Analytical Medical Device Development and Failure Testing Strategies

Deena Conrad-Vlasak, Business Development

Many of today’s medical devices use polymeric material to take advantage of the light weight, durability, and tunable flexibility. However, influences such as light, heat, oxygen, corrosive materials, and sterilization processes can lead to degradation of these materials and possible device failure. Additives can be incorporated to add clarity, color, mechanical properties, and inhibit degradation, but these additives can increase the complexity of the formulations and introduce the risk of unwanted leaching. It is well documented that leaching may pose a safety risk to the patient and has the potential to interfere with the efficacy of active ingredients. 

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