title: Major regulatory shifts as a driver of organizational change in health care: a macro and a micro perspective
Creators: name: Shatrov, Kosta Donislavov
Publisher: name: Universität Bern
Year: 2022
Subjects: subject: 350 Public administration &amp; military science

description: In this dissertation, I explore how major shifts in the regulatory environment of actors involved in the delivery of health service trigger and shape organizational change. To do so, I conceptualize different types of policy intervention as exogenous shocks and use a range of qualitative and quantitative research methods. Chapter 1 portrays the general framework of this dissertation. Adopting a macro and a micro perspective respectively, I explore two distinct types of regulatory shift: First, in Chapters 2 and 3, I focus on regulation of market entry, whereas, in Chapter 4, I focus on reimbursement regulation by analyzing how the introduction of a system based on diagnosis-related groups (DRG) affects health care provision. To do so, I analyze how two acute care hospitals that had implemented kaizen—a management technique that aims to improve business processes—in a preparatory attempt to deliver their services in a more cost-efficient way. Chapter 5 concludes and suggests an agenda for future research.

In Chapter 2, I analyze how the regulatory shift induced by the new European Union Medical Device Regulation (MDR) affects the main stakeholders of the medical device industry. The theoretical framework of this review draws on the main objectives that the MDR asserts to pursue in its preamble: to facilitate free trade and enhance public health. Taking a descriptive approach based on both theoretical considerations and empirical evidence, I assess whether the new regulation is likely to achieve these two objectives. To my knowledge, this analysis represents the most comprehensive scholarly review of the MDR so far.
Discussing a range of specific regulatory issues that arguably leave some room for improvement, I provide policy makers with a set of specific coping strategies that aim to further improve the future regulation of medical devices. My analysis indicates that the MDR is highly likely to strengthen the European internal market because it harmonizes regulations across the borders of its member states. The definitive impact of the new regulation on patient safety, however, remains unclear because there are no longitudinal studies on this topic.
Highlights
• I review the most extensive regulation of medical devices since the 1990s.
• The regulation aims to strengthen the internal market and increase patient safety.
• The initial reactions of scholars, physicians, and industry representatives diverge strongly.
• The regulation introduces multiple regulatory instruments that are likely to enhance trade.
• The effect of the regulation on patient safety, however, remains unclear.

In Chapter 3, I conceptualize the new European Union Medical Device Regulation (MDR) as an exogenous shock that elicits a major shift in the regulatory environment of the medical device industry. To make sense of this new environment, firms are forced to reorient and recreate their working practices. Using Switzerland as ground for the subject of this study, I aim to determine the preliminary economic impact of the MDR on the European medical device industry.
By focusing on the relationship between organizational capacity for change and performance, I examine whether firms capable of change show higher levels of financial performance than their rivals. In this study, top executives and business leaders of medical device firms based in Switzerland completed an online survey with a Likert-scale-design. I used structural equation modeling (1) to determine whether some firms are more capable of change than others when faced with a major shift in their regulatory environment, and, (2) to outline ways in which firms may seek to improve their capacity to react to such a shift.
My results suggest that higher levels of organizational capacity for change (OCC) are generally positively associated with financial performance (p < 0.01) but that small and medium-sized firms show higher levels of OCC (p < 0.01) and lower levels of performance than their larger competitors (p < 0.01). Furthermore, start-ups showed lower levels of financial performance than established firms (p < 0.05). Finally, I outlined (1) strategies business leaders may wish to consider if they were to make their organizations more capable of change, and (2) measures policy makers could take to ensure that medical devices with no close substitutes are withdrawn from the market, especially in times of a global pandemic.
Highlights
• The new European Union Medical Device Regulation has substantially changed the way products enter the market, conceivably inducing a period of major organizational change.
• This cross-sectional study sheds light on which organizational characteristics enable firms to adapt better to change and secure a competitive advantage in the marketplace.
• I measured organizational change capacity by using a multi-dimensional instrument in an online survey of top managers.
• I used structural equation modelling to examine how organizational change capacity interrelates with financial performance.
• Although change-capable firms generally show higher levels of performance, this relationship may be qualified by specific organizational characteristics such as firm size and age.

