By Henry Ehrlich
Where were you when you found out Auvi-Q was being recalled? Okay, I don’t remember where I was either, but I shared the disappointment of thousands of food allergy families who had embraced the sleek, talking device that was a fresh alternative to the clunky EpiPen, which dominated the market like the old IBM and AT&T used to dominate theirs. For younger readers, it was Apple to Epi’s Windows. And now that Sanofi has thrown in the towel and returned the rights to Kaléo, formerly Intelliject, the company formed by Auvi’s creators, Evan and Eric Edwards, it seemed like the right moment to follow up on a conversation with Christopher Stepanian, co-founder & CEO of Windgap, whom I met FABlogCon last fall. Chris was there carrying a trainer version of a new epi autoinjector about the size of a cigarette lighter.
Unfortunately it’s not yet under review by the FDA and can’t be marketed until the FDA grants approval to do so but I wanted to let you know what might be coming.
It improves on its predecessors in one big way, and one smaller but also significant way. The big way is that the active ingredient—the epinephrine —is stored in powder form, not liquid. This dry storage appears to give it longer shelf life and makes it more resistant to temperature changes when not in use than the epinephrine solutions in current autoinjectors. The smaller way is that it is activated mechanically, not electronically as with Auvi-Q, by simply twisting and removing the cap. This action enables the drive spring to automatically mix the wet and dry components together to form a solution, ready for injection. Once this is done, you press the autoinjector’s nose trigger against the thigh muscle and it injects automatically.
Chris is trained in mechanical, oceanic, and aerospace engineering, which seem somewhat removed from the crisis atmosphere that accompanies anaphylaxis. But engineers are trained to solve problems, and rather than ask him about the device itself, I decided to ask about how he and his colleagues set out to solve this one.
AAC: Thank you, Chris, for taking the time to talk with our readers. First, much innovation is driven by personal experience. For example, the Edwards brothers were themselves food allergic. Do you have a personal connection with this problem, and would you mind sharing it with us? If not, would you like to tell us how you decided to tackle it?
Stepanian:The person that inspired me most strongly was my mother. She’s along-time owner of an epinephrine autoinjector for her severe allergies. It made me begin to understand the need that patients have for an epinephrine autoinjector that is lifestyle compliant, one that you can take with you wherever you might need it. I don’t live my life at room temperature and I don’t think your readers should have to either. I was also able to talk with hundreds of current patients and their parents to learn more about how their lives change when they’re at risk of anaphylaxis.
AAC: Many of us mix up innovation with invention. Steve Jobs was an innovator. He could look at the inventions of others and envision revolutionary ways to use them. Your device is going to become quite familiar to our readers, but I’m more interested in how you thought about it. Can you describe for us how you looked at the problem and assembled the tools to solve it?
Stepanian: It started as a series of conversations and connections. One was on how dry epinephrine should be more stable than epinephrine in solution. The other was with my co-founder Brent Buchine on how a technology called “microfluidics” could be used to mix liquids and solids together in a very small device. Connecting those two conversations was the beginning of what is now Windgap Medical. We’ve a team of five people today and all of us have had a strong impact on the development of our product. We were helped by our board members, investors, champions, advisors, consultants, interns, and contractors who have helped us transform our basic concept into the production prototypes that we’ll be seeing in a few months. We kicked off the prototype injection molds this week!
AAC: Can you give us a feel for how the work is done? How do you design the machine—I assume a lot of it is done on a computer loaded with very special software. How many prototypes do you expect to build? How do you document the work?
Stepanian: We use software called computer aided design (CAD) running on a fast PC to develop, analyze, and refine our prototypes. We’ve found 3D printing to be really helpful in quickly figuring out how well components fit together and how a device might feel in your hand. We’ve also worked with local machine shops and injection molders to help refine our design. Over the upcoming months our manufacturing partner will be injection-molding hundreds of components to test out mold design and overall fit and function. These devices will be injected into chemical and mechanical test machines and blocks of ballistics gel to inform our design. The FDA has provided the healthcare industry with a set of guidelines on the process by which you develop your product: connecting condition, patient, drug, device and testing to help produce an epinephrine autoinjector that is both safe and effective for patients.
AAC: You are operating in a highly regulated environment, as is appropriate given the life and death stakes for patients who use your device. But patients and their families get restless. They want it NOW. Without getting too detailed or analytical, can you describe the process going forward?
Stepanian: Once we are satisfied that we understand our product and our process, we’ll produce new, high-quality molds and put the drug-filled autoinjectors that result on long-term stability testing, for at least a year. Once that testing is complete, we’ll submit those results to the FDA along with our full design package. We’re using an approval process with the FDA that is relatively rapid and we anticipate a response within a year. Some things cannot be rushed and proving that our device functions acceptably after long-term storage is critical for the FDA and their review of our application to market our product.
AAC: Thank you for your time.
Stepanian: You’re welcome Henry. I appreciate the opportunity to share some of what we’re doing with you.