Bioresorbable screws
“Scenario

In manufacturing medical devices, it is extremely important that processes are kept within specified limits to maintain product quality. Choosing the right process parameters and setting appropriate limits requires determining the relation between parameter setting and the quality of the product.

Suppose you work for a company that manufactures bioresorbable screws, made from a composite of hydroxy-apatite (HAP) and polylactic acid (PLLA). The screws will be manufactured using a process called injection moulding. Three process parameters that may decide the quality of the screw are temperature of the molten composite material (the “melt”), the injection speed of the melt into the mould and the pressure inside the mould.

You have to decide which of these factors, in isolation or in interaction, have an influence on the quality of the screws that are produced.

Assignment
Write a report of a maximum of 1000 words on the design (both experimental and statistical), power analysis and statistical procedures that you will use.

Marking criteria:

1. A reasoned discussion of how you intend to set up (or have set up) your experiment/observational series to take account of/minimise variation in your material, minimize experimental error in the method and take account of or eliminate confounding factors. (40%)

2. A reasoned discussion for choosing your sample size using Power Analysis where appropriate. (10%)

3. A reasoned discussion for choosing the appropriate statistical analysis/analyses indicating the advantages and disadvantages of that/those particular technique/s including its/their validity (eg if using a parametric test what must be checked to confirm validity). (40%)

4. Ability to convey the above information in a concise manner that shows understanding of the material. (10%)
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