Manufacturing Review

Manufacturing Review

Outlining the key manufacturing steps

describing what the product might look like

In table 15Indicate the product manufacturing cost anf how they are driven

In Table 11List the key manufacturing requirements

In table 13List the expected costs for each of the key steps and the periods during which they will be incurred.

Outlining the overall manufacturing strategy

Estimate the product manufacturing cost

Listing the key manufacturing requirements

In tabel 10Outline the:1). Key features and likely appearance of the proposed product 2). The principle operating characteristics of any associated instrumentation.

In table 12Outline the key manufacturing steps

In table 14Outline the manufacturing startegy

•\tImportance of MR (Manufacturing review):Obviously the development of a suitable manufacturing process is of paramount importance –if you cannot cost effectively manufacture a product of suitable quality in suitable quantity when it is required then you have not got a business!•\tLimitations of MRHowever in some cases it might not be possible to formulate the manufacturing process until some of the product development has been completed. In such cases it is not possible to undertake a comprehensive review of Manufacturing Development to the same extent as that of Product Development.•\tOverall strategy of MREmploy a Contract Manufacturing Organisation (CRO).Even in such cases it is very prudent upfront to undertake your own review of manufacturing as far as possible and so develop as clear a picture as possible of the key issues and their dimensions. -In any case such an assessment would provide valuable information for use in any negotiations with prospective CROs!

Indicating the key resources that might be needed to develop the key steps