Understanding Human Factors Engineering (HFE)
In 2024, the global medical devices market was valued at approximately $810.4 billion and is projected to reach $1.30 trillion by 2029. This explosive growth reflects both opportunity and responsibility. In an industry where user behavior directly impacts outcomes, Human Factors Engineering (HFE) is not a nice-to-have, it’s a necessity. It’s not just about usability, it’s about understanding the real-world interactions between users and devices and designing systems that prevent errors before they occur.
In the high-stakes world of MedTech, where the margin for error is razor-thin, HFE becomes an engine of safety, compliance, and success. At its best, it transforms complex technology into intuitive tools that feel effortless to use, because they were built with humans at the center from the very beginning. And because the lifecycle of a medical product spans from early ideation to regulatory submission and post-market use, integrating HFE from the outset is critical. Whether aiming for FDA approval or MDR compliance, human-centered design and thorough usability documentation are non-negotiable. This is where Pilotfish’s deeply integrated approach to HFE makes all the difference.
Pilotfish’s unique approach to Human Factors Engineering
At Pilotfish, Human Factors Engineering is not an isolated service but an intrinsic part of the MedTech product development process. Unlike external consultants who apply HFE as an add-on, Pilotfish embeds usability and risk management into the design and engineering phases, ensuring a holistic approach from concept to mass production. This deep integration between human factors specialists, industrial designers, and engineers ensures that usability insights translate directly into design improvements without losing key considerations in the handover process.
One of Pilotfish’s core strengths lies in its rigorous risk management approach, aligning with both IEC 62366-1 and ISO 14971. The team identifies potential use errors early in development, tracing these risks to control measures that inform iterative design refinements. By conducting real-world usability studies with actual users, Pilotfish continuously evaluates device performance, documenting improvements and validating safety enhancements. This level of traceability and documentation is not only essential for regulatory submissions but also results in more intuitive and reliable medical devices.
A broad-spectrum expertise for enhanced usability
Pilotfish brings together deep experience in industrial design, usability, engineering, and innovation strategy - domains that too often operate in silos. By uniting them, the team fosters a development environment where user insights shape every stage of the product journey. Their integrated approach empowers clients to make better trade-offs, iterate faster, and ultimately design devices that users can trust and adopt with confidence.
Pilotfish’s fluency across both physical and digital product domains makes it particularly effective in solving challenges where hardware and software must work seamlessly together. Whether refining touchscreen interfaces or validating device ergonomics through real-world testing, the team applies a rich set of methods from traditional usability techniques to advanced tools like eye-tracking to deliver meaningful, actionable insights.
Why invest in usability engineering? A strategic business case
According to IEC 62366-2 the interpretation guideline for the HFE standard IEC 62366-1, 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.
In 2024, nearly 36% of all global medical device product returns were attributed to user-related issues, not technical failures. That’s a powerful indicator of the costs of poor usability.
By applying usability engineering best practices, manufacturers benefit from simpler training due to intuitive operation, reduced need for customer support, and fewer returned devices that are mistakenly deemed defective. Better usability also promotes stronger treatment adherence, increased utilization of key features, and more creative application of existing technologies.
Ultimately, usability engineering helps manufacturers not just build safer products, but smarter businesses.
Regulatory requirements and compliance
Integrating HFE into medical device development is not just a best practice, it is a regulatory necessity. The FDA mandates stringent compliance with human factors guidelines, requiring manufacturers to demonstrate that their devices can be used safely and effectively. The European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) also necessitate usability engineering, though with less prescriptive requirements compared to the FDA. IEC 62366-1 is the globally recognized standard for integrating HFE into the design process, ensuring that risk management principles are embedded at every stage.
Additionally, ISO 14971 provides a medical device risk management framework, linking directly to usability and human factors considerations. Compliance with these standards necessitates comprehensive documentation, iterative testing, and a structured approach to risk mitigation - elements that Pilotfish seamlessly integrates into its development workflow.
Delivering comprehensive human factors solutions
Human Factors Engineering at Pilotfish is more than a checklist, it’s a strategic advantage rooted in both regulatory insight and business sense. Pilotfish’s ongoing work with EP Solutions is a clear example of this commitment, showcasing how rigorous HFE practices lead to devices that support real users in real environments.
If you’re looking to turn usability into a competitive edge - and make compliance a byproduct of good design - Pilotfish is ready to partner with you. Let’s build something that truly works for people.
