The FDA’s New Human Factors Guidance Makes Usability Part Of The Product Story
- Natalie Hussey
- Jul 12
- 8 min read
Medical-device teams have traditionally treated human factors as a regulatory requirement. Engineers study how intended users interact with the device, regulatory teams determine which findings belong in the submission, and the company validates the design to identify and reduce use-related risks before filing a 510(k), De Novo request, PMA, or humanitarian device exemption application.
Human-factors research is essential to the regulatory process, but its commercial value is often overlooked. The same work used to demonstrate safe and effective use can also show which product features require more explanation and what barriers could slow adoption after launch. FDA’s new final guidance makes this a timely point for medical-device teams and why they should reconceptualize how they use human-factors findings.
On May 28, 2026, the FDA issued its final guidance on the human factors information manufacturers should include in medical-device marketing submissions. The guidance establishes a risk-based framework intended to improve consistency and make FDA review more efficient. It applies across 510(k) submissions, De Novo requests, PMAs, and HDE applications. The FDA will hold an industry town hall on July 22, 2026, to discuss the final guidance and answer questions.
Although the guidance focuses on regulatory submissions, its commercial implications extend far beyond that. Human-factors research shows how people understand, operate, and adopt a medical device. Those findings should not remain confined to the submission. They can also determine how to position, launch, and support the product once on the market.
The Guidance Formalizes A Risk-Based Submission Framework
Human factors engineering is not new to medical-device manufacturers. The FDA has long expected companies to identify and reduce use-related risks through human factors and usability-engineering processes. FDA’s 2016 guidance established the core purpose of this work: To increase the likelihood that intended users can operate a device safely and effectively in the intended use environment. Human factors engineering helps manufacturers reduce use errors, address interface problems, and prevent patient or user harm.
Instead, the new final guidance builds on that foundation. Its focus is on which human factors information manufacturers should include in a medical device marketing submission. The FDA now provides a risk-based framework for determining the type and depth of documentation required. The framework is intended to improve consistency for manufacturers and reviewers while requiring more extensive information for devices with greater use-related risk.
The FDA’s guidance is primarily written for regulatory teams, but the underlying information matters across the business. To complete the required analysis, companies must understand:
Intended Users
Use Environments
Critical Tasks
Interface Design
Foreseeable Use Errors
Risk Controls
Validation Results
Product, training, and customer success teams need the same understanding. These findings explain how people interact with the device, what users need to learn, and which issues could affect adoption after launch.
Human Factors Is Not Just About Preventing User Error
The regulatory objective of human factors work is clear. Manufacturers should reduce the likelihood that device use leads to unsafe or ineffective outcomes. Commercial leaders should not dilute or reinterpret that purpose.
However, the same research often exposes the practical conditions that determine whether a product succeeds after clearance. Human factors work can show:
Which tasks do users find difficult
Which instructions are misunderstood
Where workflow interruptions occur
Which interface elements create hesitation
What users forget after training
Which environmental conditions affect performance
Where experienced and inexperienced users behave differently
Which assumptions made during development do not hold up in practice
These findings have commercial consequences. For example, a device that requires extensive training may need a different sales and service model. A product that works well in a controlled clinical environment may require additional support when used at home. A complicated setup process may affect onboarding, implementation costs, customer satisfaction, and renewal or reorder behavior.
Human factors research does not provide market research insights in the conventional sense. It is not designed to test pricing, positioning, or purchase intent. It does, however, provide direct evidence about the user experience that commercial teams often try to reconstruct later through sales calls, customer interviews, and post-launch support data. Ignoring those commercial insights until launch makes little sense.
The Device-User System Is Also The Adoption System
The FDA describes human factors considerations through three major components:
The device users
The use environments
The device user interface.
The outcome depends on how those components interact. A well-designed device should support safe and effective use among its intended users under the conditions in which the device will actually operate. Commercial adoption depends on many of the same variables:
The user may be a physician, laboratory professional, or patient. In many cases, several types of users interact with the device at different stages.
The environment may be an operating room, imaging center, or a patient’s home.
The interface may include physical controls, software screens, and setup procedures.
Those three details affect how the market perceives the product. For example, a hospital may see clinical value but worry about training hundreds of employees across several locations. At the same time, a physician may support adoption, while nurses object to the added workload. Further, a home-use device may appear simple to the development team but feel intimidating to patients managing a new diagnosis.
So, the device-user system is not separate from the commercial system. It is where device adoption either holds together or breaks down.
Training Requirements Should Influence the Commercial Model
Medical device companies often develop training programs after the core commercial strategy has already been set. Leadership determines the target market, distribution model, and launch timeline. Then, the company creates training materials to support those decisions. Human factors evidence may suggest the sequence should run in both directions.
The amount and type of training required can materially affect the cost of selling and supporting the device. A straightforward product may be supported through digital onboarding, distributor education, and concise user materials. A more complex device may require in-person instruction, periodic retraining, or extensive implementation support.
Training requirements influence:
Sales-cycle length
Customer-acquisition cost (CAC)
Implementation timelines
Distributor suitability
Staffing requirements
Service margins
Geographic expansion
Customer-support volume
Account management needs
A company cannot price, distribute, or scale a device intelligently without understanding what users need to operate it successfully. Thus, training is not always a post-sale expense. In many medical-device categories, it is part of the product economics.
Human Factors Evidence Can Improve Sales Enablement
Medical-device sales teams are frequently trained to explain technical features, clinical benefits, and competitive differentiation. They are not always trained to address the operational concerns that determine whether customers feel comfortable adopting the product. Human factors findings can make their sales enablement more realistic.
