KPM Center for Public Management

Effects of regulation in the medical device industry and health systems analysis

Research questions

In my dissertation, I examine (1) the equity and allocative efficiency of the Swiss and other OECD states’ health systems, (2) the effects of EU regulation on the European and Swiss medical device industry, and (3) the implementation of continuous improvement techniques in Swiss acute care hospitals as means to empower frontline caregivers and reorganize provision of care.

Method

I use a series of quantitative (e.g., structural equation models) and qualitative methods (e.g., text analysis) to address the research questions described above.

Relevance

First, health systems differ in their capacity to provide care in an efficient and equitable way. To better understand and manage health care provision, variations in health care utilization and spending for specific patient populations need to be analyzed in much greater detail. With this goal in mind, I analyze how health care utilization and costs of patients with high and complex needs vary within and across health systems. In addition, by comparing how utilization and spending indicators vary throughout the care pathway—starting with the index hospitalization and studying care provision in the rehab and outpatient care settings—I can benchmark performance and identify better practices.

Next, the European Commission strengthened the regulation of the medical device industry by enacting the Medical Device Regulation (MDR) in May 2017. Switzerland eventually adopted the MDR to maintain the access to the EU market. Notoriously, a stricter regulation is often a double-edged sword: while the higher safety requirements shall improve patient well-being in the long run, the new law also causes a substantial bureaucratic burden, which may distort competition at the expense of small and medium-sized enterprises (SME). To provide implications for policy makers and practitioners, I examine the economic impact of the MDR on the medical device industry in the EU and Switzerland.

Lastly, employees can play an important role in improving the organization they work for. Kaizen, a managerial technique that is often employed in hospitals, empowers employees regardless of their hierarchy level to contribute to continuous improvement activities. The approach puts a special emphasis on frontline employees by enabling them to take more responsibility and participate in decision-making. To discover opportunities to enhance employee participation, I examine the application of kaizen and participation behavior of nurses in two acute care hospitals. I contrast examples of positive and a negative implementation—an approach missing in literature, though strongly advocated by scholars. Finally, I describe key influencing factors for the successful implementation of kaizen management.

 

Expected Impact

Policy makers may consider ensuring that individual data is easily available for research purposes both at the national and international level. More available high-quality data would help researchers to discover potential inefficiencies in provision and hence foster mutual learning amongst jurisdictions. Next, political decision-makers should fully understand and further develop the recent medical device regulation if they are truly willing to increase patient safety. In addition, the recent regulation of medical devices of the EU seems to impair the financial performance of medtech SME. The likely market exit of medtech firms may not only reduce product availability, but may also impact prices and quality in the long run.

Practitioners might be interested in learning more out of their data by making it available for research. Physicians may also improve key quality indicators, such as readmission rates, by comparing their working methods with the ones of other clinics. Next, managers from the medtech industry could devote more effort on the establishment of organizational culture, which promotes change to improve financial performance. Hospitals willing to introduce continuous improvement techniques, can take advantage of our framework that describes key influencing factors for the successful implementation of kaizen management.

Scholars could expand the ICCONIC framework by including further patient profiles. In addition, the framework can also be applied for other countries. The long-term effect of the regulation of medical devices on patient safety and innovation remains unclear. Longitudinal studies in the years to come should be able to show the real effect of the new regulation on innovation, patient safety, and the general price level of medical devices. Measuring financial performance of SME, which are not obliged to publish their financial figures poses a major challenge for researchers. Finding applicable solutions to this problem would contribute significantly to the study of SME. Lastly, scholars could verify whether the proposed framework for the implementation of kaizen management also applies in a more general context, e.g., public administration and non-for-profit management.