Beyond Compliance: How to Maximize the ROI of Human Factors Engineering

Transforming Human Factors from a Cost Center to a Value Driver

If you look at the Medical Device and Human Factors Engineering (HFE) landscape today, our industry has reached a remarkably high standard.

Compared to the fragmented maturity we saw 10–15 years ago, our processes are now robust, compliance frameworks are mature, and most organizations employ at least some sort of HFE process within their development pipelines. But this very maturity has brought us to a critical crossroads.

We all want earlier design involvement, the opportunity to do more research, and more budget. But we will not get them if we keep providing "more of the same."

Historically, HFE has been viewed as a use-related safety gatekeeper. But safety is no longer a market differentiator - and it probably never has been. Safety is the baseline; it is what users and regulators need to expect from any medical product.

If we want to increase the return on HFE investment, we cannot offer more safety - we must look beyond use-related safety, and start to systematically contribute to product success.

To accomplish this, we need to expand the scope of the current HFE process by adding the following three strategic pillars:

1. Identifying Unmet Stakeholder Needs

Traditional, compliance-driven HFE in line with IEC 62366-1 focuses exclusively on the intended use, user, and use context. While this is essential for use-related safety and regulatory approval, it is too narrow a lens for ensuring clinical and commercial success - aka real-world value.

To drive real-world value, we have to expand the scope of our HFE activities to map the entire stakeholder ecosystem and product lifecycle. What unmet treatment opportunities exist? Who impacts the purchasing decision? Who manages the device's lifecycle? What factors are prescribers and patients taking into consideration? By uncovering the unmet needs of procurement teams, hospital IT departments, clinic managers, prescribers, patients, and payers, HFE can inject high-value insights into early product definition.

Don't just focus on developing a solution that users and clinicians can use safely; develop solutions that the healthcare system wants to use.

2. Aligning R&D with Clinical Reality

More often than not, medical devices are engineered to satisfy technical and regulatory specifications rather than the chaotic reality of a clinic or a patient's home environment. When R&D loses touch with actual needs, the resulting solution will likely be unfit for its purpose.

This is where HFE plays its most critical core role: bridging the gap between technical possibilities and limitations, regulatory requirements and expectations, and real-world workflows and needs. By introducing rigorous market research, ethnographic research, and simulated use evaluation early in the development cycle, we can ensure that R&D teams build for success. As Barbara Koop from Philips brilliantly put it during a R&Y's HFE conference in Berlin in May 2026:

"Safety does not sell. Solutions that solve problems do.”

HFE’s job is to guarantee that R&D effectively solves the right problems - ensuring a seamless real-world workflow fit that eliminates user frustration and stakeholder objections alike.

3. Providing Evidence of Safety and Value

The traditional HFE lifecycle ends with design validation - a massive compilation of data designed purely to demonstrate that the solution is safe for use. Once the clearance is obtained, that documentation is archived, completely underutilized by the rest of the organization. A value-driven HFE approach looks downstream to clinical implementation and long-term commercial needs.

The same scientific methodology we use to generate safety data can be used to generate real-world value data.

By capturing evidence of workflow optimization, reduced setup times, lower training overhead, and decreased error rates, HFE provides the ultimate toolkit for clinical and commercial teams. We hand them the empirical evidence they need to confidently drive market adoption and prove ROI to buyers.

The Bottom Line: Redefining Human Factors Value

If we want to leverage the full potential Human Factors Engineering offers to actively contribute to the clinical and commercial success of the solutions we develop, we must stop positioning it as a cost center.

Instead, we need to redefine what it delivers. By identifying holistic stakeholder needs upstream, aligning R&D with real-world workflows and needs, and equipping commercial teams with clear, evidence-based value, HFE becomes a powerful driver of product success.

In this role, HFE is no longer 'just' about safety and compliance. It becomes an enabler of a strong commercial adoption strategy, helping us moving from approval to meaningful, sustained market uptake.

Implementing a Value-Driven HFE Process

Our team has expanded the traditional, IEC 62366-1 compliant human factors process into an extended, value-driven HFE process that bridges the gap between technical potential, regulatory requirements, and commercial success.

Find out how you can improve your current process to maximize the ROI of your HFE efforts in a brief, technical review with our experts.

What we’ll cover:

• Extended Process: We will show you how we extend your process by integrating user and market insights and commercial value evidence.

• Case Studies: See practical examples of how we have been integrating stakeholder insights and supporting product adoption.

• Pipeline Check: Let's take a quick look at your current objectives to see if our approach to an extended, value-driven HFE process is right for your device and organization.

Let’s explore what's possible - together. Contact us at hello@efty.group to coordinate a time with our technical experts.

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