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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Medina, L.A., Jankovic, M., Okudan Kremer, G.E., Yannou, B.: An investigation of critical factors in medical device development through Bayesian networks. Exp. Syst. Appl. 40(17), 7034–7045 (2013)
Spender, J.-C., Corvello, V., Grimaldi, M., Rippa, P.: Startups & open innovation: a review of the literature. Eur. J. Innov. Manage. 20(1), 4–30 (2017)
Brown, A., Dixon, D., Eatock, J., Meenan, B. J., Young, T.: A survey of success factors in new product development in the medical devices industry. In: 2008 IEEE (2008)
Florén, H., Frishammar, J., Parida, V., Wincent, J.: Critical success factors in early new product development: a review and a conceptual model. IEM J. 14(2), 411–427 (2017)
Makary, M., Daniel, M.: Medical error: the third leading cause of death in the US. BMJ (2016)
Medina, L., Wysk, R., Kremer, G.: A review of success factors in NPD: medical device domain. In: 61st Annual IIE Conference and Expo Proceedings (2011)
Kirkire, M., Rane, S.: Evaluation of success factors for medical device development using grey DEMATEL approach. J. Model. Manage. 12(2), 204–223 (2017)
Russell, R.K., Tippett, D.D.: Critical success factors for the fuzzy front end of innovation in the medical device industry. Eng. Manage. J. 20(3), 36–43 (2008)
Salgado, E.G., Sanches, C.E., da Silva, C., Mello, H.P., Samaan, M.: Critical success factors for new product development in biotechnology companies. Eng. Manage. J. 29(3), 140–153 (2017)
Wu, Y.H., Li, F.A., Fan, Y.T., Tu, P.W.: A study of medical device regulation management model in Asia. Exp. Rev. Med. Dev. 13(6), 533–543 (2016)
Kemparaj, U., Chavan, S.: Qualitative research: a brief description. Indian J. Med. Sci. 67(3), 89 (2013)
Dworkin, S.L.: Sample size policy for qualitative studies using in-depth interviews. Arch. Sex. Behav. 41(6), 1319–1320 (2012)
Ernst, H.: Success factors of new product development: a review of the empirical literature. Int. J. Manage. Rev. 4(1), 1–40 (2002)
Fereday, J., Muir-Cochrane, E.: Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int. J. Qual. Methods 5(1), 80–92 (2006)
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2020 The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG
About this paper
Cite this paper
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
Download citation
DOI: https://doi.org/10.1007/978-3-030-51981-0_34
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-51980-3
Online ISBN: 978-3-030-51981-0
eBook Packages: EngineeringEngineering (R0)