Análisis comparativo entre las normas técnicas de diseño de calzado ortopédico y la oferta comercial para adultos con pie plano en la ciudad de Ambato

Abstract

This research project analyzes the comparison between technical standards applicable to the design of orthopedic footwear and the commercial offer available for adults with flat feet in the city of Ambato. The study arises from the lack of specific regulations in Ecuador and the limited technological development in production processes, which results in products that do not meet clinical or ergonomic parameters, affecting users’ quality of life. The study was conducted using a mixed approach that combined a documentary review of national and international standards with fieldwork through surveys of users and interviews with experts and local workshops. This methodology allowed contrasting regulatory requirements with market reality, identifying significant gaps in the manufacturing and commercialization of orthopedic footwear. The results show that the current commercial offer prioritizes aesthetics over functionality, lacks certifications, and presents deficiencies in anatomical customization, limiting therapeutic effectiveness and adherence to treatment. Additionally, production processes are mostly artisanal, without instrumented tests to validate biomechanical parameters, compromising clinical safety and sector competitiveness. The regulatory analysis revealed that, although general regulations exist for footwear and medical devices, none define the essential biomechanical parameters for orthopedic design, such as heel counter rigidity, arch support height, and controlled sole flexion. This regulatory gap, combined with the lack of technological innovation, restricts the local industry’s ability to meet international standards and access specialized markets. A structural gap between local practice and international technical guidelines is confirmed, requiring the implementation of specific regulations, adoption of advanced technologies, and technical training to ensure safe, functional, and aesthetically acceptable products.