Preclinical animal testing is used to give reasonable data prior to early feasibility testing in people and human clinical trials in order to show that new technologies and therapies are safe and effective. During the nonclinical phase, animal models can help support and develop medical product development. Animal models that are well-designed can solve regulatory safety issues and provide further de-risking during product validation. Animal models can be used to evaluate minimum viable products and prototypes, which can help with quality assurance and compliance. To avoid superfluous preclinical research, a roadmap for product innovation strategies (regulatory, reimbursement) must be developed. Preclinical animal model safety and efficacy data are an important aspect of medical device development and are required to make these judgments. Before moving on to costly human trials, this can assist evaluate if the gadget is effectively tackling an actual need. Academic centers, which are generally based in linked veterinary medicine schools, provide unique resources that might help academic entrepreneurs fill this preclinical need.
Title : Electroactive polymer-based smart scaffolds for tissue engineering and regenerative medicine
Federico Carpi, University of Florence, Italy