ABSTRACT

Early-onset scoliosis (EOS) is not a new spinal pathology, yet countries with limited resources are left with yesterday’s solutions. The root of this problem lies in a mismatch of expectations between healthcare providers in countries with limited resources and the industries whose innovations are focused on the reimbursement available in developed nations. The medical device industry funnels a lot of resources into research and development (R&D), distribution channels and commissions, patents protection, legal and regulatory undertaking, and marketing. Contrary to popular belief, the degree of competition between manufacturers in the spine industry is often limited. The medical device industry is particularly notable for the substantial relationships that often exist between manufacturers and physicians. A long-held view of innovation is that producers are motivated to innovate by the expectation of profits. The regulation should be limited to a framework necessary to carry innovation with precision and safety without stifling the rate at which it is undertaken.