Device Development – from Concept to Clinic
A device development institute in collaboration with clinical specialists have collaborated on the design of a novel and highly sophisticated implantable device to allow long term recordings of brain wave function in adults. Plunkett Consulting Group has been engaged to review the technology and evaluate a possible regulatory and clinical development pathway that would support local and international regulatory approval. In collaboration with clinical experts, our regulatory and clinical development teams proposed a strategy that would generate the appropriate data sought by regulatory Agencies in accordance with established international standards and guidelines. This included the development of an appropriate bench testing, biocompatibility evaluations and human clinical trials, all of which were presented in a detailed submission to the FDA. Through the establishment of a cross functional team, led by Plunkett Consulting Groups Managing Director, a comprehensive development strategy was established and ensured all engineering, clinical and regulatory requirements were effectively managed to support the realization of a great new technology.