In Chapter 4, I examine how providers of inpatient care respond to shifts in the reimbursement regulation of their services. I move forward towards an analysis from a micro perspective by examining organizational change on the example of individual providers. Additionally, I contrast examples of positive and negative implementation of kaizen—an approach thus far missing in the literature on health management research. By examining how two acute care hospitals had recently implemented the continuous improvement technique, I aim to (1) explore and understand the experiences of nurses, and (2) identify factors affecting the implementation of the technique. Based on my findings, I derive influencing factors for the successful implementation of kaizen management in hospital care.
By means of purposeful sampling, I selected 30 nurses from different units in two private acute care hospitals in Switzerland in May 2018. I used the Organizational Transformation Model developed by Lukas, et al. (2007) to conduct semi-structured interviews and perform qualitative content analysis. Lastly, originating from the two-factor motivation theory (Herzberg et al., 1959), I suggested two types of factor influencing the implementation of kaizen—hygiene factors that may prevent nurses from getting demotivated, and motivational factors that may boost their motivation.
Overall, nurses experienced kaizen as a positive practice that enabled them to discuss work-related activities in a more comprehensive manner. In some cases, however, a lack of visible improvement in the workplace lowered nurses’ motivation to make suggestions. Nurses’ attitudes towards kaizen differed across both hospitals depending on the available managerial support, resources such as infrastructure and staffing levels. From my findings, I derived several coping strategies to help health practitioners implement kaizen for the benefit of their organization and employees: Strong managerial support, appropriate use of kaizen tools, and a greater sense of team cohesion, among other factors, can influence how effectively hospital teams implement kaizen. To reap the benefits of kaizen, hospital managers should promote the exchange of opinions across hierarchy levels, allocate the necessary resources in terms of personnel and infrastructure, and show nurses how the technique can help them improve their workplace.
Highlights
• A managerial technique that aims to improve an organization continuously, kaizen is increasingly employed in health care.
• Semi-structured interviews were conducted with nurses working at two Swiss acute care hospitals in May 2018.
• I used the Organizational Transformation Model to perform qualitative content analysis and the two-factor motivation theory to synthesize the findings.
• Nurses’ attitudes towards kaizen differed across the hospitals depending on the available resources, managerial support, and staffing levels.
• From these and further findings described in this dissertation, I derived several coping strategies to help health practitioners implement kaizen for the benefit of their organization and employees.
description: In dieser Dissertation untersuche ich, wie drastische regulatorische Veränderungen im Gesundheitswesen Organisationswandel auslösen und gestalten. Dazu betrachte ich unterschiedliche Arten von Regulierungen als exogene Schocks und wende dabei eine Reihe von qualitativen und quantitativen Forschungsmethoden an.
Kapitel 1 beschreibt den konzeptionellen Rahmen der Dissertation. Zunächst aus einer Makro- und darauf aus einer Mikro-Perspektive untersuche ich zwei verschiedene Arten von regulatorischen Veränderungen: In den Kapiteln 2 und 3 konzentriere ich mich auf Marktzugangsregulierung am Beispiel der Medizinprodukteindustrie, während ich in Kapitel 4 die Rückerstattungsregulierung als Forschungshintergrund nehme und analysiere, wie die bevorstehende Einführung eines auf diagnosebezogenen Fallgruppen basierenden Abrechnungssystems die stationäre Gesundheitsversorgung beeinflusst. Kapitel 5 hält die wichtigsten Schlussfolgerungen sowie Handlungsempfehlungen für Politik, Praxis und Wissenschaft fest und schliesst mit Vorschlägen für künftige Forschung.
In Kapitel 2 untersuche ich, wie sich der regulatorische Wandel, der durch die neue Verordnung der Europäischen Union über Medizinprodukte (MDR) ausgelöst wurde, auf die zentralen Akteure der Medizinprodukteindustrie auswirkt. Meines Wissens stellt diese Studie die bisher umfassendste wissenschaftliche Analyse der MDR dar. Zusammenfassend zeigt meine Analyse, dass die MDR höchstwahrscheinlich den europäischen Binnenmarkt stärken wird, da sie regulatorische Vorgaben über die Grenzen der Mitgliedsstaaten hinweg weiter spezifiziert und harmonisiert. Die endgültigen Auswirkungen der Verordnung auf die Patientensicherheit bleiben jedoch unklar, da bis dato keine belastbaren Längsschnittstudien zu diesem Thema vorhanden sind.
In Kapitel 3 stelle ich die neue MDR als einen exogenen Schock dar, der die regulatorischen Rahmenbedingungen der Medizinprodukteindustrie erheblich verändert. Um sich in diesem neuen Umfeld zurechtzufinden, sind Unternehmen gezwungen, ihre bestehenden Geschäftspraktiken anzupassen und neue einzuführen. Das Ziel dieser Studie ist, am Beispiel der Schweiz die vorläufigen wirtschaftlichen Folgen der MDR auf die europäische Medizinprodukteindustrie zu untersuchen. Abschliessend skizziere ich (1) Strategien, die Führungskräfte in Betracht ziehen könnten, um die OCC ihres Unternehmens zu erhöhen, und zeige (2) Massnahmen auf, die politische Entscheidungsträgerinnen und -träger ergreifen könnten, um sicherzustellen, dass Unternehmen in finanzieller Notlage Medizinprodukte nicht vom Markt nehmen, für die es keine Substitute gibt und deren Rückzug die gesundheitliche Versorgung von Patientinnen und Patienten beeinträchtigen kann.
In Kapitel 4 untersuche ich, wie die Anpassung der Rückerstattungsregulierung stationärer Behandlungen Organisationswandel auslösen kann. Vor diesem Hintergrund betrachte ich, wie zwei private Akutspitäler Kaizen-Management im Hinblick auf die zum damaligen Zeitpunkt bevorstehende Einführung eines Fallpauschalensystems für die Abrechnung von gesundheitlichen Leistungen im stationären Bereich (DRG-System) implementiert haben. Kaizen stellt eine niederschwellige Managementtechnik dar, die die kontinuierliche Verbesserung einer Organisation durch kleine aber ständige Anpassungen von Unternehmensstrukturen und -prozessen bezweckt.
In dieser Studie stelle ich Beispiele positiver und negativer Implementierung von Kaizen gegenüber – ein Ansatz, der in der Fachliteratur bislang fehlt. Mein Ziel ist, (1) die Erfahrungen der Pflegefachkräfte zu untersuchen und (2) Faktoren zu identifizieren, die die Implementierung der Managementtechnik beeinflussen können. Aus meinen Erkenntnissen leite ich mehrere Bewältigungsstrategien ab, die Führungskräften helfen sollen, Kaizen zum Nutzen ihrer Organisation und ihrer Angestellten zu implementieren: Um die Vorteile des Managementansatzes zu nutzen, sollten Führungskräfte den Meinungsaustausch über Hierarchieebenen hinweg fördern, die notwendigen Ressourcen in Form von Personal und Infrastruktur bereitstellen und den Pflegefachkräften zeigen, wie die Technik ihnen helfen kann, ihren Arbeitsplatz zu verbessern.