A pediatric neurologist wants to know what type of animal testing might be needed for a device used to treat hydrocephalus, but lacks the resources and expertise to proceed to this phase of development.
In this scenario, the pediatric neurologist pursuing this need probably already used some crude works-like prototypes to show that the concept is feasible. This scenario falls into the pre-clinical stage of our process flow chart, which includes bench performance testing and animal performance testing.
The consortium will help guide the inventor to identify the least burdensome pathway to quickly move to the next stage of development.
- To determine the kind of animal testing needed, the first step is to identify the predicate devices.
- After identifying the predicated device(s), we will compare the technical characteristics of our invention to those current being marketed, and determine the required data needed to demonstrate substantial equivalence.
- Out consortium partner, MHRI/CRI has made their animal facilities available to any researcher who needs GLP or non-GLP animal studies on a fee-for-service basis.
- Our business team will also help develop a funding strategy to identify and obtain financial support the animal trial.