by Tim Rowan, editor

James Mault, MD, FACS, is a heart surgeon, a talented heart surgeon with hundreds of saved lives to his credit. Over time, he noticed that his patients were often well on their way to full recovery in post-op and for the remainder of their hospital stay, but that they might begin to fail after discharge. Even if they spent some time in a skilled nursing facility or rehab hospital, even if they had nurses visiting them periodically in their homes, a certain percentage of them would fail between home health visits.

Inspired by the necessity, Dr. Mault developed a wearable heart monitor that his patients could wear 24/7. He decided it needed to be small enough to be worn discretely under clothing, powerful enough to detect changes in heart condition, and simple enough so that patients could use it without any technical expertise. The result is the "BioSticker™," the first FDA-cleared, single-use device for up to 30 days of continuous vital signs monitoring.

The company Dr. Mault established to develop and market the device, "Biointellisense," is the fifth health IT and medical device he has founded. He spoke to us from his Denver office about his invention.

"It works in two ways," he began. "It attaches to the left side of the patient's chest with double-sided adhesives. With medical grade data capture, it monitors heart signals with clinical accuracy physicians can trust. From its internal memory, it transmits data every 10 minutes, via Bluetooth, to what we call a 'BioHub,' placed in a central location in the home. The hub is about the size of a hockey puck, includes a Qualcomm 5G cellular modem, and transmits data via an AT&T account."

Stick it on, plug it in

Dr. Mault is most proud of the system's design that requires no expertise on the part of the patient, the family, or the home health nurse who might deliver the equipment. "These days, with social distancing, we will be shipping it directly to patient homes," he explained, "but we are confident it is so easy to set up, people will not need help setting it up. We started with the premise that the user experience had to be effortless and passive. When it arrives, they plug the hub into an electrical outlet, stick the monitor onto their chest and press one button. And they're done. The monitor automatically finds the hub through Bluetooth without any user interaction. Once connected, it begins to transmit to the cloud, and from there to clinicians."

The BioSticker™ is waterproof so does not have to be removed for bathing. It is shipped with a supply of double-sided adhesives. The extras may be needed because the battery is good for 30 days. "Actually, it is FDA cleared for 30 continuous days of use," he said, "but the device tells us when it is time to change it, and it is usually longer than 30 days."

"While attached to the chest, BioSticker™ measures heart rate, temperature, respiration rate, and other vitals. It makes rich data available to hospital or ambulatory clinic physicians by delivering directly into their EMR. It can also populate other downstream dashboards and viewers. A set of APIs make it easy for any EMR to access data streaming from sticker.

Revenue model

Dr. Mault concluded by describing BioIntellisense's cost structure. "We are a data service," he insisted. "We don't sell the stickers. Our revenue comes from the data service we provide. For about $60 per patient per month, a patient get the BioSticker, the BioHub, the AT&T account, and our call center services. We have a number of strategic partners with nurse call centers and case managers, "virtual care command centers," where one nurse on a dashboard can monitor 500 to 1000 patients. Our dashboard helps them triage by display patient condition in red, yellow, and green fields."

biointellisense.com

©2020 by Rowan Consulting Associates, Inc., Colorado Springs, CO. All rights reserved. This article originally appeared in Home Care Technology: The Rowan Report. homecaretechreport.com One copy may be printed for personal use; further reproduction by permission only. editor@homecaretechreport.com