New product targets

Since the process for new products is driven by the market a business must be up to date in its understanding of the needs of both current and potential customers, since it is not a static place. All the time developments are taking place and new products are being introduced by the competition, usually without any prior warning customers come and go and their requirements change. Information coming in from any source must be converted to knowledge (see Section C, 3.5). 

In spite of these difficulties an intimate knowledge of the structures, composition and the performance of a competitor s existing products should be maintained. To do this properly requires a considerable effort particularly from R D. A significant amount of time and money will need to be expended on the analysis, identification and evaluation of competitive products. Creating a database on the innovative activities of the competition is also useful as a benchmark for a company s own performance. However, it is mainly used as help in identifying gaps in the company s product range, which need to be filled or weaknesses removed. 

The collection, evaluation and recording of data and information from the market place must be done systematically, even though a lot of it may well have been obtained in a random manner. This information will be gathered typically from the following sources. 

Having generated and analysed this information it is possible to draw conclusions about the potential targets for the R D group. A full evaluation of these potential targets is then carried out before any are converted to projects. This evaluation will involve both economical and technical issues. The questions that will need to be answered are as follows. 

The number of people allocated to each project, i.e. the proportion of the research budget, will depend largely on the size of the eventual economic return set against a desired pay back time. If getting there quickly is of overriding importance then more 

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This topic first contextualizes the medical devices as well as their definition, function and classification, and then addresses the process of developing new products targeted for medical area and its evolution/innovation. At the end, it is presented the importance of CE philosophy in the integrated development process of medical devices. 

Understanding quality perception. The starting point of a CQP-based quality assurance system should be the clear understanding of which product attributes are considered important and contribute to the quality perceptions of target consumers. This will help focus the system to control and assure only those attributes that are critical for quality perception. Decision-supporting tools can be found in the areas of consumer research, sensory studies, and new product design. 

The selection of the preservative system for multiuse new products is the responsibility of the R D formulation group. Typical shelf specifications are 80 to 120% of label specifications. The appropriate preservative system for the particular formulation should be demonstrated to be effective by microbial challenge to at least 75% and preferably 50% of the target concentration. It is recommended that during development the product be formulated with preservative concentrations of 100, 75, and 50% of the labeled amount and be subjected to antimicrobial effectiveness testing to determine the lowest effective preservative concentration. 

In conclusion, it may be expected that further development of PK and PK/PD wiU contribute to the successful development of new drug targeting products. 

Evans FJ, Natural products as probes for new drug target identihcation, / EthnopharmacolilSl—lOl, 1991. 

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