Unlocking the ROI of Minimum Viable Chaos (MVC) through Human Factors Engineering (HFE)

Most Human Factors Engineering programs are designed to pass validation, not predict real-world performance.

If we train a clinician on how to use a new medical device and then ask them to operate it in a testing lab where it’s quiet, the lighting is ideal, and there are no distractions, it may perform beautifully. But in this sort of conventional environment, the toughest obstacles remain invisible. We’re not accounting for the 85 decibels of noise in the typical emergency department. We’re not factoring in the constant interruptions that a nurse in a busy hospital must deal with daily. And we certainly aren’t anticipating the inevitable training decay that results from the weeks or months between learning to use the device and then deploying it under pressure.

Conventional HFE testing struggles because it does not replicate clinical variability under operational pressure. The issue is not a lack of HFE testing, but the absence of controlled realism within testing environments.

Regulators demand HFE compliance testing that represents the real world

If we ignore real-world chaos in medical device usability labs, we risk overlooking crucial weaknesses that might later necessitate costly redesigns. More importantly, unrealistic testing can produce devices that fail in the real world, exposing operators and patients to harm.

Development teams that fail to rigorously test against real-world conditions risk:

• Increased development costs
• Regulatory delays
• Late-stage redesigns
• Post-launch failures
• Loss of clinical trust

Will your testing satisfy FDA human factors validation and regulatory guidance?

The FDA’s 2016 guidance document, Applying Human Factors and Usability Engineering to Medical Devices mandates that simulated environments must be “sufficiently realistic to represent the actual conditions of use”.

A device might be highly intuitive to use immediately after training in a quiet laboratory. But what happens after a 6-month training decay period? When alarms are active, does the training methodology hold up, or will the operator miss critical dangers? Can a fatigued outpatient technician conduct a remote service protocol while also managing a patient? These sorts of questions have prompted regulators to mandate real‑world usability testing as an essential criterion for ensuring patient safety and regulatory confidence.

IEC 62366, an international standard for usability engineering, advises that there are numerous compelling business reasons for adopting usability engineering early in the medical product lifecycle. These include faster time-to-market by avoiding costly delays tied to late-stage design flaws, reduced regulatory review times thanks to robust and convincing usability documentation, and improved market performance through more intuitive and user-friendly products.

Minimum Viable Chaos

What does it take to create a truly representative clinical simulation lab for medical devices?

A perfectly tidy testing laboratory with uninterrupted workflows, perfect lighting, and prescient training can introduce a false sense of security that doesn’t match actual clinical conditions. So at IDE Group, we developed Minimum Viable Chaos (MVC), a methodology designed to systematically introduce real-world disruption into HFE testing. MVC is not merely an extension of HFE; it is a correction to the limitations of conventional HFE test environments.

If an ER physician is typically interrupted every three minutes in their actual practice, MVC demands that our product testing include forced interruptions every three minutes in the laboratory. If the clinical settings the device will be used in are crowded, have inadequate lighting, or poor ventilation, we need to factor in those obstacles as well.

The MVC element of IDE’s testing regime is essential because it provides a controlled but realistic representation of actual clinical conditions. Without MVC, device testing provides a false sense of confidence, and in some cases, dangerously misleading results.

MVC extends beyond the product to the entire technology management ecosystem

The MVC methodology is equally critical for the service side of MedTech as it is for device usability.

IDE Group recently evaluated a complex diagnostic system designed for busy outpatient clinics. We expanded the scope of our simulated clinical environment to evaluate the service ecosystem, asking a technician to troubleshoot a device hardware fault with remote support. To better simulate the constraints of a suboptimal clinic, we positioned the device against a wall with limited accessibility and reduced the ambient lighting by 60%. During testing, the technician was required to locate the concealed override ports, working blindly with both hands while holding a flashlight and talking with a remote service representative on the phone. Observing these obstacles, we were able to recommend redesigns for the device’s physical format as well as improvements in the remote support system that would greatly enhance the product’s usability and safety.

The success of medical devices depends on how well they fit into clinical workflows. Can the product support timely, confident decisions? Can it deliver real value for patients and providers without costly outages or repetitive user error?

