Study Of Medical Equipment Research Based On Technology Readinsee Levels

Technology Readiness Levels(TRL) are a method of estimating technological maturity based on a scale from 1 to 9 to describe technological maturity.Attention has been drawn in developed countries the fact that a low technological maturity in weapon acquisition projects cause expense overruns and schedule delays. In 1999, a report released by US General Accounting Office indicated that in the United States Department of Defense, immature technology in weapon systems was the main reason for their failure. Immature new technology in acquisition increased the research risk. Since then, many developed countries like US, UK, and Canada began to develop technological maturity evaluation in weapon acquisition according to their national defense acquisition procedure in order to reduce program development risk. Chinese army has also begun to apply technological maturity evaluation in weapon research as a method of program management. It has been issued and put into force as a standard requirement. There are similar problems in medical equipment research programs. In many parts of program management such as program assessment, phase review, test and acceptance, using technological maturity evaluation can effectively control technology levels. It is of great significance to study the application of TRL in medical equipment development management, for it could boost success and efficiency of our army’s medical equipment research programs.This paper explores the basic theories, approaches and evaluation of technological maturity. There are six parts in this study:The first part explains the background, purpose, main contents, methods and technological routes of this research. Using a method of theoretical research combined with case study, this paper studies the basic ideas, theories, concepts, method and programs of TRL. Based on the knowledge of military, logistics and medical service and guided by the system theory, modular theory, information system theory and design methods, this research uses literature research and expert consultation to explore the specific strategy of establishing TRL in medical equipment development. It aims to improve the quantification level of the standard evaluation of the management of medical equipment development.The second part is an information research of the basic theories and methods. It defines the concepts of WBS, TRL, TRA and CTE and introduces the theory of TRL, including its source demand, basic ideas and their implications. This part also covers the basic methods of TRL together with their main functions and characteristics. As system indicators of estimating technological maturity levels, TRL quantitatively defines the entire process of scientific research program technology from “pure research” to productization. TRL evaluation can be described in 2 dimensions: TRL measurement and TRL evaluation, the latter for the macro control of the entire project and the former for the micro management of the WBE in the program. TRL measurement is the basic premise of TRL evaluation, while TRL evaluation can improve TRL. These two aspects form a “closed loop” circulation system which can ensure the program proceeding in order. Therefore, TRL can be used as a powerful tool in scientific research management to control the entire process of the project management. Since there is an inverse relationship between TRL and technological risks, TRL can also be used to control technological risks.The third part is a systematic information study of the application of TRL both in China and abroad. It includes the origin, development, initial application, theoretical development and extensive application of foreign TRL research and the theoretical introduction, initial application and current research status of domestic TRL research. Bibliometrics analysis and comparative study are made concerning scientific literature on domestic and foreign TRL research. Since the concepts of TRL theory were first developed in the 1970 s, there have been thousands of articles in this fieldduring the past several decades. These concepts have become the “standard scientific language” of researchers. TRL have been used in astronomy, business, management, military, space technology, aeronautics, climatology, electronic technology and biology. More and more countries are applying TRL in more fields while the theoretical study is also going deeper. As TRL were introduced into China rather late, there are considerable gaps between the theory of our country and that abroad. However, China has been developing corresponding standards and specifications, which have been put into practice in many fields.The fourth part focuses on the application of TRL in medical equipment research management. It studies the status quo and problems of the evaluation system of Chinese medical equipment research and development. An analysis is made concerning some useful experience of TRL evaluation and the special demands of medical equipment TRL evaluation. After a comprehensive study of the subject, object, criteria, factors, index, method, phases, steps and relations of TRL evaluation of medical equipment, the present study put forward an expert-based evaluation program of integrated technology readiness levels. The following are the advantages of this program. 1. As the original TRL definition only evaluates technological maturity through medical equipment technology performance verification, it can hardly cover other factors which might afffect the project’s technological maturity. The present study explores a model of medical equipment technological maturity, which is based on the development phase and demands of Chinese army’s medical equipment. It is an extension of TRL at the levels of hardware readiness levels, software readiness levels, production readiness levels, integration readiness levels, project readiness levels. With a rather comprehensive and object structural description and measurement model of technological maturity of medical equipment, the present research studies the characteristics of medical equipment development and makes a detailed definition of each level of TRL of medical equipment. A corresponding integrated questionnaire and evaluation formula are also included to achieve a comprehensive and object evaluation of medical equipment development programs. 2. Although TRL evaluation provides a method of evaluating technological maturity, this method has no discussions of the probability of risk events(e.g. the possible results of reaching or failing to reach the requirements of technological maturity). During the practical development, especially in determining the development costs, technological risks certainly exist. Using quality risk indicator, cost risk indicator and delivery risk indicator as risk factor indicators, this paper assesses the quality cost delivery(QCD) in each phase of the project and provides an integrated risk factor evaluation methodology, which can help achieve a comprehensive and object evaluation of the QCD of medical equipment development programs. 3. Taking into account of risk factors and technology readiness levels,the present study proposes a concept of integrated technology readiness levels in medical equipment evaluation, which can comprehensively quantify technology, quality, delivery and cost risks in program management. This helps to unify scientific measurement and evaluation, as well as scientific development and management. With the assessment method of technology value added, this study also explains the relationship of the input and output of scientific and technology.The fifth part is an empirical study of TRL application with the case of TRL evaluation of operation shelter development. It analyses the development programs of each phase of operation shelter, makes a practical evaluation by using the program of integrated technology readiness levels of medical equipment to verity its rationality and feasibility. A contractive analysis is also made between before and after TRL was applied to the development management of the operation shelter project. During the phase of demonstration, the application of TRL can help scientific managerial personnel know the overall TRL level of the discussed technology. It can also quantify technology risk levels, which is helpful in project decision. During the phase of program design, TRL can quantitatively determine key technology and approaches, make elaborate master plan of research and development so as to help closed-loop management of projects, optimal selection of the equipments and quantitative evaluation of technical proposal. During the phase of engineering development, TRL can control the quality of the whole project and WBS and can also quantify the evaluation results. During theapproval phase, TRL can quantify the evaluation of scientific and technological achievements, management and manufacturers. An improvement in effect is observed after TRL is used in operation shelter development management. This proves that TRL can enhance the management level of project technology and project development planning. TRL can also improve cost, delivery and program management and reduce technological risk. The case indicates that TRL evaluation in medical equipment program can facilitate program research, develop uniform standards and test technological status.The sixth part is a conclusion of the results of the present research. It points out the innovative points as well as the problems demanding further research. It discusses theoretically an application of TRL to evaluate more military medical scientific and technological practice, analyses the general application of TRL, the demands, necessity and feasibility of TRL evaluation in military medicine. The paper aims to promote the development and application of TRL in military medical scientific management.