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Chemist Researcher for Adhesive and Resolvable Electrolyte Gel Development

Periodic Reporting for period 1 - CREG (Chemist Researcher for Adhesive and Resolvable Electrolyte Gel Development)

Reporting period: 2017-09-01 to 2018-08-31

EEG (electroencephalography) is a well-established clinical diagnostic method and a valuable tool in neurocognitive research. Lately it is becoming increasingly important for applications like Brain-Computer-Interfaces (BCI), NeuroErgonomics and NeuroMarketing. These usages would be even more effective, if EEG would not be so delicate. A lot of working time is wasted in the established applications, and the development of the newer applications is heavily impaired by electrodes that fall off or lose contact to the skin, and by incomprehensive EEG data due to overlaying movement artefacts.

This situation could be cured very often by electrodes that are fixed to head or skin in an absolutely reliable way, in order to fully benefit of the EEG’s property to be a non-invasive, uncomplicated method to register brain activity as the basis of everybody’s behaviour. Our plan was to develop with the Innovation Associate such a reliable fixation method with chemical methods.

We, the German company Easycap GmbH, are experienced in manufacturing EEG electrodes and accessories for many different applications, including a high level of support, and therefore we can make sure, that a new product for this field will be user-centered and exactly fitting. In addition, we have the structure for subsequent certification, marketing, and sales to a widespread community.

With the help of the Innovation Associate, a chemist from the USA, Easycap has successfully developed a new, reliable electrolyte gel. Further, there have been validation and verification methods which have been improved to include qualitative results in combination with some new quantitative methods. This has allowed for a better analysis of whether the new design produces the outcomes which meet the needs of both Easycap and the end user. Additionally, there was benefit to Easycap and the Innovation Associate in terms of new patent ideas, prototypes and transferable skills gained by both parties during the project and the core training on industrial innovation management by the IMProve academy.

There still are some unmet goals within the 12-month-window of the project. This includes mainly some market entry activities as well as regulatory aspects. The product development process of medical devices is a long process as the requirements of the Medical Device Directive (MDD)/Medical Device Regulation (MDR) have to be followed if the product is to be sold on the European market. This process can´t be completed within a 12-month-project which as a main goal named the development of the innovative gel. The remaining goals of the project are expected to be completed by Easycap by 2020.
The work performed within the CREG project went for the most part as planned. With the support of Easycap the Innovation Associate was able to

• define the chemical goal,
• do the research for Intellectual Property Rights and the state of the art,
• phrase the final goal, consider regulatory requirements, define a budget,
• realize several prototypes and empirically test them,
• provide regulatory information and IP relevant input,
• do some ground work regarding sales and marketing related activities,
• refine the workplan according to previous experiences and insights from the IMProve seminars offered by the EU and
• fulfil the ethics requirements.

In sum, the collaboration with the Innovation Associate has been very fruitful for Easycap. The Innovation Associate has successfully done the work he was employed for and for which his chemical competence was needed. As we as manufacturer are responsible for the further development of the gel, including more detailed user and marketing tests, and the completion of the regulatory requirements, these tasks will be fulfilled although the Innovation Associate has returned to the USA for a new job.

Regarding the dissemination of results this will be done when the product will be placed on the market via website, press reports, user courses and partner networks
The current state of the art is comprised of typical electrolyte gels of varying viscosity or as thick EEG creams which retain water long term but are difficult and time consuming to use. The materials developed during the project pushed beyond the state of the art by providing a proof of concept and prototype for a new, reliable electrolyte gel with the potential to improve long term sleep EEG’s, reduce preparation and clean up times.

After having done some further evaluation and regulatory work Easycap will be able to offer an electrolytic gel which will improve data quality and could be implemented for any application where skin electrodes are used, in clinical/medical applications as well as in BCI, NeuroErgonomics, NeuroMarketing, sports, etc. That is to say that not only the research market but the consumer market could be addressed supporting amongst others the trend of lifelogging/self tracking. The addressing of these new markets would have a wide socio-economic impact and societal implications for Easycap and the whole society.
This picture shows the setting: EEG cap with electrodes.
This picture gives examples of what the new product looks like: syringes filled with gel.