Key Takeaways
- Medical device sales and service revenue drives Bankable approval — no green card
- STEM OPT biomedical engineers at top research universities are MedTech founders
- Fund manufacturing, regulatory compliance, and working capital for OPT MedTech founders
- 48-hour decisions for medical device businesses with $15K+ monthly revenue
Biomedical engineering, medical physics, and health informatics graduates on F-1 STEM OPT are commercializing medical device innovations at record rates — from wearable diagnostic sensors to surgical tools to hospital equipment. The FDA regulatory pathway (510(k) clearance or De Novo) is the same for all applicants regardless of citizenship. Revenue-generating MedTech businesses — those with cleared devices generating sales, or services generating recurring revenue — qualify for Bankable funding.
Medical Device Business Capital Uses
- Manufacturing setup: clean room equipment, quality management systems
- FDA 510(k) submission costs and regulatory consulting
- Sales team hiring: medical device sales representatives and clinical specialists
- Working capital between device delivery and hospital/clinic payment (60-90 days)
- Clinical evaluation and post-market surveillance infrastructure
Frequently Asked Questions
Yes. Since March 2026, SBA loans require 100% US citizen or national ownership. Bankable is non-SBA — F-1 OPT founders qualify based entirely on business revenue.
No. Bankable funds US-registered business entities based on revenue. Immigration status is not evaluated.
Your business entity continues operating and servicing funding. The loan is with the business, not the individual.
Yes. Medical device company ownership through a US corporation does not require citizenship. FDA regulatory submissions (510(k), PMA) are available to companies regardless of founder citizenship.
$15,000+ in monthly device sales or service revenue with 6+ months of operating history. Pre-revenue device companies in the regulatory process require venture capital, not revenue-based funding.
Yes. 510(k) submission fees, regulatory consulting, and quality management system implementation are approved uses of Bankable working capital.
Yes. Medical devices with companion software subscriptions — digital health platforms, remote monitoring tools — qualify for MRR-based evaluation.
Bankable evaluates US business revenue. International sales revenue deposited into a US business bank account qualifies.