We bridge the divide between medical observation and market-ready instrumentation — a structured protocol for clinicians who innovate. From napkin sketch through prototyping, licensing, manufacturing, and go-to-market.
Before it was a patented instrument, the BioPen® FNA biopsy needle was a hand-drawn figure on grid paper — an outer needle to access the lesion and an inner needle designed to capture a richer tissue sample. Our founder documented the full journey, sketch to US patent (Aug 2022) to three working prototypes.
Translation of a clinical pain point into a mechanical concept. We validate ergonomic and anatomical feasibility and frame the patent narrative early.
Iterative bench models — BioPen evolved across three prototypes, from proof of concept to manufacturing-ready, with bovine-liver bench testing each round.
UltraClip Inventor · Clinical IP & Surgical Integration
Inventor of the UltraClip Breast Biopsy marker. Decades of clinical IP and surgical integration expertise for high-stakes interventional tools.
Regulatory · Manufacturing · Commercialization
We arrange the best contact in the industry for your specific device, regulatory path, and target market — from FDA consultants to ISO-certified manufacturing partners.
US Patent · Aug 2022
Patent prosecution and strategic IP — BioPen's US 11,406,364 B2 was granted in August 2022, with trademark published 2023.
Hybrid model — proprietary components in-house, standard components with ISO-certified contract partners. FDA clearance pathway: 12–18 months.
KOL-driven launch, distributor partnerships, and early-adopter clinical pilots in U.S. hospital systems.
Inventor · Physician · Device Developer
Inventor of the BioPen FNA biopsy needle. From hand-drawn sketch to granted U.S. patent and working prototype — bridging clinical insight to commercial device.
Schedule a confidential call with our team to review your concept and discuss the pathway forward.