Steffan Rhys

I’m Steffan Rhys, founder and principal consultant specializing in rare medical devices developed for low-prevalence conditions and humanitarian use. With over 20 years of experience in the medical device industry, I’ve dedicated my career to helping innovators bring critical technologies to underserved patient populations even when traditional commercial pathways fall short.

Why Rare Medical Devices?

Devices designed for rare or orphan conditions face unique challenges: limited patient populations, complex regulatory requirements, and resource constraints. Yet these devices often have life-saving potential. My work is focused on helping organizations:

• Navigate the FDA / EMA Humanitarian Device Exemption (HDE) and other rare-use pathways
• Develop robust Humanitarian Use Device (HUD) justifications
• Partner with nonprofits, mission-driven startups, and global health organizations
• Bring low-resource innovations to market ethically and efficiently

Who I Work With

I support:

• Startups developing breakthrough but niche medical technologies
• Academic and clinical teams seeking regulatory approval for rare-use devices
• Nonprofit organizations looking to expand device access globally
• Companies pursuing compassionate or humanitarian device strategies

My Mission

To ensure that every patient, no matter how rare their condition, has access to the technology they need. I believe the most meaningful innovation often happens in the margins, and I’m here to help bring it to light.

Let’s Connect

Whether you’re building a device for a rare disease, pursuing a humanitarian exemption, or navigating early-stage regulatory hurdles, I’d be honored to support your mission.