Human-Centered Design for Smarter CRT Outcomes

Closing the Precision Gap in CRT

Cardiac resynchronization therapy (CRT) has become a standard treatment for patients with advanced heart failure, but its promise remains only partly fulfilled. Despite technically successful procedures, roughly one in three patients fails to respond. A significant reason is suboptimal left ventricular lead placement. Conventional imaging methods can guide the procedure anatomically, but they cannot show where the heart’s electrical activation is actually delayed. The result is inconsistency and preventable therapy failures.

Previous monitoring systems did little to solve this problem. They were often bulky and stationary, with multiple components connected by long cables. Patches were not designed for a secure, comfortable fit and could shift during use, degrading signal quality. The systems were time-consuming to apply and impractical for busy wards, limiting their clinical adoption.

This is precisely where design and Human Factors Engineering (HFE) can make a measurable difference. At Pilotfish, we believe the way to improve outcomes is not only by innovating the technology, but by making sure it is compact, mobile, easy to apply and reliable enough for everyday use in demanding clinical environments.

Designing for Real-World Complexity

EP Solutions set out to create a system for non-invasive cardiac electrophysiology studies that would reveal actionable insights about heart activation patterns. The objective was ambitious: generate a patient-specific 3D activation map that helps clinicians quickly identify the most promising pacing site, while making the setup process fast, intuitive and repeatable.

Achieving this required much more than engineering a patch with over 120 electrodes. It meant understanding the constraints of busy wards, the variability of patient anatomy and the cognitive load of nurses and electrophysiologists under time pressure.

Our design team worked to miniaturize the system into three easy-to-apply patches with compact amplifiers that fit more than 95 percent of patients with just two sizes. Mechanical coupling had to be firm enough for reliable signal quality but gentle enough to avoid pressure on the patient. Every physical interaction was considered: from how a nurse peels the first liner to how they connect the amplifier using only two hands without pressing on the chest.

Human Factors Engineering as a Driver, Not a Checkmark

Human Factors work was not a late-stage validation exercise but a guiding principle throughout development. We observed real clinical workflows, mapped hazards and errors, and then iterated quickly.

One early insight was that nurses often forgot to clean the patient’s skin before patch placement. This simple oversight caused adhesion failures and repeated procedures. Instead of just warning about it in documentation, we redesigned the training materials to emphasize this step and placed cleaning supplies visibly near the patch kit. The result was full compliance and zero recurrence of the problem.

We also solved a common usability issue with the patch liner. Because the liner tab was hidden behind the patch, users frequently missed it. By making the patch transparent and adding clear visual cues for where to start peeling, we dramatically reduced application errors.

Even the amplifier connection sequence went through multiple iterations. Using magnets to pre-align the amplifiers allowed nurses to connect them with only two hands, while keeping the coupling force around three kilograms so that no body pressure was needed. The solution was refined through repeated user testing until it became natural and effortless.

Designing for Reliability and Speed

Reliability in clinical practice depends not just on technology but on how easy it is to use correctly every time. We streamlined the workflow to reduce cognitive load, added visual cues to guide correct use, and ensured that feedback on connection status and signal quality was immediate and easy to interpret.

Because many users encounter this system only occasionally, we placed simple, step-by-step guides right where they are needed, supporting correct use even under time pressure. In short, the system is designed to perform as well for the first-time user as it does for the experienced electrophysiology nurse.

Better Mapping, Better Outcomes

When applied, the system captures more than 120 ECGs simultaneously and fuses them with CT data to generate a patient-specific 3D activation map. This map points to the region of the ventricles that activates last, allowing the physician to plan lead placement and intraoperative access with greater confidence. The result is a measurable reduction in non-responder rates and a clear step toward better CRT outcomes.

A Seamless Path from Concept to Manufacturing

Projects like this illustrate why Pilotfish and Zign Group co-exhibit at Swiss MedTech Expo. Our partnership offers an integrated, ISO 13485 certified process covering usability engineering, industrial design, mechanical and electronic engineering, software development, verification and validation, and contract manufacturing. This combination de-risks innovation and keeps development moving smoothly from concept to production.

By Harm Hogenbirk, Co-Founder, Pilotfish