Product Development Phases

As a starting point for the planning of a development project. Tables 3 and 4 propose and summarize a phased scheme of a risk-oriented development plan. Several important milestones and decision points have already been included. Each phase must fulfil certain criteria in order to be accomplished before the next phase may start. Management decides whether a project is advanced enough to proceed to the next phase, since this decision is usually associated with the involvement of more people in different departments or of external participants and has significant financial implications. The data and information needed for an assessment of progress and criteria for the decision should be known beforehand. Most of these criteria, which are included in Table 4 as proposed milestones (and need to be specified in detail for a given project), address the critical aspects of the project and the question of what should be done to reduce these risks and to allow the project to enter the next phase. 

The first management decision will be to forward a research proposal and component to development. This decision should not be made if the active principle (the active component) is not yet available or insufficiently defined. A recombinant antigen which is incompletely characterized most likely needs much more research before it can be considered a development candidate. It should stay in the less costly research laboratory until sufficient efficacy with a clearly characterized antigen is achieved. There would be no point in testing safety features or to develop a process for a component if its essential features are still unknown. The ability to complete the product profile to a reasonable 

Proof of a reproducible active principle. Achievement of sufficient efficacy. 

Confirmation of efficacy in best available models or in target species. 

Limited, orientating safety studies. Establishment of a small-scale process, scaleable and with acceptable quality. Calculation of economic parameters. 

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There is a need for verification techniques in DFQ that can be used in the early and critical product development phases, where the quality is determined, i.e. can be applied on abstract and incomplete product models (Morup, 1993). The CA methodology is largely a verification technique that aims to achieve this. 

Before setting about the task of developing such a model, the product development process requires definition along with an indication of its key stages, this is so the appropriate tools and techniques can be applied (Booker et al., 1997). In the approach presented here in Figure 5.11, the product development phases are activities generally defined in the automotive industry (Clark and Fujimoto, 1991). QFD Phase 1 is used to understand and quantify the importance of customer needs and requirements, and to support the definition of product and process requirements. The FMEA process is used to explore any potential failure modes, their likely Occurrence, Severity and Detectability. DFA/DFM techniques are used to minimize part count, facilitate ease of assembly and project component manufacturing and assembly costs, and are primarily aimed at cost reduction. 

A side benefit of this designed type of experimentation is its potential usefulness in product and process validation. The subject of validation is of great interest to those in the operations area, but if approached rationally, validation must begin in the product development phase. The designs usually... 

Wilson DJ (1991) Project Xb, Product development - Phase 1, 06 Aug 1991, R.J. Reynolds. Bates 509308455-509308459, http //tobaccodocuments,org/ijr/509308455-8459,html... 

Product attributes, which should also be identified early on in the product development phase, come into play during the assessment of the parameter values. What exactly are product attributes In simple terms, these are those specifications that must be satisfied in order for the product or intermediate to be... 

Table 3 Product Development Phases, Main Risks and Tasks...

Table 4 Product Development Phases, Milestones and Decisions...

At the end of the product development phase and prior to process validation, a product review should be performed to ensure that the development is complete, and that the various processes for manufacture are capable of passing process validation. At this point, any gaps in the development process may be further studied and attended to, prior to performing process validation (e.g., logo printing process development), preferably at full scale. It is advisable to manufacture two or more process challenge batches to show that the product is acceptable at the upper and lower process ranges. This helps to ensure that validation will be successful. 

Product development, phase 1 studies completed in 2006, Regado Biosciences Inc. Archemix Corp. 

Rapid product development (RPD) shortens the feedback control cycles concerned with product data generation and the associated management processes. RPD exploits the potential of modem information and communication tools in order to support the necessary dynamic cooperation structures. Development times are systematically shortened by means of a holistic integration of man, organization, and technology. The learning processes can be systematically relocated to early product development phases. As a result of generative methods of production and virtual reality, physical and virtual prototypes can be made quickly available. 

Holistic balancing (lifecycle engineering of technical, economic, and environmental aspects) is now the established method used by major producers as a method of weak point analysis during the product development phase. 

Obtaining damage information during the early product development phase, based on actual prototype tests and validations. 

This paper presents a new method for the application of Bayesian theory and technology to product reliability growth during product development phase. The research work mainly focuses on how to determent prior distribution parameters of a new Dirichlet distribution and presents the relevant optimization model and method, finally demonstrate the validity of Bayesian reliability growth model by WinBUGS software. The conclusions as following ... 

Product development phase Specific requests for CE methods Requested level of CE criteria Tools and methods... 

The analysis of product failure behaviour and reliability parameters concerning the products life cycle is fundamental within the early product development phases. Initial measurements regarding the analysis of product reliability characteristics are based on prototypes. The challenge is the comprehensive analysis regarding the detection and mapping of expected failure modes and failure behaviour. Based on this analysis, product and manufacturing process optimisation is feasible. 

Reliability demonstration test is commonly adopted in product development phase to validate whether its reliability meets the specified requirement. Accelerated Life Test (ALT) could reduce test duration and has been applied in reliability demonstration for highly reliable products with long lifetime (Bris 2000, Krasich 2003). 

Safety analyses are performed at the appropriate level of abstraction during the concept and product development phases. Quantitative analysis methods predict the frequency of failures while qualitative analysis methods identify failures but do not predict the frequency of failures. Both types of analysis methods depend upon knowledge of the relevant fault types and fault models. 

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