Organisational innovation and its application in medical devices

This document aims to assess the management of organisational innovation and its subsequent organisational change within a specific innovative medical devices health sector organisation (i.e., Medtronic) and its TAVI devices. The assessment uses the available international standards dealing with innovation and medical devices as well as publications and websites. The application is selected because of its important frequency of innovative high-risk products to patients, including those emerging from disruptive innovation; and their important qualitative benefits including life expectancy and quality of life of patients. This document summarises organisational change and its specific subset (i.e., organisational innovation) in order to identify their respective main characteristics that are used as the assessment criteria. TAVI and Medtronic were assessed through two basic scenarios of worst and best cases with highly weighted factor for organisational innovation management principles, including politics and approaches. General literature for organisational change and organisational innovation; general international standards; and literature and specific international standards to the application constituted the knowledge base used for the assessment. Thirty assessment criteria were identified because of their straight linkage to organisational innovation management and approaches. The application values of ten criteria could not be evidenced in the knowledge base. The application value of one criterion was partially fulfilled. The two basic scenarios deliver the two extreme limits of the quantified assessment final score corresponding to the assessment of organisational innovation management of Medtronic. Because of high risk of failure of innovation initiatives, five recommendations have been concluded from the application: applying international standards dedicated to innovation and organisational innovation; capturing systematically values from innovation; adopting learning culture and its related politics of risk; involving researchers at the preparatory phase; and promoting the specific characteristics emerging from the selected application including the unmet needs source of innovation and the coexistence of entrepreneurs within the innovation processes.