What Investors Want to Know: How Pirouette Medical is Innovating Auto-Injectors

Pirouette was formed by a team of individuals with different skills, backgrounds, experiences, and personalities, but are drawn together by their common trait: a willingness and love to work harder than anyone else and a love of working together on difficult engineering problems. With that said, it could have been Pirouette Aerospace or Pirouette Defense, but we chose to endeavor to empower lives as advocates for patients. Most patients could not develop an elegant new engineering solution to their life-threatening clinical need – and so Pirouette stands here for them. Our objectives can be described through our company commitment as described by our Mission to place healthcare in the hands of the patient, our Vision for revolutionary devices that enable convenient healthcare, anywhere, and our Values of Family, Imagination, Advocacy, Integrity, Persistence, and Fun. 

Pirouette leverages a deep technical skillset and industry understanding to develop and manufacture combination medical devices that optimize and broaden the applicability of integrated drug product constituents. The company’s core competencies bridge advanced engineering principles, a mastery of extreme reliability, complex and highly regulated development, and medical devices/pharmaceuticals. These core competencies are built on the founding team, the experts surrounding the management team, and the employees.

At Pirouette, we’ve developed a low-profile, disk-shaped auto-injector that makes administering life-saving medications as simple as pushing a button. This design focuses on ease of use, portability, and affordability, solving common issues with traditional injectors like the visibility of needles and anxiety around usage.

Growing up, I watched my brother carry an EpiPen for his severe allergies, and I realized how little the technology had advanced over the years. The same basic design—bulky, anxiety-inducing, and complicated—was being used for decades. I wanted to change that. My background in aerospace engineering and healthcare innovation gave me the tools to reimagine how an auto-injector could work. When I saw that auto-injector technology could be improved to better serve people, especially in life-or-death situations, I felt compelled to act.

One of the biggest technical challenges has been balancing innovation with industry standards. We wanted to think outside the box and design a completely new device, but at the same time, we needed to ensure compatibility with established systems like standard pharmaceutical filling equipment. By leveraging these existing technologies, we’ve been able to avoid excessive costs and delays that might come from trying to reinvent parts of the process unnecessarily. It’s a constant balance of pushing boundaries while respecting the infrastructure already in place.

The Y Combinator program taught us the importance of efficiency, speed, and focus on key milestones. YC emphasizes de-risking as much as possible within a short time frame, which meant we had to prioritize actions that moved the needle for our fundraising and product development. The experience helped instill a mindset of continually pushing toward the next big goal, even beyond the structured YC program. This has shaped how we approach scaling—always looking ahead to the next milestone while maintaining the agility of a startup. We’ve adopted this rapid iteration and problem-solving approach as a core part of our culture. In short, Focus.​

Our path to launching our first auto-injector involves several key milestones, starting with producing registration batches and completing design validation. Following that, we will engage in a pre-NDA (New Drug Application) meeting with the FDA, which de-risks the subsequent submission of our NDA. The final step will be gaining FDA approval. We are confident in our progress so far, thanks to the rigorous design, manufacturing, and supply chain processes we’ve put in place. Each step brings us closer to market clearance, and the fact that we’re nearing design validation gives us a high level of confidence that we can meet our targeted timelines.

We’re pursuing multiple strategies to ensure widespread adoption of our device. One avenue is direct-to-consumer, especially for over-the-counter products like Naloxone, which helps combat the opioid crisis. For prescription-based products like our Epinephrine device, we’re working closely with physicians, who play a key role in prescribing. We also engage pharmacists, patients, and payers—ensuring that all stakeholders see the value of our device. Our goal is to make it easy for prescribers to recommend, and for patients to request, our product. Once people get the device in their hands, the usability speaks for itself, and adoption becomes much easier.