A clinical-stage medical device startup developing an innovative laparoscopic surgical tool entrusted us with guiding their project from concept to clinical application. Our team managed every stage of development, collaborating with an ISO-13485-certified partner to manufacture a high-quality set of devices.
We oversaw rigorous testing, progressing from bench-top evaluations to animal studies and ultimately to human trials under an FDA-approved IDE. Along the way, our comprehensive management and strategic execution helped the company secure over $5 million in grant funding and $7 million in private investment, positioning the device for commercial success.
