Evaluation a concept given by a surgeon

Situation

A neurologist demonstrated in a laboratory setting that neuroma formation in severed nerves following amputation could be prevented. The approach guided nerve growth back into the nerve itself. Neuroma can cause significant pain. Therefore, the neurologist continuously sought a way to address this problem in his patients. However, he was unable to make further progress with the concept. To attract financial resources and develop the concept into a usable medical device, he first needed to demonstrate that the approach could work in a clinical setting.

Capabilities

The neurologist needed expertise to translate his idea into a functional model according to his specifications. The model needed to generate objective evidence that the final product could work in a clinical environment. He also needed expertise in combining specific manufacturing techniques and material science. This combination was required to create a functional system for testing the concept.

Solution

BAAT developed working medical device prototypes according to the neurologist’s specifications. In addition, BAAT developed a relevant test protocol with MDR and FDA requirements in mind. The protocol was designed to generate the objective evidence needed to support the concept. It provided a structured approach for evaluating the prototype and its intended function. As a result, approval was obtained to conduct an animal study to evaluate the concept.

Result

The neurologist performed the procedure on rats using the medical device prototypes provided by BAAT. He followed the test protocol developed by BAAT. As a result, he evaluated the feasibility of the concept using objective evidence. This allowed him to make a Go/No-Go decision based on facts. The project demonstrates how medical device development can turn an innovative clinical concept into a testable solution. By combining prototyping, manufacturing expertise, material science and structured testing, BAAT helped create the evidence needed for the next development decision.