Study On TRL-Based Technology Maturity Evaluation Method For Advanced Medical Devices

The Chinese government attaches great significance to R&D of advanced medical devices and launches quite some scientific research projects to promote R&D of advanced medical devices. However, the scientific research project management and evaluation method is not ideal and lacks continuity of evaluation, leading to dragging research progress, increased research expenditure and decreased technology specifications. Technology maturity evaluation is a scientific and standard evaluation method is applicable for the entire R&D process and can improve the objectivity and continuity of project evaluation.Based on comparison of the advantages, disadvantages and applicable scope, the paper found that TRL (technology readiness level) divides the entire R&D process into 9 maturity levels, which is exactly the same as the applicable scope of scientific research project management. TRL also has an entire scientific and standard evaluation method and process, thus it is applicable for technology maturity evaluation of advanced medical devices.Based on the Medical device TRL levels developed by US Department of Defense, with reference to literature review and expert consultation, the paper modified TRL levels from the difference in medical device registration and regulation, quality management system and applicable environment (military or civilian use) between China and US. Based on the TRL calculator developed for aerospace equipment, the paper modified the TRL calculator for advanced medical devices by combining evaluation indicators and adding evaluation indicators reflecting the characteristics of advanced medical devices, such as clinical trial and GMP certification. The modified TRL levels and TRL calculator constituted the entire TRL evaluation method.The paper also applied the modified TRL evaluation method on surgical robot to test its feasibility. The empirical study indicated that it was feasible to apply the modified TRL method for technology maturity evaluation of advanced medical devices. TRL also improved the objectivity and continuity of project evaluation.It is the first time TRL is applied for advantaged medical device R&D management and evaluation in China. Compared with traditional expert consultation, TRL can improve evaluation fineness and accuracy, and provide reference and basis for decision-making at research feasibility verification, mid-term evaluation and final acceptance. It is suggested that TRL should be applied for advanced medical device R&D management and evaluation so as to promote successful R&D of advanced medical devices.