Analysis and evaluation of product development risks in the pharmaceutical industry

Nowadays, rapid changes in customer expectations and demands, high speed of technology development, shorter product life cycle, and increasing product diversity have led to changes in the business environment. These changes have increased uncertainty in the organization's performance and product development process. The dynamism and complexity of the concept of new product development and the competitive nature of more and more organizations, along with the emergence of new product manufacturing sciences and equipment, have posed new challenges in the production of new products. Based on the PMBOK project management knowledge areas, the ten areas of management (integrity management, scope management, time management, cost management, quality management, human resource management, communication management, risk management, logistics management, and stakeholder management) are implemented in four stages of product life. Risk management in the product life cycle is a critical component of product success, which makes product development and production run with fewer challenges, so all four stages of the product life cycle (introduction, growth, maturity, and change) would be successfully completed. As we know, the new product development process is a project-oriented approach with an organizational structure based on the steps of content analysis, conceptual design, detailed design, sample production, and mass production. Thus, it is necessary to implement all administrative processes based on project management principles to be controlled and examined. Therefore, in this study, firstly, using the Delfy-fuzzy method, the risks involved in developing a new product in the pharmaceutical industry are identified and categorized considering the four steps of the product life cycle. Secondly, a team of experts in the R&D department of "Osweh pharmaceutical company" was interviewed to score the importance of the risks, and then, by using the FMEA method, the new product development risks are ranked and prioritized. Thirdly, by consulting the expert comity, the control measures are implemented, and appropriate strategies for each risk are defined. Fourthly, using the goal programming method, the budget for control measures in each stage of the product life cycle is optimized and allocated.