The Government is Here to Help
by James Cavuoto, editor
It’s fashionable these days for business leaders to decry the role of government in their industry, and to be sure, there are many in the neurotechnology industry who could point to seemingly senseless regulatory decisions and policies that have been harmful to growth. But there can be no denying that the U.S. neurotechnology industry has also been the recipient of government largess over the years, when you consider the amount of funding that has been available from agencies such as the NIH, DARPA, and the VA.
Another new government-funded initiative comes from the Air Force Research Labs, which recently funded a Nano-Bio Materials Consortium in partnership with the microchip industry group SEMI. The $4.5 million program is seeking proposals in five areas: wearable/bio-signal processing; wearable integrated sensing and edge computing; human health protection and safety, dermal, transdermal, and subcutaneous sensors; and e-textile-based sensors for real-time monitoring.
The consortium is exploring novel approaches to enhance performance augmentation, decision-making capabilities and accuracy. This is crucial to the Department of Defense’s mobility resources, as Air Mobility Command is responsible for the strategic military medical evacuation of patients and the optimal performance of their pilots and ground-based warfighters.
Meanwhile, the NIH BRAIN Initiative, launched in 2013, has been the gift that keeps on giving. The $4.8 million provided to Georgia Tech and Emory for the Center for Advanced Motor BioEngineering and Research [see article p16] is a recent example of funding coming from that initiative.
The NIH does more than just fund programs though. Last month, John Ngai, director of the BRAIN Initiative, participated in a briefing with the Congressional Neuroscience Caucus that successfully showcased the transformative discoveries funded by the initiative. He emphasized that we are at the cusp of incredible breakthroughs in our understanding of the human brain and changing the course of history by pushing forward an ambitious research agenda. Ngai spoke about treatments that have so-far been developed based on BRAIN Initiative research, along with the long-term vision for more discoveries, in order to build the next generation of treatments, cures, and perhaps even preventions.
And while some neurotech vendors still have concerns about FDA regulation of their industry, a new draft guidance from the agency’s Center for Devices and Radiological Health related to opioid use disorder does offer some clarity to neuromodulation firms seeking regulatory approval of new addition therapies. Dan Powell, CEO of Spark Biomedical, recognizes the value of meaningful standards for clinical trials. “There’s a lot of snake oil in this industry and I think this document is setting the expectation that they won’t let loose open-label type studies through,” he said in an interview with NBR. “This is a really difficult disease to treat. It’s the only disease that convinces people they aren’t sick.”
While other countries in Europe and the Asia/Pacific region have also recognized the value of funding neurotechnology and adopting sensible regulatory procedures for the industry, we believe that the funding and regulatory climate for neurotechnology in the U.S. is a step ahead of the rest of the world. Maybe that’s why so many overseas firms are choosing to commercialize here first, in contrast with the situation 10 years ago.