Aspectos regulatórios aplicáveis às startups de saúde (healthtechs) com suporte da gestão do conhecimento

Abstract

Medical startups or healthtechs have been gaining great importance in the world economy with their solutions aimed at improving the quality of life and patient care. However, some of these solutions/products are regulated by specialized public bodies and, therefore, healthtechs need to prepare themselves to comply with regulatory requirements to obtain approval for marketing in the country. This is because one of the purposes of any country's health system, whether privately or publicly funded, is to establish strategies and actions to improve citizens' health standards. The objective of this research was to develop a regulatory affairs model for the aspects analysis based on knowledge management to be considered in projects of new medical devices that are subject to regularization in the health field for healthtechs. After a detailed literature review, the construction of the theoretical platform established in this research was carried out. Based on the set of criteria found, validation was carried out with the specialists through a semi-structured interview, followed by a survey with the application of the multicriteria decision analysis using the PAPRIKA method to a larger group of specialists. The established conceptual model includes all the regulatory foundations for the successful development and approval of a solution/product created by healthtechs. Thus, the model contemplates the different regulations that must be observed by health companies. In addition to the outlined regulatory model, this research also indicates the main processes, practices and IT tools used in knowledge management recognized by specialists in the field of regulatory affairs applied at some level in contemporary organizations. The results found in this research contribute to the evolution of the understanding of the application of knowledge management in the scope of regulatory affairs in Brazilian healthtechs, as well as contributing to the professionals working in medical device companies that work in the area of regulatory affairs to be able to better apply the established model, in addition to the different processes, practices and IT tools focused on knowledge management that can be applied to the area of regulatory affairs.