The human heart is full of mysteries, but solving some of them can mean the difference between life and death.
Heart disease remains the leading cause of death worldwide, according to the 2021 Statistical Update from the American Heart Association. Over the past decade, the number of deaths has increased 17.1%
When blood vessels become clogged, a breakdown in the flow of blood to and from the heart can lead to cardiac arrest and other medical emergencies. Doctors help in these situations through minimally invasive procedures known as percutaneous coronary interventions (PCI). Their success, however, often depends upon being able to properly identify occlusions and know the best area to place a stent. A stent is a tiny, expandable metal mesh coil. It is put into the newly opened area of the artery to help keep the artery from narrowing or closing again.
An innovative new intravascular imaging platform from Gentuity using a 1.8 F micro-imaging catheter is making PCIs more viable than ever before. But ensuring health-care practitioners make the most of its technology requires a best-in-class approach to user experience (UX) design. That’s why Gentuity collaborated with Loft to help lead formative research, UI development and summative usability testing. This multi-year collaboration led to a successful FDA 510(k) submission.
Founded in 2015 and based in Sudbury, Mass., Gentuity is focused on advancing patient care and improving outcomes by developing the next generation of intravascular imaging devices, particularly in areas such as cardiovascular disease. This includes a proprietary platform that fully incorporates the company’s artificial intelligence (AI) tools to enhance ease of use and procedural success.
Minimally invasive PCI stenting has been widely used for some time, but the supporting imaging technologies have not evolved much over the years. Gentuity identified an opportunity to enhance intravascular imaging by creating a smaller imaging catheter technology, giving interventional cardiologists the ability to see more of the vessel faster. This could improve patients’ safety. The company’s solution includes a catheter which is which is less than half the size of the current generation of devices, which also allows imaging of very narrowed blood vessels that wasn’t possible before.
To gain traction among physicians and interventional laboratory technicians, the HF-OCT Imaging System also needed a user interface that would be simple, intuitive and elegant. Like most medical device manufacturers, however, Gentuity’s expertise lies more in the technical details of developing a truly innovative product than UX design.
Gentuity turned to Loft to undertake a comprehensive UX development and design process that would build credibility and trust among the medical community and accelerate the adoption of advanced intravascular imaging based on research and design best practices.
Loft’s development process kicked off with foundational research to generate a body of knowledge around the proposed platform, followed by a 360-degree evaluation of the complete user experience. This helped inform the development of the platform’s information architecture, followed by prototyping the best solutions for the user interface. Testing was then conducted with physicians and nurses using simulated PCI procedures.
The UX work for Gentuity meant considering the complete journey medical professionals and their patients experience during PCI procedures, from setting up patients in the hospital’s EMR, creating “pullback” images, measuring vessel topography and retrieving previously stored images.The resulting user interface had to support the entire workflow.
Loft conducted further usability testing that included a “cognitive walkthrough” of the interface, which gathered critical feedback to further refine the solution. Loft’s work wasn’t limited to interacting with Gentuity’s team but connecting in the field with doctors and nurses across multiple geographies to ensure the UX design aligned with their expectations and needs.
Since working with Loft, Gentuity hasn’t just successfully launched its HF-OCT imaging platform. It has become recognized as a leader in its field and has since formed a commercial partnership with Nipro, a Japanese global medical technology leader.
Other highlights include:
As is common in the medical device manufacturing sector, Gentuity had to demonstrate that its product would be safe and effective in the treatment of cardiovascular health. Loft’s UX design work ensured that Gentuity could move forward with confidence as it brought its HF-OCT Imaging System to its target market.
For example, the requirements as part of FDA clearance stipulated that Genuity would need to provide a report with all usability-related activities that were conducted, as well as design inputs. Working with Loft meant Genuity was able to provide UX research that would comply with the latest human factors engineering (HFE) regulations.
In early February of 2021, physicians at Tampa General Hospital and USF Health’s Interventional Cardiology team achieved a significant milestone: treating the first coronary artery disease patient in the world by using Gentuity’s high-frequency optical coherence tomography (HF-OCT).
The procedure showed the transformative nature of Gentuity’s HF-OCT Imaging System and the interface developed in partnership with Loft, which not only guided the medical team on selecting the three stents that were used, but how to optimize their use.
While its initial focus with the HF-OCT Imaging System has been on the cardiology space and PCI procedures, Gentuity’s innovative approach could allow the company to explore applications for intravascular imaging in other areas of health care. Loft’s UX work means Gentuity can extend the same simple, intuitive and elegant approach to support medical practitioners in these areas as well.
Thanks to Gentuity, the future of cardiovascular health looks brighter than ever – and best-in-class UX is at the heart of it.