EndoEvolve
Medical device company focused on ergonomics in endoscopy.
The Project
EndoEvolve needed specialized support to secure non-dilutive funding for product development, performance testing, and commercialization efforts. They also required guidance to confirm product-market fit, source materials, navigate the regulatory pathway, and enhance their leadership team to ensure the timely execution of their business and commercialization strategy.
The Solution
Factor 7 partnered with EndoEvolve to develop and execute a comprehensive commercialization plan. This included creating RFQs, identifying and vetting domestic and international manufacturers, and assembling a network of engineering and regulatory partners. The team led collaborative planning sessions to build market intelligence, business and financial models, and capital requirements. Factor 7 also provided guidance for a 513(g) FDA submission and leveraged its grant-writing expertise to develop a robust funding strategy and manage the application process.
The Results
With Factor 7’s support, EndoEvolve successfully selected optimal materials and manufacturers to meet both functional and cost targets. They accelerated their regulatory pathway, prepared budgets for product development and usability testing, and established relationships with multiple endoscope OEMs—securing two letters of support. Additionally, they submitted a funding request to the state of Ohio, initiated NIH funding applications, and began exploring private investment opportunities, positioning EndoEvolve for long-term growth and successful commercialization.
Services implemented:
Non-Dilutive Funding
Operations
Product Development
“Factor 7 provided the needed guidance, partnership, and expertise that enabled our company to take its critical first steps toward commercialization.”
Dr. Ben Poulose, MD
CEO of EndoEvolve