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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-07-08
- Length: 45m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/245---Reducing-a-14-Step-Emergency-Injection-to-a-Two-Step-Auto-Injector-e3lo25b

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=0) Introduction: Julia Anthony and Solution Medical
- [1:01](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=61) The 14-Step Emergency Injection Problem
- [5:01](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=301) From Device Concept to Drug-Led Pharma Company
- [10:07](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=607) Prefilled Syringe and Auto-Injector Design
- [13:10](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=790) Human Factors Testing with Patients and Naive Users
- [16:58](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=1018) Real-World Access and Patient Challenges
- [21:50](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=1310) Formulation Strategy and 505(b)(2) Regulatory Pathway
- [25:13](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=1513) Aseptic Manufacturing and Supplier Trust
- [31:08](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector#t=1868) Platform Vision Beyond Adrenal Insufficiency

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies

## Mentioned

- Solution Medical (company)
- hydrocortisone sodium suxinate (other)
- 505(b)(2) NDA (other)
- Pixis (product)

## Related episodes from other shows

- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#455: MedTech Founder 101: Shifting from Corporate to Startup with John Schindler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-04-13-455-medtech-founder-101-shifting-from-corporate-to-startup-with-john-schindler) (Global Medical Device Podcast)
- [5 Actionable Lessons Learned from the RADx Initiative by NIH](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-27-5-actionable-lessons-learned-from-the-radx-initiative-by-nih) (Global Medical Device Podcast)
- [Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-sara-naab-on-going-from-idea-to-funding-to-one-of-the-bay-areas-most-innovative) (Global Medical Device Podcast)
- [S7E22 Amelia Howe | Developing Medical Device Injectrodes for Pain Reduction, & Project Management Best Practices](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-05-22-s7e22-amelia-howe-developing-medical-device-injectrodes-for-pain-reduction-proje) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-08-245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.