Research On Life Cycle Risk Management Of Patient Monitor R&D Project Of W Company

With the development of society and the continuous pursuit of human health,the medical device industry has shown rapid growth.However,because the medical device industry is highly specialized,interdisciplinary,long-period,and has strict regulatory requirements,medical device R&D projects are characterized by large investment,long period,high technical requirements,of medical device R&D projects has become a more critical concern for enterprises in the medical device industry and is of great theoretical and practical significance for the development of the medical device industry in ChinaBased on the risk management theory research,this paper applies the risk management theory and the whole life cycle theory to the patient monitor R&D project by combining the present whole life cycle theory as an example The risk management research of the medical device R&D project is further explored from the perspective of this R&D project,which mainly contains the following aspects.The research background and significance of this paper are briefly introduced.Based on the reading of the literature,the current status of risk management in medical device R&D projects is described in a comprehensive manner.The patient monitor development project was briefly introduced from various aspects such as medical device knowledge and the current status of patient monitor development.A risk management group for patient monitor R&D projects has been established and based on the whole life cycle theory.The project is divided into four stages:project establishment stage,project implementation stage,review and certification stage,and post-marketing stage.At the same time,the possible risk factors in each stage of R&D projects are identified through brainstorming method and expert method,and a total of 28 risk factors in six risk types,namely technical risk,policy risk,market risk,financial risk,production risk,and management risk,are identified.By using a combination of qualitative and quantitative methods such as hierarchical analysis and fuzzy analysis,we calculate the weight of the risk factors existing in each stage of the R&D project and come up with a list of major risks in each stage.The ten main risk factors are technology dependence,technical breakthrough difficulties,and low management capacity in the project establishment stage.There are ten main risk factors in the project implementation stage,such as technology dependence,technical breakthrough difficulties,and insufficient funds.The project approval stage is mainly ten major risk factors such as intellectual property protection,the impact of adverse events,etc.,and low management capability.The post-marketing stage is mainly the ten main risk factors such as the improper conversion of R&D and production,monopolization of major raw materials,and insufficient supply of raw materials.Study and develop control measures for the list of major risks.Responding to technical risks through measures such as good product research and technology introduction,responding to financial risks through the reasonable allocation of funds for sound accounting and cost budgeting,etc.Market risk is addressed through market research and other methods,policy risk is addressed by paying attention to policy developments and raising awareness of intellectual property rights,management risk is addressed by establishing an efficient organization to strengthen employee quality,and production risk is addressed by strengthening production management and other methods,and is applied in the patient monitor R&D project.Besides,the effectiveness of risk management through end result feedback has enabled the project to proceed smoothly and obtain product production qualification and put it into production on time.At present,the market response is good.This paper is an exploration of risk management in medical device R&D projects through the perspective of R&D project risk management.The study results have specific guidance and reference value for medical device R&D projects,especially the R&D project management of active medical devices,and contribute to further enrichment of risk management theory in medical device R&D projects.