Bringing an implantable device to market has unique challenges and faces stricter requirements due to their risk classification in comparison to lower risk class devices. Implantable devices by nature have an invasive and permanent contact with the user, due to this the risk to the patient is increased and hence implantable devices face the most rigorous implementation of the essential requirements.
Medidee can give advice and assist in all aspects for the development, verification and validation for implantable devices, throughout the device cycle.
Process development and validation for implantable devices often involves subcontractors. In manufacturing increased control of variable factors is expected to be applied, to ensure the strict quality needed for such devices, both to control physically aspects of the device to ensure performance, as well as inline and final lot release, chemical and biological based quality controls on the device, to assure a low bioburden and level of contaminants. In order to achieve this, these requirements have to be anticipated during the development of implantable devices. Critical areas and parameters of control should be identified, and a quality control plan put in place, which includes control of sub-contractors.
During pre-clinical activities, testing must take into account the nature and duration of contact with the patient. For example, during biocompatibility testing the potential for systemic and local tissue effects should be assessed, in addition, various physio-chemical tests should be carried out on exhaustively extracted extracts of the device, in order to assess the toxic potential of chemicals which may be released during the life time of the device.
Pre-clinical testing must be completed on final finished devices, which are manufactured, cleaned, packaged and sterilized via a stable and validated process.
Clinical performance and safety demonstration for an implantable device, can often mean that a clinical investigation needs to be considered, designed and planned. With the incoming Medical Device Regulations, it will become increasingly difficult to bring implantable devices to market without clinical validation.