Opto is a UK-based medical device SME with a core project team of Dr Ben Woodington (CEO), Dr Elise Jenkins (Project Lead/CTO) and Jose Lepe (Product Lead). Electrical monitoring devices are crucial for managing neurological diseases such as brain cancer, epilepsy, and Parkinson's disease. These conditions affect around 105K people annually in the UK alone. Unfortunately, current technologies have made little headway with remote treatment, as they are invasive, uncomfortable and require hospital monitoring, which limits their use to short periods and restricts at-home use. This is problematic for two reasons. First, managing these diseases costs the NHS over £2B per year, and patients lose around £3B in productivity due to ongoing assessments. Secondly, infrequent, inconsistent 'snapshot' assessments of neurological health do not provide the full benefits of the technology, which could help guide treatment, inform disease progression and provide advance warning to patients. People who do not live near major hospitals with advanced facilities (~20 % of UK residents) and lower-income groups who lack the means to travel for treatment regularly are disproportionately affected by this. Opto has developed a minimally invasive, active medical technology platform that enables remote neurological monitoring of brain cancer patients to aid disease treatment and management. This innovation will improve the quality of life of patients suffering from neurological diseases, starting with brain cancer.

Neurotechnology refers to a broad range of devices which can directly record and/or modulate the activity of the nervous system. These devices can either be implanted into the brain or nervous system (invasive) or placed on the surface of the skin (non-invasive). Neurotechnologies have been used, and are in development for, many different purposes, both medical and non-medical. Examples of medical uses include 'Deep Brain Stimulators' or 'Brain-Computer Interfaces' for injuries or diseases that effect movement. An example of a non-medical use is for gaming. Neurotechnologies for all use cases are developing rapidly and have the potential to offer enormous benefit to people. Because of this more must be done to ensure that people who would benefit from such devices have timely and safe access to them. To achieve the safe, efficient, and ethical translation of neurotechnologies from innovators to the clinic, and public, there is a consensus amongst UK regulators and innovators in academia and industry that new regulatory practices in neurotechnology are needed. In support of this reform, the UK government commissioned a report produced by the Regulatory Horizons Council (RHC) which made recommendations for stakeholders in this area. This proposal is in response to the report. Our network will establish a community of public, academic, government, and industry advisors and act to implement key recommendations from the RHC Neurotechnology Regulation report.