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

<p>In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and what it takes to build a drug-device combination product from a patient need.</p><p><br></p><p>Julia was born with salt-wasting congenital adrenal hyperplasia, a life-threatening form of adrenal insufficiency. Because her body cannot make cortisol, she takes cortisol replacement daily and may need an emergency hydrocortisone injection during a crisis.</p><p><br></p><p>The problem?</p><p><br></p><p>The current emergency injection can take upto 14 steps to prepare, mix, and administer.</p><p><br></p><p>Julia explains why the liquid and powder need to stay separate for stability, why the current process is so difficult during an emergency, and how Solution Medical is developing a proprietary dual-chamber primary container to simplify reconstitution while maintaining shelf life without refrigeration.</p><p><br></p><p>We also discuss how the company evolved from a device idea into a drug-led 505(b)(2) NDA program, the development of a four-step prefilled syringe and two-step auto-injector, human factors testing with both patients and injection-naive users, manufacturing challenges in aseptic processing, supplier trust, regulatory strategy, and the broader platform potential for other mix-before-inject drugs.</p><p><br></p><p>Chapters</p><p><br></p><p>00:00 Meet Julia Anthony</p><p>01:04 Living Without Cortisol</p><p>02:03 The 14-Step Injection</p><p>05:01 Building a Combination Product</p><p>07:54 From Device Concept to Pharma Company</p><p>10:06 Needles, Steps, and Testing</p><p>13:25 Patient Insights and Human Factors</p><p>16:58 Real-World Access Challenges</p><p>21:50 Why Not a Liquid Formulation?</p><p>24:15 Regulatory Pathway: 505(b)(2)</p><p>25:13 Manufacturing and Partner Trust</p><p>27:32 Rare Disease and Supplier Power</p><p>31:53 Platform Vision Beyond Adrenal Insufficiency</p><p>38:05 Reconstitution Is the Hard Part</p><p>41:12 COVID Tailwinds and Timeline</p><p>43:38 Where to Find Solution Medical</p><p>44:42 Final Thoughts on Cortisol</p><p><br></p><p>About Subhi</p><p><br></p><p>Subhi Saadeh is a consultant, trainer, and auditor focused on quality, regulatory, manufacturing, and supplier challenges for drugs, devices, and combination products.</p><p><br></p><p>Through Let’s Combinate, Subhi helps companies navigate the messy intersection of pharmaceutical and medical device requirements through consulting, training, audits, and practical education.</p><p><br></p><p>He also hosts Let’s Combinate: Drugs + Devices, where he speaks with leaders building, regulating, manufacturing, and improving combination products.</p>