MEDICAL | MATERIALS
delivery and renal care. In addition, for wearable devices, the design needs to appeal to the patient, but materials are in contact with the skin and therefore need to be evaluated for skin irritation. There will also be new challenges. For example, potential regulations restricting the use of certain chemical substances that require substitution with alternatives, such as phthalates currently and per-/ poly-fluoroalkyls in future. This is always a chal- lenge for the medical industry given the long evaluation and validation process. When developing new medical plastics grade,
Duckworth believes that the most important consideration is consistency and management of change. “Medical device and pharmaceutical companies typically spend two to five years in the development process, risk assessment and characterisation and evaluation of materials,” he says. “Once this is done, any change in the manu- facturing process, specification and ingredients has a profound effect on the risk and requires revalida- tion and perhaps re-submission to the regulatory authorities. The resin manufacturer or compounder needs to have change controls incorporated into daily routines and the quality management
Left: More and more medical grades are being devel- oped by a growing number of suppliers to meet the most pressing needs of the sector
process. Secondly, providing industry specific regu- latory documentation based on pre-testing and information on the ingredients used is helpful to the risk assessment process and assists the OEM design a suitable testing programme. The OEM is legally obliged to carry out evaluations on the final medical device, but not knowing what substances
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