Key Takeaways
- Bankable funds H-1B medical devices businesses up to $5M based on documented revenue
- No green card, no permanent residency, no citizenship required for funding
- SBA March 2026 rule eliminated H-1B owners from all SBA 7(a) loan access
- 48-hour funding decisions — faster than any bank or SBA lender
- Check your Bankability Score in 30 seconds — no SSN upload
Medical device companies represent the intersection of H-1B engineering talent and healthcare entrepreneurship. Biomedical engineers, electrical engineers, and mechanical engineers on H-1B who have built device companies face a regulatory-intense, capital-demanding path from concept to FDA clearance to commercial sale.
H-1B medical device founders — from diagnostic imaging innovators to surgical instrument designers to wearable health tech companies — have created some of the most significant healthcare innovations in recent years. The capital needs span R&D, 510(k) or PMA regulatory clearance, clinical validation, and commercial launch. The SBA's March 2026 rule eliminated their access to working capital loans during this capital-intensive period.
The March 2026 SBA rule eliminated H-1B medical devices businesses from all 7(a) access. Bankable provides a direct path to revenue-based funding without any citizenship test.
Capital Uses for H-1B Medical Devices Operators
- R&D and Prototype Development: Engineering labor, materials, and testing costs to develop prototype medical devices to clinical standards.
- FDA Clearance Costs: 510(k) or PMA submission preparation, regulatory consultant fees, and biocompatibility testing: $50,000 to $500,000.
- Clinical Validation Studies: IRB-approved clinical studies required for regulatory clearance and commercial adoption. Bridge funding during the study period.
- Manufacturing Setup: Initial contract manufacturing agreements, tooling, and quality system (ISO 13485) certification.
- Commercial Launch Capital: Sales force hiring, distribution agreements, and hospital system sales cycle funding before first revenue.
| Funding Source | H-1B Eligible? | Max Amount | Speed |
|---|---|---|---|
| SBA 7(a) — March 2026+ | No — US citizens only | $5M | 30–90 days |
| Traditional Banks | Rarely | Varies | 3–6 weeks |
| Bankable | Always yes | $5M | 48 hours |
For the full SBA alternative landscape for H-1B business owners, see our SBA alternative guide. Check your Bankability Score in 30 seconds to see your preliminary funding range.
Frequently Asked Questions
Yes. Bankable funds medical devices businesses based on documented revenue. No green card or permanent residency required.
Effective March 1, 2026, the SBA requires 100% US citizen ownership. All H-1B business owners are excluded from SBA 7(a) loans.
Minimum $40,000 in monthly revenue for initial consideration. Businesses at qualifying revenue levels access initial tranches of $200K to $2M.
48-hour decision from completed application. The Bankability Assessment at /bankability-score/ gives a preliminary range in 30 seconds.
No. Bankable funds H-1B holders as sole applicants based on business revenue alone.
No. Bankable has zero residency requirements. H-1B, L-1, O-1, and other work visa holders all qualify for funding assessment based on business revenue alone.
Effective March 1, 2026, the SBA requires 100% US citizen or national ownership for all 7(a) and 504 programs. H-1B holders are completely excluded regardless of revenue or credit history.
48 hours from completed application. The Bankability Assessment at /bankability-score/ takes 30 seconds and gives a preliminary range immediately.