If you or a loved one had a food allergy in the 1970s or ‘80s, you know that there has been very little innovation or improvement to the epinephrine auto-injector, and yet its price tag has skyrocketed.
Several years back, a few of my colleagues and I thought there must be a better way to deliver epinephrine. This led us to launching Windgap Medical—a Boston-based start-up committed to making a smaller, longer-lasting, and more stable epinephrine auto-injector.
Fast forward eight years, and we’re excited to announce that we have taken our product from initial concept all the way to pilot production, and have tested thousands of devices. Over the next few years, we will be producing thousands of additional devices to generate data for FDA review. After that, we plan to work diligently towards getting this life-saving medication into consumer hands—especially in light of the current epinephrine shortage. Today, two of the main epinephrine auto-injector suppliers are listed on the FDA’s drug shortage website as having limited availability.
Here’s how it all began.
In 2011, our founders started talking with food allergy patients to understand what would make epinephrine easier to carry on a daily basis. One of the challenges we saw is that patients weren’t carrying this life-saving medication on them, and we wanted to find out why.
Here were some of the leading responses:
Auto-injector sizes are problematic as they don’t fit into pockets or many purses. Making this life-saving medication smaller and more convenient for carrying two auto-injectors was a leading patient request. Our device is currently about the size of a roll of quarters, and we’ve seen an overwhelmingly positive response to date when showing patients our current design.
Another issue raised was temperature stability. Patients and families expressed concerns about exposing their devices to heat, such as carrying their epinephrine auto-injector in their pocket. In a more extreme case, a recent journal study indicated that one summer day in a hot car could degrade an epinephrine auto-injector to levels that undermined the efficacy of the medication. Our device keeps the epinephrine as a dry and stable powder which is then mixed upon activation. This makes the medication less sensitive to temperature, and extends the shelf life.
Patients and caregivers expressed concerns around the human factors of some the more popular epinephrine auto-injectors. The onset of anaphylaxis can be rapid and scary for both the patient and caregiver. An intuitive design that is easy to administer will result in fewer user errors, which would be a welcome improvement for many patients.
I’ll never forget a story from one of our team members about how her prescriber improperly advised her on epinephrine administration. If she had administered the injection as she was taught, she would have shot the needle through her thumb instead of into her daughter’s thigh. Suffice it to say, intuitive design is a must when you’re dealing with life and death, and it’s something we have taken very seriously in our design and testing.
In addition to soliciting feedback from patients, we also spoke with prescribers. While they mentioned some of the same concerns as patients, their primary concern was patient compliance:
Once prescribed, is it filled?
After it’s filled, is it carried?
If carried, is it administered when necessary?
Once administered, is the drug effective?
These are questions that we are seeking to better answer with our product. If we can do that, the value for prescribers would be significant, and it would give us an advantage over our competition.
We’re also exploring how our device or related devices could deliver drugs other than epinephrine. Anaphylaxis is not the only medical condition that benefits from a rescue auto-injector that contains a dry, stable form of a drug. For instance, we are working on a timely antidote for cyanide poisoning that may come from chemical weapon exposure or from smoke inhalation in a house fire.
In the end, our goal is to make it easier for patients to carry life-saving medications, while reducing stress and anxiety for them and their families. In the near term, we’re working hard to bring our epinephrine product to life, and help ensure the food allergy community always has ready access to this life-saving drug.
Chris Stepanian is a serial entrepreneur and the co-founder and CEO of Windgap Medical. He was on the founding team of Aspen Aerogels, a nanotechnology-based insulation company, and previously worked in the contract research, automotive, and aerospace industries. He holds 16 US patents, and multiple awards from NASA. Chris has helped to successfully grow Windgap from a concept to pilot production with multiple products in the pipeline, while raising over $25 million to support that growth. The opinions expressed in the posting are solely his own and do not express the views or opinions of his employer. Chris is a minority investor in Allergy Amulet.