In the day of an electrophysiologist — a cardiologist who specializes in the electricity of the heart — there is one distressing scenario that presents itself all too often. A patient with symptoms of an irregular heartbeat, the feeling that the heart is racing, and perhaps dizziness, shortness of breath or fainting. Numerous tests are run, but the results are inconclusive.
Before Abbott developed Confirm Rx™ ICM, an insertable cardiac monitor that links to patients' smartphones to provide real-time recording of the heart rhythm, physicians didn't have many favorable options when confronted with this dilemma. They could have the patient monitor symptoms on their own with a limited wearable device, such as a traditional EKG monitor, which can be burdensome for the patient to wear and time-consuming for the physician to obtain and interpret results, in part due to a lack of smartphone connectivity.
Abbott moved to tackle this challenge head-on from the outset: What was a better monitoring solution? What could be less intrusive, and a better use of technology allowing doctors to glean a real-time understanding of a patient's abnormal heart rhythms and potentially identify the cause of symptoms?
Finding answers to big questions
Working together, Abbott's teams found the answers, manufacturing a device that utilized new technology and would be a feasible option for thousands of patients.
Micah Meulmester, senior manager of device operations in Abbott's Cardiac Rhythm Management (CRM) business, is charged with turning Abbott engineers' designs into reality through the manufacturing process. He still marvels at the size of the Confirm Rx ICM device to this day. The implanted device is 3.1 millimeters thick or a little less than two U.S. quarters stacked together.
"Size is one of the things that's very important to our customers because their patients don't really want to know that it's there," Meulmester says of the device. "Because of its discreet size and smartphone connectivity, it's something that patients don't have to act on or worry about. The challenge for our engineers is how do you make a cost-effective product while also pushing the boundaries of technology?"
Meulmester remembers confronting those challenges in bringing Confirm Rx ICM to life — he and the team of engineers helped implement a design that was a first for implantable cardiac monitors: the ability to communicate with a patient's smartphone with Bluetooth® wireless technology. It was an important innovation to understand packaging and manufacturing the technology in such a small device while also protecting the electronics from the body's fluids and harsh internal environment.
Alex Soriano, director of mechanical development and material science in Abbott's CRM business, supported delivering that intelligent design along with cross functional engineering disciplines including systems, electrical, clinical, software, firmware, and program management. Soriano supported getting after the big issues: how to solve a problem that was vexing electrophysiologists and create a design that would work for both patients and doctors, providing a less intrusive procedure and help ensure patients are always connected.
It's one of the things Soriano loves about Abbott. "It's these types of problems that I've found fascinating, and there's a significant amount of unmet clinical need," Soriano says of Confirm Rx ICM. "I've always had an interest in wanting to improve patients' lives and do it with engineering principles."