If A Single Neuron Fires in the Brain, Will Anyone See It?

By Sam Brusco for Medical Design Technology magazine

Let me introduce Andy Gotshalk, CEO of Blackrock NeuroMed. With almost 20 years of experience in the medical device industry, Gotshalk began as a field service engineer, rising through the ranks to become the Sales/Operation manager for the US Surgical Business. After transitioning to the neuroscience field, Gotshalk was named CEO of Blackrock Microsystems in 2006. Blackrock NeuroMed was launched in January of 2012, where Gotshalk has been CEO since the company’s beginning.

Blackrock NeuroMed is pioneering innovations in EEG monitoring software with its Cervello device, an integrated system that provides long-term monitoring, clinical recording, and ambulatory monitoring capabilities. The company aspires to provide proven cutting-edge research technology to the clinical epilepsy market. As Gotshalk puts it: “It is a real unmet need in this market and I believe it is this type of technology that will be critical to improving patient outcomes in the future. Neuromed aims to become the epilepsy company of the future, providing improved diagnosis tools today and new treatments tomorrow.”

Andy Gotshalk is the CEO of Blackrock Neuromed and Blackrock Microsystems.

How is the Cervello system a departure from already existing EEG monitoring software?

Gotshalk: The significant difference with the Cervello Elite system is that it allows clinicians access to a whole new data set and gives them the ability to monitor the signals from individual neurons at the same time as they are looking at the traditional EEG. It is the only system on the market that has this capability.

Why did you feel the need to introduce real-time EEG monitoring?

Gotshalk: It’s not as much the real time capability as it is the additional data that we are presenting in real time. We are now giving the clinicians access to higher resolution data and more information than they have seen with the traditional EEG. An analogy I like to use is to compare the brain to a forest and with traditional EEG you can get a sense of what is happening in a section of the forest (tens of thousands of neurons). With the Cervello Elite you can now monitor what is happening within a single tree (or single neuron) and how signals are propagating from one neuron to the next.

The Cervello EEG/LTM System

What can healthcare professionals learn from the analysis of data received from the Cervello system?

Gotshalk: In epilepsy, for example, they will have much better data to determine where seizures are coming from and how they are propagating across the brain. We also believe they will be able to identify when seizures are starting and where they are starting from much more accurately. This is just one example and only the tip of the iceberg. With this type of data clinicians will be able to get a much better understanding of many other neurodegenerative diseases.

Are there any other possible medical application areas for the software apart from EEG monitoring?

Gotshalk: Right now we are focusing on the brain and the central nervous system, but we have had researchers approach us that are interested in using this type of technology for cardiac applications. We are still in the early stages understanding the implications here.

What development challenges did you encounter with Cervello technology?

Gotshalk: The biggest issue we encountered was figuring out how to process all this data on one system and still be able to give the clinicians the standard format for the data that they are used to looking at so it wouldn’t interrupt their existing workflows.

Were there regulatory obstacles of note that you could share? (How were they addressed?)

Gotshalk: There are always regulatory issues when it comes to medical devices, but with an experienced team and well qualified regulatory personnel the obstacles aren’t too big. The biggest challenge for us was making sure we could clearly define the different predicate devices that were equivalent to the device we were putting on the market.

What will clinicians find valuable about the integrated software?

Gotshalk: They will now be able to access all of the clinical data and the new research data from the same place with the click of a button. It will make the process of doing this ground breaking clinical research much easier and faster for everyone involved.

What actions is NeuroMed taking to help ensure clinicians embrace the software?

Gotshalk: We recognize this is new technology and how difficult it can be for clinicians to embrace something new so we are pushing forward a little more slowly than we might normally do. We are also making sure that the clinicians and the team feel very comfortable with the routine (standard) systems prior to launching the fully integrated product. We have an experienced support team that is vital for the training and ongoing support during the initial startup phase.

What’s the next step for EEG monitoring technology?

Gotshalk: Without a crystal ball this is a difficult question to answer. There are trends visible in the research space that can provide some insight into where the clinical space is heading. Firstly, we may see the convergence of various methods of accessing neural data (fmri, ecog and penetrating electrodes). In terms of diagnosis, the combination of different methods should provide a better picture of what is really happening and how things are connected. Secondly, we may see an increased need for implantable devices that allow chronic data analysis to happen. This would save costs on the hospital side while providing patients with enhanced flexibility. Following on from this would be devices that could also treat epilepsy through stimulation or other means.