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Complexity stage model of the medical device development based on economic evaluation-MedDee

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents' responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.Web of Science125art. no. 175

National Authority for Health: France

Provides an overview of France's National Authority for Health, which defines best-care standards and assesses the benefit and effectiveness of new technologies for inclusion on benefits lists. Examines its use of comparative effectiveness research

Approach to Assessing the Preparedness of Hospitals to Power Outages

Within the secondary impacts of electricity blackouts, it is necessary to pay attention to facilities providing medical care for the population, namely the hospitals. Hospitals represent a key position in the provision of health care also in times of crisis. These facilities must provide constant care; it is therefore essential that the preparedness of such facilities is kept at a high level. The basic aim of this article is to analyse the preparedness of hospitals to power outages (power failures, blackouts) within a pilot study. On that basis, a SWOT analysis is used to determine strengths and weaknesses of the system of preparedness of hospitals to power outages and solutions for better security of hospitals are defined. The sample investigated consists of four hospitals founded by the Regional Authority (hospitals Nos. 1-4) and one hospital founded by the Ministry of Health of the Czech Republic (hospital No. 5). The results of the study shows that most weaknesses of the preparedness of hospitals are represented by inadequately addressed reserves of fuel for the main backup power supply, poor knowledge of employees who are insufficiently retrained, and old backup power supplies (even 35 years in some cases)