Medical devices in the German health care system: factors of choice and effects of regulatory framework conditions

The German health care system is facing challenges such as rising health care expenditures due to demographic change and increased expenses in medical facilities (e.g., energy and personnel costs). Ensuring long-term adequate patient care through efficient treatment of illnesses and prevention of secondary diseases requires consistent utilization of effective and safe medical technologies by patients and physicians. This dissertation examines why patients and physicians decide for or against (dental) medical treatments by identifying factors of choice and their effects on decision-making. Particular attention is paid to the regulatory framework conditions in the German health care system, as these can significantly influence utilization of technologies and incurred costs. In eight articles various methodological approaches were used to implement the dissertation, including systematic literature reviews, qualitative and quantitative analyses, and mixed-method studies that focused either on patients in dental care or physicians in the inpatient sector, with physicians utilizing new technologies. In addition to the targeted examination of the German health care context, the scope was broadened in individual articles, e.g., by analyzing international literature. In the investigations, various factors influencing patients (international: n=101, national: n=53) and physicians (n=52) in their decisions for or against dental treatments and utilization of new technologies were identified. Factors such as aesthetics and out-of-pocket payments play a crucial role in decision-making for patients. Aesthetic aspects, e.g., the natural color of dental crowns (particularly for anterior teeth), were considered decisive for treatment decisions. However, high costs of dental treatments cause patients to decline treatment or to forgo amenities (e.g., vacations) to finance it. Other important factors of choice from patients' perspective include dental fear and pain. In addition, country-specific factors (e.g., religion) were identified internationally. From physicians' perspective, effects of the factors evidence base, date of product approval, safety notices & recalls, and financing instruments are to be assumed. The presence of positive evidence might favor increased utilization of new technologies, while lack of evidence can be a decisive factor for physicians not adopting them. However, it was also found that evidence may not have an impact regarding decision-making. Costs of new technologies influence utilization, with physicians considering alternative funding options or waiting for prices to fall. Some physicians suggested that hospitals with specific funding options, such as university hospitals, should utilize new technologies as pioneers. Financing instruments in dental care and the inpatient sector need to be revised. In addition to cost, other factors influencing patients' decision-making such as the consideration of aesthetically appealing dental treatments should also be addressed, referring to their needs and preferences. From physicians' perspective, clinical research should be strengthened, and access to research results improved. Furthermore, evidence-based reimbursement decisions and preventive measures to ensure (cost) efficient patient care should be promoted. Follow-up studies could further investigate the identified factors of choice and their effects.