As medical devices grow more connected and complex, their success depends on whether clinicians can rely on them to perform under the pressures of clinical practice.
For MedTech companies, Human Factors is no longer a final checkbox. It now drives adoption, streamlines development, and determines how quickly products reach the market.
In this interview, IDE Group’s Kent DiasAbeygunawardena explains how context-accurate Human Factors Engineering, usability testing and integrated development are reshaping the way medical devices succeed in the market. He also shares how IDE Group’s expanded Human Factors team brings deep, firsthand experience from specialized clinical environments such as electrophysiology labs, cardiac rhythm management, radiology, and pediatric care, yielding more accurate insights.
Why do so many MedTech companies fail to address Human Factors properly?
I think the most common issue we see is that Human Factors is treated as a late-stage requirement rather than a driver of product design. By the time many teams start usability work, the device architecture is already locked in, and the key decisions are behind them. At that stage, usability becomes about validation, not improvement. Effective usability work needs to start earlier, well before formal validation. Safety is critical, but it does not guarantee commercial success. What really matters is whether the device fits smoothly into clinicians’ daily workflow.
This perspective comes from my background in radiology and from consulting with companies such as BD, Siemens, and Hologic. Clinicians work under intense time pressure, and even minor workflow issues quickly become major problems.
What does it take to move HFE from a regulatory obligation to a source of competitive advantage?
It starts with redefining success. Regulatory clearance just gets you into the market. Real viability comes from clinician adoption.
I think historically, companies viewed HFE mainly as a compliance requirement. That’s changing quickly as Human Factors Engineering in MedTech is becoming part of commercial strategy. Technologies emerging now are introducing new treatment modalities rather than just incremental improvements. In urology, for instance, robotic water vapor therapies mean that clinicians have to rethink familiar procedures. In liver treatment, histotripsy platforms introduce acoustic ablation systems that look nothing like conventional surgical tools. So, when technology shifts dramatically, the cognitive burden on clinicians increases, and HFE becomes a vital bridge between novelty and trust.
If a system matches how clinicians already think and work, adoption happens naturally. If it feels unfamiliar or mentally demanding, hesitation follows. HFE is critical here because when clinicians feel confident with a device, adoption speeds up.
Take IDE Group’s work on the Bayer Centargo CT injection system. The technical goal was precise contrast delivery, but in a real radiology department, the pressure is on throughput. If setup is slow or line changes are awkward, clinicians notice immediately. We focused on streamlining the workflow around contrast injection, cutting setup time, and simplifying interactions so the system supported the department’s pace. This shift improved both clinical outcomes and commercial results. That’s when Human Factors Engineering actually drives product success.
How does IDE Group’s simulation strategy change the quality and speed of decision-making?
We like to tackle usability questions early. Rather than waiting until the design is nearly complete, we run realistic simulations from the start. This way, engineering and HFE shape each other throughout development.
For example, OXOS Medical’s MC2 handheld X-ray system was designed for use outside traditional radiology environments. That creates completely different ergonomic and operational conditions. Weight distribution, aiming geometry, activation controls, and fatigue all behave differently in unpredictable settings.
IDE Group’s testing approach introduced physical simulations early, so we could observe how clinicians interacted with OXOS under realistic conditions. That’s a vital component of what we call our Minimum Viable Chaos (MVC) philosophy of replicating unpredictable clinical environments during testing.
Regulators like the Federal Drug Administration (FDA) now expect HFE testing to reflect unpredictable user environments and ensure safety under pressure. With our MVC approach, we catch small issues early, problems that might otherwise take months to appear. The real benefit is not just faster iteration, but better decisions based on real use from the start.
As devices become more specialized, accurate simulation relies on people with direct, hands-on experience in those clinical settings. This is especially important in high-acuity areas like electrophysiology and pediatric care, where even minor usability issues can have really serious consequences.
Can you talk a bit about how IDE Group is expanding its team to support increasingly complex outsourced usability testing for MedTech?
There seems to be a major industry shift underway. Devices are now so specialized that most MedTech companies can’t hire HFE experts to cover every clinical area. Modern HFE is no longer just about running usability sessions. You need people who truly understand the clinical environments, the workflow pressures clinicians face, as well as the regulatory expectations for those systems.
Many internal MedTech teams are stretched thin. They may have strong engineering skills, but lack usability expertise across all specialties. That’s where IDE Group can step up, providing immediate expertise as an external HFE partner.
That’s a big part of why we’ve continued to expand IDE Group’s HFE team, bringing in specialists with deep domain experience including electrophysiology systems, pediatric dialysis programs and cutting-edge cardiac management systems.
Our team’s expertise helps clients make realistic decisions from day one. We don’t use generic usability theory. Instead, we assess systems based on how clinicians work in real environments. This leads to better feedback and more confidence before validation.
How important is realistic clinical simulation for proving safety and adoption?
I think it’s absolutely critical. One major reason is that clinical environments are operationally unpredictable. They are busy, noisy, and interrupted spaces where attention is constantly divided. Regulators understand this and increasingly expect evidence that devices perform reliably under those conditions.
