Meeting Tight Deadline Moved Complex Heart Treatment Forward
The Business Problem
Acutus Medical has pioneered a treatment that enables an electrophysiologist to see, for the very first time, an irregular rhythm as the heart beats.
This procedure, known as electro-functional guided ablation, allows EPs to visualize the anatomy of the heart chamber, map the electrical conduction of each heartbeat, identify the precise locations causing atrial fibrillation in real time, ablate only those locations, and then re-map to confirm therapy effectiveness.
There are three components to the system: the user interface which is displayed on a standard off-the-shelf LCD monitor attached to a custom computer cart, a console that rests on the cart and a catheter.
Acutus Medical engineers had already developed a functional console to prove product feasibility and conduct testing. MindFlow Design was engaged to create an industrial design strategy for the console. Our tasks included creating the user interface and defining a visual brand language.
The Client’s Challenge
As a privately held start-up, Acutus Medical was in the same race against time faced by many young medical technology innovators. Having already established proof of concept, the company faced an urgent need to achieve U.S. Food and Drug Administration approval as the basis for securing funds that would bring a revolutionary new product to market.
Accordingly, Acutus set a very aggressive timeline for MindFlow Design’s participation.
We began by holding what we call a “diagnostic discovery workshop” in which the executive and project teams shared views. Confirmation that everyone is on the same page is particularly important when tight deadlines simply do not allow time for wheel-spinning or wrong moves. The discovery workshop is a hallmark of MindFlow’s process.
Next, we conducted workflow walk-throughs with users in a mocked-up operating room to identify the right sequence of events for console set-up, preparation and the ablation procedure itself, and establish requirements for them. We studied various solutions for positioning the console in the room, access to cable, and wire connectivity and storage within a complex environment already filled with nurses, doctors and other medical devices. Issues included where to vent console heat and how to maximize console maneuverability. We created mockups for users to run through multiple scenarios and help us choose the best solution. Once we confirmed that we were going in the right direction, we could complete the industrial design.
As the project progressed, we also contributed to some of the electrical engineering work on the technology by imbedding one of our engineers on the client’s team for several months. And we helped Acutus expedite IEC 60601-1-required regulatory testing by creating prototypes of the console’s entire physical enclosure.
Having met our deadline, we were pleased to learn that in April 2019, Acutus Medical announced FDA clearance of its second-generation AcQMap platform, along with CE Mark approval for its AcQMap software. Less than two months later, the company announced that it had received $174 million in funding to bring the product to market.