An exploratory framework for the successful commercialisation of combination products

Abstract

Combination products are at the forefront of innovation in the biomedical technology sector technology sector. The successful commercialisation of these products, which combine two or more different single-entity products: a drug combined with a medical device, a drug combined with a biologic, or a medical device combined with both a drug and a biologic, has proven to be particularly challenging. However, little is known about the experiences of firms that are involved in this area. Combination product commercialisation has remained an underdeveloped area in the literature. In this paper we report on the results of an exploratory study that investigated the experiences of key informants from the biomedical technology sector that are involved in the commercialisation of combination products. This research will inform managers, R&D personnel, scientists and engineers in biomedical technology development contemplating entering the area of combination products about the experiences of those who have successful navigated the commercialisation process. The results of this research identify key factors that were found to have helped successful firms in this area. Results of the study indicate that there are a number of factors that influence the successful commercialisation of a combination product. These factors are: opportunity recognition, strategic regulatory management and product development management.