Abstract
The development of medical devices challenges developers and manufacturers not in the least since medical device development (MDD) is more and more driven by technological and scientific development. Accordingly, the identification of critical success factors for MDD has become increasingly important for developers, and especially for startups who are in critical position given their struggle to compete with the leading firms in the field with their limited resources. The main objective of this article is the identification of MDD critical success factors and benchmark with related previous studies. The research method used was semi-directive interviews with 7 MDD professionals, 3 of which were startups. The principal finding of this research is that the details related to the MDD adopted process, such as change management and related document control, and the execution of risk management requirements in the MDD early design phases are considered MDD success factors that have not been addressed in related previous studies.
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Kheir, O., Jacoby, A., Verwulgen, S. (2020). Success Factors Impacting Nowadays Technologically Driven Medical Devices. In: Mrugalska, B., Trzcielinski, S., Karwowski, W., Di Nicolantonio, M., Rossi, E. (eds) Advances in Manufacturing, Production Management and Process Control. AHFE 2020. Advances in Intelligent Systems and Computing, vol 1216. Springer, Cham. https://doi.org/10.1007/978-3-030-51981-0_34
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