Identified and chose best materials to enable product’s functionality and manufacturer to meet product cost target
Clarified/accelerated Class 1, 513(g) regulatory pathway
Identified resources and established budgets for product development, usability testing to scale operations
Generated and deepened relationships with endoscope OEMs who expressed interest in the product securing two letters of support
Submitted for funding from state of Ohio, actively pursuing funding from NIH, and investigating private funding sources
What we did
Developed RFQ, identified/vetted domestic and international manufacturers and engineering partners
Actively led group meetings and assembled expert resources to develop execution plan and budget to confirm viability of commercialization pathway
Led all aspects of assembling market intelligence, and creating business model, financial model and capital requirements to commercialize the technology
Provided regulatory and product development guidance for 513(g) FDA submission
Leveraged grant writing expertise to develop company’s funding strategy and executed grant application and submission
The Factor 7 Difference
Achieving measurable and sustainable results in healthcare is a challenging process, and having the right resources is imperative.
Whether on a fractional, project-based or full-time basis, Factor 7 Medical delivers proven, trusted, and deep expertise that can strengthen your technology, your operations, and your commercial results.
Let our expert resources ignite your innovation and amplify your success.