Two students from the University of Minnesota have designed epinephrine auto-injector (EAI) technology that is roughly the size of a credit card. Because the device is more discreet and easy to carry, developers believe it could improve compliance among severe allergy sufferers and reduce the number of anaphylaxis-related hospitalizations and fatalities.
Within minutes of exposure to an allergen, some patients develop severe skin rashes, throat constriction, nausea, and dizziness — a condition known as anaphylaxis, which is life-threatening and requires immediate intervention with a shot of epinephrine. Doctors encourage patients with severe allergic reactions to carry an EAI on their person at all times, but very few who are at risk are compliant.
“Of the 16 million who are at risk for anaphylaxis, less than a quarter currently own an auto-injector and less than half of those carry one at all times,” said Tyler Ebert, co-developer of the AdrenaCard, in an interview with Pioneer Press. Ebert asserts that currently used epinephrine auto-injectors are cumbersome and difficult to carry discreetly, which is why patients are reluctant to carry them.
Together with his partner Christopher Kuehn, Ebert developed an alternative that could fit easily into a wallet, a pocket, on a key chain, or into a smartphone case. Though it is smaller in size, the device administers medication when pressed against muscle, similar to existing EAIs.
Kuehn and Ebert believe their technology “changes the game,” but Ebert noted that, in order to disrupt the market, the startup needs to establish the AdrenaCard as the preferred product for both patients and caregivers. The AdrenaCard is currently being evaluated by the FDA, and Ebert and Kuehn are planning for a 2017 launch. At this time, no price has been set for the device.
According to a white paper published by Philips Medisize, there is a “relentless industry-wide drive” towards smarter, smaller, and more-portable medical devices,” but this next generation technology requires a regulatory process equal to its growing complexity.
“To ensure reliability and repeatability, such complex devices demand a greater number of requirements, as well as more testing and validation during their development than do the larger, simpler devices of previous decades,” said the paper’s authors.
Earlier this year, a medtech startup named Bloom introduced an inhaler slim enough to fit into a wallet. The device is still in its experimental stage, but developers told CBS News that it can be preloaded with the patient’s own prescription inhaler and holds about six doses. Bloom plans to submit an application to the FDA in June of 2016.