In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.

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The Business Process Model to represent the process of developing a medical device is presented in this paper. In the age of population aging and a growing amount of patients, enormous pressure is put on improving their care and living conditions. The development of medical devices is a complicated and expensive process. Therefore, the whole process was subjected to an analysis of business processes, and the resulting model was expressed using the Business Process Model and Notation (BPMN). The model aims to illustrate the consentient process of designing a medical device using graphical notation. This notation is suitable for displaying models of healthcare environments thanks to its user-friendliness and easy comprehensibility for all parties involved. In addition, this study demonstrates that the model in BPMN notation by its depth of specificity falls to the level of activity sub-processes. This level of abstraction allows a comprehensive view of the entire process, as well as future extensions for a more in-depth analysis and process mining techniques. the fields of biomedical science and technology gives rise to a paradoxical situation. On the one hand, the complexity of biomedical knowledge is increasing and requires more significant efforts for specialization and cooperation; on the other hand, the lifetime and timeliness of knowledge is significantly reduced [1]. It is evident that health care should be provided by safely designed [2,3] and effective [4,5] systems. These systems need to be explicitly designed to meet patient needs [1,5]. This assumption requires sufficient awareness of the patients to maintain control of their care.In terms of modeling these specific systems, it is essential to identify critical processes that will be modeled and then optimized. For most systems, it is not financially or time-feasible to analyze all processes, and even assuming this is possible, it is often unnecessary. It is always necessary to consider the priority of individual processes and focus primarily on improving processes with strategic importance for the operation of the system. Thus, process modeling becomes an important part of management, analysis, decision-making, and system optimization. There is a wide range of process approaches such as Activity-Based Costing [1], Business process Reengineering [6], Process Innovation [7] Workflow Management [8], Total Quality Management [9], and Supply Chain Management [10]. The range of these approaches, however, means a significant expansion of creators and users, which in turn places great emphasis on the clarity of these models. It is important to realize that the choice of modeling approach is inevitably dependent on the background of the decision problem or on the initial and resulting criteria. The findings of the research study by DiMasi, Grabowski, Hansen [2] revealed that the implementation of Business Process Model (BPM) contributes to resource optimization and quality enhancement. More specifically, the BPM enables to:

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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.