The Perils of Medical Device Predicates and User Interface Design

By Jenny Collinson , Director of Strategy and Advisory at ClariMed, Inc.

Medical devices are crucial in today’s healthcare, aiding diagnosis, treatment, and monitoring of various health conditions. However, the process of bringing new devices to market is complex, often lengthy and can be challenging. One such challenge is the reliance on referencing medical device predicates to gain regulatory approval in the US.

What are Medical Device Predicates?

A medical device predicate is a previously cleared or approved device that a new device is compared to. The new device must demonstrate substantial equivalence to the predicate, meaning it has essentially the same technological characteristics, intended use, and performance as the predicate device.

The Problem with Predicates and User Interface Design

While the predicate pathway 510 (K) is designed to streamline the regulatory process and is often the preference for manufacturers, decreasing the time needed to access the US market, it can also hinder innovation and impact safety.? One of the areas that can be impacted is user interface (UI) design.

It is possible that the 510 (K) pathway may lead to stagnant UI Design due to manufacturers being risk-averse, being hesitant to introduce significant UI design changes, fearing increased regulatory scrutiny.? This could lead to suboptimal user experiences/ user interface designs and embed historically inadequate design or even UI design that has been subject to a recall, potentially increasing the risk of errors and adverse events in the new products.

Additionally, the focus on incremental improvements and speed to market, rather than groundbreaking UI designs, can stifle innovation. This can lead to missed opportunities to improve patient safety and device usability.

…and sometimes the drive to demonstrate substantial equivalence can be challenging, even more so than proving a new design which can lead to increased regulatory costs and delays in bringing new devices to market.

Most interestingly, despite the apparent benefit of speed to market for ‘me too’ devices, the cost of healthcare in the US continues to be very high – could this be due to research and development spend being burned on inadequate designs that do not ensure current standards of patient safety and do not optimize workflow efficiency and patient compliance?

The Importance of ‘State of the Art’ User Interface Design in Medical Device Safety

A well-designed user interface, considering up to date requirements, is crucial for ensuring the safety and efficacy of medical devices. A clear, intuitive, and user-friendly interface can help to:

• Reduce Use Errors: A well-designed interface can minimize the risk of use errors, such as incorrect input or misinterpretation of information.
• Improve Patient Safety: By reducing use errors, well-designed interfaces can help to improve patient safety and reduce the risk of adverse events.
• Enhance Device Usability: A user-friendly interface can improve device usability, making it easier for healthcare professionals to use the device effectively.

So how do we ensure that UI designs are the safest they can be?

In order to ensure that UI designs are ‘state of the art’ and reduce risk for the end user a good design and development process should include:

• Embedding human factors engineering principles.
• Prioritizing user-centered design to ensure that devices are designed to meet the needs and capabilities of the intended users (in the current market not that of the predicate launch).
• Ensuring that rigorous usability testing is carried out to identify and address potential usability issues.

By addressing these challenges and prioritizing ‘state of the art’ user interface design rather than relying on comparison to existing UI design, we can contribute to safer and more efficient medical devices.