To perform most blood tests, a nurse draws a vial of blood from a patient and sends the sample to a lab, where it’s spun in a big machine and analyzed. Then the lab technician sends the patient’s results to the physician who ordered the test. The entire process takes up to two hours, but can be rushed for urgent cases.
But what if that same testing process could take five minutes instead of two hours? What if it could be performed right in the hospital’s ER, OR or ICU? And what if it required just a drop of blood?
Punkaj Ahuja, founder of Apollo Medical Devices, is making this a reality. The company’s point-of- care blood testing system takes blood tests out of the lab completely, letting doctors and nurses read a basic metabolic panel by squeezing a single drop of blood onto a disposable cartridge, which sends the results to a handheld analyzer.
“We think of it like a glucose meter,” says CEO Patrick Leimkuehler.
From prototype to production
Starting in 2012, Punkaj spent a year working with SMART Microsystems at the Richard Desich SMART Commercialization Center for Microsystems at the college to develop and test the technology behind his innovative blood-testing system. He thought of the idea for the product at Case Western Reserve University, where he was earning his Ph.D. in biomedical engineering, but couldn’t be sure he had a viable business until he had a working prototype produced at a competitive cost.
“We developed the proof of concept for the core technology but by working with SMART Microsystems we were able to prove scalability – that it was a commercially viable product,” he says.
Punkaj learned how to use equipment, instrumentation and clean rooms to engineer and produce microelectronics for the system’s single-use cartridges at a lower cost than competitors are able to.
“There are other devices that do this, but they’re very expensive,” he says. “Competing handheld devices cost $15,000. Our analyzer will sell for a third of that price.”
Out of the kitchen
Apollo is now in the “alpha phase” of prototype development, which will prove whether it can mass produce the cartridges without issue, says Patrick.
“We have to know if we can make a thousand at a time that respond as they come off the line and six months later — without having to wait an actual six months,” Punkaj says.
The pair is again using SMART Microsystems to do the testing, conducting environmental life tests to identify reliability issues. The work they’re doing at SMART Microsystems is accelerating their product’s time to market.
Punkaj and Patrick hope to complete their pre-clinical study this summer and move into full clinical trials in winter 2017. So far Apollo has hired four full-time and three part-time staffers.
“Last year at this time, it was me and Punkaj in his kitchen, writing on his whiteboard,” Patrick says.