Medical product design testing

With a medical product designed, it must be tested thoroughly, not just to verify its efficacy and safety, but to assure that it has those characteristics that embody a successful product. There are strategies for managing the prototyping and testing process in ways that enhance the product s likelihood of success. 

A problem had arisen with molded parts from a medical products company. Some injection-molded sheets were exhibiting small translucent areas (gels) within the opaque polymeric material, which had been designated as non-melt areas. One theory for the source of the non-melt was that a contaminant was present, while another postulate was that these areas represented a cold slug coming from the sprue. One sheet was chosen for analysis since the area of non-melt within it was largest. Both the non-melt area as well as a "normal" area were tested. 

It is not known what quality checks were in place with the device, or what tests had been performed before introduction to the market. The facts suggest weaknesses in product design and manufacture," a conclusion supported by evidence from the largest market for medical devices, the USA. 

Concern about the effect of certain plasticizers on human health, particularly the carcinogenic and oestrogenic effects, has been expressed from some quarters and there has been extensive study and testing to establish the facts. The products particularly under scrutiny have been PVC compounds for medical products and baby- and infant-care products, especially those designed to be put in the mouth. DEHP, which is particularly suitable for medical products, has been most under examination. 

Formulation Development. The formulation of the new drug product will be designed in conjunction with medical and marketing input. Excipients to be used will be tested for chemical and physical compatibility with the drug substance. The preliminary formulation design will be optimized at this stage. 

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