“Guía para la Administración de Proyectos de Transferencia de Tecnología en el Sistema de Calidad del Sector de Industria Médica para la Empresa Helix Medical”

Abstract

Helix Medical is a leading global company with experience in contract manufacturing services for medical device industry. Helix Medical decides to transfer technology from the United State of America (USA) to Costa Rica by 2012. It follows the following problem: how to transfer technology safe, efficient and meeting the business plan, between production facilities? And even more so, what are the systematic processes that Helix Medical owns, to manage technology transfer projects in the quality system during the last quarter 2011 and first half 2012?. Then, it was developed a guide to manage technology transfer projects under the umbrella of medical devices quality management system for Helix Medical Company. The results were oriented primarily to define the technical and regulatory requirements for technology transfer projects in the medical device industry. Second, it was proceeded to select five process groups of project life cycle. Then, for each group, it was identified inputs, outputs and tools. By this way, the project management process was organized simple and systemically, from top to button. Finally, a procedure was proposed to provide a set of standard processes to manage technology transfer projects in a systemic way for Helix Medical. It was concluded that a technology transfer process, between production plants, must contain processes for transferring product, process, equipment, materials, training and quality. On the other hand, the Model House of Project Management fulfilled the role of organizing, in a logical way, the Technology Transfer Project Management. This Guide standardized the minimum requirements and then increasing the project success chance. On the other hand, it was recommended to implement a Project Management Office (PMO) to coordinate technology transfer projects. Another aspect that needs to be analyzed is the managers and/or key actors skills to handle cultural differences. Finally, it was suggested to implement the procedure and designed guide to provoke a cultural change in the company, promoting the professional project management across the board.