The Problem
A small startup was developing an implantable device and associated surgical instrumentation in women’s health. The company had been awarded an NIH SBIR Phase II grant based on positive clinical testing outside the U.S., and had been tasked with making a second-generation device based on the clinical feedback, addressing outstanding FDA concerns, and conducting a larger multi-site clinical trial inside the US. The grant provided the company the financial resources, but it needed to expand its strategic, tactical, and execution capabilities to achieve these objectives and reach its next valuation inflection point.
Our Actions
Our team embedded personnel into the company on a fractional basis, assisting in several ways:
- We identified, engaged, and worked with experienced vendors for device redesign, including improved functionality and design for manufacturing.
- We led the effort to manufacture ISO 13485-compliant production of both the implantable device and the redesigned applicator, which included both domestic and international vendors while complying with NIH spending rules. We also oversaw the molding, assembly, sterilization, and packaging of clinical product.
- We submitted multiple IDE Pre-Submissions on behalf of the company, conducting interactions with FDA to come to consensus on the clinical study protocol. Based on this FDA feedback, we prepared and submitted an IDE application, gaining approval by FDA to allow the clinical study to proceed.
- We managed the clinical study from start to finish, including designing the protocol; preparing and managing the eCRF; identifying, vetting, and training clinical sites and surgeons; monitoring the study sites throughout the trial; preparing and submitting all required FDA correspondence throughout the trial; and preparing a final clinical study report at the conclusion of the study.
Outcome
Based on our engagement and successful domestic clinical study, the company earned a follow-on grant funding to conduct a larger clinical study leading towards 510(k) clearance, commercialization, and product launch.
