245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

Let's Combinate · 8 Jul 2026 · 45m

What this episode covers

Julia Anthony, founder and Chief Strategy Officer of Solution Medical, explains how her company is developing a drug-device combination product to simplify emergency hydrocortisone administration for patients with adrenal insufficiency. She details the transition from a 14-step manual reconstitution process to a proprietary dual-chamber primary container that enables a 4-step prefilled syringe and a 2-step auto-injector. Anthony discusses the regulatory strategy of a drug-led 505(b)(2) NDA, the challenges of aseptic manufacturing, and the human factors testing that validated the simplified user experience for both patients and injection-naive caregivers.

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