A team of South African biomedical engineers have built a cheap replacement for the EpiPen that could revolutionise the emergency treatment of anaphylaxis, a severe allergic reaction that can be triggered by food or insect bites.
Called the ZiBiPen, it delivers a shot of adrenaline in the form of a replaceable, R200 cartridge.
“The cost of the pen is R1,000 and we are testing to make it last up to five years,” said Gokul Nair, who helped developed it alongside fellow University of Cape Town’s Medical Devices Lab alumnus Giancarlo Beukes.
That is a fraction of the cost of the dominant device on the market, the EpiPen, which sells for R7,500 in a pack of 2; lasts only up to 18 months; and can only be used once.
“When we originally did research into the cost of the devices on the market, we found that delays in the distribution chain can mean South Africans only receive their devices with six months before expiry, which made it unaffordable for South Africans,” said Nair, who originally designed it for a master’s project at the Division of Asthma and Allergy at the Red Cross Children’s Hospital.
The rising cost of the EpiPen has seen a class action lawsuit against manufacturer Mylan. The lawsuit claims the company is engaged in an illegal scheme to dramatically increase the list price, which ten years ago was R1,100, reported CNBC.
Adrenaline auto-injectors are inserted in the thigh, through the clothes. The shot slows the allergic reaction, buying precious time to get users to a hospital.
One of the biggest challenges, Nair said, was building a spring-based design that could generate 200 newtons of force, or some 20 kilograms, from such a small device.
They also made the ZiBiPen customisable for any patient – addressing complaints that dose and needle-length of current devices are based on the average male, rather than children or the obese.
If children accidentally use long needle devices, they could end up injecting through their skin and fracturing their femurs,” said Nair.
By using 3D-printed prototypes, injected into sponges, and later porcine blocks, they were able to observe the depth of the injection.
Another innovation is changing the location of the needle. A common mistake users make is piercing their thumb and not their thigh, as the original design has the lid on the opposite end to the needle.
In April, the device placed second and was awarded a full technical and market evaluation by the Medical Industry Leadership Institute, valued at R180,000, at the Emerging Medical Innovation Competition at the Design of Medical Devices Conference.
The evaluation independently validates the product, which is still looking for investment. Nair and Beuk intend to raise R6 million to take it to market under their company Impulse Biomedical.