Go to market strategy : role of medical device regulation in EU

Abstract

This thesis focused on new Medical Device Regulation (MDR) in European Union. MDR became effective on May 25, 2017 with three years’ transition time. Change in regulation brings a disruption to medical device companies’ external environment and this regulatory landscape change has significant implications to go to market (GTM) strategy. Aim of this thesis is to study what are the significant changes in MDR affecting mostly to the GTM strategy. Methodologically this thesis followed a constructive approach aiming to develop a construction to solve a specific research problem. Thesis followed qualitative research approach with methods such as document analysis and interviews. Document analysis included 15 documents focusing on changes in MDR and the results of analysis were used to focus to the significant changes in MDR compared to previous regulations. As a result, 9 major groups of changes were identified: full life-cycle approach, new databases, product classification and approval, quality management system and related requirements, post-market surveillance system and vigilance, clinical development and surveillance, supply chain management, authorities and their roles, and implantable devices. These topics were then analyzed from GTM strategy viewpoint and linked to theoretical model of GTM strategy. Finally, practical conclusions were presented for each of the elements of GTM strategy i.e. regulatory strategy, internal analysis, external analysis, target market selection, entry mode decision, marketing plan, and tactical plan. Major recommendations included the need to rethink product portfolio because of the change in MDR and the need to start thinking GTM strategy from the very beginning of the product development in order to have all regulatory requirements implemented appropriately.