Abstract

Innovations within the medical device sector are constantly and rapidly emerging due to increasing demand, especially for orthosis systems, which usually constitute built rigids with low comfort, due mainly to the standardized production process. This article reports the design process of a plantar orthosis system from the application of Theory of Inventive Problem Solving (TRIZ) tools, known as generic parameters, matrix of contradictions, and inventive principles. The final orthosis is integrated by four modules or components (1 central and 3 movables) and customers can buy only the required ones, reducing cost in unnecessary parts. The plantar orthosis was defined based on three engineering parameters that delimited the design work by developing a customizable system that is capable of performing simultaneous functions and whose manufacture could be standardized. We identified the existence of a technical contradiction between the engineering parameters, customization, and standardization, which was solved by the inventive principles of segmentation, inversion, transition to a new dimension, and porous materials. A modular design with four components was accomplished, molds are built for each component in a machining center and injected using granulated ethylene vinyl acetate copolymer. The positions of the movable components are configured through a bolt-hole assembly mechanism to the central component, which is a flat perforated plantar base. The novelty in the design here presented is elated to supports that constitute the orthosis, which are interchangeable and adjustable to the pathological and morphological needs of each patient.

Highlights

  • The scientific-technological development allows us to increase productivity and efficiency in industries with dynamic and competitive markets [1], such as the medical industry

  • From phase 1, the formulation of the ideality of a plantar orthosis system was obtained for this work, which was expressed as follows: “a prefabricated system that allows combining the actions of shaft re-alignment and pressure redistribution according to specific morphological and pathological characteristics”

  • The modular plantar orthosis system is obtained from the approach of an inventive problem in which a solution is given to a conflict of coexistence between two requirements of the system, that it is prefabricated, and that it offers the advantages of custom-made plantar orthoses

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Summary

Introduction

The scientific-technological development allows us to increase productivity and efficiency in industries with dynamic and competitive markets [1], such as the medical industry. The medical devices sector has benefited from the incorporation of engineering principles in its product development and production process optimization to achieve competitiveness in the market through innovative and quality solutions [3]. Innovations in this field refer to the creation of new devices or the improvement of existing ones, through the development of a series of stages that start with the generation of an idea, continuing with the establishment of specifications, and ending with the commercialization of the device [4]. In 2015, the global market for plantar orthoses alone reached revenues of 2.6 billion dollars, and it is estimated that by 2021 these will increase by 45% [5]

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