Why Human Factors Engineering is vital in MedTech
Many medical devices fail not because of technical shortcomings, but because they overlook how people actually use them. In high-stakes healthcare environments, usability is not optional, it’s essential for safety, compliance, and commercial success.
In the $810 billion global medical devices market, technological innovation alone is not enough to guarantee success. In environments where decisions are made in seconds, users adapt devices to reality, and the margin for error is razor-thin, Human Factors Engineering (HFE) plays a decisive role. It transforms advanced technology into tools that are safe, intuitive, and easy to adopt and, in doing so, helps manufacturers achieve both regulatory compliance and competitive advantage.
At Pilotfish, HFE is not a service applied at the end of development. It is embedded from day one, integrated seamlessly into our industrial design, engineering, and risk management processes. This means that usability insights feed directly into design iterations, preventing late-stage redesigns that can delay market entry and increase costs.
Our team works to IEC 62366-1 and ISO 14971 standards, ensuring a systematic link between usability findings, risk controls, and design refinements. By identifying potential use errors early and validating solutions through real-world usability studies, we help our clients reduce regulatory review times, strengthen submissions to the FDA or under MDR, and improve post-market performance.
This approach is particularly valuable for devices where hardware and software must work flawlessly together. From refining touchscreen interactions to optimizing ergonomics for long-term use, Pilotfish applies both proven usability techniques and advanced tools such as eye-tracking to deliver actionable insights.
The business case is clear: in 2024, 36% of global medical device returns were due to user-related issues, not technical failures. Addressing usability early leads to fewer returns, shorter training times, reduced support needs, and higher adoption rates, all of which directly impact revenue and brand reputation.
For manufacturers looking to turn regulatory compliance into a strategic asset, Human Factors Engineering is no longer optional. At Pilotfish, we make it part of the DNA of every MedTech project we deliver.
Read the full article: Human Factors Engineering: Pilotfish Core Strength in MedTech Development
