Commercialization Challenges in the Medical Technology Sector : Navigating The Finnish Medical Technology Space

Abstract

Medical technology is a rapidly evolving field tracing its humble beginnings from the invention of the stethoscope progressing to today’s wearable fitness trackers. The global medical technology market has experienced significant growth with new products and cutting-edge technologies entering the markets frequently driving monetary benefits and locking in customers. Central to this growth is commercialization — the process of launching a product in a market and generating income. This process requires careful planning at each stage, from ideation and concept development to obtaining market authorization and product launch. Commercializing medical technology products have an added layer of hurdle, due to inherent risk involved with dealing with human lives. Thus, medical technology commercialization requires a careful step-by-step approach starting from idea creation to the launch of the product and as a result it is not devoid of challenges.

The objective of this thesis is to explore and examine the commercialization challenges experienced by Finnish start-ups and what actions must be taken to mitigate or prevent those challenges. The literature review explores various commercialization prerequisites, important commercialization challenges across different sectors, an overview of the medical technology sector and the inherent commercialization challenges specific to the medical technology sector. Due to the qualitative nature of this research, a case study approach has been employed. Five case companies operating as Research-to-Business entities or university spin-offs in Finland were chosen. Qualitative interviews were conducted with the key commercial personnel from these companies. Based on the interviews and existing literature, the different challenge themes were concretized and a thematic analysis is performed to derive the key aggregate outcomes from those challenges. Finally, a process model involving the key aggregate outcomes is constructed which delineates the commercialization pathway and gives suggestions on how to prevent or mitigate those challenges.

The findings of this study elucidate ten challenge themes: understanding sector dynamics and bridging the product-market gap, protecting innovation and getting patent approvals, saying yes/no to the Finnish ecosystem, talent acquisition and team formation, securing funding, time constraints, communicating value proposition, choosing the right business model, maneuvering regulatory pathways and designing clinical trials, and establishing networks and marketing. The challenge themes give rise to four aggregate outcomes — strategic market positioning, planning resource allocation, business strategy and compliant product development. These aggregate outcomes are consolidated to form a process model designed to guide future medical technology start-ups on where to focus initially and what challenges to anticipate. Additionally, the study taps into Finland’s unique ecosystem highlighting the challenges it presents as a market. Furthermore, it underscores the importance of securing funding, understanding market dynamics, acquiring skilled expertise, selecting a robust business model and conducting successful clinical trials as crucial components for a successful commercialization process.

The study identifies important managerial implications with the process model and highlights the importance of how neglecting one of the challenges can disrupt the entire commercialization process. It realizes the thesis objectives, by corroborating existing literature as well as introducing new findings to the literature. Finally, the study also emphasizes a few limitations and offers potential directions on future research in this area.