Christa Altenstetter, an expert in comparative public policy, health policy, and policy-making in the European Union (EU), has devoted most of her research over the last twenty years to health care reform from a comparative perspective, the impact of EU developments on the member states in the field of health, and international and cross-national regulation in health care. She holds a Ph.D. from Heidelberg University, was a postdoctoral fellow at the John F. Kennedy School at Harvard University, directed a research project at the School of Public Health at Yale University, served on the research staff of several American and European Research Institutes, and has frequently worked as a consultant to health authorities and the World Health Organization. Altenstetter is the author of Medical Technology in Japan: The Politics of Regulation (2014), Medical Devices: European Union Policymaking and the Implementation of Patient Health and Safety in France (2008), and editor or coeditor of Innovation in Health Policy and Service Delivery (1981), Comparative Health Policy and the New Right: From Rhetoric to Reality (1991), Health Policy Reform, National Variations and Globalization (1997), and Health Policy (1998). She published several articles on a cross-national project: “Bridging International and National Regulatory Policymaking on Medical Devices: A Comparison of the European Union, Japan, and the United States.” An active member of the International Political Science Association (IPSA), she founded and directed an IPSA research committee on comparative health policy, which established a research link to the major international and national health databases and websites.
The purpose of this research project is two fold: first, to analyze the role of Japanese and American regulators and industry representatives in seeking to develop a 'single window' for regulating medical devices and, second, to assess their role in domestic health strategy debates on the inclusion of medical devices as covered and reimbursable items by public or private health protection schemes and enforcing after-sales responsibilities of manufacturers and healthcare providers to report adverse incidents. Through a qualitative research strategy bridging two levels of policy-making and consisting of four methods, this project hopes to significantly contribute to a better understanding of the consequences of globalization and global alliances, national policy initiatives, and risks to patients in relation to medical devices.