Design and manufacture of a multiple material sample for implantation testing of thermoplastic materials used in a medical device

Submissions to regulatory bodies for approval of medical devices must include the results of biological evaluation. This evaluation determines whether contact with the materials used in the medical device has any effect on the user. Implantation testing is one particular evaluation that involves implanting a sample into living tissue. This can be an expensive test and must be carried out for all relevant materials used in the device. Where the cost of testing each material individually is not justified, the combination of materials into a single test sample may be carried out. This paper reports on the design of a miniature implantation sample comprising three injection moulded thermoplastic materials and an adhesive. The samples were manufactured by conventional injection moulding and used in implantation testing. The method has been shown to be a viable alternative to individually testing each material and resulted in cost savings of approximately 28%. (c) 2005 Elsevier Ltd. All rights reserved.