Product development packages

The V-model XT first describes the customer—supplier relationship. This phase determines the product scope and the fundamental requirements and is comparable to part 8, Chap. 5 (Interfaces of the distributed development). Here the author refers to the interface agreement (DIA, Development Interface Agreement) between development partners. Those agreements should determine who is responsible for the various product development packages (or product elements) and who performs which activity (who does what). 

The use is examined of plastics in medical applications with reference to the US market for additives for these products. The use of plastics for medical applications, which include products and components of equipment, and packaging, is expected to exceed 4 billion US dollars in the next two years, with perhaps double or treble that figure for the world market, it is forecasted. The regulatory bodies governing the use of additives are reviewed, and specific additives discussed include plasticisers, stabilisers, conductive additives, and lubricants. The production of compounds for use in the medical sector is examined with reference to the activities of leading companies, and brief details of product developments are included. 

Beyond perfonnance optimization, issues relative to packaging and the need for compliance with certain safety and electronics regulatory codes are cited as reasons for a customized solution. In the latter case, a systems approach is required, especially when attempting to meet the code or performance requirements for compliance with European Certification (CE) mark or electrical and fire safety codes such as National Eire Prevention Association (NFPA) and CENELEC (European Committee for Electrotechiucal Standardization). Off-the-shelf electronics may provide the necessary performance characteristics for generic applications, and their use eliminates large expenses related to product development, plus the associated time delays. Photonics-related components are solely addressed in this section because they are used to customize instruments for application-specific systems. 

New product development is a constant activity for most soft drinks producers. For the most part there are few really new products alternative flavours and different forms of packaging are widespread and no doubt will continue to be so. 

Equipment qualification is best considered at the time of equipment specification and selection. The advantages include more effective project management, ease of completing the validation package, and speed of bringing the equipment on-line. Equipment requirements and performance are based on the needs of the product, as characterized during product development. 

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