The Optimization Of IVD Product Development Process In Company Z

Product R&D, as the soul of an enterprise, has become the focus of market competition. It’s a complicated project which usually requires a certain progress procedure. It’s a work of coordination on many levels, including market demands, statutory and regulatory requirements, research capability and interdepartmental communication, with a purpose of improving R&D efficiency and product performance. The complexity of it all makes R&D project management a mixture of both necessity and difficulty. The author always considers management to be an interaction of two separated but dependent aspects. One is to confine or intervene by means of rules and regulations. The other one is about formulation and alteration of the rules foresaid, aiming at smoothing flawed workflows, which is the accent of this thesis.The product R&D department of company Z is struggling with two alarming obstacles:uncontrollable research period and incapacity in exploiting the full potential of our products. And the lack of systemic analysis of the whole workflow and the crucial procedures is one of the many causes, which make it difficult to turn around the adverse situation.To achieve a better research efficiency and an improved product quality, the author put himself into studying some renowned theories including Stage-Gate System and Agile Product Development, and some methods such as Work Breakdown Structure and Network Planning Technology. Based on those studies, the thesis presents itself with two important goals:time reduction and quality improvement. The study was centered on the essential stages in the process of in vitro diagnostic reagent development, successively listed as below:a) project establishment, b) project planning, c) product development, d) product validation, e) project output, f) product register and g) market feedback. Started with the characteristics of R&D project, the main purpose of the thesis is to absorb the concept of structuration in Stage-Gate System theory and the pursuit of adaptability and flexibility in Agile Product Development theory, so as to improve every link in the workflow, variable or not. The structure of the study, and the consequential achievements, expands through several stages as follow:a) By identifying the existed problem and analyzing the causes, the author introduces the purpose of this study, which is proposing a procedure-centered management mode for R&D project to replace the old extensive one, so that the urgent needs to improve development efficiency for the company can be met.b) By means of Work Breakdown Structure and Network Planning Technology, the author decomposes each stage of the whole project into smaller components, presented by the deliverables, estimates the duration of each activity and analyzes the logical connections among them, followed by identifying the critical path of the project and confirming the direction of optimization:One is to reduce the time consume of the key processes in order to shorten the total project duration. The other one is, according to the logical framework of the project, to add parallel works without interfering the key processes, which could most probably elevated product quality.c) The author also designs and validates specific optimization methods such as: the utilization Design of Experiments (DOE) in Six Sigma Management, one of the perfect solutions for the proceduralization of product development phase. With careful selection of designs, each one specifically targeted to the according session of the development period, we can efficiently shorten the project period; achieve a better control over the project and improve the quality of both the product and the project itself. Secondly, we make use of the idle time within the project and insert a new proceduralized process for substitution of the critical raw materials, by application of the Evaluation Protocols (EP) of National Committee for Clinical Laboratory Standards (NCCLS). As a result, improved R&D quality and better adaptability of the project could be obtained.In vitro diagnostics is an industry with innovation and advanced technologies. It has relatively higher risk than traditional industries, which producing more difficulties and challenges for product development, hence the crucial need for a systematic, practical and executable solution for product development project workflow.