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

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.

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.

The problem?

The current emergency injection can take upto 14 steps to prepare, mix, and administer.

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.

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.

Chapters

00:00 Meet Julia Anthony

01:04 Living Without Cortisol

02:03 The 14-Step Injection

05:01 Building a Combination Product

07:54 From Device Concept to Pharma Company

10:06 Needles, Steps, and Testing

13:25 Patient Insights and Human Factors

16:58 Real-World Access Challenges

21:50 Why Not a Liquid Formulation?

24:15 Regulatory Pathway: 505(b)(2)

25:13 Manufacturing and Partner Trust

27:32 Rare Disease and Supplier Power

31:53 Platform Vision Beyond Adrenal Insufficiency

38:05 Reconstitution Is the Hard Part

41:12 COVID Tailwinds and Timeline

43:38 Where to Find Solution Medical

44:42 Final Thoughts on Cortisol

About Subhi

Subhi Saadeh is a consultant, trainer, and auditor focused on quality, regulatory, manufacturing, and supplier challenges for drugs, devices, and combination products.

Through Let’s Combinate, Subhi helps companies navigate the messy intersection of pharmaceutical and medical device requirements through consulting, training, audits, and practical education.

He also hosts Let’s Combinate: Drugs + Devices, where he speaks with leaders building, regulating, manufacturing, and improving combination products.