https://orcid.org/0000-0002-1071-6390
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ABSTRACT
This study uses the publicly available International Medical Devices Database in three-phase research to present empirically grounded multi-dimensional typologies of events involving faulty medical devices. In the first phase, considering three major categorical data, i.e. event actions, event types, and countries, and, by employing descriptive analysis, we identify that perhaps ‘Field safety notice’ is the most dominant event type under which 66 event actions exist. In the second phase, employing the two-step clustering analysis technique, we identify that four distinct clusters exist. Finally, in the last phase, employing the focus group-driven content analysis approach using event reason description in conjunction with the SHELL (software-hardware-equipment-liveware) model, we classify the top 10 event actions. We also identify corresponding risk levels considering the top 10 sources of device problems. Further, the focus group employing the interest-influence framework in conjunction with pertinent self-addressed questions ascertained that the greatest number of top 10 event actions lies at the quadrant wherein the major stakeholder has a high degree of interest and influence in mitigating those medical events. Our study bridges the extant research gap about the lack of comprehensive, data-driven, and evidence-based themes around medical device events, the associated risk characteristics, and stakeholder mapping.
Acknowledgements
Open Access funding provided by the Qatar National Library.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
The data that support the findings of this study are available upon reasonable request.
Additional information
Funding
Notes on contributors
Mohit Goswami
Dr Mohit Goswami is currently associated as Associate Professor of Operations Management group in Indian Institute of Management, Raipur. Dr Goswami earned his PhD from Indian Institute of Technology-Kharagpur in the department of Industrial and Systems Engineering and Master of Science from Missouri University of Science and Technology, Rolla, USA in Engineering Management. He has more than a decade of rich industry experiences in global organisations like Tata Motors Ltd, Caterpillar Inc., Illinois, USA, and Tata Hitachi Construction Machinery Ltd. He has published research papers in reputed journals such as International Journal of Production Research, Technological Forecasting and Social Change, International Journal of Retail and Distribution Management, International Journal of Medical Informatics, Journal of Engineering Design, and International Journal of Advanced Manufacturing Technology etc. At IIM Raipur, he currently serves as Chairperson of Admissions for all degree programmes. Previously, he has also currently served as Chairperson of executive MBA and e-learning programmes.
Felix T. S. Chan
Prof. Felix Chan received his BSc Degree in Mechanical Engineering from Brighton University, UK, and obtained his MSc and PhD in Manufacturing Engineering from the Imperial College of Science and Technology, University of London, UK. His current research interests are Logistics and Supply Chain Management, Decision Making, AI Optimisation, Operations Research, Production and Operations Management, Distribution Coordination. To date, Prof. Chan has published over 16 book chapters, over 430 SCI refereed international journal papers and 330 peer reviewed international conference papers. His total number of citations >12000, h Index = 56. Prof. Chan is a chartered member of the Chartered Institute of Logistics and Transport in Hong Kong. Furthermore, based on the recent compilations from a research group of Stanford about the impact of scientists (top 2% listed), Prof. Felix Chan have been successfully listed at the top 2% world scientists for THREE consecutive years (2020–2022).
M. Ramkumar
Dr M. Ramkumar is currently working as an Assistant Professor in the Department of Operations Management at Indian Institute of Management Raipur. Prior to this, starting December 2019, Ramkumar was a Postdoctoral Researcher at the Chair of Logistics Management at the Swiss Federal Institute of Technology Zurich, Switzerland. Previously, he was with the Institute for Financial Management & Research as an Assistant Professor. He received his B.E. in Production Engineering from Anna University, Chennai (2007), Postgraduate Diploma in Management from SCMS, Cochin (2009), and PhD from the Department of Industrial & Systems Engineering, Indian Institute of Technology Kharagpur (2015). His research is interdisciplinary and lies on the interface between operations management and information systems, and encompasses supply chain technologies, supply chain sustainability, and humanitarian operations. His research has been published in international journals such as Service Science (INFORMS), International Journal of Production Economics, International Journal of Production Research, Production Planning & Control, Annals of Operations Research, Computers & Industrial Engineering, IEEE Systems Journal and other peer reviewed journals. Furthermore, he regularly presents his work at international conferences, such as the Production and Operations Management Society Conference, the Decision Sciences Institute Annual Meeting, the International Annual IPSERA Conference, or the IIE Asian Conference. For attending these conferences, he has received numerous travel grants from the conference societies or his academic home institution.
Yash Daultani
Dr Yash Daultani is a faculty member of the Operations Management Group. Before joining IIM Lucknow, he was associated with ABV-IIITM Gwalior as an assistant professor. He holds a doctoral (Fellow) degree from the Indian Institute of Management Lucknow. He has published several research articles that appeared in the International Journal of Production Research, Journal of Intelligent Manufacturing, etc. His research interests are in the domain of Industry 4.0, and Supply Chain Modelling.
Nripendra P. Rana
Prof. Nripendra P. Rana is currently a Professor in Marketing at the College of Business and Economics at Qatar University, Doha, Qatar. He has done his MBA as well as PhD from Swansea University, UK. He has also worked as Professor in Information Systems at Swansea University, UK and the Head of International Business, Marketing and Branding Research Centre and Professor in Digital Marketing at the University of Bradford in the UK. His current research interests focus primarily on adoption and diffusion of emerging ICTs, e-commerce, m-commerce, e-government and digital, social media marketing, and role of artificial intelligence on consumer decision-making and behaviour. He has published close to 300 research papers in a range of leading academic journals, conference proceedings, books etc. He has co-edited five books on digital and social media marketing, emerging markets and supply and operations management. Some of such journals where his papers got published include British Journal of Management, European Journal of Information Systems, Annals of Tourism Research, Public Management Review, European Journal of Marketing, Journal of Sustainable Tourism, and International Journal of Information Management. He has also co-edited several special issues, organised tracks, mini-tracks and panels in leading conferences. He is the Chief Editor of International Journal of Electronic Government Research and Associate Editor of International Journal of Information Management.