Why Adoption Is Central to FDA’s Updated Human Factors Guidance

As care increasingly moves into the home, products need to meet not only clinical requirements, but the realities of people’s lives, routines and preferences. This article examines why the FDA puts real-world use at the centre of its updated guidance and why designing for adoption is critical to succeed in medical device development.

When a new piece of FDA guidance is released, the immediate reaction is often to focus on what has changed: What new requirements have been introduced? What additional evidence will be expected? What impact will it have on submissions already in development?

Whilst these are important questions, I find the recent update to the FDA’s Human Factors guidance interesting for a different reason. More than anything, it reflects a broader shift that has been taking place across the medical technology industry for several years.

Advances in technology and changes in healthcare delivery are making medical devices and combination products increasingly sophisticated. At the same time, more care is moving into the home, placing greater responsibility on patients and caregivers. Treatments that were once administered by healthcare professionals are now routinely delivered by people with little or no formal medical training.

As this shift continues, products need to meet not only clinical requirements, but also the realities of people’s lives, routines and preferences. A device may perform perfectly from a technical perspective, but if it has not been designed with real-world use in mind, its intended benefits can quickly be lost. People may struggle to understand it, use it incorrectly, or develop workarounds to compensate for poor design. In combination products where device performance is directly linked to drug delivery, the consequences can be even more significant.

This is where Human Factors is critical.

The updated FDA guidance introduces a clearer framework for determining the level of Human Factors information expected within a submission. However, what stands out is not the framework itself, but the continued emphasis on understanding and managing use-related risk.

To me, this clearly signals that regulators want to see evidence that manufacturers understand how people will interact with their products in the real world. They want to understand where use errors might occur, how those risks have been identified, and what has been done to address them through the design process.

The guidance places particular emphasis on combination products, for good reason. Patients are often required to perform a sequence of critical tasks correctly and consistently, sometimes whilst managing symptoms, anxiety, pain or cognitive burden. They may be using a device for the first time. They may be distracted. They may be in environments that look nothing like the controlled settings in which products are often developed.

Understanding these realities requires more than a validation study at the end of a programme. Just as clinical outcomes alone cannot tell us everything about patients, validation results alone cannot tell us everything about use-related risk. We need to understand the people behind the data: How do they behave? What assumptions do they make? What shortcuts do they take? What frustrations have they learned to live with?

This is also where the idea of Design for Adoption becomes important. Success is not defined by technical feasibility alone, or even by whether a user can complete a task in a validation study. It depends on whether the product can be understood, trusted, integrated into everyday routines and sustained over time. In other words, adoption is not something that happens after launch; it is something that needs to be designed for from the earliest stages of development.

At PDD, our Human Sciences team combines expertise from design, psychology, ergonomics and engineering to build a detailed understanding of users and the environments in which products are used. Through our Design for Adoption approach, we connect these human insights with design, engineering, validation and post-market evidence, helping teams make better and justified decisions throughout development. We look beyond whether someone can complete a task and explore why they behave in the way that they do.

In many ways, the FDA’s latest guidance validates an approach that the industry has been moving towards for some time: Human Factors is no longer something that sits alongside development; it is becoming an increasingly important part of development itself. The same is true of adoption. As patients and end users gain more responsibility, and in some cases more choice, over the products they use, adoption should not be treated as a commercial or post-launch challenge alone. It should be considered a design objective that shapes decisions, starting from early research and development.

Organisations that invest in understanding users early and throughout development will not only be better prepared for regulatory scrutiny, but will also be better positioned to create products that people choose, trust and continue to use and genuinely improve lives.

Ultimately, isn’t that what this industry is about?

If this guidance raises questions about your own medical device or combination product development programme, PDD is offering free 30-minute consultations with our Human Sciences team. Whether you would like to discuss Human Factors strategy, use-related risk or how Design for Adoption could support your programme, book a slot with Hollie Johnston to discuss.