In advanced platforms, particularly robotic and image-guided systems, the challenge is often cognitive as much as physical. If realistic workflow pressure is absent during medical device usability testing, the evaluation is incomplete. That’s particularly true in environments like electrophysiology labs, where workflow, communication, sterile field management, and spatial constraints all affect how clinicians interact with technology. If those pressures aren’t recreated during testing, you’re not really evaluating how the system will behave in real clinical use.
Our high-fidelity MVC simulations uncover subtle issues that emerge only under real cognitive load. These simulations identify interface ambiguities, attention conflicts, and workflow bottlenecks before they reach clinical practice. With that approach, we’re enhancing safety as well as building regulatory trust by ensuring evaluations reflect actual clinical use.
How should MedTech companies think about the relationship between HFE and regulatory strategy to optimize ROI?
We don’t separate them. Those disciplines evolve together. Engineers, designers, and HFE specialists collaborate continuously so that decisions are made with a shared understanding of constraints and objectives.
Every decision is connected. Engineering choices shape usability, which in turn impacts workflow and regulatory risk. Manufacturing constraints influence interaction design. These factors must be considered together throughout development, I believe.
A system like Bayer’s Centargo is a good example. Fluid dynamics influenced the disposable geometry, which in turn directly affected connection usability. Manufacturing and sterility requirements shaped form and interaction. Those considerations don’t exist in isolation.
We’re bringing regulatory constraints into early design to prevent costly late-stage changes. When engineering, usability, manufacturing, and regulatory needs evolve together, the product stays aligned, technically, clinically, and commercially. This integrated approach helps us to keep timelines on track and preserves the original vision without eroding ROI.
How are regulatory expectations evolving around HFE?
FDA and regulatory Human Factors usability testing expectations are increasingly centered on realistic use conditions. They want to see evidence of iteration. So, regulators increasingly expect medical device Human Factors programs to demonstrate thoughtful development, not just polished documentation.
Take the example of a highly complex system, such as Cardiac Rhythm Management: regulators increasingly expect evidence of clinical usability rather than purely theoretical risk analysis. That means development programs need to generate meaningful usability insight throughout validation. Our cardiology expert, Andrew Lilja, is particularly valuable in this sort of scenario because there’s enormous pressure on information clarity, cognitive load management, and decision-making under time constraints.
A credible submission tells the story of iteration. It shows where risks were found, how they were explored, and how the design changed. I think that sort of transparency demonstrates rigor and signals that the device has been stress-tested both conceptually and in practice.
As medical devices become more connected and data-driven, how is HFE evolving?
The focus is shifting to cognitive ergonomics. Physical interaction still matters, but the bigger challenge is how information is structured, prioritized, and presented to clinicians.
Connected systems generate massive amounts of data. If that information is not organized well, it quickly overwhelms rather than helps. Managing attention, cognitive load, and alert fatigue is now central to HFE.
What role does clinical realism play in producing stronger usability evidence?
Authenticity is critical. If a usability protocol does not reflect how a procedure actually happens, the gap becomes obvious quickly. Clinical environments have operational nuances that are hard to replicate without deep procedural understanding.
Spatial constraints, training gaps, interruptions, communication dynamics, and clinician movement patterns all affect how devices are used. When validation studies mirror those realities, the resulting data carries weight. Reviewers can see that the testing conditions reflect genuine use. So, that builds trust in both the findings and the team behind them.
That’s one of the reasons IDE Group established the Simulation Usability Lab (SULi) to realize the full potential of our MVC approach to clinically accurate testing. SULi is a physical environment that allows our clients to evaluate their prototypes under the chaotic conditions found in real clinics. If a device will be used in noisy, poorly lit, or crowded environments, SULi can reproduce that chaos and reveal design shortcomings that traditional testing often misses. When testing accurately reflects those realities, the resulting evidence becomes far more credible for both regulators and customers.
What do MedTech companies ultimately gain from embedding HFE early?
There are multiple stages of benefit. Early in development, MedTech teams require both challenge and clarity, including critical evaluation of workflow concepts in real conditions. This stage involves exploration and candid discussions. Later, teams need rigor and defensibility through summative testing that meets regulatory scrutiny and demonstrates safe, effective use.
We maintain continuity across these stages. The same people who challenge early assumptions stay involved through validation. That preserves institutional knowledge and keeps the original vision intact as the documentation grows.
If we’re able to spot workflow and usability risks before major investment, that protects both the timelines and the budget. But the real value lies beyond cost avoidance. Early HFE insight leads to better development decisions. Our customers value that IDE’s process recreates the reality of how their devices will be used, not just how they will pass validation.
Rethinking HFE is becoming essential for market success
For MedTech companies building new products, usability insight cannot wait until validation. The best teams test earlier, simulate more realistically, and design around how clinicians work.
IDE Group helps MedTech teams bring high-fidelity HFE simulation and clinical usability expertise into development early. This improves decision quality, builds regulatory confidence, and reduces downstream risk before market entry.
See how IDE Group can help your team reduce usability risk and accelerate market readiness.
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.
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