Interview: How is Neural Stimulation Technology Improving Lives?

Together with Lawrence Livermore National Laboratory, Boston Scientific, UCLA, and UCSF, HTEC Group is working on the SUBNETS project. Working on a system that will be implanted in the human brain to improve people’s lives and help treat neuropsychological illnesses is very important and exciting work, and we were especially pleased to talk to Dejan Markovic about this amazing project.

Interview with Dejan Markovic, Professor at UCLA, DARPA SUBNETS project

The SUBNETS project aims to address severe neuropsychiatric disorders by using state-of-the-art neurotechnology to restore healthy brain function. However, the brain is very different from all other organs because of its networking and adaptability. Therefore, the system Dejan’s team developed is not static. The system his team is working on adjusts to brain activity, which is quite revolutionary. The main advantage of this system is that it is designed to be an entirely implantable DBS (Deep Brain Stimulation) system with real-time feedback signaling, where processing of neural activity and stimulation control is done onboard the device.

So let’s open up the topic. The SUBNETS project is looking for ways to characterize which brain regions come into play for different indications, focusing on functional brain networks. How do the technologies developed under the project enable that?

We are looking at neural networks of the human brain. Our implant uses small, high-density electrode arrays for neural sensing and stimulation. Miniaturized electronics (roughly the size of a vitamin pill) are embedded with the arrays. The system also has a data hub for modular, customized configuration, and embedded algorithms for real-time personalized treatment. These features make it far superior to existing technologies. It’s like navigating with a GPS rather than a paper map.

How do you expect that this approach would be different from what is currently possible? How might it address the lack of understanding of how mental illness specifically manifests in the brain? And why could it potentially be more effective than other existing treatment options?

This device would be the first implant to offer true closed-loop treatment, using 256 contacts for precise mapping of network-level brain function. This is light years ahead of existing devices that use up to 16 (typically 4), contacts. Our technology will provide a street-level view, in contrast to the old continent-level map of the brain.

How are you taking into account that the brain itself changes?

Our design adapts stimulation to the brain’s activity. This means the ability to stimulate multiple brain locations, but also use live neural sensing to intelligently and automatically self-adjust to optimize therapy and minimize side effects.

What steps are needed for the validation of this solution?

We need to perform a wide range of pre-clinical tests that include functional, biocompatibility, sterility, and animal tests for safety, and get an FDA clearance before we can use the device in human clinical trials. All the development so far is a significant de-risking of technology, which is exactly the space DARPA works in.

The system is in development now. However, after the validation, during first-in-human tests, what would be next steps to eventually commercialize this technology?

The early human studies would have to show great results. The prototype technology would need some revisions, a commercial iteration if you will, to make it better optimized for chronic use cases.

Commercialization of the developed technology is a complex topic and it requires serious financing. What is your experience up to now? How do today’s VC investors look upon these types of projects, considering the time required for development, validation, and commercialization?

These are projects with a long time horizon, as you pointed out, so getting VC funding at this early stage is difficult. VCs usually like to see the FDA approve an Investigational Device Exemption, which means technology has approval for human trials. All the development so far is a significant de-risking of technology, which is exactly the space DARPA works in, and that makes the demonstrated technology more attractive for future consideration.

What are the main challenges you are facing on this project, from the technology side and the business side as well?

We are pushing three major frontiers: clinical (everything starts and ends in the clinic), technical, and regulatory. Each has its own unique challenges. We have a fantastic team that sets us apart and we like to think of challenges in an opportunistic way. We are working closely and productively with regulatory bodies.

What would be your message, for engineers or tech managers who are facing similar challenges on their projects? Which you find very important to share?

Maintain a systems-oriented focus, follow your passion and have fun.

 

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