Challenges in Fetoscope Commercialization: A Market Analysis in Fetal Intervention
Brian Burnett, Amrish Nair, Michael Belfort, Cara Buskmiller.
Physicians historically receive little education on innovations and startup companies; however, many physi-cians have ideas to solve problems they frequently encounter. The National Science Foundation (NSF) helps innovators de-risk possible solutions they envision by providing basic business education and requiring 100 customer interviews to ensure innovators are providing a solution potential customers will consume. Two physi-cian innovators conducted 100 stakeholder interviews across the field of fetal surgery, a growing field aimed at saving life or avoiding disability due to congenital disease. End-users and economic buyers converged on sever-al value propositions, namely improved visualization of the surgical field, operating room instrument setup time, and a cost. Regulatory stakeholders pointed out that regulatory burden is largely placed on centers to file ethics approvals for off-label use of currently-available scopes, which are only approved for one indication. Fetal benefit is a hazy area for certain device approval pathways, since the fetus is not a legal person. The fetal surgery market is a small and volatile one: vulnerable to regulatory and supply-related changes, but eager for new instruments as secular trends have advanced minimally-invasive approaches in the past 20 years.
