regulation (QMSR) and ISO 13485, HF is not optional; it is a critical component of Design Controls.
• Risk Mitigation via Design: Integrating Usability Engineering (UE) early reduces use-related hazards, preventing costly late-stage redesigns and ensuring patient safety.
• Vertical Integration Advantage: Utilizing an integrated "single-source" partner like Kapstone Medical ensures that HF insights flow seamlessly from early engineering into manufacturing and quality systems.
• Documentation is Key: Success in audits depends on a robust Usability Engineering File that links user research to risk management and design validation.

What are Human Factors in Medical Device Development?

At its core, Human Factors Engineering is the application of knowledge about human capabilities and limitations to the design of a device. The goal is to ensure that the user interface—which includes everything from physical buttons and software screens to packaging and instructions for use (IFU)—is intuitive and safe.

FAQ: Why does the FDA care about usability?

The FDA focuses on HF to minimize "use error." Most adverse events associated with medical devices are not caused by mechanical failure, but by user interaction issues. By mandating HF integration into Design Controls, the FDA ensures that manufacturers identify and mitigate these risks before a device reaches a patient. See FDA Guidance Document, Applying Human Factors and Usability Engineering to Medical Devices for more background.

The Regulatory Framework: ISO 13485 and IEC 62366-1

To remain compliant, manufacturers must align their QMS with international standards. The standard, IEC 62366-1 (Application of usability engineering to medical devices), provides the roadmap. It requires a systematic process to analyze, specify, and evaluate usability as it relates to safety.

When integrated into your Design Controls (21 CFR 820.30), HF becomes a thread that runs through:

• Design Inputs: Clear, measurable requirements derived from intended use and user needs that define what the device must achieve.
• Design Verification: The process of objectively demonstrating that the device design outputs—including functional, performance, and user interface characteristics—conform to the defined design input requirements.
• Design Validation: Objective confirmation, through testing or evaluation under actual or simulated use conditions, that the device meets user needs and intended use.

The Kapstone Advantage: Engineering Depth and Patient Safety

At Kapstone Medical, we believe that Human Factors should never be isolated. Our "single-source" integration means our experts in quality, engineering, and manufacturing work on the same team. This vertical integration is led by industry veterans who understand the technical depth required to satisfy regulators while maintaining business agility.

• David Considine, Director of Engineering: David and his team ensure that usability isn’t just a checklist item but a fundamental part of the device's physical architecture.
• Nikhil Mangale, VP of Quality: As leaders in regulatory compliance and QMS strategy, Nikhil and his team bridge the gap between design intent and the rigorous documentation required for QMSR and ISO 13485.
• Ryan Lewis, Human Factors Specialist: With deep expertise in user-centric design, Ryan guides the project team through critical early, mid, and late-stage evaluations, ensuring that every touchpoint of the user interface is optimized for patient safety.

How to Integrate HF into Your QMS at Every Stage

*Reference: Applying Human Factors and Usability Engineering to Medical Devices 

1. Early-Stage: User Research and Formative Evaluation

Before the design is "frozen", startups should conduct formative studies. This is about learning what you don't know. By observing users in simulated environments, you can identify "known use problems" early when they are still inexpensive to fix. AAMI HE75 is a great resource at this stage for basic ergonomic and force requirements in real-life scenarios.

2. Mid-Stage: Use-Related Risk Analysis (URRA)

In tandem with ISO 14971, your team must document potential hazards. What happens if a clinician skips a step? What if a patient misinterprets an alarm? These aren't just guesses; they are documented risks that require design mitigations.

3. Late-Stage: Summative Validation

This is like a final exam. You must prove with a representative user group that your device is safe. This data forms the backbone of your Human Factors Engineering Report for your 510(k) or PMA submission. 

What Should Startups Consider with Usability?

Many startups wait too long to think about usability, leading to a "check-the-box" approach that often fails during FDA review. Common mistakes include:

• Treating IFUs as the only mitigation: You cannot simply "train away" a problematic design. The FDA prefers "inherent safety by design."

• Ignoring the environment: A device that works in a quiet office might fail in a noisy, high-stress Emergency Room.

• Fragmented vendors: Using one firm for design and another for quality may lead to gaps in the Usability Engineering File.

Conclusion: A Safer Path to Market

Integrating Human Factors into your QMS is a strategic investment. It reduces the overall risk of the product, lowers training costs, and most importantly protects the patients who rely on your innovation.

Designing a device with the user in mind is critical to the overall success of a project. Even if a device successfully passes through each stage of the regulatory process, its adoption in the marketplace depends upon whether it makes a task easier, faster or more intuitive for its users.

Kapstone Medical provides the experienced guidance and technical execution needed to weave usability into the very fabric of your quality system. From the first sketch to the final production unit, we ensure your device is not just functional, but truly ready for human use.