Usability Testing in the Real World

Successful usability testing brings together a detailed understanding of the challenges that instigate human error, with design expertise across every stage of product development. Achieving consistently positive results requires not just technical performance but a clear understanding of real‑world use cases, the suboptimal environments the product may be deployed in, and the drivers of safe, sustainable adoption. This is the core limitation of how HFE usability testing is typically implemented in practice: it validates performance in controlled conditions, but does not reliably predict performance under real-world stress.

By applying MVC in our clinical usability testing, IDE Group transforms usability testing from a compliance exercise into a predictive model of real-world performance. If we orient device design to promote optimal real‑world usability, we’re on track to reduce risk and accelerate new product adoption.

Simulated Usability Lab (SULi): the MVC testing lab for optimized usability and reduced risk

SULi, IDE Group’s Simulated Usability Lab in Minneapolis is the execution platform for our MVC methodology. SULi enables controlled, repeatable simulations of real-world clinical conditions within HFE testing. It brings together high-fidelity clinical simulation and sophisticated user-centric design to help MedTech developers accelerate innovation while minimizing risk.

IDE Group’s clients can run high-fidelity usability simulations at SULi with the expertise and hands-on guidance of the IDE team. SULi reproduces the core cognitive stressors that challenge clinicians, helping to validate the real-world usability characteristics of technology. We use SULi not to arbitrarily overwhelm test operators, but to carefully isolate and measure specific cognitive load variables. Elements like ambient noise, lighting, and spatial constraints are carefully calibrated to match real clinical conditions, and then dialed up methodically to observe user error. Applying this MVC mindset to clinical obstacles allows us to observe the precise threshold where a user’s cognitive flow is interrupted. We can then provide objective data to our clients to help them refine the design of their technology and minimize clinical risk.

There are substantial ROI benefits to be gained from MVC testing

Recent research[1] has found that user errors are a significant proportion of adverse event reports, “constituting 28.1% of reports labeled with device problem codes”. Most use error reports were attributed to issues with device output, using the device in accordance with manufacturer expectations, and physically activating, positioning, or separating device components. These sorts of problems could have been resolved with MVC testing.

When HFE testing is executed through MVC and SULi, it shifts from compliance validation to predictive performance modeling. This is where IDE Group’s approach fundamentally differs from conventional HFE testing, becoming a powerful driver of risk reduction, regulatory confidence, and commercial success.

By applying MVC through SULi, IDE Group delivers measurable ROI across these key areas:

By applying MVC testing principles in SULi, IDE Group helps development teams identify hidden risks, reduce regulatory friction, and deliver products that perform reliably under real clinical pressure.

Conventional testing no longer ensures compliance or real-world performance

The appearance of usability compliance is no longer adequate. If development teams don’t incorporate realistic cognitive load and environmental deficits in their testing, they risk unpleasant surprises later. Sanctions from regulators, poor reviews from clinicians, and post‑launch failures are all more likely in the absence of rigorous MVC-based testing.

Seen through an ROI lens, the goal of testing isn’t just compliance. IDE Group’s mission is to demonstrate unequivocally that we have anticipated environmental challenges, mitigated training decay, and built a product that’s resilient under clinical pressure.

SULi is designed to answer a question that conventional HFE testing cannot reliably resolve: how a device performs when clinical conditions stop behaving like a predictable test environment.

[1] – (Knisely, Benjamin & Levine, Camille & Kharod, Kush & Vaughn-Cooke, Monifa. (2020). An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care. 9. 130-134. 10.1177/2327857920091024.)

Kent DiasAbeygunawardena is the Director of IDE Group USA, bringing over 15 years of experience in medical device innovation and development. He specializes in human-centered design, with lengthy experience in generative research, Human Factors Engineering, and usability-driven product design.

Kent has led complex global development programs for both startups and multinational organizations, with particular strength in patient and clinician-administered drug delivery platforms, including diabetes, inhalation, and injection systems. His work aligns closely with FDA usability engineering requirements and the U.S. commercial landscape. He also brings strong expertise in workflow design and ergonomics for wearable and mobile medical devices. He holds a Master’s degree in Business from the University of Minnesota’s Carlson School of Management and a Bachelor’s degree in Industrial Design from the University of Kansas.