Thinking December 9th, 2025

What the new ANSI/AAMI HE75:2025 guidance on Human Factors means for medical device developers

Kate Cox
By
Kate Cox Director of HFE / Research
Surgeons performing laparoscopic surgery for extraction of kidney stones.

The Human Factors Engineering (HFE) landscape has evolved enormously over the past 15 years. Yet until now, the main design standard guiding safe, effective medical device development – ANSI/AAMI HE75 – hadn’t kept pace. The recently released 2025 revision is the first major update since 2009. It reflects just how much the industry has changed and recognizes the realities today’s MedTech teams face.

As someone who participated in the consultation and review process and works daily with clients navigating human factors challenges, this update is a meaningful step forward, not just for human factors specialists, but for anyone involved in the design and development of medical products. I would like to congratulate the entire AAMI Human Factors committee and especially our Co-Chairs Molly Story and Mary Beth Privitera for their excellent leadership and commitment to seeing this extensive update come to life.

Below, is a breakdown of why the standard has changed, what’s new, and what it means for you.

Why the HE75 standard needed an update

The previous edition of HE75 was written in a pre-AI, pre-connected-devices world. Much of today’s medical technology simply didn’t exist when the 2009 version of the standard was drafted. The gap between the 2009 edition and the sophistication of modern MedTech had become too wide.

Here are some of the main drivers behind the update:

Massive technological shifts

Since 2009, medical devices have become more digital, more integrated, and more frequently used outside of clinical settings. We now work with devices supported by apps, cloud platforms, AI features, wearable components, and at-home accessories. The standard needed to reflect these realities.

Evolution in FDA human factors expectations

The FDA’s human factors guidance was released in 2016, seven years after the last HE75 update. The ANSI/AMMI HE75:2025 revision closes that gap, offering much better alignment with how regulators currently evaluate usability and use-related risk.

Recognition of multi-disciplinary product teams

Human factors is no longer a niche specialty. Designers, engineers, researchers, and UI/UX professionals all contribute to product design decisions that affect usability and safety. The new standard acknowledges this cross-disciplinary reality and provides guidance relevant to all of them.

In short: the world has changed. And HE75 now better reflects this.

Young girl with diabetes uses smart remote sensor.

What’s new in HE75:2025?

While the standard is comprehensive (over 500 pages), several changes stand out as particularly important for product teams.

  1. New guidance on planning and conducting knowledge tasks. Knowledge tasks – often a major component of human factors validation – have been an area of increased regulatory focus in recent years. The ANSI/AAMI HE75 revision includes detailed guidance on how to determine when knowledge tasks are needed, how to plan them appropriately, and how to conduct them in a way that meets regulatory expectations. This is one of the most practical and immediately valuable additions, especially for teams preparing for FDA interaction.
  2. Brand-new section on integrated systems. Many devices now operate as part of a broader ecosystem, often paired with apps, sensors, hubs, digital dashboards, or shared data platforms. The standard now includes a dedicated section on integrated systems, helping teams consider how interactions, dependencies, and context-of-use scenarios affect safe and effective use.
  3. Guidance for combination products. The use of combination products has exploded, with autoinjectors, inhalers and patches now common drug delivery device formats. The new HE75 includes a standalone section addressing combination product user needs, instructions and training requirements, home versus clinical use, and device/drug interface considerations. This reflects the complexity and diversity of modern self-administered therapies.
Participants in a human factors study using an autoinjector device.

Why it matters for MedTech teams everywhere

HE75 is not a regulation. You don’t have to comply with it in the same way you must comply with ISO 62366 or FDA guidance. But you should want to. Here’s why:

  • It provides the most comprehensive design guidance available. HE75 is essentially the premier reference for designing medical devices in a way that is safe, usable, and aligned with real-world best practice. Whether you’re designing a new interface, revisiting a risk assessment, or planning a usability study, HE75 provides a robust, structured framework.
  • It reduces regulatory and commercial risk. Human factors is not a “tick-box exercise”. The FDA has been placing increased importance on ensuring devices are safe and effective in the hands of their actual users. A robust HFE process helps teams anticipate issues before they become problems, preventing use errors, strengthening regulatory submissions, improving product acceptance, and helping avoid costly remediation later down the line.
  • It supports global product teams. Medical devices launched today rarely stay within one market. The more globally relevant and compliant your design principles, the easier it is to scale your product across geographies. HE75’s guidance around cultural interpretation, use environments, and diverse user populations supports this directly.
Download ANSI/AAMI HE75:2025 guidance

Three practical tips for using the new guidance

The updated HE75 is a powerful resource, but also a substantial one. Here are three practical ways to get value from it without getting lost in 500+ pages.

Tip 1 – Don’t start by reading it cover-to-cover
Start by asking yourself: What problem am I trying to solve right now? Then go to the section that relates to that challenge. HE75 is designed to be referenced selectively.

Tip 2 – Let your priorities guide your navigation
Focus on the parts that support your immediate need. Are you designing a new UI? Planning formative or summative usability testing? Developing a combination product? Creating IFUs or training? Use HE75 to answer your specific questions, not to overwhelm yourself with everything all at once.

Tip 3 – Use available expertise and training
AAMI will be offering a course to walk teams through the new guidance, on February 18th-19th (see here to register). This will be incredibly helpful for anyone looking to understand its structure and intent in more detail.

And of course, if you have a question about how the new standard applies to your device or development stage, our Human Factors team at Ensera Design is always happy to discuss – just drop us a line.

How Ensera Design can help

Our human factors team supports clients throughout the medical device development lifecycle, from research and early design exploration to validation and regulatory submission. We work hand-in-hand with engineering, design, and manufacturing teams to ensure the human factors process is robust, evidence-based, and grounded in real-world use.

We’re proud to be active participants in the human factors community by contributing to the consultation and review process for the new HE75 update and maintaining close connections within AAMI’s human factors working groups. This helps us stay ahead of changes and interpret new guidance with clarity and confidence.

Most importantly, we’re practitioners. We conduct human factors research, design interfaces, run formative and summative studies, and solve complex usability challenges every day. Our experience means we can help you apply HE75 in a way that is practical, proportional, and aligned with your commercial and regulatory goals.

Want to talk about what HE75:2025 means for you? Our team is always happy to discuss specific challenges or help you understand which parts of HE75 are most relevant to your development pathway.

Get in touch with our Human Factors team
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