Human factors findings can help the sales team explain how the device fits into an existing workflow, which users require training, and how the interface was designed around the intended user population. These insights are especially valuable when buyers raise objections related to complexity. A customer may ask whether staff will actually use the device, how long onboarding takes, or how the product performs in a busy environment. Generic assurances are weak responses.
The sales organization needs approved, evidence-based language that explains how the company considered users and use environments during development. Obviously, that does not mean turning validation data into promotional claims without review. Human factors findings must be translated carefully, with regulatory, clinical, and commercial teams aligned on what the company can credibly communicate.
The opportunity is not to market the submission. Instead, it is to use what the company learned while preparing the submission. Then, take that information to the market as a trust-building sales tool.
Usability Can Be A Differentiator Without Becoming A Vague Claim
Many device companies describe their products as “intuitive,” “user-friendly,” or “designed around the clinician.” These phrases appear so often that they have lost much of their commercial value. Instead, buyers need more specific information (and AI too), such as:
What makes the device easier to learn?
Which steps have been reduced?
How does the interface help prevent confusion?
What information is visible at the point of use?
How are alarms or warnings prioritized?
A company should not imply that a device eliminates risk or can be used without appropriate training. It can still explain the design decisions that make the product more compatible with real users and real environments, creating a much stronger product story.
Instructions For Use Are Part Of The Customer Experience
Regulated companies often treat instructions for use, quick-reference guides, and training materials as compliance documents. Users experience them differently. To the user, these materials are part of the product. The FDA’s human factors framework reflects that reality. The user interface includes more than the physical device. It can also include packaging, controls, and elements involved in product use.
However, since instructional content is part of the user interface, weak instructions can undermine an otherwise strong device. Users may make errors, develop workarounds, or rely on informal training from colleagues. Customers may also view the product as difficult to implement, even when its underlying technology is better than competing options.
Therefore, technical writing plays a direct role in commercialization. Instructions and training materials must meet regulatory and risk-management requirements. They must also be clear, well-organized, and appropriate for the intended audience. Strong human factors work helps companies achieve both compliance and clear customer communication.
Human Factors Should Inform Launch Materials Before Launch
Medical-device companies typically begin building their launch assets when clearance appears close based on product specifications, clinical data, and regulatory language. Human factors evidence should be part of their source material. Human factors help commercial teams identify:
The steps that buyers will need to be explained
The user concerns that deserve early attention
The environments that should appear in demonstrations
The roles that need separate training materials
The operational benefits the sales team can discuss
The limitations that require careful expectation-setting
The implementation questions are likely to slow adoption
Using human factors evidence during launch planning does not mean promoting a product before authorization. The goal is to build market-facing materials around a realistic understanding of how intended users will operate, learn, and implement the device. Without that understanding, a launch campaign may communicate the product’s clinical promise while overlooking the practical conditions that influence adoption.
Human Factors Can Expose Commercial Risk Before Clearance
Founders and device executives often focus heavily on regulatory risk because the consequences are immediate. A deficient submission can delay authorization, increase development costs, and consume runway. Commercial usability risk may be less visible before launch, but it can be just as financially damaging.
A company may clear the device and then discover that customers need substantially more costly support than expected. They may find their sales cycle has lengthened because buyers view implementation as disruptive to patient throughput. Another example is that distributors may struggle to demonstrate the product correctly, or users fail to adopt key features. These are not necessarily evidence of a defective device. They may reflect a weak commercialization model built around an incomplete understanding of the user. Human factors work gives leadership an earlier view of that risk.
Cross-Functional Review Needs to Happen Earlier
The practical strategy is not to hand the human factors report to marketing after validation. Instead, companies need structured cross-functional communication throughout development:
Regulatory and human factors teams should explain what they are learning about intended users, foreseeable use difficulties, and training dependencies.
Commercial leaders should explain how those findings affect market segmentation, channel selection, and launch sequencing.
Technical writers and content teams should understand how users process instructions, where terminology is confusing, and which materials will be needed at different points in the customer lifecycle.
Clinical and medical-affairs teams should help distinguish evidence-based communication from language that overstates what the research demonstrates.
Cross-communication not only empowers marketing and sales teams but also prevents valuable product knowledge from becoming trapped within a single regulatory workstream. All departments will benefit.
FDA’s Final Guidance Raises the Strategic Value of the Work
Human factors work should do more than support the regulatory submission. The same findings can help medical-device companies build clearer positioning, stronger sales materials, and a launch strategy that appeals to the target market.
Borrowed Pen helps medical-device teams translate complex human factors information into market-facing content that supports adoption. We build messaging and launch materials around the questions buyers will ask, the barriers users will face, and the operational realities commercial teams need to address.
Book a 15-minute discovery call and learn more about how we can support your medical device launch.
Read More
U.S. Food and Drug Administration, “Content of Human Factors Information in Medical Device Marketing Submissions”
U.S. Food and Drug Administration, “Town Hall: Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance”
U.S. Food and Drug Administration, “Human Factors and Medical Devices”
U.S. Food and Drug Administration, “Human Factors Considerations”
U.S. Food and Drug Administration, “Human Factors Premarket Information: Device Design and Documentation Processes”
U.S. Food and Drug Administration, “Applying Human Factors and Usability Engineering to Medical Devices”
U.S. Food and Drug Administration, “CDRH Events”
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