New Product Development in a Medical Device Context : Managing Projects of different Novelty

Abstract: Healthcare is a topic that matters since it aims to ensure better well-being for people. An important and essential part of health care is medical devices since it has the potential to increase the quality of life for people with a health problem. Among the suppliers of innovation, the medical device industry is a dynamic field providing thousands of products to the market every year with the aim to enhance people's lives. However, there are many actors that influences the medical device development such as regulations that ensures that medical devices follow a specific procedure during development, at the same time buyers and end-users need to be integrated throughout the medical device design, this results in challenges during medical device development. This thesis focuses on new product development (NPD) and investigates how projects are managed in a medical device context. Furthermore, the thesis elaborates projects of different novelty and the influence from the characteristic of complexity. This is done with a single-case study of a case company that develop and market medical devices. The empirical findings shows that the main challenges are in the area of clinical studies and product development, furthermore, managing NPD projects in a medical device context deals with specialized knowledge that is dispersed among a group of actors which can influence the development of the medical device no matter the novelty. It was found that the difference between the studied projects was minor in terms of complexity. Though, it was noticed that the project of radical novelty had more interaction with the end-user, which can relate to uncertainty in the function of the product, as a consequence from being completely new product. As a result from the findings, the implication is that the projects can not be treated and managed similarly as a result from uncertainty, thus, it depends on the integration of actors, consequently, influencing time of development and resources. This thesis contributes to the community of companies operating in a medical device context where there is minor focus on complexity in projects, it was found that it might be beneficial to make distinctions in complexity characteristics when identifying challenges and addressing NPD projects in a medical device context.