Product adaptation management: The case of medical device changes in healthcare institutions

Abstract

Summarization: In the medical device industry change is inevitable. Innovative healthcare companies are at the constant forefront of new technological advancements, regulations and standards revision. New requirements are enforced and every document, process, and product is subject to change. Product modifications can be initiated by manufacturers before the product is approved and made available to the public (pre-market product changes) as well as after the device has been approved and is distributed into the marketplace (post-market product changes). Such modifications are more challenging because products are being actively used in Healthcare Institutions so any change of the medical device or a medical device part will require correction resulting in uncertainty and operational inefficiencies in the interim period. The scope of this thesis is to explore how healthcare institutions adapt to medical device changes initiated by manufacturers due to safety alerts, recalls, software updates or product modifications. The focus will be given on how healthcare institutions are adapting to the changes triggered by safety alerts which is very critical in maintaining patient safety. Also, it seeks to understand the existing processes of handling medical device changes, the challenges and the effectiveness of adaptation management. Based on this, it will explore ways to improve the adaptation management practices within healthcare institutions. Through interviews with healthcare institutions stakeholders, this thesis uncovers the complexities involved in adapting to these changes. Also, based on the results, this thesis explores potential improvements and/or solutions to the overall medical device adaptation management process of healthcare institutions ensuring better preparedness and adaptability while maintaining both operational continuity and patient and user safety during critical medical device changes