Internal mechanism redesigned around the case form factor. CAD complete, simulations validating dose equivalence.
9 months
A working hardware concept, a companion app, and a clear two-year path to FDA submission , with the market wide open the day the EpiPen patent expired.
Internal mechanism redesigned around the case form factor. CAD complete, simulations validating dose equivalence.
Provisional patent filed on both utility (mechanism) and design (form factor). Pre-PCT.
A drug-device-software combination product, targeting a 510(k) via substantial equivalence to a predicate auto-injector. Classification confirmed at an FDA pre-submission, Q4 2026.
A staged, capital-efficient path: validate the mechanism, lock in IP, run the regulatory loop, then scale.
Internal injector reworked to fit a phone-case envelope. Spring force, fluid path, and needle deployment redesigned from scratch.
Utility and design provisionals submitted. 12-month window opened for full filing; PCT track planned.
iOS companion app with live device status, health profile, and Demo Mode. Currently in closed beta with allergy-community testers.
Wear, drop, and temperature testing. Performance studies against a predicate auto-injector. Prototypes in the hands of clinical advisors.
Pre-submission (Q-Sub) meeting to confirm combination-product classification, align on the 510(k) pathway and predicate selection, and lock performance-testing requirements ahead of submission.
Human-factors validation and final bench performance studies. Manufacturing partner selected; pilot production lines established.
510(k) submission filed. Pharmacy and prescriber GTM motion stood up. First shipments targeted within 6 months of clearance.
Twenty-plus interviews with R&D engineers, regulatory and quality experts, manufacturers, and patients , including professionals from leading medical-device companies. We didn't just collect validation. Their feedback changed the product.
Individuals from these companies shared their expertise during customer discovery. Logos shown for context , personal insight, not company endorsements.
Every quality expert named accidental injection the #1 risk on a device you handle all day. So we engineered a two-step release and an expiry lock-out , not a hair-trigger.
Seasoned reviewers told us a phone-integrated injector is a drug-device-software combination. We're treating it as one and booking an FDA pre-submission to lock the 510(k) route before we build to it.
Patients said they'd switch the day insurance covers it. So the go-to-market leads with prescribers and payers , not a direct-to-consumer push.
Mylan's EpiPen patent expired in 2025. The mechanism, the form factor, and the companion-software loop are all ours to defend.
Spring-loaded auto-injection compatible with a phone-case envelope. Pre-PCT.
Form factor, pull-tab geometry, MagSafe integration. Distinctive trade dress in build.
Device telemetry + health profile + Demo Mode. Generates daily-usage signal no incumbent has.
Global auto-injector market · CAGR ~10%
33 M Americans with potentially life-threatening food allergies
Active-lifestyle segment , the 56% who don't carry
Runway to FDA pre-submission and a manufacturable design. Every dollar mapped to a milestone with a date and a deliverable.
Closing a $3M seed round to take EpiSafe through device verification, human factors planning, the manufacturing partnership, and the FDA briefing package. Lead investor + strategic angels welcome.
Request the deck →We're raising now and would love to send you the deck, walk you through the prototype, or just hear what you think.