Epinephrine auto-injectors, first developed in the 1970s, are the most common emergency treatments for anaphylaxis, often deadly allergic reactions. The limitations of liquid epinephrine and the device’s decades-old technology have kept these life-saving devices out of patients’ hands. Austin-based startup Windgap Medical, Inc. plans to break these barriers with a more convenient, shelf-stable alternative.

In Episode 41 of the MedTech Speed to Data podcast Key Tech’s Andy Rogers and Thomas James sit down with Windgap’s co-founder and Chief Business Officer, Brent Buchine, to discuss the data-driven development of the company’s life-saving technology.

Need to know

· Epinephrine auto-injectors are big business — A $1.3 billion market at Windgap’s founding, sales of epinephrine auto-injectors exceeded $3.1 billion in 2024.

· Few eligible patients get these life-saving devices — Only 52% of American food allergy patients ever receive prescriptions, and epinephrine auto-injectors are only available in 32% of the world’s 195 countries.

· Traditional auto-injectors are relatively large and inconvenient — Only 55% of patients with prescriptions report having immediate access to their auto-injectors.

· Liquid epinephrine is thermally unstable — Doses lose their effectiveness with prolonged heat exposure, forcing patients to refill their prescriptions more frequently.

The nitty-gritty

Buchine and his co-founders saw an opportunity to make epinephrine delivery more convenient and accessible. “We developed a freeze-dried version of epinephrine to make it more stable and double, if not triple, the shelf life,” Buchine explains.

However, lyophilization introduces an extra step in the treatment process. The dried epinephrine must be rehydrated and mixed in a solution before injection.

“If you have a rescue product for emergency use, you have to get it very quickly,” Buchine says. “With modest training, you need to make sure people know how to use the product because their life is at risk if it doesn’t work.”

Windgap’s ANDI® platform is a small, highly portable single-dose auto-injector, Buchine explains. “Simply twisting the cap automatically rehydrates that dose in a couple of seconds — no shaking, no swirling required. It’s ready to inject by pressing the device next to the injection site.”

Windgap and its pharmaceutical clients are still in the commercialization phase, but the company is already looking at the future of complex injectables.

“We see that, fundamentally, formulation pipelines are getting more and more challenging,” Buchine says. “You have multiple injections, you have mixing, you have high viscosity/high volume. The conventional options out there are not as suitable anymore. We’re solving those problems specifically because we think there’s an opportunity to be best in class in that area.”

Data that made the difference:

Developing combination products is a multi-stakeholder problem. “It’s drug, it’s device, it’s patient, it’s prescriber, it’s payer. You’ve got to think about all of those stakeholders along your development.”

Get in front of stakeholders to understand the problem. “We did a lot of surveys and uncovered the opportunity. Patients weren’t getting prescriptions filled or weren’t even going to the doctor to get prescriptions. It was that segment that we spent a lot of time talking to.”

Listen to your customers. “We’ll talk to pharmaceutical companies [and ask] what are some of the biggest challenges you’re facing in your pipeline? And then you just listen. Over time, you look for that recurring theme. That’s what really drove our product strategy.”

Use data to convince investors. “There was a vastly underserved market. Our ability to communicate that to investors and help them understand the opportunity of taking [at the time] a $1.3 billion business to something substantially above that.”