When you’re imagining an entrepreneur championing better technology for female contraception, recent Georgia Tech biomedical engineering grad Idicula Mathew might not immediately seem to fit the profile. But once you talk to Mathew, it’s clear why he’s focusing his medtech startup on improving female birth control — like any good entrepreneur, he found a pain point that needs solving.
“The project started off with this really simple problem: there are these subcutaneous arm implants that physicians are really having a hard time getting removed. And when we realized that problem, the device sort of created itself.”
The first phase of customer discovery was undertaken while Mathew and his co-founders were still in school, as a senior design project. While finishing their undergraduate studies, they conducted interviews with doctors and potential customers, worked on device protoypes, and founded their company, Hera Health.
Implantable devices allow for site-specific drug administration — a doctor injects the small device into the patient and once in, it begins automatically excreting medicine or hormones. The advantages over pills or injections include potentially lowering the drug dosage, a sustained release, improved patient adherence, and convenience.
But once the device runs out, it must be removed, a procedure that can be difficult, expensive and time-consuming. Mathew says he spoke with doctors who budget up to two hours for the procedure, and some who have had to go searching for the device because “it gets lost.”
Mathew and his team came up with a solution that seems almost too simple: an implant that uses biodegradable material so it dissolves in the body once used up. By combining an already FDA-approved biodegradable material with already on-the-market generic drugs, they have a solution that Mathew says is sure to be approved by the FDA, since it’s “really not all that novel or innovative.”
The innovation lies in the manufacturing process of a device that steadily releases a drug or hormone over a set period of time and then immediately dissolves, totally eliminating the cumbersome removal.
When Mathew graduated in 2017, he began to work full time on Hera Health. The startup was accepted into the prestigious Zeroto510 medical device accelerator in Memphis, TN and closed $100K in funding to develop the product.
While in Memphis, they worked with medical professors, FDA regulators and other medtech experts. Mathew personally spoke with 250-plus physicians, as well as 150 consumers (in interviews conducted over YouTube) across the country to hone in on how this device could most help them.
Though this exhaustive discovery, Mathew and the team identified “a serious niche for this product” in contraception, which is by far, the most commonplace usage for implants.
“We’re not a contraception company, we’re trying to make drug delivery easier,” Mathew says. “But I think the contraceptive space is perfect for us to start in because there is this obvious need.”
Moreover, contraception offers some wiggle room — rather than releasing medicine to cure a sick person or ease a chronic illness, the product will be releasing hormones which, according to Mathew, have “a huge range of variability and acceptability from a bio-standpoint.”
“From a safety standpoint, we’re super confident that the product we’re attempting to launch will be safe and effective,” he says.
The first product is Eucontra, an 18-month contraception implant that he projects will be approved by the FDA and ready for commercial use by the beginning of 2021. The product will cost only a few dollars more than the current implants on the market, not counting the avoidance of doctor’s fees for the removal procedure.
Mathew is particularly enthusiastic about the device’s potential beyond the U.S. market. He says they have seen interest from international NGOs that work in developing countries, where hygiene and medical conditions are not always ideal and contraception may face social barriers.
“My background is from India, my mom grew up in Dubai, and in countries like this a novel drug implant device is really needed,” he says. “From a global standpoint there’s a serious need for a product in the contraceptive space that is non-invasive and doesn’t require followups or checkups.”
Once Eucontra is on the market, the Hera Health team will get back on the customer discovery train to tackle additional uses for the device. Mathews says that, although contraception in itself is an $800 million market, “we know there are many more uses for this out there.”