Innovation process of mHealth: An overview of FDA-approved mobile medical applications

Mobile health or mHealth is expected to provide a way to revolutionize patient care through a wide range of usages. In reality, regulatory authorities have also begun approving mobile medical applications as medical devices. However, the key factors that drive innovations in mHealth, in particular, the dynamics of technological development and market creation, are unclear. To address these issues, the present study explores the key factors that drive the growth of the mHealth industry and potential innovation pathways that need to be incorporated into corporate development strategies of organizations. We analyzed the mHealth products approved by FDA to date (N = 189) in accordance with the novelty of market and/or products and found that new product development in the existing medical market formed the majority (N = 171) whereas diversification or new market development took up only a minor portion (N = 16 or 2, respectively). We also found that the present mHealth industry is being shaped by new entrants or start-ups with expertise in the field of information and communication technology, particularly in collaboration with incumbents in the pharmaceutical and medical devices industry in the cases of radical innovation.