The Hidden Cost of Failure to Apply Human Factors and Usability Engineering to Medical Devices: Why Your Clinical Trial Budget May Double

Contributors: Nick Benedetto, Matt Gottschalk

The Expensive Reality Check: Failure in applying human factors and usability engineering to medical devices can cost innovators. Dearly.   

Clinical trials represent one of the largest investments in medical device development, often consuming millions in resources and months of careful planning. The FDA doesn't require human factors validation before clinical trials, but this regulatory flexibility in applying human factors and usability engineering to medical devices can become a financial trap for unprepared companies. Yet many companies discover too late that inadequate human factors validation can derail even the most meticulously designed studies. When users struggle with device operation during trials, the ripple effects are immediate and costly: extended timelines, expanded participant pools, and compromised data integrity.  

“The last thing you want to have happen in a clinical trial is something like a leaking tube and an alarm, for example,” says Veranex Human Factors Director Nick Benedetto. “When appropriately applying human factors and usability engineering to medical devices, innovators should validate the reaction to an alarm, an important activity, well in advance of a clinical trial. Failure to do so creates an unpleasant experience for all participants and costly delays that should have been avoided.” 

The cost of applying human factors and usability engineering activities and associated studies to medical devices will be within a relatively tight range with account for intensity vis-a-vis formative or summative studies. (This does not account for a team’s proficiency in the field and near-immediate access to experts in adjacent pathway specialties like quality and regulatory affairs). But the time and cost wasted in a pre-mature early feasibility study (EFS) or, worse, a pivotal trial, that could have been avoided is the strongest value proposition, including time and cost de-risking, to carefully considering HFE and regulatory requirements prior to any human trial work.  

From “Understanding the ROI of Human Factors Engineering” in the Veranex Blog, Matt Gottschalk, Vice President of Strategic Development writes, “The top concern regarding human factors engineering from clients is, ‘How long is it going to take and how much is it going to cost?’ I tend to be annoying and answer this question with, ‘Do you know how much not doing this costs?’ 

“The truth: You’re likely costing yourself by not effectively integrating human factors into your development process. Let me show you what I mean. 

“As you move through the various stages of product development, design changes and cost are inversely related. The same tends to be true in terms of the innovative impact these changes will have. 

“A very tangible example of where an HFE investment is going to save you in the long run is avoiding product recall costs. 

“Let’s say last year you had a product recall due to use-related error of 10,000 units at $1,000 each (and we’re completely excluding the cost of potential lawsuits [and reputation damage] here). In total, just replacing the updated devices cost your organization $10M. 

“You’re confident that the root cause of this use error would have been identified if a stronger HF/usability program were incorporated into the development of the product. Unfortunately, your proposal of adding $500,000 in HF activities was denied. 

"Even though the upfront investment applying human factors and usability engineering to medical devices would have been [perceived as] large, the cost avoidance of performing HF would have proved to be much larger (1900% return on investment)."

Early HF work helps you catch problematic issues before they show up in a high-stakes environment. De-risk your trial, and create a higher quality device overall, by identifying and mitigating potential use errors in advance, ultimately increasing your trial’s velocity and likelihood of success. 

From 100 to 130 Participants: The Usability Multiplication Effect When Failing to Apply Human Factors and Usability Engineering to Medical Devices 

Poor usability doesn't just frustrate users; it fundamentally undermines statistical confidence in clinical outcomes. When medical device clinical trial sites and participants struggle to operate a device correctly (due to insufficient training, for example), the resulting data variance forces researchers to expand their sample sizes significantly.  

According to Benedetto, a study designed for 100 participants might suddenly require 130 or more to achieve the same statistical power. This expansion cascades through every aspect of trial management: recruitment costs, site coordination, data collection, and timeline extensions. The device's core functionality may be sound, but if users can't operate it intuitively, the clinical evidence becomes murky and unconvincing. 

The Debug-Before-Deploy Strategy 

Smart companies integrate HF expertise and apply human factors and usability engineering to new medical devices between phase zero and phase one of product development, treating usability validation as essential infrastructure rather than optional enhancement. This proactive approach identifies and resolves user confusion before it can create avoidable, costly delays or contaminate clinical data.  

“By applying human factors and usability engineering to medical devices including conducting formative testing early, companies create cleaner trials with more predictable outcomes,” Benedetto says. “The investment in upfront HF work pays dividends in streamlined clinical execution, clearer regulatory pathways, reduction in risk of recalls and churn, and stronger market positioning. Consider it debugging for humans rather than just hardware.” 

De-risk Your New or Generational Device for Submission Ready Documents and Products that Stick. 

When applying human factors and usability engineering to new medical devices, Veranex creates and utilizes real-world insights across diverse user groups and conditions. The results: superior designs, de-risked devices, submission ready documentation and ultimately superior products that stick with customers. Coupled with the availability of end-to-end medical device development and commercialization experts at every phase of the product lifecycle, along with ISO / IEC 62366 certification, we bring to bear what you need, precisely when you need it. 

Get in touch with the team today. It’s never too early.

Why Smart Innovators Invest in Human Factors Before Clinical Trials  

Human factors engineering ensures your device works not just in the lab, but in the hands of real users under real conditions. Early usability validation prevents costly trial delays and creates submission-ready documentation that regulators expect. The payoff: faster approvals, lower development costs, and a device built for lasting market success.