Translational Neural Engineering- Hypothesis-based devices design

Zehra Morçimen

Prof. Bikson has shared with us an amazing diligence story with us. This was the story of a hypothesis turning into a product. Prof. Bikson has shown that the hypothesis is the key for translational neural engineering and the device is a physical manifestation of the hypothesis and gave us three meaningfully examples.

Translational neural engineering is end with medical devices which are designed to treat more neurological and psychiatric disorders. All this devices starts with a scientific hypothesis. And the way the hypothesis turns into a product tells us about translational engineering.

Scientific hypothesis come from translational research which is applying knowledge from basic biological research and clinical research to critical medical issues. It could be any levels about the cellular or behavioral mechanisms. After reaching the scientific hypothesis, trials are started to adapt it to real life. Preclinical research is the first step in this adaptation. Preclinical testing is a research phase in medical device development that begins before clinical trials and typically collects device safety data in laboratory animals or cell culture. Prof. Bikson has generated a hypothesis and completed preclinical research for Hd-Tdcs device during his doctoral studies.

Device design starts with the pre-clinical design and continues until the end of the project. One of the device design methods is model driven design. It uses to simulate the device before any experimental design steps and to support model precision. This method important because no one can build many versions of the device and test it. But computational modeling is very cheap to simulate a hundred of the design models. Computational model gave the optimum direct current stimulation to Prof.Bikson. As a result of this model, they created a new workflow and achieved the first computational pipeline for neuromodulation.

Following this, patenting, licensing and certification processes begin. These intellectual property and regulations necessary for commercialize the medical device. In addition, clinical trials are initiated.

All these steps are part of the product design. Product design important to reduce regulatory hurdles, reducing cost, simplifying set-up, and making it usable. The product should be easy to understand by the clinician. The clinician should be able to operate it without necessarily needing to be an expert in programming. One more important point for the product design, it does not have to be elegant from an engineering perspective, preferably it should be applicable and useful for the regulatory approach.

After Prof.Bikson received permission for human trials (cascading system), product design continued and the cap design continued to be changed. They created a unified design that records and simulates the signals. This is a step showing the importance of collaboration in translational medicine and it is the result of multidisciplinary studies.

Here we understand what is the translational neural engineering. It is a never-ending process and all step shows us how to modify and regenerate our product according to need.