Key Takeaways
- Medical device companies with US sales revenue owned by L-1 holders qualify for Bankable funding
- FDA clearance is a strong positive factor — 510(k) cleared devices are premium profiles
- Manufacturing equipment, distribution, and working capital all eligible
- SBA closed to L-1 holders — Bankable funds medical device businesses on revenue
- Decisions in 48 hours, $100K to $5M
Medical device entrepreneurship is particularly well-represented among L-1 holders because many large device companies — Medtronic, Abbott, Boston Scientific, Stryker, Zimmer Biomet — transfer product engineers, clinical specialists, and regulatory affairs directors through L-1 programs. These specialists develop expertise in specific device categories, understand the FDA regulatory pathway intimately, and often identify unmet clinical needs that their employers are too large to prioritize. Independent medical device businesses follow.
A Class II medical device with 510(k) clearance and US distributor relationships generates recurring sales revenue that Bankable can underwrite. The path from inventor to revenue-generating medical device company is capital-intensive — prototype development, clinical validation, FDA submission, and distribution build-out all require capital. Bankable funds the commercial stage of this journey, after FDA clearance, when real US revenue is flowing.
Medical Device Capital for L-1 Holders
- Manufacturing ramp-up: Scaling from prototype to production-grade manufacturing requires equipment, QMS implementation, and manufacturing staff
- Distributor and GPO onboarding: Group purchasing organization agreements require product samples, sales representative support, and clinical evidence materials
- Sales team development: Medical device sales representatives are highly paid ($150K-$250K OTE) — hiring in advance of contract revenue requires working capital
- Clinical study support: Post-market studies and registry data collection required by hospital value analysis committees
- International regulatory submissions: CE marking and Health Canada submissions alongside US revenue generation
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Frequently Asked Questions
Yes. Medical device companies with FDA-cleared products and documented US sales revenue owned by L-1 holders qualify for Bankable funding. No green card required.
FDA clearance is a strong positive factor — it validates your product's safety and effectiveness and enables commercial US sales. We evaluate your post-clearance revenue performance, not the regulatory status alone.
Hospital and clinic direct sales, distributor purchase orders, GPO contract revenue, and DTC medical device sales all qualify. Recurring consumable or accessory revenue from capital equipment placements is particularly strong.
Yes. Capital equipment for manufacturing scale-up — injection molding machines, assembly jigs, quality testing equipment — qualifies for asset-backed financing as you transition from prototyping to volume production.
Yes. Hiring medical device sales representatives in advance of their territory revenue requires working capital. Bankable provides working capital advances against your existing product revenue to fund sales team expansion.
Working capital for CE marking, Health Canada submissions, and other international regulatory filings qualifies as a business development investment. We evaluate the cost against your existing US revenue capacity.
Bankable requires US commercial revenue. A device still in clinical validation without US commercial sales does not meet the revenue requirement. Post-clearance commercial-stage companies are the target profile.
Some device categories (orthopedics, sports medicine) have seasonal surgery volume patterns. We evaluate annual revenue with seasonal accommodation in repayment structure.