By Brian Brus
Courtesy of The Journal Record
OKLAHOMA CITY – Within hours of approval by the Food and Drug Administration, David Albert was already taking sales orders from across the U.S. for his app that turns a smartphone into an ECG heart rate monitor.
Buyers overseas immediately followed under the CE mark signifying European Union conformity, and worldwide sales are expected soon afterward.
And then? Market copying and theft, he said.
“We’re just now revving up speed. We haven’t started selling yet in the EU, but we’ve hired a general manager for that market,” he said. “I see us moving around the world to South America to Asia to Africa.
“I have absolutely no doubt that we will have significant competition,” Albert said. “We have some first-mover advantage. But good ideas are copied; great ideas are stolen. I have absolutely no doubt that we will have competitors, so we must continue to deliver the best products at the best value while remaining the most innovative.”
Approval from the FDA is not a simple process for any product, much less an Apple iPhone app. Most companies simplify their approach to appeal to a more generic level of health assistance and avoid the problems of scientifically backed medical labeling. Albert didn’t shy away from the challenge, however, when he started work on the AliveCor portable ECG.
Albert said he wanted to make heart monitoring easy, affordable, and accessible to allow caregivers and patients in developing nations the ability to monitor chronic heart problems. And the latest smartphone technology was much easier to modify to that end than building entirely new hardware infrastructure. Ultimately Albert found a way to embed electrodes in a smartphone casing that can read a patient’s vital signs and download them for analysis.
An electrocardiogram, or ECG, is a diagnostic test that allows medical providers to analyze the heart’s electrical activity to identify the source of problems such as inadequate blood flow and irregular heartbeats. The machinery normally costs thousands of dollars. Now that AliveCor has FDA Class II clearance, the company is selling ECG monitors online for $199 to registered physicians.
Although other news media have identified AliveCor as a San Francisco-based company due to the source of venture capital acquired last year, Albert said he has no intention of letting the company move.
“I live in Oklahoma; I’m not going anywhere, I promise,” he said.
AliveCor has raised nearly $15 million over the last year, which is sufficient to roll out the product, he said.
AliveCor won the overall Journal Record Innovator of the Year award this year.