MODERN ASPECTS OF BUSINESS PLANNING OF MEDICAL PRODUCTS MANUFACTURING COMPANIES FOLLOWING THE REQUIREMENTS OF INTERNATIONAL QUALITY STANDARDS
Authors: Kazak Oksana , Riabyk Serhii 
Published: January 2025

The article investigates the current problems of bringing new products to the market by enterprises engaged in the production of medical devices. The main factors of restrictions are identified as regulatory changes related to the need to comply with international quality standards in the integration conditions of medical device manufacturers. The essence and requirements of the international standard ISO 13485 for the design and development of new products are analyzed. The author clarifies the differentiation between the need for manufacturing companies to comply with the requirements of this standard and the consideration of the most important factors for drawing up thorough business planning as the main tool for determining the company’s strategic goals and ensuring its stable and efficient operation. The article presents the essence of business planning in the system of strategic management of a company and defines it as a systematic process of making effective management decisions by allocating resources and choosing the best course of action from alternative options, aimed at assessing the feasibility of the chosen direction of the company’s development, as well as formalizing the decision-making process for project implementation. It is proved that the optimal tool for evaluating the most effective projects is carried out using investment analysis tools. The methods for evaluating investment business projects are outlined: methods based on discounted estimates and methods based on accounting estimates. The main aspects of investment analysis are defined: functions, evaluation tools, and factors of influence. The project cycle of strategic business planning of the company’s activities is presented. The analysis of the attractiveness of the business idea and the analysis of the business plan as a whole are defined as the main components of the expert analysis of the business plan before its implementation. In particular, the author identifies the criteria for express assessment of the prospects and feasibility of a business idea and the main parameters for assessing a marketing plan and marketing strategy, technological analysis, analysis of an organizational plan, and financial and economic analysis for business planning. Special attention is paid to the analysis of project risks. In particular, the classification of project risks is presented, the expediency of applying the Markowitz portfolio theory to form a campaign investment portfolio for optimal asset selection based on the required return/risk ratio is substantiated. The experience of applying business planning standards by leading international and national institutions in the field of investment and business consulting, such as UNIDO, TACIS and the EBRD, is reviewed and systematized. The use of automated analytical tools Wrike, Microsoft Project and Microsoft Dynamics 365 is proposed for making decisions on strategic business planning tasks. It is established that the introduction of activities related to the use of modern methods and automated programs for business planning and project management, the creation of a system of staff motivation during business planning and implementation can bring medical device companies to a qualitatively new level for successful integration into the Global System of Medical Devices Manufacturers.