Key Takeaways
- E-2 medical device company owners with documented hospital and distributor revenue qualify for Bankable funding
- Manufacturing equipment, regulatory compliance, and sales team expansion are all eligible uses
- Israeli, German, Japanese, and Korean E-2 investors build US medical device operations
- FDA 510(k) cleared products with documented US hospital revenue are ideal Bankable clients
- Funding from $300K to $5M with 48-hour preliminary decisions for established device companies
The US medical device market is the world’s largest at $180 billion annually, and it attracts E-2 investment from nations with strong medical technology traditions: Germany (Siemens Healthineers supply chain), Israel (medical imaging and diagnostics), Japan (precision medical instruments), South Korea (healthcare diagnostics and imaging), and Italy (specialized surgical tools). These investors establish US subsidiaries, distribution companies, or manufacturing facilities for their medical device businesses, with initial investments that satisfy the E-2 substantial investment requirement and ongoing operations that generate documented hospital and healthcare system revenue.
Medical device revenue is among the most creditworthy documentation available. Hospital purchase orders are backed by institutional buyers with strong credit ratings. GPO (Group Purchasing Organization) contracts represent long-term supply relationships that Bankable values highly. FDA clearance documentation demonstrates regulatory compliance and market legitimacy that our underwriters note positively in their assessments.
Medical Device Capital Uses
- Manufacturing equipment: Medical-grade production equipment, inspection systems, and cleanroom infrastructure
- Regulatory compliance: 510(k) submissions, PMA applications, ISO 13485 certification, and quality management systems
- Sales team: US medical device sales rep network to grow hospital accounts
- Inventory: Finished device inventory for distributor and hospital stocking
- Clinical studies: Post-market clinical follow-up and clinical evidence development
Equipment Financing
Fund medical device production equipment with asset-backed terms and faster approval.
Learn More →Working Capital
Fund inventory and regulatory costs while growing your hospital account base.
Learn More →Biotech Lab Funding
Related capital solutions for life science and biotech service companies.
Learn More →Frequently Asked Questions
Yes. E-2 medical device company owners with documented hospital and distributor revenue qualify for Bankable funding. No green card required.
Device manufacturers, US distributors of foreign device brands, surgical supply companies, and diagnostic equipment providers with documented US revenue.
We accept hospital POs, GPO contract documentation, distributor agreements, invoice aging reports, and bank statements.
Yes. Medical-grade manufacturing equipment qualifies for asset-backed financing with the equipment as collateral.
Most Bankable medical device clients have $700K+ in annual US revenue. Companies with GPO contracts may qualify at lower levels.
Yes. Our underwriters are familiar with FDA 510(k) clearance, PMA, and quality management system requirements that affect medical device company operations.
Yes. FDA submission and compliance program costs are eligible working capital uses for medical device companies.
Yes, provided the US entity has been established (as required for E-2) and has begun generating US revenue from hospital or distributor accounts.