Lessons Learned: The Power of Early Prototyping in Medical Device Design

In the world of medical device development, user-centered design isn’t just a best practice - it’s essential. One of the key lessons I’ve learned over my career is the value of early prototyping and user testing. It’s a strategy that can save time, money, and, ultimately, lives. An experience I had while working on Biosense Webster’s nGEN RF generator, part of the CARTO ablation system, perfectly illustrates this.

The Challenge: Designing for Complex Environments

The nGEN RF generator was a crucial component of the CARTO ablation system, used in complex cardiac procedures. We knew the device would be used in crowded, high-pressure environments where technicians juggle multiple tasks. Getting the design right was critical, not only for usability but also for ensuring the device would fit seamlessly into these spaces. This meant considering everything from the device’s size and shape to its physical controls and user interface.

 The Approach: Prototyping Early and Testing Often

To tackle this challenge, we decided to create early prototypes with different hardware designs. We varied everything: size, aspect ratio, and physical controls such as knobs and buttons. Our goal was to gather user feedback as early as possible. I travelled to hospitals across the US and Europe, speaking to technicians who would eventually use this device. It was essential to understand their workflow and the environment in which the nGEN would operate.

Key Insights: Making It Fit

One of the most significant insights from this early formative usability study was the importance of space management. Technician rooms in catheterization labs are incredibly crowded. It’s not just a matter of fitting the device into the room; it has to fit on a table already cluttered with other monitors, equipment, and devices. If we designed a device that was too large or cumbersome, it would be a non-starter, no matter how advanced the technology inside.

Another key takeaway was the issue of visibility and legibility. In these environments, technicians don’t always sit or stand directly in front of the monitor. They’re moving around, handling multiple tasks. This meant we had to consider glare and reflections on the monitor and ensure the UI was readable from different angles and distances.

Impact on Design: Informed Decisions

These insights had a direct and profound impact on the device’s final design. We refined the physical size and aspect ratio to fit comfortably into the crowded space. We adjusted the controls, ensuring they were easy to operate in tight quarters. We also improved the UI, making sure that critical information was legible from various angles and in different lighting conditions.

The following formative and summative usability tests I performed validated these decisions. Technicians found the device easy to use and navigate, and it integrated well into the existing setup. The feedback was overwhelmingly positive, confirming that we had successfully addressed the key issues identified early on.

Lesson Learned: Test Early, Test Often

This project was a powerful reminder of something I’ve always believed: test early and test often. Early prototyping and user testing are invaluable. They allow you to catch potential issues before they become costly mistakes and help you design products that truly meet user needs.

In the end, early and iterative testing isn’t just about fine-tuning details - it’s about understanding the broader context in which a device will be used. It ensures that you’re not designing in a vacuum but instead creating something that genuinely integrates into the user’s environment and workflow. For the nGEN project, these early insights shaped not only the device’s form and function but also its success with users.

Final Thoughts

The nGEN project reinforced a fundamental truth for me: no amount of lab-based brainstorming can replace the value of real-world feedback. By engaging with users early and often, we can create medical devices that are not just innovative but also practical and user-friendly. This approach not only improves usability but also enhances the overall safety and effectiveness of medical procedures.

For anyone working in medical device design, I can’t stress enough the importance of early prototyping. It’s not just about testing a product - it’s about validating your assumptions, discovering unforeseen challenges, and ultimately ensuring that your design truly meets the needs of those who will rely on it.

Get in touch now to find out how my expertise in human factors and user testing can improve your product.